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Compliance In Focus
Posted by Shawn Kennedy on Thu, Sep 24, 2015

The Common Rule (1991)

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an The_Common_Rule_1991eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar years.

The Department of Health and Human Services (HHS) published the Federal Policy for the Protection of Human Subjects in 1991.  More commonly known as “The Common Rule,” this set of ethics involving the protection of human subjects is codified under Title 45, Part 46 of the Federal Regulations, depicted here by the image of an open book with the numbers “45” and “46”.  These HHS regulations are divided into four subparts:

  • Subpart A: The Federal Policy, or “Common Rule”
  • Subpart B: Additional protections for pregnant women, human fetuses, and neonates
  • Subpart C: Additional protections for prisoners
  • Subpart D: Additional protections for children

Back in July of 2011, HHS issued an Advance Notice of Proposed Rulemaking (ANPRM) where they indicated they would be seeking the public’s input on updating the Common Rule.  On 02 September 2015, HHS officially released this Notice of Proposed Rulemaking which aims to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.  HHS will be accepting feedback regarding the NPRM for 90 days from 08 September 2015, which will be taken into consideration before releasing the final rule.  The goal of the proposed revisions is to “modernize, strengthen, and make more effective” the Common Rule.  Some of the major changes to the Informed Consent and Institutional Review Board (IRB) review processes included in the proposed revision are summarized below:

  • Improve informed consent by increasing transparency and imposing stricter new requirements regarding the information that must be given to prospective subjects, and the manner in which it is given to them, to better assure that subjects are appropriately informed before they decide to enroll in a research study.  This will include a one-time posting requirement for the consent forms for clinical trials, so that anyone drafting a consent form will do so knowing that it will eventually be subject to public scrutiny.  The location where these will be posted would need to be determined. 
  • Change the requirements for written consent for use of an individual’s biological samples so that very rarely would researchers be able to collect and bank them for future use unless they obtain consent to do so.
  • Streamline requirements for (IRB) review based on risk. Some studies that currently require IRB review could now be considered “exempt”, while others that are currently exempt could be declared as “excluded” from requiring IRB review.  A web-based “decision tool” that investigators will use to provide them with a determination of whether or not a study can be considered exempt or excluded based on the level of risk involved for subjects is also mentioned.  The idea is to focus efforts on more detailed review of studies involving greater risk while reducing the level of review required for those involving less risk.
  • Mandate, in most cases, that multi-site research studies use a single IRB, and encourage that the IRB chosen is not affiliated with institutions conducting the research.  Also, this single IRB would be held directly responsible for compliance with the Common Rule. The proposed revision also eliminates the continuing review requirement for studies that undergo expedited review or have completed study interventions and are merely analyzing data or following subjects long-term.
  • Apply the Common Rule to all clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding for research involving human participants from a Common Rule agency, such as the Department of Health and Human Services, the Department of Defense, or the Department of Education to name a few.

Here at IMARC, we feel these proposed changes are significant and may help afford greater protections to research subjects.   How do you feel about the proposed changes?  Please respond and share

 Image Credit: Nicolette Capuano

The History of Clinical Research

Topics: History of Clinical Research Timeline, IMARC Research, The Common Rule


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