Integrity
RESEARCH Research
and Assurance
V 4.21.16
Application for Human Subject Research – Full Board or Expedited Review
Please complete this application for all non-exempt research involving human research participants. You may
choose to email the application and supporting document to irb@princeton.edu or deliver ONE copy by person or
by mail to:
IRB Office:
307 87 Prospect Ave. 3rd Floor
RIA administrators are pleased to offer consultative service for researchers with IRB inquiries regarding expedited
review eligibility, risk determination, consent procedures, policies and procedures, etc. Please contact us at
irb@princeton.edu or call (609) 258-0865 to make an appointment.
SUBMISSION GUIDE
Check each item to indicate that you have completed all of the following, as appropriate.
Answer all questions and submit your application to avoid delays.
Submit Informed Consent documents as appropriate.
Include IRB approvals from collaborating institutions along with permission letter(s).
Provide all supporting documentation such as interview questions, survey instrument(s), recruitment materials,
data-use agreements, etc.
CITI Human Research Training Certificate(s): If not completed, access CITI here:
Include IRB approvals from collaborating institutions along with permission letter(s).
Provide all supporting documentation such as interview questions, survey instrument(s), recruitment materials,
data-use
agreements,
etc.
Submit
Expedited
Review
Request with
your
application
to request
expedited
review.
If your
research
involves
minimalthe
risk
to subjects,
your application
may
qualify
for expedited
review
procedures,
which
means
that the
application will be reviewed by only one board member. Once reviewed, an approval notice or a memo
requesting changes will be issued by email.
Applications eligible for expedited review are accepted daily on a rolling basis. If your research involves greater than
minimal risk to participants, Full Board review is required. To be considered at a Full Board meeting, protocols
involving greater than minimal risk must be received in the IRB office by noon on the deadline of the desired meeting
date below.
Submission Deadlines
IRB Meeting Dates
August 31, 2015
September 21, 2015
September 21, 2015
October 12, 2015
October 19, 2015
November 9, 2015
November 23, 2015
December 14, 2015
December 21, 2015
January 11, 2016
January 18, 2016
February 8, 2016
February 22, 2016
March 14, 2016
March 21, 2016 April
April 11, 2016
18, 2016
May 9, 2016
May 23, 2016
June 13, 2016
1
SECTION A: GENERAL STUDY INFORMATION
1. State the title of the proposed research.
2. Study Personnel (Only Princeton faculty and appropriate staff may be named as Principal Investigator. All students
must list their faculty advisor as Principal Investigator below).
Principal Investigator/Faculty Advisor:
Department:
Departmental Address:
Email:
Phone:
Student Investigator (if applicable):
Student Year/level: Choose a year:
Email:
Phone:
Choose a level
Study Contact Person:
Email:
Phone:
3. List all co-investigators and key study personnel. Provide the name of their department, departmental address, e-mail
address, phone number and fax number (if applicable).
4. Briefly describe the role of each study personnel listed above (i.e., Research Coordinator – data collection, consent
subjects, administer survey etc.)
2
Application for Human Subject Research – Full Board or Expedited Review
5.
6.
Is this a student project?
Yes
No
If yes, please choose the project type: Choose a project type or specify:
Will research be conducted outside of the United States? Yes
No
If yes, complete the International Supplement B at the end of the application and submit along with the
application for review.
Important Note: Researchers conducting research outside the United States must comply with the relevant
laws of the host country. If an international institution or site is engaged in research, and the research is
supported by federal funding, additional requirements may apply. Describe the process being undertaken to
secure IRB and/or other appropriate institutional approval necessary to conduct research with subjects at
another institution or organization. Participants may be recruited elsewhere only with written permission of
an appropriate official. Attach copies of the approval.
7. Please list the agencies that are funding or have been asked to fund this research. Attach a copy of the grant
application submitted for funding.
8. State approximate dates for starting and ending this research project (including enough time for data analysis).
(Note: The project may not start until it has been approved by the Board.)
Start:
End:
3
Application for Human Subject Research – Full Board or Expedited Review
SECTION B: RESEARCH PURPOSE
9. Provide a summary of the purpose of your research project. Include a description of the background and rationale for
the study, explain the research design, research methodology, hypotheses and goal(s). Specify the problems to be
addressed, what is to be learned, and identify the specific objectives of the proposed research using non-technical
language understood by a person unfamiliar with this area of research.
4
10. Describe in detail the procedures that will be used to achieve the objectives of the research project and specify what
you will do with the results of your study (e.g., publish, share in presentation or conference, etc.)
5
SECTION C: RESEARCH PROCEDURES:
11. Categories of Research: The research involves the following (check all that apply):
Education Research
Internet-based research
Questionnaires/Surveys
Analysis of Existing Data
Ethnographic/Field Research
International Research (complete supplement B)
Use of pre-existing Tissues
Chart Review – retrospective
EKG/EEG/fMRI/Chest X-ray
Chart Review – prospective
Clinical Observations
Collection of Clinical Specimens
Clinical Tests
Tissue banking
Drugs/Biologics (complete supplement F)
Stored Data for Future Use (complete supplement E)
Audio/Video recording
Other:
SECTION D: RESEARCH SETTING:
12. Describe the settings in which research procedures will be carried out (e.g., hospital, clinic, school, home, lab, etc.)
13. Indicate all Princeton campus sites, or off campus sites that are owned or operated by Princeton, where the research
procedures will be carried out.
6
14. Is this a multi-site, organization or institution study: Note: A multi-site study is any study where the Princeton
investigator is conducting research at a site(s) that is not owned, operated or under the control of Princeton
University?
Yes
No
If yes, please specify the following:
a.
Is the Princeton Investigator the lead investigator for the multi-site study :
b.
Is Princeton University the lead site:
c.
If either of the above is yes, describe the provisions for the management of information obtained from the
different site that might be relevant to the protection of participants (e.g., data coordinating center).
d.
Yes
Yes
No
No, If no, please specify:
List all non-Princeton sites where the procedures will be carried out. For each site, specify the contact
information and indicate whether the site has IRB approval and/or has granted permission for the research
to be conducted at that site. If permission has been granted, please attach a copy of the permission letter
and/or notice of IRB approval.
7
Application for Human Subject Research – Full Board or Expedited Review
SECTION E: PARTICIPANT SELECTION AND POPULATION:
Equitable Subject Selection: Selection of subjects must be fair and equitable. That is, the selection process must
avoid exploiting potential subjects (taking advantage of their circumstances) and minimize coercion.
Note: In making this assessment, the IRB will take into account the purpose of the research, the setting in which
the research will be conducted as well as additional safeguards to protect vulnerable populations, such as children,
prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
15. Explain how the subject selection process in this research is fair and equitable, taking into account eligibility criteria,
vulnerability and recruitment process:
Note: When some or all of the research 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 subjects.
16.
The research involves the following (check all that apply):
Healthy Participants
Prisoners
Students, Specify School:
Pregnant Women, Fetuses, or Neonates
Children or Minors, Complete Supplement C
Children who are Wards of the State
Cognitively Impaired, Complete Supplement D
Non-English Speakers
Employees, Specify Employer:
Institutionalized Individuals (not prisoners)
8
Application for Human Subject Research – Full Board or Expedited Review
17.
Please provide a description of the participant population. Describe the characteristics of the participant population
such as gender, age range, ethnic background and health status, as applicable to the research.
18.
Please provide a rationale for the use of special groups or subjects whose ability to give voluntary informed
consent may be in question (e.g., cognitively impaired).
19. Provide the total number of research participants you anticipate are needed for this research (include number of
participant records, specimens, etc., if applicable) for IRB approval. Note: the number of people enrolled should include
those individuals who agree to participate (i.e., those who provide consent or whose records are accessed, etc.)
20. In the chart below, please indicate the number of subjects per category, if known:
MALE
FEMALE
TOTAL
ADULTS
0
CHILDREN
0
TOTAL
0
0
0
Please specify any alternate numbering system, specific to the type of research being conducted, as appropriate:
21. Will any groups or categories of subjects be excluded from research?
Yes
No
If yes, please specify and provide the rationale for excluding these subjects:
9
SECTION F: PARTICIPANT RECRUITMENT PROCEDURES
22. Describe all inclusion/exclusion criteria that will be used to select research participants. Provide a detailed description
of how research participants will be selected and by whom (specify name and role).
23. Describe your recruitment plan and attach all recruitment materials including advertisements, emails, flyer, letter of
introduction, etc.
10
24. Check all recruitment materials that apply:
Letter of Introduction
Recruitment Email
Flyer
Advertisements
Other, please describe
25. Will participants be recruited by searching records (e.g., school records, medical records, mailing list, databases, etc)?
Yes
No
a.
If yes, will this include paper files?
Yes
No
State where paper files will be located?
b.
If yes, will this include electronic files?
Yes
State who will maintain these electronic files?
No
c.
Will existing databases be utilized?
Yes
No
If yes, please specify types and locations of databases:
d.
Other, please describe:
26. Will subjects be offered compensation for participating in the research?
Yes
No
If yes, describe the nature of the compensation. (Indicate the amount and schedule of payments as well as
conditions for subject receiving compensation for participating in the research) Substantiate that:
 Proposed payments are reasonable and commensurate with the expected contributions of the participant
 Participant payments are fair and appropriate.
 They do not constitute (or appear to constitute) undue pressure or influence on the perspective research
participants to volunteer for, or to continue to participate in, the research study, and
 That the payments do not constitute (or appear to constitute) coercion to participate in, or continue to participate
in, the research study.
11
Application for Human Subject Research – Full Board or Expedited Review
SECTION G: CONSENT PROCEDURES
Unless waived by the IRB, Informed Consent is necessary for all research involving human subjects and must be
documented. The investigator may determine which method would best serve the interest of the subject population,
but the IRB reserves the right to require alternative or more stringent means of securing consent.
Note: Use of subjects unable to give personal consent for reasons of age, mental state, legal or other such status, requires
that parental permission or consent from a legally authorized representative (surrogate consent) be obtained. For
research involving children complete Supplement C or Supplement D for cognitively impaired subjects. Information
regarding assent of subjects will be requested in those sections.
27.
Do you plan to obtain signed documented consent from all study participants?
Yes
No
If yes, specify the following:
a. Specify where the informed consent process will take place:
b. Specify who will obtain consent and describe their experience in obtaining consent from subjects:
c. How will it be determined that the subjects or the subjects’ authorized representatives understand the
information presented?
d. If English is not the subjects’ native language, will translation be provided?
Yes
No
12
If no, or you plan to use oral consent, please complete Supplement A to request a waiver of consent or
documentation. If you plan to use a consent form or oral script, please complete the template on the IRB website
and attach a copy for IRB review.
Important Note: Consent that is being presented orally must also include all required consent elements.
In order to use Princeton’s Standard Consent Template for this purpose, please simplify the language to adopt a
conversational tone and omit the signature lines as there is no specific oral consent template currently available.
Please note that a copy must be provided to participants.
28. Does the proposed research involve deception, e.g., through provision of misinformation, withholding information,
etc.? Explain why it is necessary to involve deception(s) in the research. Note: Withholding the full hypothesis does
not amount to deception.
29. Provide a full account of the debriefing procedures to be followed, if deception will occur. Note that all psychology
department participant pool subjects must receive a full debriefing for educational purposes. If you plan to debrief,
please attach a copy of the written debriefing or the debriefing interview protocol.
13
Application for Human Subject Research – Full Board or Expedited Review
SECTION H: RISK TO SUBJECTS:
Risks to research subjects posed by participation in research should be justified by the anticipated benefits to the
subjects or society. This section is to assess “benefits” and “risks" to subjects including how those risks may be
minimized -- i.e., the possibility of physical, psychological, sociological, breach of confidentiality, or other harm as a
consequence of participation in the proposed research project. Please use as much space as needed to answer each
question.
30. Risk Classification: What is the overall risk classification of the research?
NOTE - According to HHS regulations, minimal risk means: "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."
Minimal
Greater than minimal
Unknown?
31. What are the possible anticipated risks and discomforts to the participants? Describe all possible risks including
psychological, physical, sociological or economic harm (e.g., risk of criminal or civil liability, damage to their financial
standing, employability, insurability, reputation, or stigmatization, etc.)
 Check all that apply, and describe each:
 Loss of confidentiality, describe:
 Loss of Social Status, describe:
 Emotional stress or discomfort, describe:
 Physical injury or discomfort, describe:
 Loss of Employment, describe:
32. Please describe any additional risks to participants or others:
33. Describe how you will minimize these risks and their potential impact to the participants or others?
14
34. Are there any direct benefits to the research participants? Note: Direct benefit is a valued or desired outcome; an
advantage (please do not include monetary inducement or compensation).
 Yes  No. If yes, please describe:
35. In a few sentences, please address the benefits of the research, both to science and/or society. The ethical review
requires the IRB to balance how any possible risks that may be involved in the research, even though the risks may be
minimal, are justified by the potential benefits resulting from the investigation.
36. If the risk in this study is more than minimal, explain how the risks are reasonable in relation to the benefits:
SECTION I: CONFIDENTIALITY, DATA AND SAFETY MANAGEMENT:
37. Will you record any demographic data or direct participant identifiers?
Yes
No
If yes, indicate the types of data that will be recorded:
38.
Names
Ethnicity
Addresses
Marital Status
Phone numbers
Income
Age
Social Security number
Gender
Job title/Name of employer
Other:
Explain why it is necessary to maintain such identifiers and describe the coding system you will use to protect against
disclosure.
15
Application for Human Subject Research – Full Board or Expedited Review
39.
Will you retain a link between study code number and direct identifiers after the data collection is complete?
Yes No
If yes, explain why it is necessary and describe the coding system you will use to protect against disclosure(if different
from above).
40. Describe what procedures will be used to ensure secure storage of study materials including, consent forms, survey
responses, etc. during the course of the project. Specify who will have access to these materials:
41. Describe specifically what will be done with all study materials at the conclusion of the study. Include paper records,
audio and video recordings, field notes, transcripts, etc. in your response. If materials are to be retained, describe the
secure storage of those materials. Please note: Documentation of the signed informed consent of the subjects,
written protocol and other records related to conducted research that are typically held by investigators, must be
retained for at least three years after completion of the research.
42. In the event that outside organizations are involved (in data gathering, processing, and storage), how will the rights of
the subjects be guaranteed by that agency?
16
43. If your proposed research involves more than minimal risk, describe the data and safety management plan (DSMP).
The DSMP should address:
a.
b.
c.
A description of the plan to monitor research progress and subject reactions, including who will do the
monitoring and ensure monitoring will be accomplished
Identification of a Data Safety Monitor or Data Safety Monitoring Board, where applicable
A plan for dealing with adverse events and unanticipated problems involving risk to subjects or others
d.
A description of the plan to assure compliance with reporting of adverse events and/or unanticipated
problems involving risks to participants or others
e.
A description of the plan to assure data accuracy and protocol compliance
SECTION J: TRAINING AND CERTIFICATION:
44. All research investigators who propose to work with human subjects in their studied must have human subjects
training. Princeton has adopted the CITI program for this purpose though other training may be acceptable. Please
refer to SOP 202 for details.
Please note that the IRB will not issue final approval unless all proper training is completed or
certifications are received.
17
SECTION K: UNANTICIPATED PROBLEMS OR ADVERSE EVENT
45. Federal regulations require prompt reporting to the IRB of any unanticipated problems involving risks to subjects or
others. The Office for Human Research Protections (OHRP) considers unanticipated problems to include
any incident, experience, or outcome that meets all of the following criteria:
 unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in
the protocol-related documents, such as the IRB-approved research protocol and informed consent document;
and (b) the characteristics of the subject population being studied;
 related or possibly related to participation in the research (possibly related means there is a reasonable
possibility that the incident, experience, or outcome may have been caused by the procedures involved in the
research); and
 Suggest that the research places subjects or others at a greater risk of harm (including physical, psychological,
economic, or social harm) than was previously known or recognized.
Your signature at the end of this application certifies that you understand these criteria and agree to promptly report
any unanticipated problems involving risks to subjects or others to the IRB.
SIGNATURES:
Include the signature of the Principal Investigator and the date. Also include the advisor’s signature, if applicable.
Faculty or staff projects:
Principal Investigator
Professional Title:
Date:
Student projects:
Faculty Advisor Assurance
I am the faculty advisor for the student submitting this protocol. By my signature, I certify that I have reviewed the
protocol and believe that it is scientifically and ethically sound. Furthermore, I believe that the student has the necessary
training, experience and knowledge to conduct the research in a manner consistent with the regulations governing human
subject research and sound research principles. I agree to:
•
•
•
Oversee and monitor the conduct of this research by communicating regularly with the student investigator;
Assist with the resolution of any problems or concerns encountered during the research;
Assure that the Princeton IRB is notified in the event of a protocol deviation or an unanticipated problem involving
risks to subjects or others.
I understand that as faculty advisor I am responsible for the conduct of this research.
Principal Investigator
Date
____________________________________
Student Investigator
____________________________________
Date
18
SUPPLEMENT CHECKLIST
Please check all the categories that apply to this research. For those checked, please proceed on to complete those
supplements indicated. You do not need to complete any supplements for which you answer no.
To open a supplement, click on the title and you will be automatically taken to the supplement of your choice.
REQUEST FOR WAIVER OF CONSENT – Click here to complete IRB Supplement A
INTERNATIONAL RESEARCH– Click here to complete IRB Supplement B
CHILDREN – Click here to complete IRB Supplement C
COGNITIVELY IMPAIRED SUBJECTS– Click here to complete IRB Supplement D
STORED DATA FOR FUTURE USE–Click here to complete IRB Supplement E
RESEARCH INVOLVING DRUGS/BIOLOGICS – Click here to complete IRB Supplement F
*Please save each applicable supplement separately and submit along with your application for IRB review
19