Improving knowledge and decision readiness to participate in cancer clinical trials: Effects of a plain language decision aid for minority cancer survivors
Short Communication
Aisha Langford, Jamie L. Studts, Margaret M. Byrne
Patient Education and Counseling, 7 July 2020
Abstract
Objective
To evaluate the impact of a web-based, plain language decision aid (CHOICES DA) on minority cancer survivors’ knowledge of cancer clinical trials (CCTs), readiness for making decisions about clinical trial participation, and willingness to participate in a clinical trial.
Methods
Participants were 64 Black and Hispanic cancer survivors from Miami, Florida. In a single arm intervention study, participants completed self-report assessments of CCT knowledge, decision readiness regarding clinical trial participation, and willingness to participate at three time points.
Results
Black and Hispanic participants did not differ on demographic characteristics. Post-test and follow-up measures of CCT knowledge and decision readiness were significantly greater than pre-test measures for the sample overall, and for Black and Hispanic participants separately. Few significant differences were observed between Black and Hispanic participant outcomes at each survey time point, and willingness to participate did not change overall and for either group independently.
Conclusions
Reviewing the CHOICES DA was associated with significantly improved knowledge and decision readiness to participate in a CCT immediately and at 2-week follow-up.
Practical Implications
These findings suggest that CHOICES DA may support informed decision making about CCT participation within an acute, yet clinically relevant window of time for minority cancer patients who are substantially under-represented in cancer research.

Informed consent for HIV phylogenetic research: a case study of individuals living with HIV in an urban area who were contacted for participation in an HIV study
Abby E. Rudolph, Omar Martinez, Robin Davison, Chineye Brenda Amuchi
Ehquidad International Welfare Policies and Social Work Journal, 4 July 2020; 14
Open Access
Summary
Introduction: Phylogenetic analyzes can provide information on the dynamics of HIV transmission. National and state differences in HIV criminalization and disclosure laws and advances in next-generation sequencing could affect the study’s perceived risks. Methods: We present the study opt-out rates and the reasons provided during enrollment for a study conducted in Boston (6 / 2017-8 / 2018). Results: Of the 90 patients who came to participate, 45 did not consent to participate. Reasons for not participating included an unwillingness to discuss their HIV status, privacy and confidentiality concerns, disinterest and lack of time. Conclusions: Given the low participation rates and concerns related to HIV status disclosure, privacy and confidentiality, these questions remain (1) should informed consent be required for all phylogenetic analyzes, including anonymous information and surveillance data? (2) What additional steps can investigators take to protect people’s privacy, particularly in contexts where HIV is criminalized or there have been civil / criminal cases investigating HIV transmission? And (3) what role can community members play to minimize potential risks, particularly for the most marginalized? These questions require input from both researchers and community members living with HIV / AIDS.

Understanding voluntariness of consent in first-in-human cell therapy trials
Perspective
Kristina Hug
Regenerative Medicine, 1 July 2020
Abstract
Consensus about contents of voluntariness in informed consent is lacking. Core criteria for voluntary consent are needed to ensure voluntariness. This article outlines the multidimensionality of voluntariness and identifies what could reduce voluntariness, especially in first-in-human clinical trials involving cell therapies. In such trials, truly voluntary consent is especially important because: such trials may involve risk of serious harm, while in case of some diseases, eligible patients often have potentially effective therapeutic alternatives; patients considering participation in high-risk first-in-human trials may feel more desperate and some may be dependent on their caregivers, including those in the family; implanted cells cannot be taken out of the patient’s body if the patient wants to withdraw.

Assessment of the quality of Patient Information Sheets and Informed Consent Forms for clinical trials at a Hospital Neurology Service
Andrea G Jaramillo Vélez, Margarita Aguas Compaired, Montserrat Granados Plaza, Eduardo L. Mariño, Pilar Modamio
European Journal of Neurology, 28 June 2020
Abstract
Background and purpose
Clinical trials (CTs) aimed at vulnerable groups such as patients with mental disorders create ethical complexity. The Patient Information Sheet (PIS) should provide all the information about the CT that is relevant to the subject’s decision to participate. After being informed, the subject will decide freely whether to take part in the CT and will read and sign the Informed Consent Form (ICF). The objective was to assess the quality of PIS/ICFs from a Hospital Neurology Service (NS). The assessment was made using validated and reliable checklists of the information included in the PIS/ICFs of CTs with medicinal products.
Methods
Analyses of the compliance with the checklists of 21 PIS and ICFs reviewed/approved during 2016‐2017 by a medicinal Research Ethics Committee.
Results
All PIS/ICFs were from multicenter CTs sponsored by pharmaceutical companies in different therapeutic areas, mainly Parkinson’s (52.4%) and Alzheimer’s (38.1%) diseases. The PISs from the NS demonstrated good compliance (≥ 80%) with the checklist, while ICFs should be improved. Sponsors omitted some relevant information such as study title or that the participant be informed of any information arising from the research that may be relevant to the subject’s health, although this information may be in the PIS.
Conclusions
The PIS/ICFs of CTs of medicinal products currently used need improvement. PISs and ICFs should be separate documents for each CT. The PIS/ICFs should consider, in particular, those criteria related to the decision of participants, protect their rights and ensure that the information received is complete.

How Health Literacy Can Enhance the Design and Conduct of Clinical Trials From Consent to Conclusion
Catina O’Leary, Chris Casey, Diane Webb, Deborah Collyar, Andrew Pleasant
Studies in Health Technology and Informatics, 25 Jun 2020; 269 pp 275-284
Abstract
Health literacy research and interventions have provided multiple tools to improve communication between professionals and patients in clinical contexts for many years. Despite the reality that many patients participate in clinical trials in conjunction with standard medical care, only recently have efforts extended to address and improve the health literacy of both clinical trial researchers and participants. To date, the primary focus of health literacy activities in clinical trials has centered on communicating trial results to trial participants. This report describes the opportunities and strategies necessary to layer health literacy activities across the clinical trial process from consent to conclusion.