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Institutional Review Board

Purpose of the Policy Who Must Apply Definitions General Principles Composition and Overview

Procedures

Application Form Consent Form Contact Us Useful Web Links Level II Research and Review Level III Research and Review

VI. Procedures for IRB Review

Research using human subjects falls into one of three categories:

    LEVEL I: Research that presents no foreseeable risk, and
    therefore is exempt from a full-board IRB review. Normally
    the Chair alone (or a designated alternate) will review
    proposals determined to be Level I.

    LEVEL II: Research that involves only minimal risk (see
    definition above), and therefore can be expedited by the
    IRB Chair. This normally means that the Chair and one
    other member of the committee will review the
    research.

    LEVEL III: Research presenting more than minimal risk,
    funded by federal grants, and/or involving subjects
    from a group awarded special protections (e.g., children).
    Level III research requires evaluation by the full board of
    the IRB.

The Institutional Review Board Chair will determine which level of review is necessary for a given project. This means that all research proposals involving human subjects must be submitted for IRB review and approval.

To submit an application for review: Submit one copy (electronic strongly preferred) of the following to the IRB Coordinator (Eileen Fahey, MBH 412):

* The Request for Approval Form, including a signed cover
   page.
* The full protocol and/or any relevant grant application(s)
* Copies of any source instruments (e.g., questionnaires,
   interview scripts, manipulation protocols, debriefing forms,
    etc.); please provide translations if these are not in
    English
* A proposed informed consent document or narrative
* A certificate showing completion of the National Institutes
    of Health's online course "Protecting Human Research
    Participants" http://phrp.nihtraining.com/users/login.php.

Level I and Level II proposals are reviewed every two weeks and Level III proposals once a month.

A majority of the committee members must be present to constitute a quorum. They may at in the case of a Level III review only on materials distributed one week before the scheduled meeting or by the unanimous consent of the entire committee. The action of the committee is generally by consensus; if there is no consensus, the committee will decide in favor of the major opinion. If the committee is split, the administrator will vote.

Approval of a human subject research proposal is normally good for one year, unless the project has acceptable but significant enough risk that the committee elects to extend approval for only a six-month period. If the project will continue beyond the approval period, the principal investigator should resubmit documents for review prior to the expiration date of the initial approval. These documents should include a status report of the project to date, including

* The number of subjects accrued;
* A summary of adverse events and any unanticipated problems involving risks to subjects or others and withdrawal of subjects from the research or complaints about the research since the last review;
* A summary of any relevant amendments or modifications to the research since the last review;
* Any other relevant information, especially information about risks associated with the research; and
* A copy of the current informed consent document and any newly proposal consent document.

The initial approval letter sent to the principal investigator will ask the PI to promptly report to the Institutional Review Board any unanticipated problems or adverse effects that the PI encounters in the process of completing the research.

Researchers whose applications are not approved by the IRB will be provided a list of the concerns cited by the committee. Normally such researchers will be invited to respond, revise, and resubmit their application for a new review.

Appeals: In the event that an application is denied because the Institutional Review Board feels the risks outweigh the benefits of the research, and the investigator disagrees with the committee's disapproval decision, the researcher may appeal the decision by re-submitting the same application form and 1) a letter of appeal presenting the researcher's arguments for approval; and 2) any other pertinent information in support of the appeal. The letter should be directed to the Chair of the Board and mailed with enclosures to Eileen Fahey, IRB Coordinator, McCardell Bicentennial Hall 412. Applications submitted for appeal will be considered by the full board at the next scheduled meeting date. The final decision of the IRB will be stated in writing to the investigator. If the proposal is not approved, the research cannot be conducted.

Nature of the College Records: The College keeps records of all original human subjects research on the Review Form, along with copies of any research documents (informed consent forms, questionnaires, interview scripts, stress protocols, behavioral manipulation protocols, drug protocols, non-FDA device protocols, debriefing forms, etc.), and a copy of any publication resulting from the research. Part A and Part B of the Review Form are signed by the researcher and co-signed by a faculty sponsor if the PI is a student. The cover Sheet (Part A) should also identify the Institutional Review Board members who have performed the review. The aforementioned documentation constitutes the full College records of any project approved by the Committee.

The IRB will review a list of all projects initiated or completed at the College or by College employees at least once a year.

Institutional Review Board

Purpose of the Policy

Who Must Apply

Definitions

General Principles

Composition and Overview

Level II Research and Review

Level III Research and Review