View Rule

This regulation would permit an Institutional Review Board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent under limited conditions, for certain minimal risk clinical investigations. This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat diseases or conditions and would harmonize, to the extent practicable and consistent with statutory provisions, with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies. This regulation is intended to aid patient access to new products by facilitating investigators’ ability to conduct studies that may contribute substantially to the development of products to diagnose or treat diseases or conditions, including products that may address unmet medical needs.