HIC#________
YALE UNIVERSITY
HUMAN INVESTIGATION COMMITTEE
Application to Involve Human Subjects in Biomedical Research
Biologic Material and/or Repository
440 FR1 (2015-1)
Title of Research Repository:
Principal Investigator:
Yale Academic Appointment:
Campus Address:
Campus Phone:
Fax:
Protocol Correspondent Name & Address:
Pager:
Campus Phone:
E-mail:
Fax:
E-mail:
SECTION I: PRINCIPAL INVESTIGATOR AGREEMENT
As the Principal Investigator of this research repository, I certify the following:
 The information provided in this application is complete and accurate.
 That I assume full responsibility for the protection of human subjects and the proper conduct
regarding the collection and distribution of subject information.
 That subject safety and confidentiality will be of paramount concern, and every effort will be
made to protect subjects’ rights and welfare.
 That the collection of information and subsequent research will be performed according to
ethical principles and in compliance will all federal, state and local laws, as well as institutional
regulations and policies regarding the protection of human subjects.
 That all members of the research team will be kept apprised of research goals.
 That I will obtain approval for the development and maintenance of the repository and any
subsequent revisions prior to initiation.
 That I will report to the HIC any serious injuries, breach of confidentiality, or other
unanticipated problems involving risk to participants.
 That I will identify a successor if I stop being Principal Investigator and facilitate a smooth
transfer of investigator responsibilities.
________________________________________
Signature
Date
SECTION II: FUNDING, TRAINING AND PROTOCOL-RELATED CONFLICT OF INTEREST
1. Funding Source: Indicate all of the funding source(s) for this study. Check all boxes that apply.
Provide information regarding the external funding source. This information should include
identification of the PI on the award, agency/sponsor, the funding mechanism (grant or contract),
and whether the award is pending or has been awarded. Provide the IRES PT Proposal Number
July 1, 2016
Page 1 of 16
HIC#________
(also referred to as Institution Number) and Agency name (if grant-funded). If the funding source
associated with a protocol is “pending” at the time of the protocol submission to the HIC (as is the
case for most NIH submissions), the PI should note “Pending” in the appropriate section of the
protocol application, provide the IRES PT Proposal Number and Agency name (if grant-funded)
and further note that University (departmental) funds support the research (until such time that an
award is made).
PI
Title of Grant
Name of Funding Source
Funding
Funding Mechanism
Federal
State
Grant-IRES PT Proposal
Number
Non Profit
Contract#
Industry
Contract Pending
Other For
Profit
Other
Investigator/Department
Initiated
Sponsor Initiated
Other, Specify:
Federal
State
Grant-IRES PT Proposal
Number
Non Profit
Contract#
Industry
Contract Pending
Other For
Profit
Other
Investigator/Department
Initiated
Sponsor Initiated
Other, Specify:
Federal
State
Grant-IRES PT Proposal
Number
Non Profit
Contract#
Industry
Contract Pending
Other For
Profit
Other
Investigator/Department
Initiated
Sponsor Initiated
Other, Specify:
IRB Review fees are charged for projects funded by Industry or Other For-Profit Sponsors. Provide
the Name and Address of the Sponsor Representative to whom the invoice should be sent. Note: the
PI’s home department will be billed if this information is not provided.
Send IRB Review Fee Invoice To:
Name:
Company:
Address:
2. Investigator Interests:
July 1, 2016
Page 2 of 16
HIC#________
Does the principal investigator, or do any research personnel who are responsible for the design, conduct or
reporting of this project or any of their family members (spouse or dependent child) have an incentive or
interest, financial or otherwise, that may affect the protection of the human subjects involved in this project,
the scientific objectivity of the research or its integrity? Note: The Principal Investigator (Project Director),
upon consideration of the individual’s role and degree of independence in carrying out the work, will
determine who is responsible for the design, conduct, or reporting of the research.
See Disclosures and Management of Personal Interests in Human Research
http://www.yale.edu/hrpp/policies/index.html#COI
 Yes
 No
Do you or does anyone on the research team who is determined by you to be responsible for the design,
conduct or reporting of this research have any patent (sole right to make, use or sell an invention) or
copyright (exclusive rights to an original work) interests related to this research protocol?
 Yes
 No
If yes to either question above, list names of the investigator or responsible person:
The Yale University Principal Investigator, all Yale University co-investigators, and all Yale University
individuals who are responsible for the design, conduct or reporting of research must have a current
financial disclosure form on file with the University’s Conflict of Interest Office. Yale New Haven Hospital
personnel who are listed as con-investigators on a protocol with a Yale University Principal Investigator
must also have a current financial disclosure form on file with the University’s Conflict of Interest Office. If
this has not been done, the individual(s) should follow this link to the COI Office Website to complete the
form: http://www.yale.edu/coi/
NOTE: The requirement for maintaining a current disclosure form on file with the University’s
Conflict of Interest Office extends primarily to Yale University and Yale-New Haven Hospital
personnel. Whether or not they are required to maintain a disclosure form with the University’s
Conflict of Interest Office, all investigators and individuals deemed otherwise responsible by the
PI who are listed on the protocol are required to disclose to the PI any interests that are specific
to this protocol.
3.
Research Team: List all members of the research team. Indicate under the affiliation column whether the
investigators or study personnel are part of the Yale faculty or staff, or part of the faculty or staff from a
collaborating institution, or are not formally affiliated with any institution. ALL members of the research
team MUST complete Human Subject Protection Training (HSPT) and Health Insurance Portability
and Accountability Act (HIPAA) Training before they may be listed on the protocol. See NOTE
below.
July 1, 2016
Page 3 of 16
HIC#________
Name
Affiliation: Yale/Other Institution
(Identify)
Net ID
Principal
Investigator
CoInvestigator(s)
Study
Personnel
NOTE: The HIC will remove from the protocol any personnel who have not completed required
training. A personnel protocol amendment will need to be submitted when training is completed.
Are all Yale-affiliated individuals listed on this protocol employees of Yale University or Yale New
Haven Hospital?
YES
NO
If NO, indicate which study personnel are not:
For any Yale-affiliated study personnel who are not Yale/YNHH employees, are they covered by a
personal services agreement?
YES
NO
Department Chair’s Assurance Statement
Do you know of any real or apparent institutional conflict of interest (e.g., Yale University ownership of
a sponsoring company) that might compromise this research?
Yes (provide a description of that interest in a separate letter addressed to the HIC.)
No
As Chair of the Department, I certify the following:

The Principal Investigator of this study and all members of the research team are qualified by
education, training, licensure and/or experience to assume participation in the conduct of this research
and has the support of the department for this project.

I further assure that the P.I. meets the requirements to serve as P.I. as indicated in the Yale
University faculty Handbook and as per Yale University Policy, has departmental support and sufficient
resources to conduct this research.
__________________________________
Signature of Chair
July 1, 2016
Page 4 of 16
Department
Date
HIC#________
For HIC Use Only
__________________________
Date Approved
____________________________________
Human Investigation Committee
Protocol is valid through: ___________________________
July 1, 2016
Page 5 of 16
HIC#________
SECTION III: GENERAL INFORMATION
1. Biologic materials and or data will be obtained from the following subject populations:
(Choose all that apply: )
Children
Decisionally impaired
Employees
Females of childbearing potential
Fetal material, after delivery, placenta, or dead fetus
Healthy Controls
Non-English Speaking
Pregnant women
Prisoners
Students
2. Internal Location[s] of the Study:
Magnetic Resonance Research Center
Yale-New Haven Hospital
Yale University PET Center (MR-TAC)
YCCI/Church Street Research Unit (CSRU)
Yale Cancer Center/Clinical Trials Office (CTO)
YCCI/Hospital Research Unit (HRU)
Yale Cancer Center/Smilow
YCCI/Keck Laboratories
Yale-New Haven Hospital—Saint Raphael Campus
Cancer Data Repository/Tumor Registry
Specify Other Yale Location:
3. External Location[s]:
APT Foundation, Inc.
Connecticut Mental Health Center
Clinical Neuroscience Research Unit (CNRU)
Other Locations, Specify:
(Specify location(s)):
Haskins Laboratories
John B. Pierce Laboratory, Inc.
Veterans Affairs Hospital, West Haven
International Research Site
_______________________________________________________________________________
Please answer this and all other questions on the form with font size 12.
4. Probable Duration of Project: Please state the expected duration of the research repository.
Ongoing
5. Number of Subjects: Please state the approximate number of subject biological samples or data
records that are anticipated to be enrolled in the repository. Also indicate the number of subject
biological samples or data records that are anticipated annually.
SECTION IV: RESEARCH PLAN
July 1, 2016
Page 6 of 16
HIC#________
1. Statement of Purpose: What are the scientific aims of the collection of biological samples
and/or data into the repository? Describe the nature and purpose of any subsequent research
projects as “specifically” as possible but using general areas of scientific interest.
Example: The purpose of this study is to create a Yale School of Medicine Neuro-Oncology
patient registry that will be used for current and future research projects involving the study of
cancer biology and brain biology and related medical issues.
2. Background: Describe the background information that led to the development of this research
repository. Please provide references to support the collection of useful scientific data. When
available, previous work in animal and/or human studies should be included.
3. Research Plan: What are the types of future research studies, or the hypotheses that will be
tested using biologic materials or data from the repository? Please provide a description of the
types of study designs planned for the future and research procedures as they directly affect the
subjects.
1. Genetic Testing N/A
A. Describe
i. the types of future research to be conducted using the materials, specifying if
immortalization of cell lines, whole exome or genome sequencing, genome wide
association studies, or animal studies are planned
ii. the plan for the collection of material or the conditions under which material will be
received
iii. the types of information about the donor/individual contributors that will be entered into
a database
iv. the methods to uphold confidentiality
B. Is widespread sharing of materials planned?
4. Statistical Considerations: Describe the statistical analyses that support the study design.
Example: As this research protocol entails a repository, no formal statistical analysis is
planned. Rather, statistical analysis may be appropriate for future research studies utilizing
the information stored in the repository.
SECTION V: OPERATION OF THE RESEARCH REPOSITORY
1. State the mechanism under which the biologic materials and/or data will be accepted into
the repository.
Subject information will be collected via consent and entered into a database.
July 1, 2016
Page 7 of 16
HIC#________
NOTE: The investigator may request that the IRB consider a waiver of informed consent for
banking the data when the information was originally collected for clinical purposes and the
investigator no longer has a health care relationship with the individual whose information will be
banked. The investigator may also request that the IRB consider a waiver of consent when
wishing to bank data or specimens collected under previous research projects. However, the
investigator must specify the purpose of the original research for which the biologic material and/or
data were collected and any conditions cited in the consent document regarding secondary use or
data or sample destruction.
2. State what information about the subject-donors is being collected and entered into the
repository and retained for future reference or use. For example, Name, age, medical
record numbers, surgery date, clinical test results (such as MRI, lab tests and
neuropsychological results), symptoms, risk factors, medical history and other pertinent
medical information.
3. State the conditions under which the biologic materials and/or data will be shared with
other researchers for future research projects.
Describe the mechanism for assessing requests for biologic materials and/or data. For
example, there may be a Board of Governors (BOG) that oversees and approves requests for
use. Clarify if all researchers, including those named on the repository protocol, must go
through this process of application to the BOG. This oversight body can approve distribution
of deidentified or coded samples and data without subsequent review by the IRB.
a) Deidentified or coded distribution:
Data will be distributed for research projects of the same nature and purpose specified in
this protocol and agreed to by the donor-subject in his/her informed consent document and
HIPAA authorization documents or the compound permission and authorization document.
Data released to collaborators for research will be assigned a unique code, and will not be
identifiable by the recipient investigator.
The Principal Investigator is responsible for receiving appropriate attestation by recipient
investigators prior to permitting access to the database for activities considered
preparatory to research. Attestation will be obtained by using the Request for Access to
Protected
Health
Information
for
a
Research
Purpose
Form.
http://www.yale.edu/hrpp/forms-templates/hipaa.html
b) Identified distribution:
If the recipient investigator requests identified samples or data, these will be distributed
only after the recipient investigator has obtained HIC approval for the proposed research
objective. The operator of the repository is responsible for checking that the IRB has
approved the newly proposed secondary research project.
4. Conditions whereby the subject can withdraw their participation.
July 1, 2016
Page 8 of 16
HIC#________
Donor-subjects may withdraw their consent for the use of their biological material and/or data at
any time, if the material or data is identifiable, by calling the Principal Investigator or a member
of the research team. To revoke authorization of the use and disclosure of PHI, the donor subject
may call or write to the Principal Investigator. In this event, the Principal Investigator will
indicate in the data base that consent from the donor-subject is no longer active and that
specimens and data can no longer be used.
5. What will be done with the biologic material or data when a research subject withdraws
permission for the identifiable biologic material or data to be used for future research
purposes?
Researchers may still use the material or data that was distributed before the subject withdrew
permission/authorization in order to complete the research that has already commenced.
OPTION 1: All specimens and data retained in the repository will be destroyed upon receiving
notice of a subject’s withdrawal of permission.
OPTION 2: The researchers will anonymize the [tissue/specimen/data] by removing and
destroying all identifiers and links to identifiers so that it can never be associated with the subject,
but the researchers will not destroy the [tissue/specimen/data].
SECTION VI: HUMAN SUBJECTS
1. Recruitment Procedures: How will potential subjects be identified, contacted and recruited to
donate their biological materials or data?
Example: Adult patients (age >18) with brain tumors presenting to the Yale Neuro-Oncology
group and Yale New Haven Hospital for clinical care or research interventions will be invited to
donate their biological material and data into the registry.
If the intention is to create a repository protocol for currently existing tissue/specimen/ data,
address how consent for banking will be obtained from subjects
Example: Existing clinical data has been collected from patients prior to the physician-investigator
establishing this [tissue/specimen/data] repository. If these patient-donors have an active and
continuing relationship with a physician- investigator listed on this protocol, the patient will be
approached by his/her physician and asked to donate their tissue/specimen/data through the
process of informed consent. If a subject with existing [tissue/specimen/data] has been lost to
clinical follow-up and contact is not possible a waiver of informed consent and HIPAA
Authorization for these donors will be requested
Please note that a researcher may not use an individual’s Protected Health Information (PHI) for
recruitment into research without first obtaining an authorization from the individual, or a Waiver
of Authorization from the HIC. A treating provider does, however, have the option to:
 Discuss with his/her own patients the option of enrolling in a study.
 Obtain written authorization from the patient for referral into a research study.
 Provide background information about the study to the patient so that the patient can initiate
contact with the researcher.
July 1, 2016
Page 9 of 16
HIC#________

Provide the individual’s PHI to a researcher without authorization when the researcher has
obtained an approved Waiver of Authorization for recruitment purposes from the HIC.
2. Inclusion/Exclusion Criteria: What are the criteria for subject inclusion or exclusion? How will
eligibility be determined, and by whom?
3. Subject Population: Provide a detailed description of the proposed involvement of human
subjects. Describe the characteristics of the subject population, including their anticipated number,
age range and health status.
4. Vulnerable Subjects: Certain populations are considered to be vulnerable and require special
protections when asked to participate in a research study.
Will vulnerable subjects be enrolled in the study? If so, identify the vulnerable population and
provide a justification for their involvement. Also address any additional safeguards necessary to
protect the rights and welfare of vulnerable subjects.
SECTION VII: CONSENT/ASSENT PROCEDURES
1. Consent Personnel: Please list all personnel who will be obtaining consent.
2. Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the
personnel obtaining consent will assess the potential subject’s ability and capacity to consent to
the research being proposed.
3. Process of Consent: Describe the setting and conditions under which consent will be obtained,
including any steps taken to enhance subjects’ independent decision-making.
4. Non-English-Speaking Subjects: For research involving non-English-speaking subjects, fully
explain provisions in place to ensure comprehension. If enrollment of these subjects is anticipated,
please submit translated copies of all consent materials.
4(a) As a limited alternative to the above requirement, will you use the short form* for consenting
process if you unexpectedly encounter a non-English speaking individual interested in study
participation and the translation of the long form is not possible prior to intended enrollment?
YES ☐ NO ☐
July 1, 2016
Page 10 of 16
HIC#________
Note* If more than 2 study participants are enrolled using a short form translated into the same
language, then the full consent form should be translated into that language for use the next time a
subject speaking that language is to be enrolled.
Several translated short form templates are found on our website at: http://www.yale.edu/hrpp/formstemplates/biomedical.html. If the translation of the short form is not available on our website, then the
translated short form needs to be submitted to the IRB office for approval via amendment prior to
enrolling the subject. Please review the guidance and presentation on use of the short form available
on the HRPP website.
If using a short form without a translated HIPAA Research Authorization Form, please request
a HIPAA waiver in the section below.
5. Parental Permission and Assent: For research involving children, please explain how parental
permission and child assent will be obtained.
If children are providing assent, does the investigator plan to re-contact them when they reach
the age of majority? Please explain your answer. NOTE: If repository includes genetic
information, the HIC may require re-consent.
6. Documentation of Consent: Specify the forms that will be used among the following: adult
consent form, parental permission form, LAR (Legally Authorized Representative) (next of kin,
caregiver), permission form, adult assent form, adolescent assent form (ages 13-17 inclusive), child
assent form (ages 7-12 inclusive), and information sheet. Copies of all forms should be appended
to the protocol, in the same format that they will be given to subjects.
7. Consent Waiver: In certain circumstances, the HIC may grant a waiver of signed consent,
or a full waiver of consent, depending on the study. If you will request either a waiver of
consent, or a waiver of signed consent for this study, complete the appropriate section below.
Not Requesting a consent waiver
Requesting a waiver of signed consent
Requesting a full waiver of consent
A. Waiver of signed consent: (Verbal consent from subjects will be obtained. If PHI is collected,
information in this section must match Section VII, Question 6)
Requesting a waiver of signed consent for Recruitment/Screening only
If requesting a waiver of signed consent, please address the following:
a. Would the signed consent form be the only record linking the subject and the research?
Yes
No
b. Does a breach of confidentiality constitute the principal risk to subjects?
Yes
No
July 1, 2016
Page 11 of 16
HIC#________
OR
c. Does the research activity pose greater than minimal risk?
Yes If you answered yes, stop. A waiver cannot be granted. Please note:
Recruitment/screening is generally a minimal risk research activity
No
AND
d. Does the research include any activities that would require signed consent in a non-research
context?
Yes
No
Requesting a waiver of signed consent for the Entire Study (Note that an information sheet may
be required.)
If requesting a waiver of signed consent, please address the following:
a. Would the signed consent form be the only record linking the subject and the research?
Yes
No
b. Does a breach of confidentiality constitute the principal risk to subjects?
Yes
No
OR
c. Does the research pose greater than minimal risk?
Yes If you answered yes, stop. A
waiver cannot be granted.
No
AND
d. Does the research include any activities that would require signed consent in a non-research
context?
Yes
No
B. Full waiver of consent: (No consent from subjects will be obtained for the activity.)
Requesting a waiver of consent for Recruitment/Screening only
a. Does the research activity pose greater than minimal risk to subjects?
Yes If you answered yes, stop. A waiver cannot be granted. Please note:
Recruitment/screening is generally a minimal risk research activity
No
b. Will the waiver adversely affect subjects’ rights and welfare?
Yes
No
c. Why would the research be impracticable to conduct without the waiver?
d. Where appropriate, how will pertinent information be returned to, or shared with subjects at
a later date?
Requesting a full waiver of consent for the Entire Study (Note: If PHI is collected,
information here must match Section VII, question 6.)
If requesting a full waiver of consent, please address the following:
a. Does the research pose greater than minimal risk to subjects?
Yes If you answered yes, stop. A waiver cannot be granted.
No
b. Will the waiver adversely affect subjects’ rights and welfare?
Yes
No
c. Why would the research be impracticable to conduct without the waiver?
July 1, 2016
Page 12 of 16
HIC#________
d. Where appropriate, how will pertinent information be returned to, or shared with subjects at
a later date?
8. Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA Authorization for
either the entire study, or for recruitment purposes only)
Choose one:
☐ For entire study
☐ For recruitment purposes only
☐ For inclusion of non-English speaking subject if short form is being used
i. Describe why it would be impracticable to obtain the subject’s authorization for
use/disclosure of this data;
ii. If requesting a waiver of signed authorization, describe why it would be impracticable to
obtain the subject’s signed authorization for use/disclosure of this data;
By signing this protocol application, the investigator assures that the protected health
information for which a Waiver of Authorization has been requested will not be reused or
disclosed to any person or entity other than those listed in this application, except as
required by law, for authorized oversight of this research study, or as specifically
approved for use in another study by an IRB.
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale
HIPAA-Covered entity must be accounted for in the “accounting for disclosures log”, by subject name,
purpose, date, recipients, and a description of information provided. Logs are to be forwarded to the
Deputy HIPAA Privacy Officer.
9. Required HIPAA Authorization: If the research involves the creation, use or disclosure of protected
health information (PHI), separate subject authorization is required under the HIPAA Privacy Rule.
Indicate which of the following forms are being provided:
Compound Consent and Authorization form
HIPAA Research Authorization Form
SECTION VIII: PROTECTION OF RESEARCH SUBJECTS
1. Risks: What are the reasonably foreseeable risks, discomforts, or inconveniences associated with
donating biological material and data into the research repository?
Example: Potential research risks may include, for example, breach of confidentiality.
July 1, 2016
Page 13 of 16
HIC#________
2. Minimizing Risks: How will the above-mentioned risks be minimized?
Data released to collaborators for IRB approved research will be de-identified or assigned a
unique code, unless permission is granted by the HIC to include specific identifiers.
De-identified or coded data will be released to researchers only when the recipient researcher will
have no means to re-identify the subject.
The information, samples, data] contained in the repository will be coded with a separate
password protected file for the linking the code. [If the repository contains biologic samples,
explain where they will be stored, for example locked freezers] Information about the subjectdonors will be maintained in a password-protected computer and password-protected data files.
Only researchers responsible for operating the data bank will be provided with access.
Information resides on a server considered by ITS-Med to adhere to the HIPAA Security Rule.
3. Data and Safety Monitoring Plan: Please include a Data and Safety Monitoring Plan (DSMP)
that includes an explicit statement of overall risks, addresses attribution and grading of adverse
events and describes procedures for monitoring the ongoing progress of the research and reporting
adverse events. For more information, please see the HIC website:
http://www.yale.edu/hrpp/forms-templates/biomedical.html
4. Confidentiality and Data Security.
Investigators are reminded that subject identifiers and the means to link subject names and codes with
research data should not be stored on unencrypted moveable media, (e.g., laptops, compact discs,
jump drives, thumb drives). Identifiers and code keys must be stored in a secure manner, e.g., Yale
network servers. If identifiers are stored on moveable media then investigators must use encryption
methods to protect access to these files or other methods as appropriate for the types of information
stored on these devices.
a)
What private identifiable information about individuals will be collected and used?
(Note that HIPAA requires that the standard of “minimal necessary” be used when identifiable
information is collected. Therefore investigators are urged to collect only information which is
necessary to conduct the research and not collect information which is not needed.)
b)
How will research data be collected and recorded?
c)
How will information be shared or distributed to other secondary investigators?
Data released to collaborators for IRB approved research will be de-identified or assigned a
unique code, unless permission is granted by the HIC to include specific identifiers.
July 1, 2016
Page 14 of 16
HIC#________
d)
How will digital data be stored? (check all that apply) CD,
DVD,
Flash Drive,
Portable Hard Drive, Secured Server,
Laptop Computer, Desktop
Computer,
Other (specify)________
e)
What methods and procedures will be used to safeguard the confidentiality and security
of subjects study data and storage media indicated above? (If using coded information
that can still be linked to subject names, please indicate if the codes and names will be
kept in separate physical locations.)
f)
Do all portable devices contain encryption software?
If no, see http://hipaa.yale.edu/guidance/policy.html
Yes
No
Information about the subject-donors will be maintained in a password-protected computer and
password-protected data files. Only the members of the research [tissue/specimen/data] bank staff
and researchers who have received the approval of the HIC to use the [tissue/specimen/data] will
know the identity of the subject(s).
f)
What mechanisms are in place to ensure proper use and continued protection of these
data?
g)
If the research will be completed, what will be done with the data at the completion of
the study? Are there plans to destroy the identifiable data? If yes, describe how, by whom and
when identifiers will be destroyed. If no, describe how the data and/or identifiers will be
secured.
.
h)
Which external or internal individuals or agencies (such as the study sponsor, FDA,
Yale Cancer Center Data and Safety Monitoring Committee, YCCI Science and Safety
Committee, Yale Accounts Payable etc.) will have access to study data? (Please distinguish
between PHI and de-identified data) Representatives from the sponsor and from the HIC may
inspect study records during auditing procedures. However, these individuals are required to
keep all donor information confidential.
i)
Are there any mandatory reporting requirements? (Incidents of child abuse, elderly
abuse, communicable diseases, etc.)
j)
If appropriate, has a Certificate of Confidentiality been obtained?
See IRB policy 400, PR 2, http://www.yale.edu/hrpp/policies/index.html#SpecialIssues
5. Potential Benefits: Please identify any benefits that may be reasonably expected to result from the
research, either to subjects or to society at large.
Subjects will not receive any direct benefit for donating their [tissue/specimen/data] for future
research use. We hope that the information we learn in future research studies will increase our
July 1, 2016
Page 15 of 16
HIC#________
knowledge of human health and that this information will lead to better diagnoses and treatments
in the future.
SECTION IX: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS
1. Alternatives: What alternatives are available to subjects?
Subjects will have the option to decline donating their [tissue/specimens/data] to the research
repository. Alternatively, subjects may choose to donate their biologic specimens in a deidentified manner.
The relationship between the subjects and the study doctors, Yale University or Yale-New
Haven Hospital will not be affected if subjects choose one of the alternatives noted above.
2. Payments for participation (Economic Considerations): Describe any payments that will be
made to subjects (including direct monetary payment, payment in the form of a gift, or
reimbursement for costs such as travel, parking, childcare, etc.), and the conditions for
receiving this compensation.
Subjects will not receive any payments for donating their [tissue/specimen/research data] into
the research data bank.
[Tissue/Specimen/Data] obtained from subjects in this research may be used to establish a
[product or information] that could be patented and licensed. There are no plans to provide
financial compensation to subjects should this occur.
Costs for participation (Economic Considerations): Clearly describe the subject’s costs
associated with participation in the research.
SECTION X: FORMATTING
Please ensure that your protocol contains the header and footer formatting as demonstrated on this
document and version date. Consent, assent, permission, and information sheets must also contain
these headers, footers and version dates.
July 1, 2016
Page 16 of 16