AASLD Members Have Opportunity to Improve Common Rule 

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By Lyle Dennis, Cavarocci – Ruscio – Dennis Associates, Consultants to AASLD

As every AASLD member knows, the conduct of research is the lifeblood of the membership of the Association. But as every member also knows, getting everything together to begin a research project is a long and laborious process. It is impacted by a variety of factors ranging from federal funding levels, the quality of yours and other applications, the complexity of the application process, the level of support (or non-support) from your institution, and so on. Doing research in 2011 is not for the faint of heart!

However, once a project is developed and funded and it is time to get underway, the provisions of the Common Rule governing research funded by most entities takes effect. And, at this point, things can really get complicated.

On July 26, an Advanced Notice of Proposed Rule Making (ANPRM) was issued by the US Department of Health and Human Services in the Federal Register to revamp the Common Rule significantly. The changes that are proposed mark the first major revision in about twenty years.

The changes are summarized in an article by Drs. Zeke Emanuel and Jerry Menikoff published in the New England Journal of Medicine describing both the changes that were promulgated to improve effectiveness of the research process and those whose intent is to enhance research protections.

While there is insufficient space here to analyze the entire 20 page ANPRM, several of the changes are clearly significant. Among the most notable are:

• A single IRB of record would be allowed for the oversight of all domestic sites in a multistate study rather than the current system of IRBs at all sites.
• For research posing minimal risk, no annual review would be required unless requested by the researcher.
• The Common Rule would be extended to all research conducted at an institution that receives any money from a Common Rule agency.
• All records of adverse events and unanticipated problems would be submitted to and stored in a central database.
• Informed consent documents would be clearer, more concise, simplified and streamlined.

For the truly ambitious who would like to review the original document, the entire ANPRM can be downloaded from the Federal Register at http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18792.pdf. 

The reader will note in that document that the ANPRM sets the deadline dates for comments at September 26. Recently, that deadline was extended to October 26, so there is plenty of time for members to review and comment on the proposal.