Request for Review of Research Activity Involving Human Subjects

Manhattanville IRB: Request for Review of Research

INSTITUTIONAL REVIEW BOARD

REQUEST FOR REVIEW OF RESEARCH INVOLVING HUMAN PARTICIPANTS

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A. PROJECT SUMMARY
Principal Investigator (PI) or Proposer:
Name: Department:
Telephone: Email address:
Proposer is: Faculty Student Staff Other - Please Explain:
Faculty Sponsor (if applicable):
If the proposer is a student, a faculty sponsor is required.
Name: Department:
Telephone: Email address:
Title of Project:
Abstract: (Briefly describe, in a few sentences, the participant and methods of the project)
Start date (actual or proposed) of this research activity:
Expected end date of this research activity:
(Note that IRB approval is always for a period of one year or less. To continue with this research after the approval period, reapproval of renewal from the IRB is required.)
B. FUNDING STATUS
This project is (or is expected to be):
externally funded.
If so, give name of funding agency:
and date of award, or potential award:
internally funded.
If so, please describe:
unfunded.
C. PROPOSAL CATEGORY
This proposal is for:
a new project (not previously approved).
renewal of a previously approved project (with no changes).*
amendment to a previously approved project.
If this proposal is for renewal* or amendment,
Date of most recent IRB approval:
Approximate number of study participants enrolled to date:
*Proposals are only required to be renewed (after one year) if you are continuing to recruit participants and collect data. If all data collection is complete, it is not necessary to submit a request for renewal.
If this proposal is an amendment to previously approved research, briefly summarize all proposed changes in the space below. (For example, “Additional questionnaire added to methodology,” “Changes in wording of debriefing script,” “One student investigator replaced,” etc.) The personnel list (Section D) and research description (Section E) should also incorporate the proposed changes.
D. RESEARCH PERSONNEL
Please list all investigators, including the principal investigator, collaborators, and student researchers, that are expected to participate in the project during the approval period. All student principal investigators must identify a Manhattanville College faculty member as a co-principal investigator on the project. Do not include individuals who have participated in the past but are no longer involved.
Include titles (e.g. co-investigator, student research assistant, dissertation advisor) and role(s) in research (e.g. explain informed consent, recruit participants, conduct interviews). Indicate whether the individual would be an author on any publication arising from the research. All individuals listed below must have completed the appropriate course of ethics training for human participants research using the CITI online training program at *
(Note: A request for amendment must be filed with the IRB if any personnel changes are made during the approval period.)

NAME

Manhattanville faculty/student/staff?

Yes No /

Participant’s Title in This Research

/ Participant’s Role in This Research / Author on Publication?
Yes No / CITI Training Completed?
Yes No
(*)
Jane Q. Example (delete this example when you submit) / Principal Investigator / Recruit participants, Conduct interviews, Analyze Data

* Most likely, principal investigators and co-principal investigators will complete the Social/Behavioral research module if the project is non-exempt research.

If any investigators are not Manhattanville faculty, students, or staff, please give full institutional affiliation, mailing address, and email address for each here:

E. NATURE OF RESEARCH ACTIVITY

So that the IRB is able to evaluate both the scientific and ethical soundness of your proposed research, please provide the information requested below, within the provided textboxes. Please be aware that the IRB reviews proposals with the following standards in mind:
 Risks to subjects should be minimized
 Risks should be reasonable in relation to anticipated benefits
 Selection of subjects should be equitable
 No subjects may be unduly influenced or coerced to participate
 Informed consent must be sought and documented for each subject
 Privacy and confidentiality of subjects must be protected
In your responses below, include sufficient detail so that the scope of your project can be understood,but not as extensive as would be expected in a grant proposal, dissertation proposal, or journal article.
1) Describe current knowledge about the research question (with citations and references). Maximum of 10 pages.
2) State the objective(s) of the research.
3) Provide a rationale for the current project and proposed methodology.
4) Who will you be recruiting to participate in your research? (How many participants, age, ethnicity/race, sex, length of involvement, frequency, etc.)
5) Do the samples or data come from individuals who may need special safeguards? (e.g., individuals under 18 years of age, pregnant women, or persons with whom members of the research group have other relationships/roles)? If so, describe procedures for providing additional protections for these individuals.
6) Describe methods for recruiting, instructing, and debriefing participants; provide the text of any advertisements or scripts used for these purposes. Specify the source of potential participants. If recruiting off-campus, in separate attachments, provide letters approving research at this location or a sample recruitment script/poster to recruit at the location. These attachments must be provided before the IRB can grant approval of a proposal.
7) Provide detailed information about procedures/materials to be used to collect information/data from participants. Will you have direct contact or intervention with the human participants? What kind of data (e.g., private information, responses to questionnaires, interviews, etc.) will be involved? Include all surveys and interview protocols as separate attachments.
8) Include copies of informed consent forms, (and assent forms for children if applicable)attached as separate documents. Have you completedthe required informed consent form checklist?
9)Are the samples or data you expect to collect/receive/send anonymous? If not, who will have access to data and how will confidentiality of data be maintained?
10) What procedures will be utilized to prevent/minimize any potential risks or discomforts (physical, social, psychological, economic, and/or legal) for participants?
11) Briefly describe the benefits that will accrue to each human participant or to humankind in general, as a result of the individual’s participation in this project, so that the committee can assess the risk benefit/ratio. All proposals should include mention of benefits. If no benefits are expected, this should be stated.
12) Briefly describe the risks that will accrue to each human participant or to humankind in general, as a result of the individual’s participation in this project, so that the committee can assess the risk benefit/ratio.
13) Other pertinent information for the IRB to know about your proposal that is not covered in the above questions.
Note that any change of protocol or personnel during the course of the research requires re-approval by the IRB.
F. CERTIFICATIONS
I/We CERTIFY as follows concerning the above-named research proposal:
• The rights and welfare of the participants will be adequately protected.
• Risks or discomfort (if any) to participants have been clearly indicated, and it has been shown how they are outweighed by potential benefits to the participants or to humankind.
• The informed consent of participants will be obtained by methods that meet appropriate ethical standards.
• Any proposed changes in this research activity will be reported to the IRB. These changes may not be initiated without IRB review and approval.
• Any unanticipated problems involving risks to human participants will be reported to the IRB immediately.
• If the research is to continue after the approval period (normally one year), re-approval will be sought from the IRB.
Signed: Date:
Principal Investigator
Signed: Date:
Faculty Sponsor (if applicable)
Signed: Date:
Co-Investigator (if applicable)

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