Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration

Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration
Grace Gartel, Heather Scuderi, Christine Servay
Ochsner Journal, March 2020; 20(1) pp 76–80
Open Access
Abstract
Background
The Common Rule, which governs federally funded clinical research involving human subjects, formally defines the requirements for institutional review board (IRB) membership, functions and operations, and review of research, as well as the requirements for obtaining informed consent from research participants. The revisions to the Common Rule effective in January 2019 changed some content requirements for informed consent forms.
Methods
This article summarizes the history of informed consent requirements, the changes made to the requirements by the revision to the Common Rule, and the ways in which IRBs and research staff work together to develop informed consent forms that comply with the regulations and provide all the information potential research subjects need to decide whether to participate in a study.
Results
Clinical research coordinators, under their investigators’ supervision, are responsible for ensuring that research consent forms comply with the requirements of the federal regulations and the institution. Many IRBs have provided education regarding these new requirements, as well as consent templates that contain all the required elements. To ensure that the Common Rule’s requirements are met, the IRB reviews each study submission, including the consent form. The IRB panel makes revisions to the consent forms as needed and returns the approved consent form to the investigator and clinical research coordinator.
Conclusion
Research coordinators play an essential role in developing consent forms and providing the required review information to the IRB. In turn, through optimizing and standardizing consent forms and ensuring that all requirements of the Common Rule are followed, IRBs ensure that the rights of participants are protected and upheld.

Editor’s note: The Ochsner Journal is a peer-reviewed quarterly medical journal.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s