Instructions for Submitting a Human Subjects Proposal
The U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) oversee operations of the IRB.
Federal Regulation 45 CFR 46- Protection of Human subjects: applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. Protection of Human Subjects mandates research that involves human subjects must be approved by an Institutional Review Board (IRB) to ensure the safety and the appropriate use of humans as subjects in research studies.
All protocols involving human subjects must be submitted to the Protection of Human Subjects Committee at William & Mary for exemption or approval. William & Mary institutional policy does not permit self-exemption.
Based upon guidelines provided by the DHHS, the W&M Protection of Human Subjects Committee will either 1) exempt the protocol from formal review or require that it undergo, 2) expedited review by the Chair, and typically, selected member(s) of the committee, or 3) review by the full committee during a convened meeting.
A properly completed protocol will include a rationale for the study, full procedures, description of the participants, copy of all tests, questionnaires, all interview questions, the informed consent form, documentation of all required CITI training, and other pertinent information. You must use the Protocol and Compliance Management system to submit your project proposal. Normal review times are three to four weeks for an expedited review, and more than one month for a full review, provided all the necessary detailed information has been included in the submission.
**Please allow sufficient time (3-4 weeks) for review; and, if necessary additional time to correct and submit for approval any revisions required by the PHSC committee to the protocol.**
Please note: human subjects protocols once approved are valid for a term of one year. If the project is to continue beyond the expiration date, please select the clone function and carefully review the data that transfers to the new protocol. All deviations from the original approved protocol must be modified in the new protocol submission. Once submitted for committee review, the protocol undergoes a thorough review. A notice of approval will be sent electronically to the PI(s) of record.
