Policy on Protection of Human Subjects
V. Procedures
Research using human subjects falls into one of three categories: Level I: Exempt (no foreseeable risk), Level II: Expedited (minimal risk), and Level III: Full Board (more than minimal risk and protected subjects). The Institutional Review Board Chair will determine which level of review is necessary for a given project. This means that all original research must be submitted for IRB review and approval.
The Institutional Review Board will review a list of all projects initiated or completed at the College or by College employees at least once a year.
Submit for approval: Submit two copies of the following to the IRB Coordinator (Eileen Fahey, BIH 412):
The Request for Approval FormThe 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 EnglishA proposed informed consent document or narrativeYour NIH certificate of completion (http://cme.nci.nih.gov).
Approval of a human subject research proposal is good for one year, unless the project has acceptable but potential risk, in which case approval is given for a six-month period. If the project will continue beyond the approval period, Principal Investigators are required to 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; andA copy of the current informed consent document and any newly proposed consent document.
In the initial approval letter, principle investigators are asked to promptly report any unanticipated problems or adverse effects of the research to the Institutional Review Board.
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, 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.
The researcher may at any point submit a revised proposal, which will be reviewed as a new application.
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.