IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
INTEGRATED APPLICATION FOR
INSTITUTIONAL REVIEW BOARD (IRB) &
THE INSTITUTE OF TRANSLATIONAL HEALTH SCIENCES CLINICAL RESEARCH
CENTER NETWORK (ITHS CRCN) AND AFFILIATED RESOURCES
*Fill in header information. Note: Version Date in header refers to version date of this
application, not to version dates of protocols or any other document.
Key:
(Text highlighted throughout supplement are hyperlinks to these types of information)
Investigator Help (includes background information and/or sample answers)
Federal Regulations
Seattle Children’s Policy
Type in text (as appropriate)
Instructions:
 MINIMUM REQUIREMENTS for new study submissions to the IRB using this form (for
studies that do not qualify for other IRB forms):
o This IRB-ITHS CRCN Application;
o Applicable Supplements* (if any) to this Application available on the IRB Web site;
and
o Local Implementation Plan available on the IRB Web site.
Sample Answers (embedded in Investigator Help links): Please keep in mind that the
sample answers are meant to be helpful examples of answers. They are not intended as the
only acceptable answers. Research teams are encouraged to provide their own answers that
may indeed differ from the sample answers provided; answers should include all of the
information asked for in the actual question.
1. Preliminary Information
1.1. Have you had a consultation with a HSPP Analyst about this application?
Yes  Provide Analyst’s full name:
No
1.2. If the review of this application is time-sensitive for any reason, please explain
below:
Funding  Explain:
Potential participant waiting to enroll in this therapeutic study  Explain:
Other  Explain (e.g., vaccine trial needs to begin prior to flu season):
1.3. Has this research project received prior review by any other groups/committees
(e.g., National Institutes of Health study sections, Scientific Review Committees,
etc.)?
Yes  Provide names of groups/committees & nature of reviews:
IRB – ITHS Application (long) 4.3.15
Page 1 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
No
1.4. Do you have the ability to make changes to this project’s protocol?
Yes
No  Explain why:
1.5. Is this application associated with any other IRB-approved studies (e.g., is this
application the next part/phase of a previously-approved application)?
Yes  List IRB #(s):
and PI name(s):
No
2. Responsibility for Study Conduct
Principal Investigator Assurance: As Principal Investigator, I affirm that:
 I will supervise and accept responsibility for the conduct of this research.
 I accept responsibility for the safety of the human participants taking part in this research.
 I certify that all information submitted as part of this application is accurate, complete and
true to the best of my knowledge.
 I confirm that I will report any serious or unanticipated problems, adverse effects or
protocol deviations to the IRB in a timely manner.
 I will ensure every participant meets eligibility criteria.
 I acknowledge that no changes will be put into effect without prior approval from the IRB
except when necessary to eliminate apparent immediate hazards to research
participants.
 I will renew this application with the IRB as directed but no less than annually.
 I will conduct the research project in compliance with the IRB conditions of approval.
 I will provide all of the information about the research project necessary for complete
review by the IRB.
 All investigators and research team members as outlined in the IRB-ITHS CRCN
application and protocol have completed acceptable training in Human Subjects
Protection (see IRB Policy-017 “Investigator and Research Team Member Training in the
Protection of Human Subjects” regarding acceptable training).
 All investigators and research team members as outlined in the IRB-ITHS CRCN
application and protocol have submitted the required Significant Financial Interest (SFI)
Disclosures to the Office of Research Compliance.No research participants will be
involved, recruited or enrolled or their private records reviewed until the research
receives final approval from the IRB.
Principal Investigator Attestation: In lieu of my signature, by virtue of submission of this
application from my e-mail account, I attest to my intention to apply for IRB approval as well
as to the accuracy and completeness of the statements contained herein. I further attest to
the fact that I understand and accept the responsibilities conveyed to me as a Principal
Investigator.
In addition, by virtue of submission of this application, I attest to the fact that I have informed
and obtained approval from the appropriate institutional officials (i.e., Division Director,
Department Chairperson, Children’s Executive Administrator, Faculty Sponsor for Students
IRB – ITHS Application (long) 4.3.15
Page 2 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
and Trainees) for this research.
__________________________________________________________________________
PI Signature (Optional signature if submitted from PI’s email account or if PI copied on email
Date
3. IRB Approval
IRB Approval
__________________________________________________________________________
IRB Chairperson’s Signature
Date
IRB Decision:
Approve
Disapprove
Subject to the Following Conditions: __________________________________________
__________________________________________________________________________
__________________________________________________________________________
Conditions met on: _________________________________________________________
Period of Approval: From: __________________ Through: _____________________
VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED.
4. Research Center Membership
The Seattle Children’s IRB will review only those applications that are programmatically led by a
Research Center Member and are being submitted with the approval of the appropriate
Research Center authority or are otherwise allowable under Institutional Research Institute
Administration (RIA) Policy-801.
Seattle Children’s Policy: See Institutional RIA Policy-801 “Research Center Membership
Requirements to Obtain Research Support Services Department Support”.
Investigator Help: Individuals who are not yet members of a Research Center, but are seeking
to join a Research Center should follow the information available on the Research Web site at:
http://www.seattlechildrens.org/research/centers/membership/ and work with the Center Director
and the Center Business Manager to obtain center membership prior to submission of an IRB
application.
4.1. PI’s Research Center(s):
Ben Towne Center for Childhood Cancer Research
Center for Child Health, Behavior and Development
Center for Global Infectious Disease Research
Center for Clinical and Translational Research
Center for Developmental Biology and Regenerative Medicine
IRB – ITHS Application (long) 4.3.15
Page 3 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Center for Developmental Therapeutics
Center for Genetics and Development
Center for Immunity and Immunotherapies
Center for Integrative Brain Research
4.2. If the PI is not a Research Center member, then please list the name of a CoInvestigator who is and indicate their Research Center below:
Ben Towne Center for Childhood Cancer Research
Center for Child Health, Behavior and Development
Center for Global Infectious Disease Research
Center for Clinical and Translational Research
Center for Developmental Biology and Regenerative Medicine
Center for Developmental Therapeutics
Center for Genetics and Development
Center for Immunity and Immunotherapies
Center for Integrative Brain Research
5. Contact Person for IRB Administrative Purposes
The PI may designate a contact person for IRB administrative purposes. The contact person
does NOT have signatory authority by virtue of being listed as a contact, but will be copied on
IRB correspondence (including IRB approvals and renewal reminders). The PI is responsible
for keeping the IRB informed of changes to the contact person.
5.1. Please list the contact person’s information in the table below:
Name &
Degree
Role in
Research
(e.g.
Research
Coordinator)
Department/
Division
Phone
Mail Stop/
Address
Email
6. Research Team Members
6.1. Complete the table below for each person who:
 Shares responsibility for the design, conduct, or reporting of this research; and
 Will be covered by Seattle Children’s IRB review (including via a cooperative
agreement); and
 Is not CRCN staff or pharmacy staff (as there is a general exclusion from research
team member definition for these staff members).
The table must include each research team member.
Please pay special attention to the information contained in the footnotes to this table.
IRB – ITHS Application (long) 4.3.15
Page 4 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Principal Investigator Name & Degree (Last, First, Degree)
Role in Research Project
(e.g., PI, Research
Coordinator)
Principal Investigator
Human Subjects
Protection Training (date,
location, type of
training)1:
School/Department/Division (e.g.,
School of
Medicine/Pediatrics/Nephrology):
Phone & Pager:
I am an employee of Seattle Children’s2:
Yes
No  See NEAT info2
I have medical staff privileges at Seattle
Children’s Hospital4:
Yes
No  Why not needed?
Email:
Position/Title
(e.g., Associate
Professor, Nurse
Practitioner):
Mailstop /
Address:
I am a member of Seattle Children’s
workforce3:
Yes
No
I will be obtaining consent from
participants.
Yes
No
Significant Financial Interest (SFI)5
I DO NOT have SFI that may be related to this research, its products or its sponsor
and I affirm my SFI Disclosure on file with the Office of Research Compliance (ORC) is
up to date.
I HAVE the following SFI that may be related to this research, its products or its
sponsor:
Compensation
Equity
Intellectual Property
Sponsored/Reimbursed Travel
and I affirm my SFI Disclosure on file with the ORC is up to date.
Is a Management Plan in place for this SFI?
No
Yes - please submit the plan to the IRB. Clearance Memos do not need to be
reviewed.
Name & Degree (Last, First, Degree)
Role in Research Project
(e.g., PI, Research
Coordinator)
School/Department/Division (e.g.,
School of
Medicine/Pediatrics/Nephrology):
IRB – ITHS Application (long) 4.3.15
Position/Title
(e.g., Associate
Professor, Nurse
Practitioner):
Page 5 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Human Subjects
Protection Training (date,
location, type of
training)1:
Phone & Pager:
I am an employee of Seattle Children’s2:
Yes
No  See NEAT info2
I have medical staff privileges at Seattle
Children’s Hospital4:
Yes
No  Why not needed?
Email:
Mailstop /
Address:
I am a member of Seattle Children’s
workforce3:
Yes
No
I will be obtaining consent from
participants.
Yes
No
SFI5
I DO NOT have SFI that may be related to this research, its products or its sponsor
and I affirm my SFI Disclosure on file with the Office of Research Compliance (ORC) is
up to date.
I HAVE the following SFI that may be related to this research, its products or its
sponsor:
Compensation
Equity
Intellectual Property
Sponsored/Reimbursed Travel
and I affirm my SFI Disclosure on file with the ORC is up to date.
Is a Management Plan in place for this SFI?
No
Yes - please submit the plan to the IRB. Clearance Memos do not need to be
reviewed.
1
Human Subjects Protection (HSP) Training
Provide the date, location, and type of training (e.g. Web-based training or in-person
workshop). All study team members are required to have HSP Training that includes a pediatric
component. Research team members should not be listed here nor be allowed to begin human
participants’ research unless they have already completed HSP training. They should instead
be added to the study via modification after they have completed training.
Seattle Children’s Policy: See IRB Policy IRB-017 “Investigator and Research Team Member
Training in the Protection of Human Participants”.
Employee of Seattle Children’s
Please indicate the employment status of each research team member with regard to Seattle
Children’s. The most common indication of employment is that one receives a paycheck from
Seattle Children’s. Note: If a research team member is not an employee of Seattle Children’s,
they should consult the information available as they may need to complete the Non-Employee
Action Tracking (NEAT) process.
2
Member of Seattle Children’s Workforce
Please indicate whether each research team member is a member of Seattle Children’s
workforce, which is defined as: employees of Seattle Children’s, Children’s University Medical
Group (CUMG) members, and residents and fellows working at Seattle Children’s. This
information most often impacts duties to track disclosures of Protected Health Information (PHI)
3
IRB – ITHS Application (long) 4.3.15
Page 6 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
under the Health Insurance Portability and Accountability Act (HIPAA). See section 20: HIPAA
Issues below.
4
Medical Staff Privileges
Research team members that will have direct patient/participant contact often (but not always)
need to have medical staff privileges. This requirement is based upon the research team
member’s role in the research. Please provide an answer regarding each research team
member’s medical staff privileges, including why they do not need privileges for this project if
applicable.
Seattle Children’s Policy: For additional information, see
http://www.seattlechildrens.org/healthcare-professionals/medical-staff/.
5
SFI
Each member of the research team must indicate whether or not they have a “significant
financial interest” that may be related to the research and affirm that they have an up to date
SFI disclosure on file with the ORC. For information on how to submit SFI disclosures or
updates, please visit the Office of Research Compliance web page on CHILD or
seattlechildrens.org
Investigator Help: This information is needed for each study because a research team
member may have interest(s) related to one study but not related to others. Further, this
information is needed at the time of IRB review because it can carry implications for the
informed consent process and documentation.
Seattle Children’s Policy: See Institutional Policy ORC-003 “Financial Conflicts of Interest”
Federal Regulations:
 NIH Web page on conflicts of interest: http://grants1.nih.gov/grants/policy/coi/index.htm
 42 CFR 50, Subpart F (grants) and 42 CFR 94: http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&sid=fa4cc8a225c1ac961e129922db412bc5&rgn=div6&view=text&node=42:1
.0.1.4.21.6&idno=42 http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf
 National Science Foundation FAQ page:
http://www.nsf.gov/publications/pub_summ.jsp?ods_key=faqinfin
 Washington State – Ethics in Public Service:
http://apps.leg.wa.gov/RCW/default.aspx?cite=42.52
7. Research Within Seattle Children’s Clinics/Departments
7.1. Will any of the activities taking place for research purposes (as opposed to
standard of care (SOC) purposes), including recruitment, consenting, or
interventions, take place at a Seattle Children’s clinic/department outside of the PI’s
clinic/department or the PCRC?
Yes  List the other Seattle Children’s clinics/departments involved:
No
IRB – ITHS Application (long) 4.3.15
Page 7 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
8. Research Sites Outside of Seattle Children’s
8.1
Will any of the activities taking place for research purposes (as opposed to SOC
purposes), including recruitment, consenting, or interventions, take place at an
institution/location outside of Seattle Children’s? This question should be
answered regardless of whether such activities will involve Seattle Children’s
participants and regardless of the size or nature of the outside institution/location
(can include community clinics, schools, etc.)
Yes  List the institutions/locations involved:
No
Note: For each institution/location EXTERNAL to Seattle Children’s that is listed above, attach
a Letter of Support from the EXTERNAL institution/location. Emails regarding support are
acceptable.
Investigator Help: The IRB asks for this information to help ensure the feasibility and
appropriate resourcing for the safe conduct of the research.
The Letter of Support must include:
 The study title;
 A statement that the institution/location is aware of the research project;
 A statement that the involvement of the institution/location in the research is
supported; and
 Apparent authority of the person writing the letter to support the involvement of the
institution/location.
8.2
Is this study part of a multi-center research project?
Yes  Answer question 8.2.1
No  Skip to section 9: Research Resources & Facilities.
8.2.1 Is Seattle Children’s the coordinating center for this multi-center research
project?
Yes  Complete and attach the Coordinating Centers Supplement to this
application. Proceed to questions 8.3 and 8.4.
No  We are one performance site in a larger multi-center trial. Please
identify which institution is serving as the Coordinating Center and Skip to
section 9: Research Resources & Facilities:
Investigator Help: Coordinating Center: an institution, department, or center that
agrees to be responsible for the conduct or administrative/coordinating functions of
a Multi-Center Study.
8.3
Seattle Children’s IRB needs information about the extent of the involvement of other sites
to determine if it rises to the level of “engagement” in the research. To help the IRB
determine whether other sites are “engaged” in the research, please indicate if any
employee/agent of another institution/entity will do any of the following activities at
an institution/location outside of Seattle Children’s:
Obtain* information/data about individuals by intervening or interacting with them for
research purposes.
IRB – ITHS Application (long) 4.3.15
Page 8 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Obtain identifiable private information about individuals from any source (even if
already in the employee/agent’s possession) for research purposes.
Obtain informed consent of individuals for research purposes.
Obtain a direct funding award for research purposes.
*Note: “Obtain” is defined as the “use, study, or analysis” in federal regulatory guidance
(see cite below) and so it matters what will be taking place at the external sites in
determining whether they are or are not “engaged” in the research.
If any of the above research activities are performed by agents/employees of an
institution/entity, it is likely that institution/entity is “engaged” in human
participants research. Most institutions engaged in human participants research
must submit a written promise to comply with federal research regulations. This
document is called a “Federalwide Assurance” (FWA). They will also need to have
IRB approval in place for the research activity.
If you have any questions about whether other institutions are “engaged” in the research,
please contact the HSPP office for a consultation with an analyst. Because this area
involves complex issues (referenced in the federal regulatory guidance cited immediately
below), it is highly recommended that you contact the HSPP office for a consultation. To
request a consultation, please fill out the consultation request form and submit it to the
irb@seattlechildrens.org.
Federal Regulations:
Office of Human Research Protections (OHRP) Guidance:
http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html
OHRP’s Frequently Asked Questions: http://www.hhs.gov/ohrp/FWAfaq.html
Seattle Children’s Policy: See IRB Policy-016 “Engagement in Non-Exempt Human
Subjects Research Activities”.
8.4
List the “Engaged” institutions (other than Seattle Children’s) and their FWA
numbers below. Also list whether the institution wants to rely upon Seattle
Children’s for IRB review, or if they will conduct their own IRB review.
Investigator Help:
 If an institution that is “engaged” in research does not have an FWA of its own, the
institution can obtain one from OHRP, or it may ask to rely on Seattle Children’s FWA.
 You can search the OHRP Web site for institutions that have FWAs on file:
http://ohrp.cit.nih.gov/search/ (it may be easiest to search by city).
Engaged Institution:
FWA Number:
IRB – ITHS Application (long) 4.3.15
Institution wants to
rely on SCH IRB
(Yes/No):
Institution will
conduct their own
IRB review
(provide name of
IRB):
Page 9 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Investigator Help:
 For each site listed above, attach a Letter of Support from the site. Emails regarding
support are acceptable.
The Letter of Support must include:
o The study title;
o A statement that the site is aware of the research project;
o A statement that the involvement of the site in the research is supported; and
o Apparent authority of the person writing the letter to support the involvement of the
site.
Note: Each person from the “engaged” sites that want to rely upon Seattle Children’s IRB
review who will share responsibility for the design, conduct, or reporting of this research, will
need to be listed as Research Team Members above. This means all information requested of
Research Team Members in that section (including SFI information and signatures) will have to
be provided for these persons as well.
Investigator Help: Why does the IRB need this information? Because if there is reliance upon
Seattle Children’s IRB by such sites, then Seattle Children’s IRB bears responsibility to ensure
regulatory and policy requirements are met for these individuals just as they need to be for
Seattle Children’s research team members.
9. Research Resources & Facilities
9.1. Are you using resources of the ITHS CRCN?
Yes  Complete the ITHS CRCN Services Supplement and then submit the
supplement directly to the CRCN along with any other documents required by the
CRCN.
No
10. Funding Sources for the Research Project
Federal Regulations: Institutions must certify that the activities contained in funding
documents have been reviewed and approved by the IRB. 45 CFR 46.103
Federal regulations require that the IRB review the actual application or proposal for HHS
support. The IRB’s review should ensure that all research described in the funding application
or proposal is entirely consistent with any corresponding protocol(s) submitted to the IRB.
10.1. Provide information for all funding sources (grants, contracts, etc) in the table
below whether awarded or pending, that support the research activities described in
this application. If there is more than one funding source, then copy the table and
make a separate table for each funding source. If any question below is not
applicable or cannot be answered fully, then please indicate why in your answer.
Note: A copy of the entire final version of any grants/subcontracts/etc. that are available are
required for IRB review in accordance with the directions below.
IRB – ITHS Application (long) 4.3.15
Page 10 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Is there funding to conduct the research?
Yes, for grants/contracts/subcontracts, complete the sections below.
Yes, if using departmental/seed funds, please describe:
Pending, complete the sections below and provide justification for pursuing IRB approval
at this time (e.g., NIH requested Just In Time documentation):
No, explain why funding is not needed (i.e., why the institutional costs are minimal):
Name of PI on Funding Proposal:
If this is a sub-contract, please also provide the name of the PI with the direct award
and his/her institution:
Title of Funding Proposal:
Type of Funding Proposal (choose one that is most appropriate):
Grant, Fellowship, Training Grant  Provide a copy of the entire final version of the
funding proposal if available. If not available, explain why:
Subcontract from Grant  Provide a copy of the final version of the proposal; if grant
proposal is not available, then provide the Scope of Work if available. If neither available,
explain why:
Contract  Provide a copy of the Scope of Work if available. If not available, explain
why:
Consortium/Cooperative Group  Identify the consortium/cooperative group & provide
available information about the relationship of this study to that group and the main
funding source:
If a grant/research plan is available, it needs to be attached.
Other. Describe:
Name of Funding Agency (often the Sponsor):
Type of Funding Agency:
Public (e.g., NIH)
Private (e.g., grant from a family)
Non-profit (e.g., Thrasher Foundation)
Corporate (industry sponsor)
ID Number Assigned by Agency/Sponsor to Funding Proposal (e.g., R01012345-01A1):
Funding Period:
Funding starts: MM/DD/YYYY
Funding ends: MM/DD/YYYY
Funds (monies) to be Administered by (What institution is the prime awardee?):
Seattle Children’s
University of Washington
Fred Hutchinson Cancer Research Center
Other. Provide name:
Are all the research activities described in this funding proposal consistent with the
current IRB application?
Yes
No  Describe differences in appropriate textboxes immediately below.
If there are differences, include details about specific aims/sections that differ and note
section and/or page numbers of funding proposal/document if possible:
If there are aims/sections that are covered by other IRB applications at Children’s,
please provide information regarding the aims and the relevant IRB number(s):
If you have plans to submit future IRB applications to cover some of the aims
IRB – ITHS Application (long) 4.3.15
Page 11 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
described in the funding proposal, please briefly explain here:
Other (For example, the funding may be through a consortium/cooperative group and
the funding may be for “the conduct of separately approved projects, of which this is
just one”):
11. Commercial/Intellectual Property Interests
11.1. Does this study anticipate the development of commercial or intellectual property
interests (e.g., patents, copyrights, royalties, etc.)?
Yes
No  Skip to section 12: Research Participants.
11.2. Will participants receive any compensation related to these interests?
Yes
No
11.3. Does the consent form clearly disclose this potential for commercial or intellectual
property development?
Yes  Include the sample language:
No
Investigator Help: If an interest is anticipated and no compensation is offered, the IRB
will generally require a statement in the consent form to the following effect: “Your samples
may be used to make new products, tests or findings. These may have value and may be
developed and owned by the research team and/or others. If this happens, there are no
plans for you to receive payment.”
12. Research Participants
Investigator Help: IRB review is required for research involving human participants. When
determining who should be considered a “human participant” of the research, please consider
the regulatory definitions included below.
Note: Adult participants may be providing information/specimens about themselves and/or
giving permission for a child to participate (IRB Policy-020 “Parental Permission and Child
Assent”). If you have questions about whether a population should be treated as participants of
the research study, please consult with a HSPP analyst. As an example, when parents are
completing questionnaires that are entirely about their children, then the IRB will probably not
consider the parent to be a human participant of the research. If the parent is being asked to
complete a questionnaire that asks how they feel about their child’s illness, then the parent will
probably be considered a human participant.
Seattle Children’s Policy: See IRB Policy-003 “Human Participants of Research”.
Federal Regulations: From 45 CFR 46.102(f): Human subject means a living individual about
whom an investigator (whether professional or student) conducting research obtains
 Data through intervention or interaction with the individual; or
 Identifiable private information.
IRB – ITHS Application (long) 4.3.15
Page 12 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Intervention includes both physical procedures by which data are gathered (for example,
venipuncture) and manipulations of the subject or the subject’s environment that are performed
for research purposes. Interaction includes communication or interpersonal contact between
investigator and subject.
Private information includes information about behavior that occurs in a context in which an
individual can reasonably expect that no observation or recording is taking place, and
information which has been provided for specific purposes by an individual and which the
individual can reasonably expect will not be made public (for example, a medical record).
Private information must be individually identifiable (i.e., the identity of the subject is or may
readily be ascertained by the investigator or associated with the information) in order for
obtaining the information to constitute research involving human subjects.
Investigator Help: If you think your research project may not fulfill the definition of human
participants research, please consult with a HSPP analyst about whether this application is
appropriate for your study.
Equitable Selection
Federal Regulations: Selection of participants is equitable, taking into account the purposes of
the research and the setting in which the research will be conducted. 45 CFR 46.111 (a)(3)
Targeted/Planned Enrollment
12.1. Does your planned enrollment differ from the general population of King County
(see King County Statistics provided in percentages below)?
Yes  Update the table below to reflect your planned enrollment.
No, enrollment is consistent with the general population of King County.
Targeted/Planned Enrollment:
Ethnic Categories
Hispanic or Latino
Not Hispanic or Latino
Ethnic Category Total of All Participants*
Sex/Gender
Females
Males
3.9%
3.9%
46.2%
46.2%
50.0%
50.0%
Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Racial Category Total of All Participants*
0.5%
7.5%
0.4%
3.3%
36.0%
2.3%
50.0%
0.5%
7.5%
0.4%
3.3%
36.0%
2.3%
50.0%
*“Ethnic Category Total of All Participants” must equal “Racial Category Total of All
Participants.”
IRB – ITHS Application (long) 4.3.15
Page 13 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
12.2. If the gender and/or minority representation in your sample differs from the general
population, please explain the rationale below. Please speak to the IRB’s concern
that research data include equitable gender and minority representation of
individuals affected by the disorder or condition being studied.
Investigator Help:
Sample answer: The study is open to all participants regardless of gender or ethnicity.
Efforts will be made to extend the accrual to a representative population, but in a Phase I
clinical trial which will accrue an estimated maximum of 67 patients, a balance must be
struck between patient safety considerations and limitations on the number of individuals
exposed to potentially toxic or ineffective treatments on the one hand and the need to
explore gender, racial, and ethnic aspects of clinical research on the other. If differences
in outcome that correlate to gender, racial, or ethnic identity are noted, accrual may be
expanded or additional studies may be performed to investigate those differences more
fully.
Fragile X Syndrome occurs almost exclusively in males (10:1 ratio, M:F), thus it is likely
that males will be overrepresented in this project.
Special Populations
Federal Regulations: When some or all of the participants are likely to be vulnerable to
coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled
persons, or economically or educationally disadvantaged persons, additional safeguards have
been included in the study to protect the rights and welfare of these participants. 45 CFR
46.111 (b).
12.3. Will you be enrolling participants from any of the following categories? If you
check “yes” for any of the populations listed below, please also complete the
Special Populations Supplement.
Investigator Help: If you have any questions about these categories after reading the
Special Populations Supplement, please consult with a HSPP analyst.
Yes No
Wards of the State or Foster Children (can be living in state facility, foster care, or
with other family members):
Neonates (newborns up to 4 weeks of age):
Pregnant women or fetuses (if you intend/anticipate will be enrolled)
Prisoners (juveniles in detention would be considered prisoners)
Persons with diminished decision making capacity/mentally disabled persons
who may not be competent to provide informed consent or assent (e.g.,
cognitively impaired, critically ill, mental disorders)
IRB – ITHS Application (long) 4.3.15
Page 14 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Economically or educationally disadvantaged persons
13. Standard of Care vs. Research
Standard of Care (SOC): Interventions and interactions that are part of routine clinical care and
generally not billed to the study.
Research: Interventions and interactions that are completed for research purposes only and will
generally be billed to the study.
Investigator Help: If you have a final version of the Financial Responsibility Analysis (FRA)
available to you, that can be a valuable resource to you in answering questions in this section
because the FRA also asks for a distinction to be made between SOC and research procedures
– albeit for different reasons than the IRB asks.
Please consider all interventions and interactions dictated by the protocol when answering the
following questions:
13.1. Are ALL of the interventions and interactions dictated by the protocol considered to
be SOC at SCH?
Yes
No  List the research procedures here:
Investigator Help:
Sample answer: We are examining the neural basis of major depression in adolescents
utilizing fMRI and an emotional activation paradigm. This is considered experimental and
would not be part of any SOC currently offered to treat depression in youth.
13.2. Please explain who will be billed for research interventions (e.g., the sponsor, the
participant or their insurance, etc):
13.3. Explain how the research interventions or interactions differ from standard care:
Investigator Help:
Sample answers: (1) ECGs are routinely completed as part of standard care, but will be
completed on 2 extra occasions for research purposes; (2) We will administer quality of life
questionnaires that are not typically completed as part of routine care; (3) In addition to the
standard chemotherapy regimen, we will be administering an investigational agent; (4)
After the conclusion of therapy, we will continue to review medical records for 2 years.
13.4. Explain whether this study will preclude or delay standard care:
Investigator Help: For randomized trials, the IRB will want to know whether there is
genuine uncertainty in the medical community about the preferred treatment. Ethical
concerns arise in clinical trials when the investigator begins to believe that one arm of the
trial is more beneficial than another. According to the concept of "clinical equipoise," a
randomized controlled design may be justified where there is a current or likely dispute
IRB – ITHS Application (long) 4.3.15
Page 15 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
among expert members of the clinical community as to which of two or more therapies is
superior in all relevant respects. Should the investigator discover that one treatment is of
superior therapeutic merit, he or she is ethically obliged to offer that treatment. Once there
is sufficient evidence in favor of one treatment, the research is usually stopped since
clinical equipoise is no longer met.
Sample answer: The local practice at Seattle Children’s is to perform a combined general
and regional anesthetic. The decision to use a combination technique (general and
regional anesthesia) or each individually is up to the discretion of each anesthesiologist on
a case by case basis. Either a regional anesthetic or a general anesthetic are acceptable
for this surgical procedure and are often performed individually at other centers. The
research participants will not receive inferior care due to randomization at Seattle
Children’s Hospital.
Sample answer: Participants will be asked to refrain from taking over-the-counter
medications 24 hours prior to the study visit. Additionally, participants who take
psychostimulants will be asked to abstain from medication for the 36 hours preceding the
study visit.
13.5. If relevant, describe alternative treatments available to research participants that
might be of advantage to them.
Investigator Help:
Sample answers: (1) Participants could be treated with commercially available growth
hormone products; (2) Patients in this situation may be offered treatments using
commercially available drugs, other investigational options on different phase 1 or 2
studies (based on availability), palliative care or no additional interventions; (3)
Participants could receive all the same research drugs/interventions outside of this
research study.
14. Research Risks Management
14.1. Is it possible that you will discover a previously unknown condition (e.g., disease,
pregnancy, suicidal intentions, genetic predisposition, child abuse) as a result of
study procedures?
Yes  Explain how you will manage this situation to minimize risks.
No
Investigator Help: For more information about risks of genetic studies, see the IRB’s
Information sheet entitled “Genetic Studies.”
Sample answers:
 Genetic predisposition will NOT be identified as part of this study. Blood specimens
will be analyzed for genetic polymorphisms that direct drug metabolism. These are not
aberrant genes but rather individual variation in genes that impact overall activity of the
encoded drug metabolizing protein. These research samples will not be analyzed in
real time and results will be correlated only with drug metabolism. Results will not be
provided to the site investigators or participants. The remaining genetic analyses
proposed in this protocol pertain to somatic mutations (i.e. tumor specific mutations)
IRB – ITHS Application (long) 4.3.15
Page 16 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:


not germ line mutations and therefore does not provide genetic predisposition
identification).
It is possible that a previously unknown pregnancy could be revealed from the required
pregnancy test. During the research, if a participant has a positive pregnancy test, she
will be notified about the test results. By law, she must give her permission in order for
the hospital to share the positive results with a parent or guardian. If a participant has
a positive pregnancy test, she will be withdrawn from the study.
It is possible that suicidal intentions, child abuse or the emergence of a depressive
disorder may be revealed during the study visit. The safety of the adolescent will
supersede all study procedures. If researchers become aware of a participant who
appears to be at imminent risk for suicide, Dr.
or Dr.
will be immediately
consulted to assess the participant and develop a treatment plan. Factors to consider
when assessing a participant who may be at risk for harming him/herself or others
include: 1) presence of plan or intent, 2) pervasiveness of suicidal thoughts, 3) access
to means of suicide, 4) level of support from family and friends, 5) ability to utilize
support from family and friends, 6) current substance use, 7) current environmental
stressors, 8) level of depressive symptoms, and 9) adherence to pharmacological
treatment regimen, if relevant. A management plan to reduce the risk of suicide will
consider the following: 1) hospitalization to maintain safety, with involuntary
commitment if needed, 2) need/efficacy of current pharmacological treatment, 3) need
for initiation or increased frequency of psychosocial treatment, 4) increase social
supports, 5) consider contact with clinicians and/or caregivers. Study participants who
are actively suicidal and/or homicidal with a presence of plan or intent will be excluded
(or discontinued) from study participation, and will complete an evaluation to determine
safety with referrals to the age appropriate Emergency Department or Inpatient
Psychiatry Service as needed. Please see the attached Teen Coping Study Suicidality
Protocol. Study participants whose responses indicate the likely presence of a
depressive disorder will be provided referrals for follow-up care. Prior to the
completion of the study visit, interviewers will complete the Teen Coping Study
Referral & Suicidality Protocol. This will guide the interviewer with procedures related
to the need to complete the suicidality protocol, as well as when it is appropriate to
provide the participant with therapy referrals.
14.2. Who will provide medical care to participants injured as a direct result of the
research? Note: This is usually based on where the research takes place.
Seattle Children’s
University of Washington
Other. Explain:
14.3. Are the facilities where the research will be conducted adequate for handling
research-related injuries?
Yes
No  Explain:
14.4. Who will be financially responsible for treatment of research-related injuries?
The following is provided as general information for purposes of choosing the box that
represents who will be financially responsible here. However, the details provided in the
following guidance should be consulted in answering this question: IRB Information Sheet
entitled “Who Pays for Research Related Injuries.”
IRB – ITHS Application (long) 4.3.15
Page 17 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
If there is an industry study sponsor  Industry study sponsor is responsible
If there is no industry sponsor and the study offers the prospect of direct benefit 
Research participant/insurance company is responsible
If there is no industry sponsor and no prospect of direct benefit and there is a potential
for bodily injury  Children’s compensation plan applies
Other. Describe:
Seattle Children’s Policy: Additional details about the Children’s compensation plan are
available in the IRB Information Sheet entitled “Policy on Compensation for Injuries
Sustained by Research Participants”.
14.5. Does the research involve deception or withholding of complete information?
Yes  Justify why the use of deception is necessary and attach a debriefing
statement.
No
Investigator Help:
Sample answer: For the interpersonal speech task, adolescents will be instructed to
prepare a speech. The participants are told that they will be required to deliver the speech
that will be videotaped and rated by same-age peers. After the speech preparation task, a
video screen is shown, informing the participant that s/he will not have to deliver a speech
after all. This task has been used with this age group and has been shown to illicit a
sufficient stress response for the physiological measures being used. All participants will
be provided with a debriefing handout, in addition to an opportunity to discuss the use of
deception.
Example of a Debriefing Statement:
This study looks at how people deal with stress. Studies done in the past have found that
different people deal with and respond to stress in different ways.
In this study, we asked you to prepare a speech. We told you that you would deliver this
speech to your peers. You then learned that you would not need to give a speech. You
also learned we would not share any part of today’s study with your peers. But we wanted
you to believe that this was true to see how you would handle the stress of the situation.
Most people find this type of task stressful because they worry about what others will think
about them. There is a lot of research showing a strong connection between stress and
depression. Not surprisingly, higher levels of stress put people at increased risk for
depression. We are also interested in how teens that have had depression physically
react to stress. We think that people with a history of having a depressive disorder will
react differently to stress. We hope that the information we learn from this study will teach
us how we can help teens with depression learn to manage their stress.
If you have concerns about your rights as a participant in this experiment, please contact
the Seattle Children’s Institutional Review Board (IRB) at (206) 987-7804. Thank you for
taking part.
15. Children in Research, 45 CFR 46.401
IRB – ITHS Application (long) 4.3.15
Page 18 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Children are persons who have not attained the legal age for consent to treatments or
procedures involved in the research, under the applicable law of the jurisdiction in which the
research will be conducted. 45 CFR 46.402(a).
 In Washington State, a minor is an individual who is below age 18 except where
otherwise provided by law. RCW 26.28.010.
Federal Regulations: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd
and http://www.hhs.gov/ohrp/policy/index.html#children.
The IRB will determine the appropriate Risk Category for the study, and the Board’s
determination will be communicated to the PI in the outcome letter. This risk category has
implications for the number of parents who must be asked to provide permission for their child’s
participation, as well as whether the Seattle Children’s IRB can approve the study under federal
regulations.
The application asks these questions to give the investigator the opportunity to provide
their own assessment of the Risk Category for their study.
Federal Regulations: 45 CFR 46.404-407.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
Investigator Help: For more information about risk categories, please see the IRB Information
Sheet “Regulations for Research with Children”.
15.1. If your study involves different categories of child participants (e.g. transplant
recipient versus transplant donor; participant receiving placebo vs. investigational
drug) who will fall into different research Risk Categories, check all categories that
apply and provide an explanation for each category.
Category 404 - Research not involving greater than minimal risk to the individual child.
Generally the permission of one parent is sufficient for the child’s participation in the
research.
Investigator Help: For example, chart reviews, data analysis, certain blood draws.
Practice Tip: If only one parent signature is required, but both parents are present at
the time of the consent/parental permission conference, obtaining both parent
signatures (using “/” to separate signatures) is a best practice.
15.1.1. Explain why the research is minimal risk.
Federal Regulations:
Definition of “minimal risk”: Minimal Risk means that the probability and
magnitude of harm or discomfort anticipated in the research are not greater in
and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests (45 CFR
46.102(i)).
IRB – ITHS Application (long) 4.3.15
Page 19 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Determining that a research activity presents no more than minimal risk involves
comparing the possible harms or discomforts experienced in normal daily life or
during routine physical or psychological examinations or tests with the possible
harms or discomforts that will be faced by participants as a consequence of
research participation. The nature of the harms or discomforts (e.g., physical,
psychological, legal) should be considered, as well as the chances that they will
occur and the seriousness of their impact if they were to happen. Depending on
what kind of experience(s) are involved in participation in a specific research
activity, it may be easier to compare the anticipated experience of participation in
research to the possible harms or discomforts of daily life, or to the possible
harms or discomforts of a routine physical or psychological examination or test.
Including measures to prevent or decrease the likelihood of harm or discomfort
from the research may affect whether the proposed research activity involves no
more than minimal risk.
Category 405 - Research involving greater than minimal risk but presenting the
prospect of direct benefit to the individual participants. Generally the permission of
one parent is sufficient for the child’s participation in the research.
Investigator Help: For example, therapeutic drug/device trials, transplant.
15.1.2. Summarize briefly the main risks of the study:
15.1.3. Explain why you anticipate benefits specific to the agent or intervention
used in this study:
15.1.4. Explain why the risks are justified by the anticipated direct benefit to the
child.
15.1.5.
Explain how the relationship between research risk and prospective benefit
is at least as favorable as presented by available alternative approaches.
Category 406 - Research involving greater than minimal risk and no prospect of direct
benefit to the individual participants, but likely to yield generalizable knowledge about
the participant’s disorder or condition. Under this category, both parents must give
their permission unless one parent is deceased, unknown, incompetent, or not
reasonably available, or when only one parent has legal responsibility for the care and
custody of the child. The IRB must consider the following information when
determining whether a study can be approved under this category:
15.1.6. Summarize briefly the main risks of the study:
15.1.7. Explain why the risk represents only a minor increase over minimal risk.
15.1.8. Explain how the interventions/procedures in this research are reasonably
commensurate with those inherent in the child’s actual or expected
medical, dental, psychological, social, or educational situations. (For
IRB – ITHS Application (long) 4.3.15
Page 20 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
instance, an oncology patient would be expected to have more risky procedures
than a flu patient).
15.1.9. Explain whether the interventions/procedures are likely to yield
generalizable knowledge about the participants’ disorder or condition and
why it is of “vital importance” (45 CFR 46 406(c)) to the understanding or
amelioration of the participants’ underlying disorder or condition.
15.1.10. What alternative methods/approaches were considered to gain this
knowledge?
Category 407 - Research not otherwise approvable which presents an opportunity to
understand, prevent, or alleviate a serious problem affecting the health or welfare of
children (407). This category of research cannot be approved by the local IRB;
therefore if you feel your study falls into this category, you must contact an HSPP
analyst for consultation.
16. Consent & Assent Conferences
16.1. Consent Conferences
Federal Regulations: Informed consent will be sought from each prospective participant or the
participant's legally authorized representative, or informed consent is appropriately waived. 45
CFR 46.111 (a)(4).
The IRB will review your response to the following questions to ensure all requirements for
regulatory protections afforded participants are met. This includes but is not limited to privacy
and minimization of the possibility of coercion/undue influence (see IRB Policy-013 “Informed
Consent” for additional details). Documentation of consent is covered in section 18: Waivers
and Documentation of Consent.
Note: If you do not plan to have any discussions with potential participants about the research,
please answer “N/A” to applicable questions below and explain why potential participants will
not be approached.
16.1.1.
Describe who will obtain consent. For clinical research (studies that involve
medical/therapeutic interventions), the consent should be obtained by a qualified
healthcare professional, e.g., RN, MD).
Investigator Help: Generally speaking, the IRB expects that the research study
will be explained in person with participants. The IRB sometimes allows other
scenarios, including the use of telephones for consent conferences. The person
obtaining consent/parental permission must be qualified to answer questions
about the research risks, benefits, procedures and when applicable, alternative
treatments or procedures available.
Sample answers:
IRB – ITHS Application (long) 4.3.15
Page 21 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:


For medical or drug interventions: Treating medical providers who are also
research team members (primarily attending physicians and in rare
instances, the neuro-oncology nurse practitioner) will obtain consent.
For behavioral or survey studies: A trained member of the research team
under supervision of the PI will obtain consent.
Note: All research team members who will obtain informed consent should be
listed on the first page of the consent form.
16.1.2.
Describe when (the timing of) the consent and/or parental permission
conference will take place.
Investigator Help: The timing of consent needs to be sensitive to the family and
child’s situation. Sufficient time should be allowed to present the information to
potential participants, answer their questions and consider the option to take part
in the research.
Sample answer: Consent will be obtained when the participant comes for
his/her pre-op visit so that we are not obtaining consent from participants on the
day of surgery.
16.1.3.
Describe where consent and/or parental permission will be obtained.
Investigator Help: Consent should be obtained in a setting where participants
are ensured privacy and are free from potential coercive influences.
Sample answer: Consent will be obtained in a private outpatient exam room,
inpatient room, or conference room.
16.1.4.
Describe how you will complete the following in order to ensure that
research participants understand the research and what is expected of
them.
16.1.4.1. Provide a full explanation of the research (in a language
understandable to the potential participant) by a research team
member/investigator qualified to do so.
Investigator Help:
Sample answer: The study physician will discuss all available
treatment options to the patient including this study. The study will then
be discussed in detail. The discussion will include information about
what is known about the drugs, toxicities, risks associated with the
study, potential benefits, and that being a participant in the study is
completely voluntary.
16.1.4.2. Provide sufficient opportunity for potential participant to ask
questions.
Investigator Help:
IRB – ITHS Application (long) 4.3.15
Page 22 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Sample answer: The informed consent process is extensive and
occurs over several visits. Each visit allows the family to ask questions
while the time between discussions allows patients to process the
information and think of questions they may have regarding the study to
be discussed with the physician.
16.1.4.3. Assess the potential participant’s understanding of the research
and what is involved if they choose to participate.
Investigator Help: Possible methods include asking participants to
describe key points of the research in their own words, asking questions
to ascertain comprehension of key points, reviewing key points that are
known to be difficult for participants to comprehend, or developing a
written or verbal test to ascertain comprehension.
Sample answers:
 Assessment of the participant’s understanding of the research and
what is expected of them is accomplished by asking participants to
repeat their understanding of the study, its risks, and what is
expected of them. In addition, physicians and nurses can assess
how well participants understand the study through the types of
questions, and appropriateness of questions, raised by participants
during discussions related to the protocol.
 Throughout recruitment, screening and the research visit, the
researcher will assess participants’ understanding of the research
and expectations about the research by asking them to use their
own words to describe the project, including their role on the project.
Efforts to clarify and simplify the research and participants’ roles will
be prioritized, as well as providing reminders that research
participants always retain the right to withdraw from the study at any
time. Additionally, researchers will invite questions from the
participants, reiterate the participants’ right to refuse participation,
and ask whether the participant is comfortable with participation
prior to beginning procedures.
16.2. Assent Conferences
Federal Regulations: The IRB shall determine that adequate provisions are made for soliciting
the assent of the children, when in the judgment of the IRB the children are capable of providing
assent. 45 CFR 46.408.
Assent means a child’s affirmative agreement to participate in research. Mere failure to object
should not, absent affirmative agreement, be construed as assent. 45 CFR 46.402(b).
Investigator Help: When the IRB requires assent for children to take part in research, then the
child’s decision is binding and must be respected by the researchers and parents. Note: In
general, even if you obtain assent from a child participant but they then demonstrate dissent
(e.g., they pull their arm away during a blood draw or refuse to complete a questionnaire), their
refusal must be respected.
IRB – ITHS Application (long) 4.3.15
Page 23 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Note: If you do not plan to have any assent discussions with potential participants about the
research, please answer “N/A” to applicable questions below and explain why there will not be
any assent discussions with potential participants.
Please check here if you will not be enrolling children in this research  Skip to
section 17: Waivers & Documentation of Consent.
16.2.1.
Describe who will obtain assent.
Investigator Help: Generally speaking, the IRB expects that the research study
will be explained in person with participants. The IRB sometimes allows other
scenarios, including the use of telephones for assent conferences. The person
obtaining assent must be qualified to answer questions about the research risks,
benefits, procedures and when applicable, alternative treatments or procedures
available.
Sample answer: A trained member of the research team under supervision of
the PI will obtain assent.
Note: All research team members who will obtain assent should be listed on the
first page of the assent form.
16.2.2.
Describe when (the timing of) the assent conference will take place.
Investigator Help: As a general rule, the IRB requests that parental permission
be sought first and only after parental permission is obtained should the assent of
the child be sought. The potential child participant should be informed that
having their parent/legal representative’s permission only allows the research
team member to present the study to them and offer them the option to
participate. Note: This is true even if these conversations are held in the same
room at about the same time.
The timing of consent and assent needs to be sensitive to the family and child’s
situation. Sufficient time should be allowed to present the information to potential
participants, answer their questions and consider the option to take part in the
research.
Sample answer: Assent will be obtained when the participant comes for his/her
pre-op visit so that we are not obtaining assent from participants on the day of
surgery.
16.2.3.
Describe where the assent conference will be held.
Investigator Help: Assent should be obtained in a setting where participants are
ensured privacy and are free from potential coercive influences.
IRB – ITHS Application (long) 4.3.15
Page 24 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Sample answer: Assent will be obtained in a private outpatient exam room,
inpatient room, or conference room.
16.2.4.
Describe how you will complete the following in order to ensure that the
potential child participant understands the research and what is expected
of them.
16.2.4.1. Provide a basic explanation of the research in a language
understandable to the potential participant (language appropriate
to their developmental level) by a research team
member/investigator qualified to do so.
Investigator Help:
Sample answer: The study physician will discuss the basic aspects of
the study in sufficient detail and using simple terms appropriate for the
potential participant’s developmental age.
16.2.4.2. Provide sufficient opportunity for the potential child participant to
ask questions.
Investigator Help:
Sample answers:
 The informed consent process, including assent, is extensive and
occurs over several visits. Each visit allows participants to process
the information and think of questions they may have regarding the
study to be discussed with the physician.
 The child or young person will be given the opportunity to ask
questions of the study nurse either in private or in the presence of
their parent/legal representative.
16.2.4.3. Assess the potential participant’s understanding of the research
and what would be involved if they choose to participate.
Investigator Help: Possible methods include asking potential child
participants to describe key points of the research in their own words,
asking questions to ascertain comprehension of key points, reviewing
key points that are known to be difficult for participants to comprehend,
or developing written or verbal tests to ascertain comprehension.
Sample answer: Assessment of the potential participant’s
understanding of the research and what is expected of them is done by
asking the child or young person to describe in their own words what
they would do if they agreed to participate. In addition, study team
members can assess how well participants understand the study
through the types of questions, and appropriateness of questions,
raised by participants during discussions related to the study.
17. Waivers & Documentation of Consent
IRB – ITHS Application (long) 4.3.15
Page 25 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
The following questions will help you to determine the appropriate consent & assent
documentation for your study.
Federal Regulations: Informed consent will be appropriately documented (signed written
consent form or short form), or is appropriately waived. 45 CFR 46.111 (a)(5).
17.1. Directional Questions
17.1.1.
Are you requesting a full waiver of consent (i.e., you will not ask
participants for written or verbal consent at any point during the research)?
Yes  Skip to question 17.2.
No  Continue answering question(s) directly below.
17.1.2.
Are you requesting a partial waiver of consent for recruitment purposes
(i.e., you may need to look at or collect identifiable information before you
approach participants about the study; this may also apply if you will call
participants and ask them eligibility questions prior to their enrollment in
the research)?
Yes  Skip to question 17.3.
No  Continue answering question(s) directly below.
17.1.3.
Are you requesting a waiver of documentation of consent (i.e., you will
provide the elements of informed consent either verbally or in written form
but will not obtain a signature on a consent form)?
Yes  Skip to question 17.4.
No  Skip to question 17.5 re written consent.
17.2. If you are requesting a full waiver of consent, respond to all of the following criteria
for your study; the IRB will use this information to determine if your study meets the
minimum criteria for this waiver.
17.2.1.
Explain why the research involves no more than minimal risk.
Investigator Help:
Sample answer: Loss of privacy is the only risk to the participant. No one other
than the Seattle Children’s research team will have access to identifiable study
data.
17.2.2.
Explain why the waiver will not adversely affect the rights and welfare of
the participants.
Investigator Help:
Sample answer: There are no changes in clinical practice and no therapeutic
interventions, as this study involves review of medical records only.
17.2.3.
Explain why the research could not practicably be carried out without the
waiver.
Investigator Help:
IRB – ITHS Application (long) 4.3.15
Page 26 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Sample answer: The scientific validity of the study, to determine the true
incidence of opioid tolerance among patients admitted to the PICU requires
100% of eligible patients over the study interval.
17.2.4.
Explain if participants will be provided with additional pertinent information
after participation, whenever appropriate.
Investigator Help: If you will not provide any information to participants, please
state.
Note: If you are requesting a waiver of consent, then in most cases you must
also meet the criteria for a waiver of HIPAA authorization below.
17.3. If you are requesting a partial waiver of consent for recruitment (i.e., you may need
to look at or collect identifiable information before you approach participants about
the study; this may also apply if you will call participants and ask them eligibility
questions prior to their enrollment in the research), then respond to all of the
following criteria for your study; the IRB will use this information to determine if
your study meets the minimum criteria for this waiver.
Investigator Help: In this section, you are only asking for a waiver of consent for limited
eligibility screening purposes. If this is the only type of waiver you request, then all eligible
participants should subsequently be approached and asked to give informed consent to
participate in the study.
17.3.1.
Explain why the recruitment procedures involve no more than minimal risk.
Investigator Help:
Sample answer: The waiver of consent is being requested for preliminary
screening purposes only. Preliminary screening procedures are minimal risk;
they include a basic review of the participant’s medical records to identify
whether or not the participant meets basic eligibility requirements. This process
will happen concurrently with the physician/patient discussion of treatment
options which will include potential participation in the study. This will be
considered the initial stages of the informed consent process. No study activities
occur prior to the documentation of informed consent by the participant. If an
individual does not choose to participate in the study or they are found not to be
eligible to participate in the study, no documentation of preliminary screening for
eligibility is retained.
17.3.2.
Explain why the waiver for recruitment will not adversely affect the rights
and welfare of the participants.
Investigator Help:
Sample answer: The preliminary screening procedures are limited to accessing
and reviewing medical records. No documentation associated with this process
is retained if the participant chooses not to participate in the study or is found to
be ineligible. However, if a patient is found to be potentially eligible for the study
IRB – ITHS Application (long) 4.3.15
Page 27 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
and the patient chooses to participate in the therapeutic study the preliminary
screening ensures that all necessary eligibility requirements have been identified
in a timely manner. This will allow timely enrollment, scheduling, and start of
treatment for patients that consent to participate.
17.3.3.
Explain why the recruitment procedures could not practicably be carried
out without the waiver.
Investigator Help:
Sample answer: There are a limited number of potential study reservations
slots for patients on phase 1 studies. Therefore, it is necessary to ensure that
the process reviewing eligibility is done quickly and accurately to ensure a patient
has the option of enrolling in the study.
17.3.4.
Explain if participants will be provided with additional pertinent information
after recruitment, whenever appropriate.
Investigator Help:
Sample answer: If a participant is found to be eligible through the screening
process, they will be approached about the option of participating in the study. If
they express interest, a member of the research team will review the study
procedures in detail and obtain documented consent before the patient begins
active participation.
17.4. If you are requesting a waiver of documentation of consent (i.e., you will provide the
elements of informed consent either verbally or in written form but will not obtain a
signature on a consent form), then please choose the one criterion below that best
fits your study design and provide information about how your study meets that
criterion. The IRB will use this information to determine if your study meets the
minimum criteria for this waiver.
The research presents no more than minimal risk of harm to participants and
involves no procedures for which written consent is normally required outside
of the research context. Explain:
Investigator Help: This is the most commonly selected option, often used for minimal
risk survey/interview procedures.
Sample Answer: Spirometry 360 is a quality improvement program that practices
routinely sign up for outside of the research context. We believe risk to these potential
practice participants is minimal. All results will be presented in aggregate for all
practices participating in the study.
Or
The only record linking the participant and the research would be the consent
document and the principal risk would be potential harm resulting from a breach
of confidentiality (i.e. this is a minimal risk study and no identifying information
other than name/signature/etc. on consent form will be collected or retained).
IRB – ITHS Application (long) 4.3.15
Page 28 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Each participant will be asked whether they want documentation linking them
with the research and their wishes must be followed. Explain:
Investigator Help:
Example: A minimal risk questionnaire study about a mental health condition.
Note: In cases where the documentation requirement is waived, the IRB may require
the investigator to provide participants with a written statement (i.e., information sheet)
regarding the research.
Seattle Children’s Policy: See IRB Policy-018 “Waiver or Modification of Informed
Consent”.
17.5. Written Consent
Investigator Help: Written consent is required in most cases, in addition to the verbal
presentation of the research.
Seattle Children’s Policy: See IRB Policy-019 “Documentation of Informed Consent”.
17.5.1.
Are copies of consent forms attached? Note: These copies need to be
submitted as Microsoft Word documents.
Yes  List them and the readability grade level of each consent form in the
list.
Investigator Help: For most studies, readability should be 8.0 grade level or
lower.
No  Why?
Investigator Help: Instructions for checking readability grade level of
Microsoft Word documents: Go to Tools menu, choose Options, Spelling and
Grammar. Set your spelling and grammar options to show Readability
Statistics. After you run a spelling and grammar check on a document, a
Readability Grade Level will be one of the statistics shown. Please also note
that you can check readability at many levels within a document by
highlighting a sentence, paragraph, section, or the entire document and
following the directions as outlined above.
Phone Consent: Please note the following procedure for obtaining consent
by telephone (as opposed to an in-person discussion):
 Provide a copy of the consent form to the participant and allow sufficient
time for review (for formulating questions, etc.);
 Researchers must hold a conversation via telephone to provide the
participant an opportunity to ask questions;
 The participant(s) should sign and date when they are consented/reconsented and mail it back (it does not have to be mailed the same day
necessarily); and
IRB – ITHS Application (long) 4.3.15
Page 29 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:

The research team can sign the day that they receive it back and make a
note on the consent form of when the consent conference took place and
that it was by phone (so as to explain the difference in dates).
18. Waivers & Documentation of Assent
Please check here if you will not be enrolling children in this research and skip to
section 19: HIPAA Issues.
Seattle Children’s Policy: See IRB Policy-020 “Parental Permission and Child Assent”.
18.1. What are the ages of minor participants who will be involved in the research? Check
all that apply. Information about the typical IRB assent requirements is provided below for
reference.
Age 0-6  The IRB generally does not require written assent from children younger
than age 7. The IRB still expects researchers to explain to the child what is
happening.
Age 7-13  For minimal risk studies, the IRB generally requires written assent on a
simple form. For studies that are greater than minimal risk but provide the prospect of
direct benefit, the IRB will usually require a simple assent form for optional procedures
only (e.g., interviews/questionnaires that will require the child’s participation, extra
needle pokes for blood draws) and not for the other study procedures involved.
Age 14-17  To respect the developing decision-making abilities of children age 14
and older, the IRB generally requires written assent from child participants. This is
usually documented by asking them to co-sign the consent (permission) form with a
parent/guardian.
NOTE  If the developmental age of the population of children to be involved in the
research may be younger than the chronological age, please check this box and
explain:
18.2. If you will Not Obtain Assent:
18.2.1.
Identify the minor participants who will not be asked to provide assent:
NONE of the minor participants will be asked to provide assent.
SOME of the minor participants will not be asked to provide assent.
18.2.2.
Describe the participants who will not be asked to provide assent:
Table 18.2.
Indicate the regulatory basis for not obtaining assent. One or more of
the following three conditions must apply.
 The capability of some or all of the minors is so limited that they
cannot reasonably be consulted.
[45 CFR 46.408(a)]
 The research holds out a prospect of direct benefit that is important
to the health or well-being of the minors and is available only
through the research. [45 CFR 46.408(a)]
IRB – ITHS Application (long) 4.3.15
Yes
No
Page 30 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
 All of the following apply [45 CFR 46.116(d)]:
o The research involves no more than minimal risk to the minor
participants. Explain:
;
o The waiver will not adversely affect the rights and welfare of
minor participants. Explain:
;
o The research could not practicably be carried out without the
waiver. Explain:
; and
o Whenever appropriate, participants will be provided with
additional information after participation. Explain:
18.2.3.
In some circumstances, even though assent is not sought/required, dissent
should still be respected. Please indicate if there is any circumstance of this
study where dissent will still be respected even though assent will not be
sought.
18.3. If you will Obtain Assent:
Investigator Help: Depending on the age range of your study sample, it may be
appropriate for older participants to complete a written assent and younger participants to
complete a verbal assent. See the Special Populations Supplement for more information
about the local ‘rule of 7’s’, as well as IRB Policy-020 “Parental Permission and Child
Assent” for more details on age-related assent.
18.3.1.
Written Assent. At what ages will you obtain written documentation of
assent? Please see the typical IRB assent requirements provided above for
reference. Age/Developmental Age:
to
Investigator Help: Age 17 is the maximum for assent; when the participant
turns 18, there is no need for assent, because they can provide legal consent
Sample answer: Participants age 14-17 will be asked to document their assent
by co-signing the consent form with a parent/guardian. Participants age 7-13 will
be asked to sign a separate assent form pertaining to optional elements only.
18.3.1.1.
Is a copy of the assent form attached? Note: This copy needs to
be submitted as a Microsoft Word document.
Yes  Include the readability grade level of the assent form:
Investigator Help: For most studies readability should be 3.0 grade
level or lower.
No  Why?
Investigator Help: Instructions for checking readability grade level of
Microsoft Word documents: Go to Tools menu, choose Options,
Spelling and Grammar. Set your spelling and grammar options to
show Readability Statistics. After you run a spelling and grammar
check on a document, a Readability Grade Level will be one of the
IRB – ITHS Application (long) 4.3.15
Page 31 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
statistics shown. Please also note that you can check readability at
many levels within a document by highlighting a sentence, paragraph,
section, or the entire document and following the directions outlined
above.
18.3.2.
Verbal Assent. At what ages will you provide a verbal explanation of the
research with an assent conference but not document the conference with
a signed assent form? Please see the typical IRB assent requirements
provided above for reference. Age/Developmental Age:
to
Investigator Help: Consider the developmental age of the participants and their
ability to understand the research (see IRB Policy-020 “Parental Permission and
Child Assent” for additional details).
18.4. Plan for Participants Who Turn 18 During the Course of the Study
There is a requirement to re-approach when child participants turn 18.
Federal Regulations: See http://www.hhs.gov/ohrp/informconsfaq.html#q25.
The Office of Human Research Protections notes that informed consent should be viewed
as an ongoing process throughout the duration of a research project. When a child who
was enrolled in research with parental or guardian permission subsequently reaches the
legal age of consent to the procedures involved in ongoing research, the participant’s
participation in the research is no longer regulated by the requirements of 45 CFR part
46.408 regarding parental or guardian permission and participant assent.
Unless the IRB determines that the requirements for obtaining informed consent can be
waived, the investigators should seek and obtain the legally effective informed consent for
the now-adult participant for any ongoing interactions or interventions with the participants.
This is because the prior parental permission and child assent are not equivalent to legally
effective informed consent for the now-adult participant. However, the IRB could approve
a waiver of informed consent under 45 CFR 46.116(d), if the IRB finds and documents that
the required conditions are met.
Similarly, if the research does not involve any ongoing interactions or interventions with
the participants, but continues to meet the regulatory definition of “human participants
research” (e.g., it involves the continued analysis of specimens or data for which the
participant’s identity is readily identifiable to the investigator(s)), then it would be
necessary for the investigator(s) to seek and obtain the legally effective informed consent
of the now-adult participants. The IRB may consider, if appropriate, a waiver under 45
CFR 46.116(d) of the requirements for obtaining informed consent in order for the
participants to continue their participation in the research.
18.4.1.
If any child participants may turn age 18 during the study, please provide
information about how you will re-approach adult participants to obtain
informed consent and HIPAA authorization.
Investigator Help:
IRB – ITHS Application (long) 4.3.15
Page 32 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Sample answer: Participants who reach the age of majority (18 years) while
participating in this study will be re-approached by one of the research
investigators. The research investigator will continue the informed consent
process acknowledging that the individual has reached the age of majority and
will ask the participant to sign the informed consent document if they voluntarily
choose to continue participating in the clinical trial. If the individual chooses to
withdraw from participating in the study, they will be removed from protocol
treatment just as any other individual that chooses to withdraw consent from
participation. If the participant requests we do so, we will ask the coordinating
center to remove all data from their database pertaining to the patient. We will
also ask that any specimens that have yet to be analyzed are destroyed.
18.4.2.
If you will NOT re-approach adult participants, please explain why not, and
complete the following waiver criteria for consent and HIPAA as they relate
to participants who turn 18 during the research.
18.4.2.1.
Explain why: The research involves no more than minimal risk
to research participants and their privacy.
Investigator Help:
Sample answer: Collecting follow-up data on participants who have
completed the therapeutic interventions is analogous to a chart
review. The waiver would involve no more than minimal risk because,
when it comes to submitting personal data, there are no new privacy
risks. The coordinating center is already aware of participant’s
medical history to date. PHI will strictly be used to access the data, it
will not be shared. PHI is only stored for clinical or research purposes
that are previously IRB approved. We do not destroy identifiers
because this information is needed in the event that late effects occur.
Our database that stores PHI is on a secured server, only available to
departmental staff.
18.4.2.2.
Explain why: The waiver of consent and authorization will not
adversely affect the rights, including the right to privacy, nor
adversely affect the welfare of the participants whose records,
data, or specimens are being used.
Investigator Help:
Sample answer: Reviewing medical records for follow-up data is
analogous to a chart review. The data is submitted de-identified. We
would not be able to submit de-identified follow-up data without the
waiver. For the same reason we cannot mail out 500 consent forms,
we can not mail HIPAA forms.
18.4.2.3.
Explain why: The research could not practicably be carried out
without the waiver of consent and waiver of authorization.
Investigator Help:
IRB – ITHS Application (long) 4.3.15
Page 33 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Sample Answer: The number of patients that reach the age of
majority during the long-term follow-up phase makes the collection of
data impractical without the waiver. We enroll close to 150 patients a
year on these consortium studies. Patients can receive active
treatment for 3 years, after which time their progress is followed for
more than 10 years after enrollment. Therefore, it is likely that most
patients will turn 18 during the follow-up data collection phase of the
study. Attempting to obtain consent forms by mail from all patients
who turn 18 could affect the integrity of the data by excluding nonresponders form the dataset. In addition, some candidates for reconsent will die prior to re-consent. Systematic exclusion of data on
these patients will compromise the overall study data quality.
18.4.2.4.
Explain why: The research could not practicably be carried out
without access to PHI.
Investigator Help:
Sample Answer: PHI was released to the coordinating center at the
time of enrollment. There is no new PHI being disclosed during
follow-up. We need to use PHI to be able to access the data for the
correct patient. However, this data is de-identified when shared with
the coordinating center.
19. HIPAA Issues
Federal Regulations: 45 CFR 164.502(a)(1) - Will valid permission from participants to use,
create and share PHI for research purposes be obtained using a Authorization under HIPAA
Form OR will the IRB approve a waiver of authorization under HIPAA.
HIPAA Privacy Rule: In addition to the informed consent requirements, the Privacy Rule
(HIPAA) regulations generally require that research participants provide a written “authorization”
to use their PHI in connection with research. In requesting an authorization from potential
participants, investigators specify how the information will be used and how the privacy of that
information will be protected.
Protected health information is defined as any information that identifies research participants
and relates to their past, present and future physical and mental health or conditions, or the
provision of health care, or payment for that health care. In other words, PHI is health
information in any form that is also identifiable because it includes one or more of the 18
identifiers listed in the table below.
19.1. Please indicate which identifiers will be used for the research (if any):
Name
Social security number
Medical record number
Address by street location
Address by town/city/zip code
Dates (except year), e.g., date
of birth; admission/discharge
IRB – ITHS Application (long) 4.3.15
Page 34 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
date; date of procedure; date of
death
Telephone number
Fax number
Electronic email address
Web URLs
Internet protocol (IP) address
Health plan beneficiary
number
Account number
Certificate/license number
Vehicle identification number and serial number, including license plate number
Medical device identifiers and serial numbers
Biometric identifiers (finger and voice prints)
Full face photographic image
Any other identifier or combination of identifiers likely to identify the participant.
Investigator Help: For most studies, research participants must be asked to provide
authorization for the investigator to use or disclose PHI about the participant. Of note, there are
some situations when an authorization is not required. The following are examples that would
not require a written HIPAA authorization.
 The research does not use or create PHI (e.g., school based educational research).
 The research uses or creates PHI; however, the recorded information is entirely deidentified. (This standard is quite stringent because none of the 18 identifiers listed
above can be recorded for the research.)
 The research uses or creates information that is almost, but not completely, deidentified. In this situation the data may be considered a limited data set.
o A limited data set is health information that excludes certain direct identifiers but
that may include city; state; ZIP Code; elements of date; and other numbers,
characteristics, or codes not listed as direct identifiers. For the list of information that
may be collected as part of a limited data set, please see:
http://privacyruleandresearch.nih.gov/pr_08.asp#8d.
o If you believe your data may qualify as a limited data set, please consult with an
Analyst to confirm that your data qualifies and discuss how to obtain a Data
Use Agreement.
 The investigator seeks a waiver of authorization from the IRB. These are granted in
limited circumstances. Tracking requirements for disclosures may apply (see below).
19.2. Are you creating, using, or sharing PHI for the purposes of this research?
Yes  Attach a HIPAA Authorization Form OR request a waiver of authorization.
Complete the remainder of this section.
No  Skip to section 20: Translation & Interpretation.
Seattle Children’s Policy: IRB Policy-031 “Research Using Protected Health
Information”; Guidance.
Federal Regulations:
 Helpful guidance on HIPAA and research from the NIH can be found here:
http://privacyruleandresearch.nih.gov/pr_02.asp.
IRB – ITHS Application (long) 4.3.15
Page 35 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:


Regulatory language: 45 CFR 164.512(i),
http://www.access.gpo.gov/nara/cfr/waisidx_02/45cfr164_02.html.
Washington State regulatory language: RCW 70.02,
http://apps.leg.wa.gov/RCW/default.aspx?cite=70.02.
19.3. If you indicated that you will use PHI for the research, please answer the following
question:
19.3.1.
Will you ask participants to sign a HIPAA authorization form BEFORE you
use, create, or share their PHI for research purposes?
Yes  Complete the Children’s HIPAA Authorization Form.
Investigator Help: HIPAA Authorization Form:
 Please note that except for the gray boxes on the form, the HIPAA
Authorization Form should not be modified.
 Seattle Children’s does not permit the information in the authorization form to
be integrated into the consent form; the consent and HIPAA forms must be
separate documents.
 When indicating which types of information you will use for the study, please
consider both information that will be “used” and “disclosed”:
o In general, “use” refers to communicating PHI within the covered entity
(Seattle Children’s).
o “Disclosure” means communicating information outside the covered
entity (Seattle Children’s).
o For example, if you will store participant names and addresses at Seattle
Children’s, but will only send coded information to the study sponsor, you
should still check the boxes for “Name” and “Address,” because this
information is being used locally for the research.
Note: If you have different groups of participants from whom you will collect
different types of health information, you may need more than one HIPAA form
for your study. For example, you might be collecting more types of information
from children in the study compared to the parent participants. Or you may be
banking different types of information than you will be using in the underlying
study.
No HIPAA authorization will be used  Address waiver criteria below.
Study will use the HIPAA Authorization Form but may also need a HIPAA
waiver for part of the study (e.g., recruitment, medical record review of a
population that will not be approached)  Address waiver criteria below.
19.4. If you will NOT ask Children’s patients to sign a HIPAA Authorization Form before
you use, create, or share their PHI for research purposes, you will need a WAIVER
of HIPAA Authorization. There are different types of waivers for different research
purposes:
19.4.1.
A full waiver is granted when the IRB determines that no Authorization will be
required for a covered entity to use and disclose PHI for a particular research
project. If you plan to use identifiable health information without asking individual
IRB – ITHS Application (long) 4.3.15
Page 36 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
participants (or their legally authorized representative) to sign a HIPAA
Authorization Form, then you need to request a full waiver of HIPAA
authorization by completing the questions below.
19.4.1.1. Are you requesting a full waiver of HIPAA authorization (i.e., you
will not ask participants for HIPAA authorization at any point
during the research)?
Yes  The IRB must make findings based on your answers to all
waiver criteria below.
No  Skip to question 19.4.2.
19.4.1.2. Explain why the use or disclosure of PHI involves no more than a
minimal risk to privacy of individuals, based on, at least the
presence of the following elements:
19.4.1.2.1. An adequate plan to protect the identifiers from
improper use and disclosure.
Investigator Help:
Sample answer: A unique study code will be assigned to
participants and the link to that unique study code will be
kept at Seattle Children’s in a locked secure cabinet.
Aggregate de-identified data will be maintained at the Data
Coordinating Center for the purpose of future trial preliminary
data and experimental design. PHI will not be reused or
disclosed to any other party.
19.4.1.2.2. An adequate plan to destroy identifiers at earliest
opportunity consistent with conduct of research.
Investigator Help:
Sample answer: Identifiers will be destroyed by [date]
19.4.1.2.3. Assurances that PHI will not be reused or disclosed to
any other party or entity, except as required by law or
for authorized oversight of the research.
Investigator Help:
Sample answer: PHI will not be reused or disclosed to any
other party.
19.4.1.2.4. Explain why the research could not practicably be
conducted without the waiver of authorization.
Investigator Help:
Sample answer: The scientific validity of the study, to
determine the true incidence of opioid tolerance among
patients admitted to the PICU requires 100% of eligible
patients over the study interval.
IRB – ITHS Application (long) 4.3.15
Page 37 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
19.4.1.2.5. Explain why the research could not practicably be
conducted without access to and use of the PHI.
Investigator Help:
Sample answer: The electronic and paper medical records
of all eligible patients admitted to the PICU will need to be
reviewed for this study.
19.4.2.
A partial waiver of Authorization occurs when an IRB determines that an
Authorization is not needed for certain uses and disclosures of PHI for research
purposes, such as disclosing PHI for research screening/recruitment
purposes. If, prior to presenting the study to participants, you will need to review
patient medical records or fill out screening questionnaires (containing PHI) to
determine eligibility, you need to request a partial waiver of HIPAA for
recruitment purposes by completing the questions below.
19.4.2.1. Are you requesting a partial waiver of authorization under the
HIPAA for screening/recruitment purposes (i.e., you may need to
use or record identifiable information before you approach
participants about the study)?
Yes  The IRB must make findings based on your answers to all
waiver criteria below.
No  Skip to section 20: Translational & Interpretation.
19.4.2.2. Explain why the use or disclosure of PHI for recruitment involves
no more than minimal risk to privacy of individuals, based on, at
least the presence of the following elements:
19.4.2.2.1. An adequate plan to protect the identifiers from
improper use and disclosure.
Investigator Help:
Sample answer: This request for a waiver of authorization
under HIPAA is only for screening purposes. No PHI will be
created or shared outside of the specified research team
denoted in this application during this process. Once a
participant is found to be potentially eligible for the study and
chooses to participate in the study as documented by
signing the informed consent document a signed HIPAA
authorization form will also be requested from the patient. If
a patient chooses not to participate in the study or are found
to be ineligible for the study then all documentation
associated with the pre-screening process is immediately
destroyed.
19.4.2.2.2. An adequate plan to destroy identifiers at earliest
opportunity consistent with conduct of research.
IRB – ITHS Application (long) 4.3.15
Page 38 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Investigator Help:
Sample answer: All identified will be destroyed immediately
if the patient chooses not to participate in the study or is
found not to be eligible for the study.
19.4.2.2.3. Assurances that PHI will not be reused or disclosed to
any other party or entity, except as required by law or
for authorized oversight of the research.
Investigator Help:
Sample answer: All identifiers accessed during the
prescreening process are done via Seattle Children’s Clinical
Information Services electronic medical records, minimal
information is extracted from the medical records, if at all,
and stored in a research chart. Once the patient has been
found to be ineligible or has chosen to not to participate in
the study, the research chart is destroyed. Alternatively, if
the patient chooses to participate in the study then a signed
study specific HIPAA Authorization form is requested and
placed in the participants research chart.
19.4.2.2.4. Explain why the recruitment could not practicably be
conducted without the waiver of authorization.
Investigator Help:
Sample answer: Due to the limited number of potential
study reservations slots for patients on phase 1 studies it is
necessary to ensure that the process of identifying eligibility
is done quickly and accurately to ensure a patient has the
option of enrolling onto the study if they choose to. The
preliminary screening process allows for identifying whether
or not a patient may be eligible for the phase 1 study while
identifying any study specific eligibility requirements that may
still need to be ascertained, and verified, prior to the patient’s
enrollment.
19.4.2.2.5. Explain why the recruitment could not practicably be
conducted without access to and use of the PHI.
Investigator Help:
Sample answer: All eligibility requirements associated with
enrollment onto this study are found in the patient’s medical
records.
Alteration: An IRB may also approve a request that removes some PHI, but not all, or alters
the requirements for an Authorization. To permit an alteration, the IRB must find that all of the
HIPAA waiver criteria are met, as they apply to the particular alteration. If you will not be able to
get a signature on the form, for example, you would need to request an alteration. Please
consult with an analyst about the need for an alteration.
IRB – ITHS Application (long) 4.3.15
Page 39 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Note Regarding OTHER Institutions: If you are requesting a waiver and need access to
medical records from the University of Washington or Harborview Medical Center for research
purposes, please complete the UW Confidentiality Agreement for each applicable study
(required despite the fact that Seattle Children’s has a cooperative IRB review agreement with
the UW).
Investigator Help: Instructions for completing the form can be found here:
http://www.washington.edu/research/hsd/formRetrieve.php?ver=accreditation&id=203.
20. Translation & Interpretation
Targeted/Planned Enrollment of Limited English Proficient Participants (LEP)
Federal Regulations: The IRB needs to determine that selection of participants is equitable.
In making this assessment, the IRB will take into account the purposes of the research and the
setting in which the research will be conducted. 45 CFR 46.111(a)(3).
Investigator Help: In cases where potential research participants are LEP, researchers must
make special provisions to ensure that the informed consent process is completed in a
language understandable to the participant and/or their legally authorized representative.
Seattle Children’s Policy: Read IRB Policy-021 “Informed Consent from Persons with Limited
English Proficiency” which thoroughly explains the IRB standards for inclusion of LEP
participants. If you anticipate enrolling participants who are LEP, the IRB will general expect
you to translate the documents into the anticipated language. Please note that the translations
should not be obtained until AFTER you receive final IRB approval of the English versions
(translated documents are added later through a modification request). Generally, cost is not
an acceptable justification for excluding LEP participants, but scientific and
methodological limitations may be acceptable.
Translation costs: In limited circumstances, researchers may be eligible to apply for additional
funding for translation costs. Please see Office of Institutional Assurances Policy-001
“Translational Costs for Research Documents”.
20.1. Do you anticipate enrolling participants with LEP?
Yes  Complete the remainder of this section.
No  Explain your rationale for not anticipating enrollment of participants with LEP and
skip to section 21: Data Security & Confidentiality Protections:
Investigator Help: In light of the IRB’s concerns about this issue, acceptable answers
here might be:
 We are recruiting from another study population (IRB
) where it is known that all
patients/families speak English;
 The assessments involve evaluation of language abilities and are only validated in
English; or
 The focus group must be conducted in one language only, and will be done in English
for the pilot phase.
IRB – ITHS Application (long) 4.3.15
Page 40 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Sample answer: We will translate consent and assent forms as needed as quickly as
possible. If needed, interpreters will be available throughout approach and study
participation, just as they are for clinical care. We will likely use short form procedures
since translations cannot occur quickly enough to give families time to review translated
materials prior to the limited enrollment window expiring. It is impossible to predict which
languages will be needed and unlikely that any translations will be required. In a recent
review of phase 1 and 2 translations, done in a 5 year period in our division, we found that
5 translations in 3 different languages were conducted. This represents a period of 212
enrollments. Given the targeted enrollment of 6 local patients, it is very unlikely we will
need a translated consent form and even if we do, it is not possible to predict the
language.
20.1.1.
What steps will be taken to have recruitment materials, research tools, and
consent and assent forms translated?
Investigator Help: Certified translations of recruitment materials and
consent/assent forms should not be obtained until AFTER the English versions
have received final IRB approval (translated documents are added later through
a modification request). Research tools should be translated and validated in the
target language(s) as well.
Note: HIPAA Authorization Forms already translated to the most common
languages at Seattle Children’s are available for your use on the IRB Web site.
20.1.2.
What steps will be taken to have certified medical interpreters available for
the recruitment of participants, during the research, and for emergency
situations?
In cases where the need for a translated consent form was not anticipated, the IRB (per Policy021) will allow the use of the Short Form Consent in very limited situations:




The research offers the prospect of direct benefit to the participant;
There is urgent medical necessity such that enrollment of the participant cannot be
delayed while the certified translation is being done or approved;
An IRB-approved translation of the Short Form Consent is available in a language
understandable to the participant or legal representative on the IRB Web site; or
A certified translation of the Short Form Consent is obtained by the researcher and
approved by the IRB.
20.2. In light of the above criteria, do you intend to use a Short Form Consent/Assent
form to enroll potential LEP participants?
Yes  See IRB Policy-021 for the procedural requirements for using the Short Form
Consent/Assent forms and explain procedure:
Investigator Help:
Sample answer: We will translate consent and assent forms as needed as quickly as
possible. If needed, interpreters will be available throughout approach and study
participation, just as they are for clinical care. We will likely use short form procedures
since translations cannot occur quickly enough to give families time to review
IRB – ITHS Application (long) 4.3.15
Page 41 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
translated materials prior to the limited enrollment window expiring. It is impossible to
predict which languages will be needed and unlikely that any translations will be
required. In a recent review of phase 1 and 2 translations, done in a 5 year period in
our division, we found that 5 translations in 3 different languages were conducted.
This represents a period of 212 enrollments. Given the targeted enrollment of 6 local
patients, it is very unlikely we will need a translated consent form and even if we do, it
is not possible to predict the language.
No  Our research does not satisfy ALL criteria specified in IRB Policy-021, therefore
we will only enroll LEP participants once we have obtained an IRB-approved certified
translation of the full English consent/assent form.
21. Data Security & Confidentiality Protections
Federal Regulations: The federal regulations require the IRB to determine that when
appropriate, there are adequate provisions to protect the privacy of participants and to maintain
the confidentiality of data. 45 CFR 46.111 (a)(7).
Investigator Help: What is the difference between Privacy and Confidentiality?
 Most simply, privacy applies to the person, whereas confidentiality applies to the data.
 Relevant definitions:
o Privacy: Refers to an individual’s right to control access to him/herself. This includes
access to the individual’s personal information as well as access to their body or
biological specimens. Federal regulations (45 CFR 46.102(f)) define “private
information” as “information about behavior that occurs in a context in which an
individual can reasonably expect that no observation or recording is taking place, and
information which has been provided for specific purposes by an individual and which
the individual can reasonably expect will not be made public” (for example, a medical
record).
o Confidentiality: Refers to how private information provided by individuals will be
protected by the researcher from release to other individuals or entities. Describing how
the confidentiality of research data will be maintained is an important part of the informed
consent process. If potentially relevant to the study at hand, it is important to note in
consent process materials and in discussions with human participants that there are
some instances in which confidentiality cannot be maintained. More specifically,
researchers may be required to compromise confidentiality in instances of reports of
“danger to self or other” and/or reports of “child abuse or neglect.”
Identifiers: If your data/specimens contain any of the HIPAA identifiers in section 20: HIPAA
Issues, the data/specimens are “identifiable”.
Data that is “identifiable” can be “de-identified” by removing all of the elements listed above.
Relevant Definitions:
 Anonymous: Data that do not contain any of the above elements are considered to be
anonymous. Alternatively, if your data include identifiers, it can be de-identified and made
anonymous by removing all 18 of the above elements that could be used to identify the
individual or the individual's relatives, employers, or household members.
IRB – ITHS Application (long) 4.3.15
Page 42 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:

Linked/coded data means that: (1) identifying information (such as name or social security
number) that would enable the investigator to readily ascertain the identity of the individual
to whom the private information or specimens pertain has been replaced with a number,
letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code
exists, enabling linkage of the identifying information to the private information or
specimens.
Seattle Children’s Policy: See IRB Policy-024 “Recruiting Potential Research Participants” &
IRB Policy-031 “Research Using Protected Health Information”.
Federal Regulations: 45 CFR 46.111(a)(7).
21.1. Does the research involve audio or video taping or photographing of research
participants?
Yes  Explain if research participants are identifiable in the photographs or recordings
made:
If identifiable photographs or recordings are made, explain how long they will
be retained and any plans to destroy them, who will have access to them, how
they will be used and if they may be used outside the research, e.g., training,
presentations, publications.
No
Investigator Help:
Sample answers for Yes:
 Both the CDRS-R and LSI will be audiotaped for scoring and interpreter reliability
purposes. Only those involved in coding/recording of data and the investigators
involved in analysis will have access to the audio tapes. The CDRS-R will be
made for the purposes of the research team, who will review the tape in order to
ensure that the interview was administered appropriately and that the participant
has been assigned to the appropriate condition. The tape containing all diagnostic
information will be erased within six months following the visit. The LSI is designed
to be administered by one person and scored by a research team in order to
generate objective ratings for episodic stress. In addition to ensuring that the
interview was administered appropriately, audiotapes will be used to score the
stressful events. All tapes will be labeled with the participants’ study ID number,
rather than names. The tapes will be stored separately in a secured, locked
cabinet. The tapes will only be used for gathering and analysis of relevant data.
They will not be used for instruction, broadcast, or any public format. The
audiotape of interviews will be destroyed after six months, or after the tape has
been reviewed by the research team (whichever comes sooner).
 Videotapes of therapy sessions will be made in an effort to assess therapist
adherence to the treatment manual. While research participants may be
identifiable in these video recordings, the videos will only be labeled with the
participant’s study identification number. Videotapes will be stored in a locked file
cabinet in Dr.
office. They will be retained for a period of seven years and
then destroyed. Only essential study personnel will have access to these
videotapes. While the videotapes of actual therapy sessions may be used for the
purposes of training and presentations related to the application of the
IRB – ITHS Application (long) 4.3.15
Page 43 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
therapy model with adolescents, adolescents and their parents must provide a
separate videotape use consent/assent for this to take place.
21.2. Indicate if the research data / specimens / other are:
Directly identifiable (names, etc.)  Skip to question 21.4.
Anonymous  Answer question 21.3 and then skip to question 21.5.
Coded (linked to identifiers via study code).  Answer questions below.
21.3. If data/specimens/other are anonymous or coded, how are they labeled?
21.4. If data/specimens are coded or identifiable, explain the provisions to maintain the
confidentiality of the research data by providing information requested below.
21.4.1.
For local storage, how and where will the research data be stored? Check
all that apply.
Separate from identifiable information about participants.
Locked file cabinet with access restricted to research team members.
Password protected computer with access restricted to research team
members.
Other. Explain:
21.4.2.
If you will send/store data outside Seattle Children’s, how will the research
data be protected? Consider whether your data collection forms include
identifiers when answering. Check all that apply.
Sending only de-identified data
Sending coded data without any links
Protections in place for identifiable data. Explain:
Investigator Help:
Sample answer: Research data will be stored in a locked filing cabinet within a
locked office at the University of Washington. All data will be coded with a
number. The key linking participant numbers to participant names will be locked
in a separate filing cabinet, in a different locked office. Identifiable participant
information (consent forms, receipts of payment, demographic information) will
be locked in a third filing cabinet in a third locked office, separate from both the
key and the data. Audio recordings will be kept in a fourth locked filing cabinet in
a fourth locked office. All electronic data will be stored on a password protected
computer with access restricted to research team members.
Other. Explain:
21.4.3.
If data collected in this research study will be placed in participants’
medical records or other confidential records (e.g., school records), then
explain why and how this will be done.
Seattle Children’s Policy: IRB Policy-019 “Documentation of Informed
Consent” states “when research is providing patient care or management, a copy
of the consent form goes in the medical record.”
IRB – ITHS Application (long) 4.3.15
Page 44 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Investigator Help:
Sample answers:
 Only consent forms and study specific roadmaps for drug administration will
be placed in the medical record. This is done to increase the likelihood that
care providers unknown to the participant (such as in emergencies) might
note that the participant is taking investigational drugs when taking care of
the patient. Participant identification numbers are never put on any
documentation that goes into the medical records.
 Study information will be kept separate and will generally not be included as
part of a participant’s general medical records. However, for participants who
are also patients at Seattle Children’s, routine clinical information gathered
during this study may be added to their medical record by the Seattle
Children’s PCRC staff and/or Seattle Children’s Laboratory personnel.
21.4.4.
How is access to the research data controlled? Who controls access?
Investigator Help: Generally the PI will control access to local data, but other
entities (such as a sponsor) may also have control.
Sample answer: The PI will control access to the research data. Access will
only be granted to essential study personnel.
21.4.5.
Explain if anyone other than the local research team will have access to
identifiable study data (e.g., study sponsor, FDA, participant’s primary care
physician, child’s school teacher).
Investigator Help: If others will have access, this should be explained in the
consent form.
Sample answer: Nobody outside the Hematology/Oncology research team
(which includes the Office of Clinical Research laboratory and Research Institute
compliance personnel) will have access to the link between Children’s Oncology
Group (COG) number and patient name. The COG and their monitors will have
access to study data as needed for auditing. Enrollment data including limited
demographics is also shared within the Seattle Cancer Care Alliance for
enrollment statistics.
21.5. What provisions are in place to prevent disclosure, directly or indirectly, of
participants’ identities in any publication or presentation of research data?
Investigator Help:
Sample answers:
 Publications include group analyses and statistics such that one individual could not be
identified.
 Facial photos will only be used for subsequent publication if separate written consent
(and assent, if child is older than 7 years) is provided. In all cases this consent will
include the forms provided by the publisher. Consent/assent will be obtained prior to
IRB – ITHS Application (long) 4.3.15
Page 45 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
submission. No identifiable information (other than facial image) will be disclosed in
publications.
21.6. How long will study data/specimens be retained?
Investigator Help:
Sample answers:
 Data: Coded data will be kept permanently by the coordinating center. Local files with
identifiers are retained permanently. When data collection to the sponsor is complete,
we store local research files off site at Iron Mountain per hospital policy. Specimens:
Specimens will be destroyed after they have been analyzed for the purposes of this
study (in approximately 6 years).
 Data will be retained for 7 years from the date when the last patient completes all
study interventions.
21.7. At what point in time will the study data/specimens be de-identified (if at all)?
Investigator Help: It is acceptable for researchers to keep identifiable data indefinitely,
so long as they are not accessing it for new research purposes (if it will be re-accessed for
a new aim, IRB approval is required).
The IRB will want to ensure that your answer in this section is consistent with the
information in the consent form and the expiration period in the HIPAA form.
Please consider that once you de-identify data/specimens, participants can no longer
remove their specimens from a bank/repository; this should be clarified in your consent
form.
21.8. Will the stored data/specimens be used for future research purposes?
Yes  Complete the Banking Supplement.
No
21.9. Will the data from this study be deposited in a public repository such as the
database of phenotypes and genotypes (dbGaP) or the National Database of
Autism Research?
Yes  Please be sure your consent form is compliant with IRB Policy-45. Sample
language is available in the Language Resource Text document .
No
If you will record research data that is both sensitive and identifiable, please contact a HSPP
Analyst about the possible need for a Certificate of Confidentiality. The University of
Washington has prepared a helpful guidance document about Certificates.
22. Data Safety Monitoring
Federal Regulations: When appropriate, the research plan makes adequate provision for
monitoring the data collected to ensure the safety of subjects. 45 CFR 46.111 (a)(6).
IRB – ITHS Application (long) 4.3.15
Page 46 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
If your study poses any risks to participants, then at a minimum, the IRB requires a plan for data
safety monitoring, which may/may not include a Data Monitoring Committee (DMC) charter as
appropriate.
Investigator Help: The level of monitoring required by an investigation is dependent on the
type and complexity of the trial and risks to study participants. For information on how to
determine the level of monitoring appropriate for your investigation, please see the ITHS Partner
Institutions Joint Tool for Data and Safety Monitoring Plans (DSMP). Use your assessment of
the trial level below to guide your DSMP. Final decision regarding level of monitoring required
by your investigation resides with the IRB.
22.1. Study Level for Purposes of Determining Monitoring Plan: Please choose the box
that best represents your assessment of the level of your study based upon the
descriptions provided.
Study Level
for
purposes of
Description
determining
monitoring
plan
Non-interventional studies: for example, infrequent peripheral blood draws,
nutritional assessments, behavioral surveys, imaging (not using sedation), use
of left over samples from clinically indicated procedures, EKGs, gait
assessments.
Level I
Adverse events: No adverse events are anticipated; if any occur, the PI or
Physician of Record will report them to the SCH IRB according to SCH IRB
guidelines. Adverse events will be graded as Mild, Moderate or Severe, and as
Related / Possibly Related / Not Related to study procedures.
Safety review: The PI or designated study personnel will review all data,
including completeness of study data, enrollment, protocol deviations, dropouts, adverse events on a regular basis and an annual report of all adverse
events and a summary of the investigation will be submitted to the Seattle
Children’s IRB.
For Level I studies, STOP HERE. You do not need to complete the rest of
the DSMP section.
Level II
Non-therapeutic interventional trials: for example, behavioral trials,
psychiatric surveys, nutritional therapies, low risk procedures (e.g., endoscopy,
glucose-tolerance tests, induced sputum, skin or muscle biopsy, nasal wash,
lumbar puncture, bone marrow biopsy, imaging requiring sedation), as well as
therapeutic trials involving agents with known safety profiles already licensed for
the indication and age group.
IRB – ITHS Application (long) 4.3.15
Page 47 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Study Level
for
purposes of
Description
determining
monitoring
plan
Level III
Level IV
Non-IND therapeutic intervention trials: for example, moderate risk
procedures (e.g., insulin clamp studies, organ biopsy), Phase II trials of agents
with available safety data in the same population. In general, Risk Level III
trials require review by an external monitor or safety monitoring committee.
Therapeutic trials involving investigational agents or devices: for example,
investigator initiated INDs, Phase I trials, gene therapy, high-risk clinical
procedures if performed solely for research purposes.
Note: Phase III multi-center comparative trials are considered Level IV and per
NIH policy, generally require a Data Safety Monitoring Board (DSMB).
22.2. Identify who will periodically review study conduct and safety data.
Does your group/sponsor/protocol provide a document that describes your DSMP?
If you checked Yes, please attach your DSMP and indicate the approving
organization:
COG/PBTC/NANT/SWOG/GOG and other NCI cooperative group studies
FHCRC/UW Cancer Consortium. If your DSMP is online, provide the link
here:
TDN-sponsored trials
Yes
Other NIH-sponsored cooperative group trial. Please identify:
Other group or sponsor. Please identify:
If you checked this box, please attach your DSMP and complete the rest
of this section below.
IRB – ITHS Application (long) 4.3.15
Page 48 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Does your group/sponsor/protocol provide a document that describes your DSMP?
Who will be performing the safety monitoring of research participants?
(Select one)
Named in my DSMP (attached)
The PI or Physician of Record
Study team (for multi-center investigations)
External Monitor (an individual not directly involved in the design or conduct
of the study).
No
Internal Safety Monitoring Committee (two or more people not directly
involved in the design or conduct of the study and who have no vested
interest in the study outcome, but who may be associated with the sponsor,
either industry or institute). Attach list of committee members with name,
affiliation, area of expertise and contact information.
Independent Data Monitoring Committee (also known as a Data Safety
Monitoring Board – DSMB) – several independent people with appropriate
expertise with access to data from all centers. Required for Phase III MultiCenter Trials and most Level IV studies.
How often will the data be reviewed?
If data review is enrollment dependent, please describe:
22.3. Written Safety Reporting Frequency
22.3.1. How often will written monitoring reports be provided to the IRB?
22.4. Data Monitoring Committee or Data Safety Monitoring Board (DMC or DSMB)
Will you have a DMC/DSMB?
If you checked yes, please attach:
 DMC/DSMB charter
 Contact information for DMC/DSMB chair
Yes
 Names of DMC/DSMB members, if available, and/or their clinical
No
disciplines or expertise
 Any potential conflicts of interest including members' relationship to
sponsor or research team (if any)
22.5. Interim Analysis
IRB – ITHS Application (long) 4.3.15
Page 49 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Will your investigation have a planned interim analysis/review?
Yes
No
If you checked yes:
Is the interim analysis/review for:
Safety only
Safety and efficacy
Is the plan for interim analysis/review described in your protocol (or Part
II of the Local Implementation Plan)?
Yes
No  Please describe:
22.6. Adverse Events Definitions
Adverse Event: Any unfavorable and unintended sign (including an abnormal laboratory
finding), symptom or disease temporally associated with the use of a medical treatment or
procedure, regardless of whether it is considered related to the medical treatment or
procedure.
Serious Adverse Event:
Any adverse event that results in any of the following outcomes:
 Death
 Life-threatening adverse event
 Event requiring inpatient hospitalization or prolongation of existing hospitalization
 Persistent or significant disability/incapacity
 Congenital anomaly/birth defect
22.6.1.
Adverse Event Reporting
To whom will Adverse
Events be reported?
Check all that apply.
IRB (required)
ITHS RSB core (required if using the CRCN)
FDA
Sponsor
DMC/DSMB or other monitoring entity
NIH Office of Biotechnology Activities
Other  Clarify:
IRB – ITHS Application (long) 4.3.15
Page 50 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
All unexpected serious adverse events potentially related to study procedures require
expedited reporting. Describe any additional adverse events that will require expedited
reporting for this trial or attach the relevant document.
Children’s IRB adverse event reporting guidelines applies to
IRB reports —
http://www.seattlechildrens.org/research/formspolicies/irb/adverse-event-forms/
Reporting timeline attached.
Included in attached DSMP.
Other  Clarify:
What is the reporting
timeframe for
expedited adverse
events, including
Serious Adverse
Events? Check all that
apply.
23. IRB Submission Checklist
This checklist reflects items requested/required by any of the submission forms (not limited to
this application form). Items are listed under the submission forms in which they are referenced.
Special emphasis is given below to items that are commonly misunderstood to be required at
the time of submission, but if applicable, all items listed below should be included with your
submission, unless otherwise noted. Completion of this checklist is required for
submission. If your submission is incomplete (including an incomplete/inaccurate
checklist), you will be notified, and you will need to resubmit when complete.
Did you include (if applicable)?
Yes
Local Implementation Plan (LIP) (REQUIRED at submission)
Yes
Yes
Yes
Yes
Yes
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Protocol
Recruitment materials: flyers, advertisements, approach letters, etc.
Data collection forms
Surveys, questionnaires, interview scripts
References cited in support of research plan/experience of research team
Application signed or submitted from PI email (REQUIRED at submission)
Yes
Yes
Yes
N/A
Yes
Yes
Yes
N/A
N/A
N/A
Yes
N/A
Yes
Yes
N/A
N/A
N/A
PI or Co-Investigator is a center member
All team members have HSP training (REQUIRED at submission)
Letters of Support from participating research sites outside of
Seattle Children’s
Copy of funding proposals (REQUIRED if applicable)
Enrollment table updated if differs from general population
Copies of consent forms (Listed in application with appropriate
reading level)
Copies of assent forms (Listed in application with appropriate
reading level)
HIPAA Authorization Forms (Study information filled in)
Data Safety Monitoring Committee Charter attached (if applicable)
Banking Supplement: Fill out if study involves storage of specimens or
data for future research, whether by same or other investigator. Note:
Consultation is required for a PI’s first submission of a banking study to
Seattle Children’s IRB.
IRB – ITHS Application (long) 4.3.15
Page 51 of 52
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Yes
N/A
Foundational consent forms from other research
Yes
N/A
Coordinating Centers Supplement: Fill out if Seattle Children’s is to be
the Coordinating Center for a Multi-Center study. Note: consultation
is required for any Seattle Children’s coordinating center study.
Yes
N/A
Drugs, Devices and Biologics Supplement: Fill out if study involves a
drug for human use, biological product for human use, medical device
for human use, human food additive, or any other article subject to
regulation by the Food and Drug Administration.
Yes
N/A
Yes
Yes
N/A
N/A
Investigator’s Brochure (for investigational drugs) or Package Inserts (for
marketed drugs)
Manufacturer’s notebook (for investigational devices)
FDA correspondence or other supporting documentation attached
Yes
N/A
ITHS CRCN Services Supplement: Fill out if requesting ITHS CRCN
resources.
(TO BE SUBMITTED TO CRCN ONLY; you do not need to submit this
to the IRB).
Yes
N/A
Special Populations Supplement: Fill out and submit if you wish to enroll
members of a special population listed below in this research project:






Yes
N/A
Yes
Wards/Foster Children
Neonates
Pregnant Women & Fetuses
Prisoners
Persons with Diminished Decision-Making Capacity/MentallyDisabled Persons
Economically or Educationally Disadvantaged Persons
Note: Since children are so frequently participants of research at Seattle
Children’s, the regulatory requirements for enrolling children have been
incorporated into this application.
Specimen Collection/Testing; Radiation Exposure Supplement: Fill
out if study involves new or existing specimens (including blood) being
collected or tested OR if the study involves radiation exposure.
N/A
Radiation Safety Committee Approval. Note: obtaining this approval
will most likely be an IRB contingency if not obtained prior to IRB review.
Other – Describe:
Yes
All applicable questions answered (unless directed to skip)?
(REQUIRED)
Submit completed Application, Local Implementation Plan, relevant Supplements and
documents to: irb@seattlechildrens.org.
IRB – ITHS Application (long) 4.3.15
Page 52 of 52