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

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.

Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov

“…While many of the sampled KI sections in our analysis aligned with the few expectations specified in the preamble to the revised Common Rule, we also identified areas in which KIs could be significantly improved. Although many have called for the issuance of formal regulatory guidance to clarify the regulatory requirements for KI sections [7,16,40], more systematic research is needed to inform development of such guidance. In the short term, the research community should strive toward consensus-based guidelines to support the development of effective and understandable KI sections.…”

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials

“…Although the U.S. Food and Drug Administration has not harmonized its regulations with the 2018 revised Common Rule, our observation indicates that a concise summary as mandated by the 2018 revised Common Rule has been widely adopted, but its application in industry-sponsored drug development clinical trials remains varied and puzzling. 54,55 It should be noted that the scope of this study does not include investigating the extent to which the key information section aids in increasing understanding of informed consent or whether it just simply instructs potential research participants to read the entire ICF for more details, which may paradoxically end up lengthening an already lengthy ICF rather than assisting the research participants in making betterinformed decisions. [56][57][58] In this study, the ICFs slightly exceeded grade 8 language complexity and scored below 60 in the formal reading ease metric, indicating that they were somewhat difficult to read.…”

Hacia la objetividad en la valoración ética: legibilidad como parte de la comprensión de los formatos de consentimiento informado

“…[5][6][7] En investigación, el proceso de consentimiento informado requiere documentar la información que se proporciona al posible participante en un formato escrito que debe resumir las características del estudio, la participación voluntaria, los riesgos, beneficios y derechos. 8,9 Obtener el consentimiento informado es un requisito ético y legal, por ello su revisión es una de las principales funciones del CEI. [5][6][7] Se recomienda que la información escrita contenida en el formato de consentimiento informado (FCI) esté redactada en un lenguaje común en el que se eviten tecnicismos, para que sea entendida por las personas a las que va destinada.…”