DHHS Receives Comments on Proposed Human Research Protection Regulations

November 21, 2011

by Paula Skedsvold

In mid-2011, the Department of Health and Human Services and Office of Science and Technology Policy proposed the most extensive changes to the regulations governing human research protections since they were first enacted over three decades ago.  The focus of the proposed changes was on Subpart A of 45 CFR 46 (known as the Common Rule).  An initial 30-day public comment period was extended by 30 days, and 1111 responses were submitted before the deadline.  

In the proposed rule, specific attention was given to social and behavioral science research. Social and behavioral scientists have raised a number of concerns over the years and the proposed regulatory changes provided an opportunity to revisit these in the context of the DHHS proposed changes to Subpart A. FABBS joined with AERA and other colleagues to prepare a joint response on behalf of 22 social and behavioral science societies. In addition, a number of SBS societies and individual scientists submitted separate responses.

The proposed changes addressed seven primary areas: calibrating the level of review to the level of risk; using a single IRB for domestic sites in multi-site studies; updating the forms and processes related to informed consent; mandating data security standards when data may be identified; creating a systematic approach to data collection and analysis on adverse events; extending the regulations to all research at institutions receiving federal funds from Common Rule agencies; and providing uniform guidance on federal regulations.  Responses addressed one or more of these areas. 

According to DHHS, the public input “will be critically important to the government’s efforts to ensure that regulations keep up with today’s changing research environment.” In addition to the public input, other federal agencies such as NSF offered comment on the proposed changes. Presumably DHHS will be working with other Common Rule agencies as the proposed regulations are developed.

In parallel, the Presidential Commission for the Study of Bioethical Issues is conducting its own review of the regulations governing human research protections.  The Commission was charged by the President to “determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal government.”  The Commission sees its work as “dovetailing” with the DHHS proposed revisions. 

Public input will again be sought once the comments have been reviewed and the proposed regulations have been drafted.

View the SBS Joint Response »

Other Responses »