Changes to the Common Rule

In July, the U.S. Department of Health and Human Services (HHS) proposed sweeping changes to the review of scientific research on human subjects.  The proposed modifications to the “Common Rule” are the first since 1991 and they seek to address shifts in the research landscape over the past twenty years.

HHS has asked the scientific community to comment on the proposal before it is finalized.  We encourage you to read up on the suggested changes, which have the potential to significantly transform the IRB process for social and behavioral researchers.

To read the actual proposal, click here (PDF). If that documents brings to mind “it’s all Greek to me”, here is an easier-to-understand synopsis, which includes a helpful table.

An attempt to simplify the process is a breath of fresh air for many researchers. However, the amendments overlook certain types of methodology and research topics. For example, observational methodologies are only briefly mentioned, ethnographic research and common IRB issues related to internet research are not discussed, and international research gets scant attention. There are no changes at all for certain research topics, such as sexuality studies.

The deadline for comments is October 26th. For more on what people are saying about the suggested changes, check out the Institutional Review Blog. To submit comments, go here: http://www.regulations.gov/.

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Author: Rachel Lovell

Rachel Lovell is the Senior Research Methodologist at the SSRC where she is responsible for designing, developing, implementing, and analyzing empirical research studies generated within SSRC and also by faculty researchers affiliated with SSRC. Rachel received her Ph.D. in sociology from The Ohio State University in 2007. Her more recent research interests include women, public health, and sex work.

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