On September 8, the Federal Register published a Notice of Proposed Rulemaking from the Department of Health and Human Services (HHS) noting proposed changes to the Common Rule, a set of federal regulations that guide the protection of human subjects in research. A 90-day comment period is now underway.
In releasing the document, HHS issued a summary statement that signals a number of important changes for education researchers. The proposed revisions would add a new category for exempt research in cases where the research involves education tests, surveys, interviews, or observations of public behavior when sensitive information may be collected, provided that data security and information privacy protection policies are followed. Another new category of exempt research would apply to secondary research use of identifiable private information originally collected as part of a non-research activity, where notice of such possible use was given. The process to determine whether research is categorized as exempt would not require administrative or Institutional Review Board (IRB) review.
More broadly, the proposed Common Rule changes would increase transparency for informed consent and impose stricter new requirements regarding the information that must be given to prospective subjects. The changes would exclude from coverage certain categories of activities that are deemed not to be research, are inherently low risk, or are subject to separately mandated protections similar to those usually provided by IRB review. The changes also mandate that U.S. institutions engaged in cooperative research rely on a single IRB for the portion of the research that takes place within the United States, with certain exceptions.
The proposed rulemaking changes acknowledge the National Research Council’s Proposed Revisions to the Common Rule for the Protection of Human Subjects in Research in the Social and Behavioral Sciences. AERA Executive Director Felice J. Levine served on the committee that produced that report. Prior to that, Levine was senior author of a white paper submitted on behalf of 22 scientific organizations in the social and behavioral organizations in response to questions posed by HHS in its Advanced Notice of Proposed Rulemaking in 2011.
“We are pleased to see that rule making changes have been announced and speak to important issues in enhancing human research protection aligned with research and the level of risk involved,” said Levine. “The proposed revisions are complex and worthy of close study by AERA and other research associations.”
AERA is in the process of reviewing the proposed regulations and will prepare public comments. AERA welcomes direct input on the proposed revisions from association members who have been engaged on these issues. Feedback for AERA should be directed to [email protected].
AERA members whose institutions are planning to submit comments are encouraged to also provide relevant administrators (e.g., Office of Research, Office of Government Relations) with examples of where these revisions would reduce burdens or be helpful in conducting research.
Comments to the Department of Health and Human Services are due on December 7 at 5:00 p.m. Eastern Time.