Institutional Review Board
200 Jefferson Ave. SE
Grand Rapids, MI 49503
P: 616.685.5213
F: 616.685.3044
IRB Application for Initial Review
Receipt of your application by the office of the IRB does not confirm
your study will be placed on the next IRB agenda.
Assigned IRB number: ___________________________________ (to be completed by IRB administration)
Full study title:
Protocol #
Short title:
The documents listed below must be included in your submission packet.
Missing documents may result in delay of IRB review or approval.
Please make sure you have included all documents applicable to your study.
Protocol Documents
Version/Date
Research Protocol
:
Version/Date
Informed Consent/Assent Form(s)
:
Request for Waiver of Written Informed Consent
Request for Waiver of Assent (Complete Appendix C)
Saint Mary’s Health Care HIPAA Authorization Form (if appropriate language not included in ICF)
Version/Date
Data Collection Tools
:
Recruitment Material (Ads, Flyers, Posters, Press Releases) Version/Date
:Version/Date
Investigator’s Brochure
:
Version/Date
Other (please specify)
:
Investigator/Research Study Staff Documents
N/A
SMHC Confidentiality Agreement (all research study staff) -ORConfidentiality Agreement on file w/SMHC
Financial Disclosure Form (all investigators) - This is not required for retrospective record reviews.
CITI Certificate (required for all research study staff)*
Copy of Principal Investigator’s CV
NOTE: *Saint Mary’s Health Care requires all individuals who are involved in the conduct of research within
Saint Mary’s to be trained in human subject protection prior to their participation in a research project.
Have you contacted the department/agency location where you expect to recruit participants for this
research study?
Yes
No (If yes, please obtain signature of the department’s director; if no, please
explain.)
If you intend to conduct off-site campus research or recruitment, letters of compliance may be necessary.
_____________________________________
Signature
IRB Application for Initial Review, v.07/22/11
______________________
Date
Study Type(s) (Check all that apply):
Device
(Complete Appendix A)
Drug
(Complete Appendix B)
Observational
Survey
Expanded Use
Prospective Study
Tissue Bank / Biologic
Humanitarian Device Exemption (HDE)
(Include evidence of HDE from the FDA)
Retrospective Record Review / Registry
Case Report (submit Case Report form in lieu of this application)
Principal Investigator:
Resident
Name and Degree(s):
Mailing Address:
Phone: (
)
Fax: (
)
Pager: (
E-mail address:
*If student, please provide name of university and professor for this project:
University:
Professor:
Student*
)
Sub-Investigator(s):
Name & Degree(s):
Resident
Mailing Address:
Phone: (
)
Fax: (
)
Pager: (
E-mail address:
*If student, please provide name of university and professor for this project:
University:
Professor:
Resident
Name & Degree(s):
Mailing Address:
Phone: (
)
Fax: (
)
Pager: (
E-mail address:
*If student, please provide name of university and professor for this project:
University:
Professor:
Resident
Name & Degree(s):
Mailing Address:
Phone: (
)
Fax: (
)
Pager: (
E-mail address:
*If student, please provide name of university and professor for this project:
University:
Professor:
Student*
)
Student*
)
Student*
)
Study Coordinator
Name & Degree(s):
Mailing Address:
Phone: (
)
E-mail address:
Fax: (
)
SMHC Faculty Advisor/Mentor (required for residents & students)
Name & Degree(s):
Mailing Address:
Phone: (
)
Pager: (
)
IRB Application for Initial Review, v.07/22/11
Fax: (
)
E-mail address:
Pager: (
)
Study Sites
SMHC
Saint Mary’s SW Campus
Wege Institute
Clinica Santa Maria
Browning Claytor
Pine Rest
Advantage Health Office(s) (please specify)
Other (please specify)
Proposed Study Dates: (Please remember you may not begin data collection without IRB approval)
From:
To:
month/day/year
month/day/year
Proposed Budget: (Complete even if no funding is available)
Source
Amount
$
$
$
Study Populations (Please check all that apply):
Vulnerable Populations
Yes
This is addressed in the protocol
Prisoners
Pregnant women
Children (<18)
Cognitively impaired persons
Economically or educationally disadvantaged persons
Fetuses
Targeted or Limited to Specific Ethnic Group
Non-English speaking participants
NOTE: Failure to address this information in your protocol may delay approval of your study.
Vulnerable populations include those individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the
expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
hierarchy in case of refusal to participate. Examples are: members of a group with a hierarchal structure such as students,
subordinate personnel, members of the armed forces and persons kept in detention. Other vulnerable subjects include patients with
incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic
minority groups, homeless persons, refugees, minors, and those incapable of giving consent.
IRB Application for Initial Review, v.07/22/11
Subject Privacy/Confidentiality
Every protocol must address the following items relating to confidentiality. If you
have a sponsor-supplied protocol, please address these questions as they relate to your
specific site.
Will data be collected in such a manner that subjects are identified either directly or
through identifiers linked to the subjects? If yes, please explain:
Will data be reported in such a manner that subjects are identified either directly or
through identifiers linked to the subjects? If yes, please explain:
Is there a description in the protocol of how will you ensure the de-identification of
research data? If no, please explain:
Is there a description of your plan for protection of written research data included in the
protocol? If no, please explain:
Is there a description of your plan for protection of electronic research data included in the
protocol? If no, please explain:
Miscellaneous
Are there any personal/professional relationships that are associated with your participation
in this study that could constitute a conflict of interest? If yes, please explain:
Does your study include collection of human source materials (i.e. blood products, tissues
or body fluids) by invasive means?
Does your study include collection of blood that exceeds 50 ml (3 tablespoons) in an 8week period, and does the collection occur more than two times per week?
Does your study include radiologic exposure (i.e. x-rays, CT, PET scans) or radiation
therapies?
Does your study include audio or video taping or photographing of research participants?
If yes, specify where these items are addressed in the protocol:
 How the research participants are identifiable page #
 How long identifiers will be retained and any plans to destroy them page #
 Who will have access to them page #
 How they will be used outside of the project (training, presentations or
publications) page #
Additional Information/Comments:
IRB Application for Initial Review, v.07/22/11
Yes
No
Person to contact regarding questions pertaining to this application
Name & Degree(s) or Title:
Mailing Address:
Phone: (
)
Fax: (
)
E-mail address:
Complete checklist on page 1 before submitting.
IRB Application for Initial Review, v.07/22/11
Assurance of Principal Investigator:
As the principal investigator on this study, I certify by my signature below that:

I will not initiate the proposed research until approval is granted by Saint Mary’s Health Care IRB.

I will submit continuing review reports to Saint Mary’s Health Care IRB as required.

The research will be conducted according to Good Clinical Practice and ethical principles of the Belmont Report,
federal and state regulations, the Saint Mary’s Health Care IRB approved protocol, and to comply with all
applicable Saint Mary’s Health Care policies.

I will promptly report to Saint Mary’s Health Care IRB proposed changes in previously approved research
activities. Proposed changes may not be initiated without prior Saint Mary’s Health Care IRB review and
approval, except where necessary to eliminate apparent immediate hazards to subjects. Emergent changes will be
reported within 24 hours of occurrence.

I will promptly report to Saint Mary’s Health Care IRB all on-site unexpected or significant adverse events, or any
unanticipated problems (e.g. breaches of confidentiality, complaints about the study, withdrawal of study subjects,
etc.) within 24 hours of the occurrence.

I will promptly report to the Saint Mary’s Health Care IRB all sponsor-reported unexpected or significant adverse
events, or any unanticipated problems (e.g. breaches of confidentiality, complaints about the study, withdrawal of
study subjects, etc.) within 10 days of receipt.

I will maintain and protect the privacy and confidentiality of all protected health information (personally
identifiable information) on human research subjects, except as required by law or released with written
permission of the subject.

I will promptly notify Saint Mary’s Health Care IRB when the study status changes (e.g. closed to accrual, placed
on hold, completed or terminated).

I will disclose any current or future conflict of interest, including financial, associated with the implementation of
this study.

The information provided in this application is accurate and fully describes any and all procedures regarding
human subjects under which I will conduct this research.

I will ensure the selection of human research subjects for participation is equitable, and appropriate safeguards are
included to protect the rights and welfare of vulnerable populations (e.g. children, cognitively impaired,
economically disadvantaged).

I will ensure that all research personnel assisting with the research are trained on human research protections,
informed of their research responsibilities and qualified by training and experience to conduct delegated
responsibilities.

I will retain study related documentation and informed consent forms for at least seven years after completion of
the study or in accordance with the terms of the Clinical Trial Agreement, which may be longer.

I have read the attached addendum stating the guidelines for the protection of data and will ensure all research
staff adheres to these guidelines.

I have read the above listed research responsibilities as they relate to the protection of human subjects and accept
responsibility for my sub-investigators and other personnel involved on this project, in regards to their compliance
with the above stated policies.
_______________________________________________________
Signature of the Principal Investigator
____________________________
Date
_______________________________________________________
_____________________________
Date
Signature of Faculty Advisor / Mentor (if PI is resident or med. student)
IRB Application for Initial Review, v.07/22/11
Addendum to IRB Application
(Please print and distribute to all research staff)
Protection of Data
It is the Principal Investigator’s primary responsibility to protect any data related to a research project as outlined
in Saint Mary’s Health Care Institutional Policies 11.104 through 11.503. If the data is lost by anyone associated
to the research study, the Principal Investigator is responsible.
Data in electronic format must be carefully monitored, stored and transported consistent with IRB approval and
Saint Mary’s Health Care Information Security Policies.
http://nexus.trinity-health.org/policies/security.shtml
Information that is drawn from a patient’s chart must:
 Remain on a secure part of the hospital network
 Be kept in a locked file cabinet in a locked office
 Be in an encrypted file on a SMHC laptop or PC
REMEMBER:
 Password protection is not encryption
 Passwords should be a strong mix of alpha and numeric characters
Data Transmission and Transport:
 E-mail is not a secure means of transmitting patient information unless the message has been encrypted.
 An e-mail sent within the Trinity Health network (from a Trinity address to another Trinity address) is
encrypted and secure.
 A message sent from a Trinity address to an address outside of the Trinity Health Network is not secure
and must be encrypted.
 To encrypt a GroupWise e-mail that is to be sent to a non-Trinity entity (Mary Free Bed, Spectrum
Health, MSU, GRMERC, etc.) follow these steps:
 Select New Mail
 Click on Send Options
 Go to the “Classification” drop down list
 Select “Confidential” from the list of drop down choices
 Return to the Mail tab
 Your e-mail is now ready for secure delivery
 Avoid using your home e-mail account for sending patient information unless you are certain you are
able to encrypt the message.
 Transmission of patient information via FAX is secure provided you are certain the proper recipient
receives the fax.
 Transmission via U.S. Mail is considered secure.
 Transporting patient information on a flash drive, CD or other mobile media is very risky. Portable
media must be kept secure from theft or accidental loss. Data stored on such devices should be password
protected and encrypted.
Failure to properly secure patient data can result in civil or criminal sanctions and fines should
the data be subject to a security breach or inappropriate disclosure.
IRB Application for Initial Review, v.07/22/11
Institutional Review Board
200 Jefferson Ave. SE
Grand Rapids, MI 49503
P: 616.685.5213
F: 616.685.3044
Initial Application
Appendix A: Devices
1. List each device being evaluated for safety or effectiveness
Name of Investigational
Device
IDE# Required
Y
N
Y
N
Y
N
IDE# or HDE#
IDE Holder
SR or NSR
Investigator
Sponsor
Investigator
Sponsor
Investigator
Sponsor
Name of Sponsor
or Manufacturer
NSR
SR
NSR
SR
NSR
SR
2. Describe how the investigators are qualified to utilize the above named devices and perform the procedures required by the
study (describe if there is any specialized device training)
3. Describe the plans to control the device so it will be used/implanted only in research subjects and be used only by authorized
investigators
4. If the device has an IDE, please attach the FDA approval letter for the device to this form.
5. If this is an investigator initiated trial, please attach a letter of support for the device to be used in the proposed manner from the
device manufacturer.
6. If this is an investigator initiated trial, and you are proposing to utilize the device in an “off-label” use to evaluate its safety and
effectiveness for a new indication, please provide a written explanation supporting the Significant Risk (SR) or Non-Significant Risk
(NSR) determination. You may reference the protocol section that contains this information or you should enter the information here
N/A
7. If you are indicating that this study is a NSR study, please provide an explanation of how the device meets the following required
regulatory criteria:
a) The device is not intended as an implant and poses no serious risk to the health of the patient
b) The purpose of the device is not to support or sustain life and does not present a serious risk to the health or the patient
c) The purpose of the device is not for use of substantial importance in diagnosing, curing, mitigating or treating disease or
otherwise preventing impairment of health and does not present a serious risk to the health of the patient
d) The device does not otherwise pose a serious risk to the health of the patient
This form prepared by:
Date:
Mail completed form and documentation to: Brenda Hoffman, IRB Coordinator, Saint Mary’s Health Care, 200 Jefferson Ave.
S.E., Grand Rapids, MI 49503 / Fax: 616.685.3044 / E: hoffmabs@trinity-health.org
Initial Application
Appendix B: Drugs and Biologics
IRB Application for Initial Review, v.07/22/11
Institutional Review Board
200 Jefferson Ave. SE
Grand Rapids, MI 49503
P: 616.685.5213
F: 616.685.3044
1. List each drug or biologic being evaluated for safety or effectiveness
Name of Investigational
Drug
IND# Required
Y
N
Y
N
Y
N
IND#
IND Holder
Name of Sponsor or Manufacturer
Investigator
Sponsor
Investigator
Sponsor
Investigator
Sponsor
2. Describe how the investigators are qualified to utilize the above named drugs/biologics and perform the procedures required
by the study (describe if there is any specialized drug/biologic training)
3. Describe the plans to control the drug/biologic so it will be used only in research subjects and be used only by authorized
investigators
4. If the drug has an IND, please attach the FDA approval letter for the drug to this form.
5. If the drug does not require an IND, you must submit one of the following:
 Communication from the FDA that the use of the drug/biologic in the study is IND Exempt (attach letter to this form)
 An explanation of how the drug meets the following required regulatory criteria:
o The investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication
for use nor intended to be used to support any other significant change in the labeling for the drug
o If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is
not intended to support a significant change in the advertising of the product
o The investigation does not involve a route of administration or dosage level or use in a patient population that
significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug
product
o The investigation will be conducted in compliance with the requirement for institutional review set forth in part 56
and with the requirements for informed consent set forth in part 50
o The investigation will be conducted in compliance with the requirements of 312.7
6. Please attach a copy of the drug’s package insert if one is available.
This form prepared by:
Date:
Mail completed form and documentation to: Brenda Hoffman, IRB Coordinator, Saint Mary’s Health Care, 200 Jefferson Ave.
S.E., Grand Rapids, MI 49503 / Fax: 616.685.3044 / E: hoffmabs@trinity-health.org
Initial Application
Appendix C: Request for Waiver of Assent
I.
Request for Waiver of Assent
IRB Application for Initial Review, v.07/22/11
Institutional Review Board
200 Jefferson Ave. SE
Grand Rapids, MI 49503
P: 616.685.5213
F: 616.685.3044
A. Are you requesting a waiver of the assent requirement for all or some of the subjects?
All Subjects
Some of the Subjects (those who are not capable of providing assent)
Individual Subject (provide age of subject
)
A waiver of assent may be considered by the IRB if B. or C. are met.
B. Does the intervention or procedure involved in the research hold out a prospect of direct benefit that is important to
the health or well-being of the child(ren) AND is it available only in the context of the research?
Yes, describe and no further questions need to be addressed:
No
C. Is the capability of some or all of the children so limited that they cannot reasonably be assented?
Yes, describe and no further questions need to be addressed:
No (*complete D. through G.)
*A waiver of assent may still be considered by the IRB for children capable of providing assent if the following conditions (D – G)
are met:
D. Is the research minimal risk to subjects?
Yes
No
E. This waiver will not adversely affect the rights and welfare of the subjects because:
F. Describe how the research could not practicably (feasibly) be carried out without the waiver of assent (note: time,
inconvenience and limited resources are not considered justifiable reasons for a waiver of assent):
G. Whenever appropriate, children/parents/guardians will be provided with additional pertinent information after
participation.
Yes
No
If yes, describe what will be provided and how findings will be communicated (example: a summary of study results
will be provided to subjects in a newsletter):
H. Is it appropriate to provide an information sheet (written summary) to the minor subject about the research?
Yes, information sheet will be provided and is attached with this submission
No, explain:
II.
Request for Waiver of Parental Permission (Note: a waiver cannot be granted for FDA regulated research)
A. Is the research minimal risk to children?
Yes
No
B. Explain why the research could not practicably (feasibly) be carried out without the waiver of parental permission:
IRB Application for Initial Review, v.07/22/11
C. Explain why the waiver of consent will not adversely affect the rights and the welfare of the children:
D. Whenever appropriate, children will be provided with additional pertinent information after their participation.
Yes
No
If yes, describe what will be provided and how findings will be communicated (example: analysis of study information
indicates subjects are at increased risk):
E. Are the children allowed, by state law, to provide informed consent for medical care involved in the research (e.g.
STD testing)?
Yes
No
F. Is the research protocol designed for conditions or for a subject population for which parental or guardian permission
is not a reasonable requirement to protect the subjects (e.g. child abuse research)?
Yes
No
G. Describe the process and mechanisms used to obtain assent from the children:
This form prepared by:
Date:
Mail completed form and documentation to: Brenda Hoffman, IRB Coordinator, Saint Mary’s Health Care, 200 Jefferson Ave.
S.E., Grand Rapids, MI 49503 / Fax: 616.685.3044 / E: hoffmabs@trinity-health.org
IRB Application for Initial Review, v.07/22/11