Department of Health & Human Services Proposal | FTI Consulting

The Department of Health and Human Services Announces Proposal to Improve Rules Protecting Human Research Subjects

Health Solutions

December 1, 2015

On September 2, 2015, the U.S. Department of Health and Human Services (HHS) announced proposed revisions to the 1991 Federal Policy for the Protection of Human Subjects (45 CFR 46 Part A), which is commonly known as the Common Rule (“Common Rule”). According to an HHS press release that accompanied the announcement, the current Common Rule regulations were developed at a time when research was predominantly conducted at universities, colleges and medical institutions, and each study generally took place at a single site. The expansion of research into new scientific disciplines, such as genomics, along with an increase in multisite studies and significant advances in technology, has highlighted the need to update the regulatory framework. Notably, a more participatory model of research has also emerged, with individuals looking for more active engagement with the research enterprise. Thus, the intent of the proposed revisions is to modernize, strengthen and make more effective the Common Rule.

Subsequently, on September 8, 2015, the HHS, along with fifteen other Federal Departments and Agencies, published in the Federal Register a notice of proposed rulemaking (NPRM) regarding the previously announced proposed revisions to the Common Rule. The proposed revisions, when and if finalized, will have a profound impact on human research protection operations. Below is a list of the most significant proposed revisions to the Common Rule:

  1. Informed Consent. The NRPM proposes stricter new requirements regarding what information must be given to prospective subjects, and the manner in which it is given to them, to better assure that subjects are appropriately informed before they decide to enroll in a research study. In addition, the NPRM proposes a one-time posting requirement for clinical trial consent forms; so that anyone drafting a consent form will do so knowing that it will eventually be subject to public scrutiny.
  2. Secondary Research Involving Biospecimens. The NRPM proposes that, in general, informed consent will be required 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 the individual to whom the specimens belong. According to the NRPM, such consent could 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.
  3. Excluded Activities. The NPRM introduces a new category called excluded activities. Such activities would be excluded from coverage under the Common Rule because such activities are deemed not to be research, are inherently low risk, or where protections similar to those usually provided by IRB review are separately mandated.

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