On July 24, 2017 the FDA announced a new guidance, effective immediately, which will have significant impacts on industry, IRBs, and investigators. In short, the guidance is being issued to permit IRBs to waive or alter informed consent for minimal risk clinical investigations so long as the IRB determines and documents that the following criteria are satisfied:
- The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The clinical investigation could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
The guidance is an interim step to enable such waivers while the FDA updates its regulations as required under the 21st Century Cures Act. This guidance, and the regulatory changes to follow, support the use of “real word evidence” to enhance and streamline pre- and post-market activities. Expected applications include certain registries, observational studies, and studies using existing data and specimens.
Human Research Protection Programs and IRBs are encouraged to review the new guidance (linked above) and develop a plan for implementation including any needed updates to materials (SOPs, forms, checklists, guidance documents) and educating their research community regarding the changes.
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