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Applying to the IRB

Initally, user access must be granted by the IRB Administrator. This access will give the principal investigators and/or key study personnel the ability to complete submission forms, apply electronic signatures, and to receive IRB approval letters. All submissions to the IRB whether full board or expedited have to be completed on-line meaning DMH has an electronic submission process. Besides completing submission forms, there may also be documents that are required with the submission (e.g. protocol, consent form, HIPAA authorization, investigator’s brochure.)

For all new investigators and key study personnel, a copy of the physician’s license is required along with a signed and dated copy of their curriculum vitae, a copy of their NIH training certificate, and a copy of the Investigator’s Assurance. These items must be received before user access will be granted.

Once user access is granted, all submissions to the IRB require review, either by the full committee which generally meets the first Thursday of the month, or by one of the two co-chairpersons. Review and approval by a co-chairperson means the study qualified for expedited review because it met the requirements as set forth by 45 CFR 46.101(b) or 45 CFR 46.110. These studies are minimal risk studies that may be exempt from periodic review. There are six (6) exemptions and nine (9) expedited review categories.

Another type of exemption not included above is the Humanitarian Device Exemption (HDE). An HDE is a premarket approval application submitted to the FDA seeking an exemption from the effectiveness requirement of the Food, Drug and Cosmetic Act. It falls under 21 CFR 814.2. The labeling for the HDE must state that the device is (1) a Humanitarian Use Device [HUD] (2) is authorized by federal law, and (3) the effectiveness of the device has not been demonstrated. An HUD is a device that is intended to benefit patients in the treatment or diagnosis of a disease or condition affecting fewer than 4,000 individuals in the U.S. per year.

The initial IRB submission for an HDE should include a copy of the FDA approval letter, in addition to other relevant material. Unlike 45 CFR 46.101(b), IRB approval is required on an annual basis. Often times, these continuing reviews are accompanied by an annual report generated by the sponsor. However, it is important to maintain the data collected on these patients, especially any adverse effects. When appropriate, the completion of a Medical Device Reporting Form may be necessary.