Model consent clauses for rare disease research
Research Article
Minh Thu Nguyen, Jack Goldblatt, Rosario Isasi, Marlene Jagut, Anneliene Hechtelt Jonker, Petra Kaufmann, Laetitia Ouillade, Fruszina Molnar-Gabor, Mahsa Shabani, Eric Sid, Anne Marie Tassé, Durhane Wong-Rieger, Bartha Maria Knoppers
BMC Medical Ethics, 1 August 2019; 20(55)
Open Access
Abstract
Background
Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants’ overall protection.
Methods
A global Task Force was set up to develop model consent clauses specific to rare diseases research, that are comprehensive, harmonized, readily accessible, and internationally applicable, facilitating the recruitment and consent of rare disease research participants around the world. Existing consent forms and notices of consent were analyzed and classified under different consent themes, which were used as background to develop the model consent clauses.
Results
The IRDiRC-GA4GH MCC Task Force met in September 2018, to discuss and design model consent clauses. Based on analyzed consent forms, they listed generic core elements and designed the following rare disease research specific core elements; Rare Disease Research Introductory Clause, Familial Participation, Audio/Visual Imaging, Collecting, storing, sharing of rare disease data, Recontact for matching, Data Linkage, Return of Results to Family Members, Incapacity/Death, and Benefits.
Conclusion
The model consent clauses presented in this article have been drafted to highlight consent elements that bear in mind the trends in rare disease research, while providing a tool to help foster harmonization and collaborative efforts.

An Important Gap in Informed Consent Documents for Oncology Clinical Trials: Lack of Quantitative Details About Expected Treatment Outcomes
Viewpoint
Charles A. Schiffer
JAMA Oncology, 22 August 2019
Excerpt
Written informed consent must be obtained in addition to the discussions that physicians have with patients considering participation in clinical trials. Implicit in this requirement is the assumption that these dialogues with the caregivers are insufficient, requiring supplementation by written documents to reinforce what had been presented and/or to provide details that may not have been mentioned. The consents should be written in lay language with clear explanations of scientific and medical terms.1 Over the years, consent forms have become longer and more detailed and there is an extensive literature about how much information is actually retained by the patient after reading about Health Insurance Portability and Accountability regulations, handling of biologic specimens, long lists of potential adverse effects, the nature of randomization, etc.2 There are concerns that this litany of details distracts attention from the most critical features, including the aims of the study and the extra requirements and inconveniences compared with standard care.

A survey of informed consents from FDA’s center for devices and radiological health
Fabienne Santel, Isatu Bah, Katherine Kim, Ja-An Lin, Jack McCracken, Adaeze Teme
Contemporary Clinical Trials, 21 August 2019
Abstract
Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDA’s Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs.

The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension.

The investigators found that the mean grade-reading levels of the ICFs ranged from 10th grade to college level (Table 2), higher than the recommended 6th to 8th grade level [1], when measured by major readability evaluation tools (the SMOG readability grade level formula, the Flesch-Kincaid Index Grade Level Readability Formula, the Flesch Reading Ease test, and the Dale-Chall readability formula).

Overall, the ICFs and informed consent (IC) processes, as described in the IDE application, lacked components that enhanced participants’ comprehension, such as short sentences (e.g., no more than 8 to 10 to words) and the use of pictures, tables, and diagrams.

CDRH investigators believe that information about ICFs’ readability, comprehension, and structure will help support current and future efforts to improve the IC process. The intent of the article is to demonstrate that improvements are needed in the IC process and to encourage clinical trial stakeholders to consider implementing those approaches that optimize patient comprehension in the development of their IC processes.