Common Rule Changes and the Informed Consent Form

 

NEW -  Important Information for Investigators with International Collaborations

Common Rule Changes and the Informed Consent Form

December 14, 2018

As we are getting closer to the implementation of changes to the Common Rule we would like to begin communicating these changes to the research community. One major change is to the informed consent form. The new requirement is to include “key information” and that the “key information” must appear at the beginning of the informed consent form. The rationale behind this change is that the inclusion of “key information” will help the potential participant better understand the research.

What comprises “key information”? There are five factors that encompass “key information”. The five factors include the following:
1. Consent is being sought for research purposes and that participation is voluntary
2. Purpose of the research, expected duration of participation and procedures that would need to be followed
3. Any reasonably foreseeable risks/discomforts to the participant
4. Any reasonably expected benefits to the participant or others
5. Any alternative procedures that might be advantageous to the prospective participant

Additionally, investigators need to present the information in the informed consent form in enough detail and in a way that a prospective participant can comprehend the information.

The Office of Research Compliance is reformatting the consent template to include this “key information”. The template will be available by December in the IRBNet Forms and Templates Library. All applications submitted after December 21, 2018 will require the use of the new template which includes a “key information” section as well as other required changes.

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