November 2018


NEW -  Important Information for Investigators with International Collaborations


Common Rule Changes and the Informed Consent Form

One major change to the informed consent form is the requirement that “key information” appear at the beginning of the form. The “key information” is to help the potential participants’ understanding of the research. What comprises “key information”? There are five factors that would encompass “key information”.

  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 also 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 mid-December. All applications submitted after December 21, 2018 will require the inclusion of “key information”. You can find the consent form template inthe IRBNet electronic submission system.


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