NPRM-2015-Significant Change #2: Biospecimens

Significant change to the Common Rule proposed in the NPRM: Use of biospecimens

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.” The following is the second of these significant changes and a brief summary prepared by Quorum Review’s regulatory attorneys:

Change proposed in the NPRM

Generally require informed consent for the use of stored biospecimens in secondary research (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is. That consent would generally be obtained by means of broad consent (i.e., consent for future, unspecified research studies) to the storage and eventual research use of biospecimens. 

Quorum’s description of the proposed change

The proposed NPRM seeks to modify the definition of “human subject” to include all uses of biospecimens by an investigator conducting research. This approach would explicitly add the use of biological samples as an element of human subject research and thereby remove the controversial exercise of trying to determine whether a biospecimen may be identifiable now or in the future.

The consequence of this modification is that most future uses of biospecimens require at least a broad informed consent for future use that is obtained either at the point of collection or prior to the subsequent use. The NPRM’s motivation for this modification is to increase the public’s trust and sense of partnership in this expanding area of research, which is expected to lead to improved treatment plans and breakthrough new therapies.

The modified definition of human subject will be enforced three years after publication of the final rule and only to biospecimens that are collected prospectively from that enforcement date.

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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