The Revised Common Rule & IRBs
Implemented January 21, 2019
What is New?
Members of the Gettysburg community should be aware of changes to the Common Rule, which sets forth the federal rules that our IRB (Institutional Review Board) is charged with upholding with regard to research with human subjects. These are the first changes to the Common Rule since it was introduced in 1991! Some important changes in IRB rules and procedures include the following:
- Exempt categories have been added to and amended (though Expedited and Full review categories remain largely unchanged). Now, more research will be considered Exempt than in the past, with the goal of lightening the burden for researchers and the IRB. Exempt research must still be reviewed to ensure that the research is low-risk and properly categorized as Exempt. There are also new rules for “limited IRB review” of exempt proposals. However, the things that the IRB must review are much less numerous, and the Exempt form is now much shorter. Also, if your research is Exempt you will not need to submit a “Continuation” form if your project lasts more than one year.
*an important new addition to Exempt research is “benign behavioral interventions” that would include lab experiments with or without verbal or written responses.
**Audiovisual recording, either in conjunction with “benign behavioral interventions” or in conjunction with interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior are also now permitted under Exempt categories.
***another important change is that low-risk research on children and pregnant women now falls into a number of Exempt categories, though certain types of research with children still require full review.
- Continuation requirements have been lightened. Exempt review never had a time-limit, but now research that is Expedited does not need to be resubmitted to the IRB for permission to continue after a year. Even research that falls under full review can continue beyond the one-year mark without the researcher having to seek IRB permission, provided data-collection has ended and only analysis is taking place.
- The rules on informed consent have been changed to require that consent forms include “key information” up front and that information is presented in an accessible manner that facilitates decision-making. We had already provided good templates for informed consent, but we have tweaked them a bit to conform fully to the new federal guidelines.
- The definition of what is “research” has been clarified to purposely exclude journalistic endeavors, oral histories, historical scholarship, and data collection for professional, non-research purposes (e.g., public health surveillance, criminal justice activities, and national security purposes).
- Research on biospecimens has been targeted for a number of new IRB rules. Previously, such research was not clearly designated as “research with human subjects,” but now it is. As such, there are a number of new issues that must be covered in consent forms, and a new procedure, called “broad consent,” that must be used when secondary research with stored biospecimens is foreseen in the future or undertaken with biospecimens already collected.