Consent Form Reporting on ClinicalTrials.Gov, 2013-2023
Research Letter
Sydney A. Axson, Reshma Ramachandran, Alexa Lisenby, Nicholas A. Giordano
JAMA Open, 21 June 2024; 7(6)
Introduction
Informed consent documentation is legally, ethically, and scientifically imperative for research and provides prospective trial participants key study information. Historically, consent documents have been difficult to obtain and not consistently publicly available. As of July 21, 2019, and after a 2-year voluntary period, the revised Common Rule required select federally funded interventional trials to publicly post consent forms no later than 60 days after the last participant visit. The revision intends to increase research transparency and inform consent development. Although transparency efforts addressing trial registrations and results are well studied, less is known about public availability of consent forms in the context of the revised rule’s recent implementation. This cross-sectional analysis examined National Institutes of Health (NIH)–funded trial consent form availability on ClinicalTrials.gov.

Reshaping consent so we might improve participant choice (III) – How is the research participant’s understanding currently checked and how might we improve this process?
Research Article
Hugh Davies, Simon E Kolstoe, Anthony Lockett
Research Ethics, 24 February 2024
Open Access
Abstract
Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals (n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focused upon this, concentrating more on written material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved.

Informed Consent Writing: Facing the Patient Is in the Interest of the Sponsor
Tatiana Zhiganova, Olga Golubeva, Maxim Belotserkovskiy
American Medical Writers Association Journal, 13 June 2024
Abstract
This article analyzes the most common findings of the European Medicines Agency (EMA) and regulatory agencies regarding the quality of essential documents that led to delays in study approvals and major observations by EMA inspectors. The authors analyzed the content and length of informed consent forms used within clinical trials within the last 10 years and revealed a tendency toward increased length and complexity of the documents. Criteria for developing patient informed consent forms are suggested to implement in medical writing practice to make informed consent forms short and simple to read and understand by a layperson.

Simplifying informed consent as a universal precaution
Iris Z. Feinberg, Ajeet Gajra, Lori Hetherington, Kathryn S. McCarthy
Scientific Reports, 8 June 2024
Abstract
One barrier to participating in clinical research is that patients with low literacy skills (1 in 5 US adults) may struggle to understand the informed consent document (ICD). Writing consents using health literacy and plain language guidelines including simplified syntax and semantics can increase understandability and facilitate inclusivity of research populations with literacy challenges. Our study aim was to evaluate a simplified ICD for understandability while considering factors known to relate to comprehension (reading skills and working memory). We performed an on-line survey of 192 adults ages 18–77 in Georgia. Participants performed significantly better on the simplified ICD test. We built an additional model with all version x measure interactions (i.e., age, sex, race, urbanicity, GMVT, WM). This model did not significantly improve model fit, F < 1.00, suggesting that individual differences did not moderate the effect of simplification. Our findings suggest that using plain language and simplified syntax and semantics in ICD as a universal precaution may reduce cognitive reading burden for adults regardless of differences in reading skill or working memory. Increasing understandability in ICD may help improve targets for clinical trial enrollment.

Enhancing diverse representation in clinical studies: Recommendations from external subject matter experts (SMEs) and patients to optimize protocols, informed consent and study designs
Meeting Abstract: 2024 ASCO Annual Meeting I
Gregory A. Vidal, Haiying Cheng, Andrea Curry, Oana Cristina Danciu, Balazs Halmos, Jennifer Hopton-Jones, Stephen Huddleston, Kapil Kapoor, Maya Khalil, Ryan Huu-Tuan Nguyen, Jason Porter, Brieyona Reaves, Meredith Russell, Suyasha Gupta, Lauren Henderson, Meghan Mckenzie, Diana Ndunda, Noah Rosenberg, Ruma Bhagat
Journal of Clinical Oncology, June 2024
Open Access
Abstract
Background
Well-characterized disparities in clinical research have disproportionately affected patients of color, particularly in underserved communities. To tackle these barriers, the Roche-Genentech U.S. Advancing Inclusive Research Site Alliance solicited feedback from external SMEs about recommendations for strategies and tactics to increase Black, Hispanic/Latinx and older adult patient clinical research participation.
Methods
Feedback was received virtually and via 1:1 interviews from 13 external SMEs defined as investigators, study coordinators or other clinical research roles that engage directly with patients regarding a Phase III small-cell lung cancer protocol as a use case. Two patients provided recommendations for future clinical study protocols and designs. Additionally, multiple healthcare providers from International Society of Geriatric Oncology provided recommendations for the inclusion of older adults in study protocols. A cross-functional, pan-Roche-Genentech team reviewed the feedback and finalized all materials.
Results
Six key themes emerged: (a) use lay terms and humanizing language in patient materials; (b) integrate patient lifestyle realities by allowing flexibility in protocol inclusion/exclusion criteria; (c) improve the ease of patient participation and seek only what is clinically necessary for study assessment; (d) incorporate options for sites to enable them to make the right, and fastest, decision(s) for patients without sacrificing safety or data quality; (e) show commitment to diversity in words and actions such as including target enrollment goals in protocols and incorporating patient input on protocols before protocol finalization; (f) include older patients > 70 years. Patient feedback reinforced the SME themes, except for inclusion of older patients. Patients suggested efficiency, clarity and local community realities be factored into future study designs. Some examples are fewer clinic visits, remote visit options, providing patient transportation and food support in connection with protocol-required visits. Patients also highlighted the importance of explaining the probability of side-effects, clinics being present in the community and the need for greater education and awareness regarding barriers to clinical trial enrollment. One patient relayed the importance of early trial education through general physician offices before a trial is actually needed for a given patient.
Conclusion
These SME recommendations provide actionable insights to inform protocol design and patient recruitment strategy and tactics to enhance future protocols from an inclusivity-specific lens. Study teams can use these recommendations to address barriers that make enrollment/retention by underrepresented patient populations difficult.

The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies’ Soft Impacts into Account
Original Article
Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel, Johannes J. M. van Delden
Health Care Analysis, 19 May 2024
Open Access
Abstract
Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to, for example, data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials.

When describing harms and benefits to potential trial participants, participant information leaflets are inadequate
Research
Laura Cuddihy, Jeremy Howick, Ellen Murphy, Frances Shiely
Trials, 1 May 2024
Open Access
Abstract
Background
Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs).
Methods
A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third.
Results
Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas.
Conclusion
Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.

Editor’s note: The seven principles as described in the abstract appear in Table 2 in the paper.

What Is “Key Information”? Consideration of the Reasons People Do or Do Not Take Part in Research
Article
Kara Berwanger, Jon F. Merz
Ethics & Human Research, 17 April 2024
Abstract
We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

Translating “medicalese”: The case of informed consent forms
Raluca Chereji
Medical Writing, March 2024; 33(1) pp 44–47
Abstract
Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their linguistic and textual features exceed the comprehensibility needs of their non-expert target audience. These issues also impact medical translators who translate ICFs for prospective participants of international trials. This article discusses some of the main challenges of translating ICFs, such as specialised terminology and jargon, lexico-syntactic complexity, and text length, and argues for increased training and collaboration to mitigate these difficulties in medical translation.