Do I need to submit an IRB application?

Are there any preliminary steps to take before I submit an IRB application?

How do I submit an IRB application?

What happens after I submit an application?

When does the committee meet?

When can I begin my research?

What if I need to change my study after approval?

What if my study has resulted in an adverse effect to a subject?

How long is my IRB approval good for?

Additional information about the IRB



Do I need to submit an IRB application?

All research involving human subjects must be submitted for IRB approval.  Refer to Chart 1 below to determine of your project is considered Human Subjects Research.  If relevant, also view our guidance regarding class projects, independent studies and honors projects; and documentaries and ethnographies.  If you have reviewed Chart 1 and these documents and are still unsure whether you need to submit an application to the IRB, please email IRB@bowdoin.edu or contact the IRB Chair, Scott Sehon, at 725-3753.

Researchers that are not affiliated with the College (off campus) require permission from the College prior to initiating their research. Please contact Cara Martin-Tetreault, director of sponsored research for more information.

Chart 1

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Are there any preliminary steps to take before I submit an IRB application?

Any investigator, faculty member, staff member, student, or guest of the college who is planning to participate in a research project involving human subjects must receive training in Human Participant Protection. The required training reviews concepts such as the use of ethical principles and federal regulations, definitions of research terms (such as Informed Consent), and a description of the roles of both the IRB and the investigator. Online training is available at no cost through the Collaborative Institutional Training Initiative for any researcher not otherwise trained in these areas.  All members of the research team must complete training before participating in human subjects research. Documentation of training must be submitted to the IRB before a research project will be reviewed, and evidence of training must be submitted with all applications even if they have been previously submitted with another project.

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How do I submit an IRB application?

If you determine that you need to submit an application, the IRB requests that you submit your protocol at least two weeks in advance of scheduled IRB meetings to give the committee enough time for proper review. Protocols submitted in less time may not be reviewed until the next scheduled meeting. Even for projects not requiring full committee review (including modifications or continuing reviews of existing protocols), investigators should allow two weeks for appropriate review.

Each research proposal submitted to the IRB shall consist of the following components:

  • Human Subject Protocol Application Form
  • Proposal, including detailed study plan
  • Informed Consent Form (See an example Informed Consent Template here)
  • Copies of all instruments (e.g. questionnaires, surveys, interview scripts) to be used
  • Examples of recruiting tools to be used (e.g. letters, fliers, advertisements)
  • Evidence of completion of human subjects training for all investigators and faculty sponsor(s) listed. (Choose "Social & Behavioral Research Investigators" module)
    **Please note that faculty and students must show evidence that training has been completed in the past 3 years. Reviews will not be completed until updated training certificates are presented for all PIs and faculty sponsors listed, even if they have been previously submitted with another protocol**

Please electronically submit forms to IRB@bowdoin.edu and send one signed, original hard copy (single-sided) to IRB administrator Jean Harrison, Philosophy (103 Edward Pols House).  Reviews cannot be completed until all application components listed above have been received.

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What happens after I submit an application?

Applications will be reviewed by the IRB chair as they are received.  There are three categories of review.  The extent of the review of the project will be based on the following criteria:

  • Exempt Research – Most research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior in which the identity of the subject cannot be established will be categorized as exempt. This includes collecting or studying existing data, records or specimens, if these sources are publicly available or if the information is recorded in a way that the subjects cannot be identified. The IRB chair makes the determination of whether a research project is "exempt" from further IRB review. Thus, even if an investigator expects that a project will be exempt from research, he/she must submit it to the IRB for review.  Investigators will be informed in a timely manner if their protocol has been deemed exempt.
  • Expedited Review – This includes research in which the probability and magnitude of harm or discomfort anticipated are not greater than those encountered in daily life or during the performance of routine physical or psychological tests. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing. Projects eligible for expedited review will be reviewed by a member of the IRB, and the investigator will be notified of a decision in a timely manner. Expedited review does not need to take place at a convened meeting of the IRB.

A determination that research is exempt or eligible for expedited review will be communicated to the investigator.

  • Full Committee Review – Procedures that are potentially harmful to the subjects (even if the investigator views the harm as not unreasonable) are subject to full committee review. Research published with the identity of the subject, invasive collection of body fluid or tissue samples, manipulative observations including deception, or stressful physiological recordings fall into this category. Research involving prisoners, pregnant women, children, fetuses, the seriously ill or mentally or cognitively compromised adults as subjects must be reviewed by the full committee. Full Committee Review must take place at a convened meeting of the IRB with a quorum present.

The committee meeting dates for the 16-17 year are

  • August 31, 2016
  • October 5, 2016
  • November 2, 2016
  • December 7, 2016
  • Spring meetings TBD

No meetings scheduled during the summer

An investigator submitting a proposal that undergoes full committee review should expect to receive feedback from the IRB within 48 hours of the conclusion of the convened IRB meeting.

Once a project has been reviewed, there are three possible outcomes:

  • Approval – A protocol that has been approved by the IRB requires no further action by the investigator before the research may commence. If a protocol is approved, the PD/PI will be provided with a copy of an approval letter.
  • Revise/Resubmit – A protocol that has been deferred by the IRB usually requires that additional information be submitted, or that changes to the protocol have been recommended. The investigator will receive written details describing the committee's concerns. For projects requiring full committee review, the revised protocol may be reviewed at the next convened IRB meeting.  For projects requiring expedited review, the chair may ask the original reviewer to again consider the revised proposal.
  • Deny – A protocol that has been denied by the IRB cannot be initiated. The investigator will receive written details describing the reasons for denial of approval.

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When can I begin my research?

The investigator is required to wait for approval from the IRB prior to initiating the research study.  No contact with potential subjects is to be made prior to approval.

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What if I need to change my study after approval?

If you desire to make a change to the research procedures or the research staff, you must submit a Modification Form. The IRB reviews and approves any proposed modifications to approved research activities before they are initiated. The letter from the IRB to the Principal Investigator at the time of approval states that any proposed changes must be submitted to the IRB prior to implementation. Principal Investigators should use the Modification Form (above) to describe any modifications to either the described research procedures or staff.

In the unlikely event that a change to approved research must be initiated without IRB approval in order to eliminate apparent immediate hazards to a research participant, these changes must be submitted to the IRB within 3 business days after the event. The IRB reviews these changes to certify that they were consistent with ensuring the participants continued welfare.

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What if my study has resulted in an adverse effect to a subject?

If a subject has experienced an unexpected or serious event that is related to study procedures, researchers must submit an Adverse Event Form.

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How long is my IRB approval good for?

Projects are approved for a maximum of 12 months.  Researchers who wish to continue a project beyond this must submit a Continuing Review form, updating the IRB on the status of the research and whether any new risks or benefits have been identified.  If a study has been discontinued, researchers are asked to complete a Closure Form.

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Additional information about the IRB

Bowdoin College is required to assure the federal government that the welfare, rights, and privacy (where applicable) of research subjects are being safeguarded. This follows from a set of principles outlined by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the Belmont Report.

The three ethical principles expressed in the Belmont Report as being relevant to research involving human subjects are

  • Respect for Persons
  • Beneficence
  • Justice

Bowdoin College has submitted a Federal Wide Assurance (FWA) to the Office for Human Research Protections (OHRP) at the United States Department of Health and Human Services (DHHS). This assurance is mandatory for the College as federally-funded human subject research is being conducted on campus. Having submitted this assurance means that the College must be in compliance with the HHS regulations (45 CFR 46) for the protection of human subjects.

The Bowdoin IRB has been established to monitor the College’s compliance with these federal guidelines and approve all research projects under the auspices of the College which involve the use of human subjects – regardless of the funding source for the research.

The IRB is composed primarily of faculty members, appointed to the committee by the Committee on Governance and Faculty Affairs. Each member serves a three-year term on the committee, on a rotating basis. In addition to the requirements of committee composition designated by the College, the composition of the IRB is mandated by the federal government, as per 45 CFR 46.107.

2016-2017 Committee Members:

  • Faculty: Patsy Dickinson, Zachary Rothschild, Scott Sehon (Chair), Daniel Stone
  • Staff: Cara Martin-Tetreault, Director of Sponsored Research, Jean Harrison, Academic Department Coordinator
  • Others : Herbert Paris (community member), David Nadeau (community member)

Federal regulations require that all IRB records be retained for at least three (3) years after completion of the research. These files will be kept with the IRB administrator at IRB@bowdoin.edu. Files to be retained include:

  • copies of all proposals reviewed, approved consent documents, progress reports, and reports of injuries to subjects
  • detailed minutes of all IRB meetings
  • records of continuing review activities

For more information about the role of the IRB, or for answers to questions about the submission process, please email IRB@bowdoin.edu or contact the IRB Chair, Scott Sehon at 725-3753.

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