On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”. The Common Rule is a uniform federal policy for the Protection of Human Subjects, originally issued in 1991. The U.S. agencies and departments adopting the Common Rule generally agree to the same set of basic protections to be applicable to human subject research activities they will conduct or support, but adopt such protections within their own applicable regulations. The NPRM is expected to appear in the September 8, 2015, issue of the Federal Register, and to be open for public comment through December 7, 2015.
The federal agencies and departments issuing the NPRM (the “Issuing Agencies”) are the Department of Homeland Security; Department of Agriculture; Department of Energy; National Aeronautics and Space Administration; Department of Commerce; Social Security Administration; Agency for International Development; Department of Justice; Department of Labor; Department of Defense; Department of Education; Department of Veterans Affairs; Environmental Protection Agency; Department of Health and Human Services; National Science Foundation; and the Department of Transportation. This list includes some entities that had not formally adopted the Common Rule previously.
In addition, certain other federal agencies and departments, including the Central Intelligence Agency, the Consumer Product Safety Commission, and the Department of Housing and Urban Development generally support the Common Rule, but are not issuing proposed rules at this time for various reasons.
According to the Issuing Agencies, the following list describes the most significant proposed changes:
“1. Improve informed consent by increasing transparency and by imposing stricter new requirements regarding the information that 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.
2. 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.
3. Exclude from coverage under the Common Rule certain categories of activities that should be deemed not to be research, are inherently low risk, or where protections similar to those usually provided by IRB review are separately mandated.
4. 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:
a. certain research involving benign interventions with adult subjects;
b. 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;
c. secondary research use of identifiable private information originally collected as part of a non-research activity, where notice of such possible use was given;
d. 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.
5. 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.
6. Mandate that U.S. institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the United States, with certain exceptions. To encourage the use of IRBs that are otherwise not affiliated with or operated by an assurance holding institution (“unaffiliated IRBs”), this NPRM also includes a proposal that would hold such IRBs directly responsible for compliance with the Common Rule.
7. Eliminate the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing data or involve only observational follow-up in conjunction with standard clinical care.
8. Extend the scope of the policy to cover all clinical trials, regardless of funding source, conducted at a U.S. institution that receives federal funding for non-exempt human subjects research.”
If finalized, the NPRM would represent the largest substantive revision to the Common Rule since its adoption in 1991. In drafting the NPRM, the Issuing Agencies were informed by public comments previously submitted in response to a 2011 Advance Notice of Proposed Rulemaking, as well as certain other recent regulatory actions. While many issues are called out for solicitation of public comment (there are at least 87 numbered questions with respect to which comments are specifically sought), comments can be submitted on any topic relevant to the NPRM.
Accordingly, industry stakeholders involved in any aspect of human research should carefully review the NPRM and consider providing appropriate comment. A large number of industry stakeholders are potentially significantly impacted by the NPRM, including but not limited to biopharmaceutical and medical device manufacturers; laboratories, tissue banks, hospitals and health care providers; academic centers; and other entities such as clinical research organizations and independent review boards.