NPRM-2015-Significant Change#4: Exempt Research

Significant change to the Common Rule proposed in the NPRM: Exempt Research

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 fourth of these significant changes and a brief summary prepared by Quorum Review’s regulatory attorneys:

Change proposed in the NPRM

Add additional categories of exempt research to accommodate changes in the scientific landscape and to better calibrate the level of review to the level of risk involved in the research. A new process would allow studies to be determined to be exempt without requiring any administrative or IRB review. Certain exempt and all non-exempt research would be required to provide privacy safeguards for biospecimens and identifiable private information. New categories include:

  1. certain research involving benign interventions with adult subjects;
  2. research involving educational tests, surveys, interviews or observations of public behavior when sensitive information may be collected, provided that data security and information privacy protections policies are followed;
  3. secondary research use of identifiable private information originally collected as part of a non-research activity, where notice of such possible use was given;
  4. storing or maintaining biospecimens and identifiable private information for future, unspecified secondary research studies, or conducting such studies, when a broad consent template to be promulgated by the Secretary of HHS is used, information and biospecimen privacy safeguards are followed, and limited IRB approval of the consent process used is obtained

Quorum’s description of the proposed change

The proposed NPRM introduces significant changes to the exemptions from the Common Rule.  These revisions attempt to address the criticism that the current system “overregulates” research and does not calibrate the review process appropriately to the risk of the research. The changes would anticipate the development of a “tool” which could determine for investigators and institutions whether research is exempt. Institutions could utilize this tool instead of the current practice- in which an individual not involved with the research assesses whether the research is exempt. In addition, the rule modifies a number of the existing exemption categories and introduces several new exemption categories. These changes will significantly broaden the scope of research that can be considered exempt from the requirements of the Common Rule.

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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