Spotlight Articles

In this issue’s Spotlight section we include two recent articles analyzing the structure and components of ICFs [informed consent forms].

In Characterization of Key Information Sections in Informed Consent Forms Posted on ClinicalTrials.gov published in the Journal of Clinical Translational Science the authors assess the presence, length, readability and other parameters of KIs [key information sections] in ICFs posted on ClinicalTrials.gov in alignment with the revised Common Rule. The authors argue that “…widely adopted guidelines could also facilitate compliance analyses that are currently challenged by the broad subjectivity in interpreting the KI requirement [in the revised Common Rule].”

In the Perspectives in Clinical Research article Redefining informed consent form in cell and gene therapy trials, Dalal et at. address the need to adapt the informed consent process and ICFs to the unique context of gene therapy trials [see Fig 3 below] as well as the  cultural contexts in which the trials are implemented.

Characterization of Key Information Sections in Informed Consent Forms Posted on ClinicalTrials.gov
Luke Gelinas, Walker Morrell, Tony Tse, Ava Glazier, Deborah A. Zarin, Barbara E. Bierer
Journal of Clinical and Translational Science, 14 August 2023
Abstract
Introduction
Recent revisions to the United States Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a “concise and focused” key information (KI) section in informed consent forms (ICFs). We performed a systematic study to characterize KI sections of ICFs for federally-funded trials available on ClinicalTrials.gov.
Methods
We downloaded ICFs posted on ClinicalTrials.gov for treatment trials initiated on or after the revised Common Rule effective date. Trial records (n=102) were assessed by intervention type, study phase, recruitment status, and enrollment size. The ICFs and their KI sections, if present, were characterized by page length, word count, readability, topic, and formatting elements.
Results
Of the 102 trial records, 76 had identifiable KI sections that were, on average, 10% of the total length of full ICF documents. KI readability grade level was not notably different than other sections of ICFs. Most KI sections were distinguished by section headers and included lists but contained few other formatting elements. Most KI sections included a subset of topics consistent with the basic elements of informed consent specified in the Common Rule.
Conclusion
Many of the KI sections in the study sample aligned with practices suggested in the preamble to the revised Common Rule. Further, our results suggest that some KI sections were tailored in study-specific ways. Nevertheless, guidelines on how to write concise and comprehensible KI sections would improve the utility and readability of KI sections.

Redefining informed consent form in cell and gene therapy trials
Review Article
Varsha Dalal, Geeta Jotwani, Munna Lal Yadav
Perspectives in Clinical Research, 28 July 2023
Abstract
Informed consent is a foundation of the ethical conduct of research involving human participants. Based on the ethical principle of respect for persons, the goal of informed consent is to ensure that participants are aware of the risks and potential benefits and make a voluntary decision about participating in clinical trial research. The extraordinary scientific advances happening globally have demonstrated the potential of regenerative therapies in transforming the health of the nation by providing a therapeutic option for diseases that were previously considered incurable. These therapies, which include cells and gene therapy (GT) labeled as Advanced Therapeutic Medicinal Products globally, have complex mechanisms of action. Owing to their highly personalized and intricate nature of these therapies, developing the latter often presents unique challenges above and beyond those encountered for small molecule drugs. We recently looked through some cell and GT clinical trials and realized the lacunae in the informed consent form (ICF) provided by the investigators. Especially in a country like India, where the general understanding and perception of patients is limited regarding clinical trials, it is felt that any lapses in the consent process may jeopardize the informed decision‑making and safety of the participants and tarnish the reputation of India globally. The present article highlights the need for appropriate patient and public education on the various aspects of cell and gene therapies and aims to address all the elements of ICF in light of the challenges associated with these innovative therapies.