NPRM-2015-Significant Change#5: Waiver of Consent

Significant change to the Common Rule proposed in the NPRM: Waiver of consent

After years of debate and speculation, sixteen federal agencies have collaborated on a notice of proposed rulemaking (NPRM) with the stated purpose of modernizing, strengthening, and making more effective the federal policy for the protection of human subjects. While the NPRM does not tackle as many issues as the Advanced Notice of Proposed Rulemaking (ANPRM) of July 2011, it nevertheless proposes a number of bold moves to streamline the clinical trial process. The U.S. Department of Health and Human Services has identified eight of the proposed changes as “most significant.” Here is the fifth of these significant changes and a brief summary prepared by Quorum Review’s regulatory attorneys:

Change proposed in the NPRM

Change the conditions and requirements for waiver or alteration of consent such that waiver of consent for research involving biospecimens (regardless of identifiability) will occur only in very rare circumstances.

Quorum’s description of the proposed change

The NPRM seeks to place new limits on an IRB’s ability to waive or alter the consent procedure for research involving biospecimens.  First, the NPRM proposes two new stringent waiver criteria for biospecimen research; the research must have a compelling scientific purpose and it must not be able to use biospecimens for which consent was or can be obtained. In addition, the NPRM would remove any ability to waive the documentation of consent in the context of biospecimen research.

These limits aim to reinforce the ethical principle of respect for persons. They also will necessitate the obtaining of informed consent for the vast majority of biospecimen research.  Importantly, the NPRM has considered the severity of such a requirement and endorses a new type of consent labeled as a “broad consent,” which will have its own required elements and for which the Secretary of HHS will provide a template.

Read all the changes

Click here to read all of the significant changes to the Common Rule proposed in the NPRM.

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