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.
Highlights
The basis for obtaining informed consent in medicine originated in US legal cases in which patients sued their surgeons for battery
The Nuremberg Code outlined the basic requirements of ethical human subjects research, including the need for informed consent.[3,4]
The consent reviewer assesses the informed consent document to ensure that all required elements of the consent are present and redundancies are removed, the document is in simple lay language, all procedures in the consent form match the procedures listed in the protocol and are explained in detail when necessary, and risks listed in the consent form are consistent with the protocol and the drug/device information submitted.[25]
Summary
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. 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. To ensure that the Common Rule’s requirements are met, the IRB reviews each study submission, including the consent form. Conclusion: Research coordinators play an essential role in developing consent forms and providing the required review information to the IRB.
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