HHS Announces Proposal to Improve Rules Protecting Human Research Subjects

The U.S. Department of Health and Human Services has announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991.  A Notice of Proposed Rulemaking (NPRM) (copy here) was published today, September 8, with a 90 day comment period. 


The NPRM proposes to strengthen the effectiveness and efficiency of the oversight system by making the level of review more proportional to the seriousness of the harm to be avoided.


Some of the proposed changes include: 


1.     Improve informed consent by increasing transparency and by imposing stricter new requirements regarding the information that must be given to prospective subjects to better assure that subjects are appropriately informed before they decide to enroll in a research study.


2.     Require broad informed consent (i.e., consent for future, unspecified research) for the storage and use biospecimens in secondary research even if the biospecimen is de-identified. For example, for use of a leftover blood sample after being drawn for clinical purposes.


3.     Exclude certain categories of activities from IRB review and oversight (e.g., Oral Histories, Public Health Surveillance, some Quality assurance/improvement activities).


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.  New categories include:


a.      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 specific data security and  information privacy protections policies are followed; and

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.


5.       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.


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.  


The proposed modifications are designed to continue to uphold the ethical principles upon which the Common Rule is based, as applied to the current social, cultural, and technological environment.


The Office of Research – Human Research Protections unit will be providing updates and additional information about the NPRM as information becomes available.  For example, we anticipate that the Department of Health & Human Services Office for Human Research Protections will offer several webinars that will explain the changes proposed in the NPRM, and is planning a town hall meeting in Washington, D.C. in October.  Stay tuned!


Karen Allen
Director, Research Protections
UC Irvine – Office of Research
5171 California Avenue, Ste. 150
Irvine, CA  92697-7600
(949) 824-1558



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