Medical Board Review Process
Medical board review applies to human subjects research that involves the use of blood or body fluids, ingestion, injection or inclusion of a food products, supplement, or similar product related to an intervention or evaluation and physical interventions. If assigned to medical board, you have the opportunity to be available during the meeting to provide additional information or answer questions. These studies may require submission to Clinical Trials.gov.
Studies that involve IND or IDE or meet the FDA definition of a medical Clinical Trial must be reviewed by an external Institutional Review Board. The cost of external review should be included in sponsor and external budgets or provided by investigator identified sources. These studies must be submitted to Clinical Trials.gov prior to enrolling the first subject. Medical Device Procedures are located here.
The research proposal is presented and discussed at a meeting at which a quorum of IRB members who have relevant medical expertise are present. For the research to be approved, it must receive the approval of a majority of those voting members present. (Note that, in effect, an abstention counts as a negative vote.)
Continuing Review Required
Medical full board research projects are reviewed annually for renewal and can be renewed as long as the project remains ongoing. The IRB application pieces (narrative, informed consent, etc) must be updated to accurately reflect the research to receive renewal.
This approval path may require a minimum of 4 to 8 weeks to complete. The Medical Review Board meets on a called basis.