Axiom Research Compliance

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The Common Rule - Preparing for Changes to Research Administration

There has been much discussion among Research Compliance professionals about proposed changes to 45 CFR 46 , aka “The Common Rule” These discussions have been ongoing for years and if you’re like me you’re wondering what the final rules will be and when they will be published. Rumor has it in my neck of the woods that it will be finalized by the end of the year, prior to the next White House administration.

shutterstock_350999261.jpgThere is a rush to get it finalized because apparently the next administration can reject the current version midstream and the OHRP’s panel will have to return to the drawing board. Now, that would be a nightmare for those of us who have been waiting with baited breath.

There has been much discussion among larger institutions about the proposed changes to the regulations regarding biospecimens and multi-site collaborations. But, not a lot of discussion has occurred around how these proposed changes may affect those of us at smaller institutions and how we process our IRB applications.

One of the most significant changes that has been proposed is allowing for “Exempt” level protocols to be submitted by a PI, enabling them to make their own determination as to what meets Exempt criteria, with an after-the-fact audit of those activities to make sure they were determined correctly.

A lot of people found this idea disturbing. How could we allow a PI to make their own determination?

Nearly every experienced Research Compliance professional has been in the situation of having a PI clearly not make the correct determination and, accordingly bumped the review up a risk level, or sometimes down to an even lower level of Not Human Subjects Research (NHSR). For me, this was easy to tackle because our university has an online submission system.

The idea of a registry for Exempt protocols, to me, is the easiest approach. This method would allow a PI to log in to the online IRB submission system and go through a few easy steps:

  • ANSWER A QUESTIONNAIRE ABOUT THE RISK LEVEL (in accordance with the Common Rule guidelines on Exempt research, of course!)
  • SUBMIT THE INFORMATION TO THE SYSTEM
  • INFORMATION IS REVIEWED BY IRB REVIEWER OR STAFF
  • SUBMISSION ENTERS A REGISTRY OR PROCEEDS TO ANOTHER LEVEL OF REVIEW
  • ONCE REVIEWED, IT IS DOCUMENTED SECURELY IN THE SYSTEM, ALWAYS AVAILABLE TO REVIEW IF NECESSARY
  • NO AUDIT NECESSARY! TIME AND ENERGY SPARED!

The proposed changes to the Common Rule due later in 2016 allude to a “decision tool”, and everyone is desperate to get a glimpse of this tool prior to release. However there already seems to be enough information in place for those of us at small to mid-size institutions to act. While the larger biomedical institutions scramble with the difficult task of determining how they are going to gain consent for any use of biospecimens, most of us are just trying to figure out how best to capture the lower risk levels that we receive daily for projects at our institutions.

I think in some ways, lower risk levels, have always been difficult to review; since there are always risks to every research study (I do recall someone stating a risk of paper cuts in one I reviewed early in my career). There are many nuances in lower risk studies. The proposed “Excluded” will add a new layer of complexity on our record keeping. Those of us that have an electronic IRB submission system can breathe easier.

Before these changes are solidified, you should ask yourself, your colleagues and your IRB members if they have the time to mine through IRB applications word by word to figure out if the proposed project is, in fact, considered Exempt research, or if an electronic system that can do this for you simply through a one page questionnaire, saving time (money), stress, and paper.

Some of us are ready for this, and relieved that we have an online system that can capture these projects, considering they are a huge part of the IRB inventory. For those of you who still finding filing room for your three years of paper applications, consider an electronic system and get ahead of the new Common Rule.

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