Informed Consent: A Monthly Review
This digest aggregates and distills key content around informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_August 2020
Virtual consent for virtual patients: benefits of implementation in a peri- and post-COVID-19 era
Subhabrata Mukherjee, Asif Raza
British Journal of Hospital Medicine, 20 July 2020
The COVID-19 pandemic has caused major disruptions to the healthcare system, including increased reliance on virtual services, particularly clinic appointments. This leads to difficulty in obtaining informed consent; the vast majority of patients now need to be consented on the day of the procedure. To reduce problems with this process, the practice of obtaining electronic consent may be the correct way forward.
The ethics of deferred consent in times of pandemics
Rieke van der Graaf, Marie-Astrid Hoogerwerf, Martine C. de Vries
Nature Medicine, 10 July 2020
In the current COVID-19 pandemic, many researchers are applying to research ethics committees for deferred-consent procedures for protocols that aim either to test treatments or to obtain tissue or samples from research participants. However, the deferred-consent procedure has not been developed for pandemics. In this Comment, we interpret existing guidance documents and argue when and under which conditions deferred consent can be considered ethically acceptable in a pandemic.
Informed Consent for Emergency Obstetric Care During COVID-19 Pandemic
Saswati Tripathy, Satyajit Mohapatra
The Journal of Obstetrics and Gynecology of India, 3 July 2020
Informed consent process has become a challenging issue before surgery for any emergency obstetric care during this COVID pandemic. There is an increased risk of morbidity if there is a need of intensive care unit postoperatively and a risk of high mortality if patient has symptoms of COVID-19. Admission to intensive care unit adds on to the financial burden to the patient. Also, there is an increased risk of perinatal anxiety and depression during the COVID pandemic. When an asymptomatic carrier develops symptoms of COVID after delivery or caesarean section, the morbidity increases. So we have designed an informed consent form for patients undergoing emergency obstetric surgeries incorporating some points specific for COVID-19.
How should surgeons obtain consent during the covid-19 pandemic?
Views And Reviews
Daniel Sokol, Rupen Dattani
BMJ, 30 June 2020; 369
…Many surgeons are now resuming elective work, yet we are aware that some make no mention of the additional risks related to covid-19. Although the British Association of Spine Surgeons and some private hospitals have produced information sheets for patients undergoing surgery during the pandemic, to our knowledge no formal guidance has been published by the General Medical Council or the Royal College of Surgeons on obtaining consent in such circumstances. The surgical community remains unclear as to what to tell patients about to undergo elective surgery…
Improving knowledge and decision readiness to participate in cancer clinical trials: Effects of a plain language decision aid for minority cancer survivors
Aisha Langford, Jamie L. Studts, Margaret M. Byrne
Patient Education and Counseling, 7 July 2020
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.
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.
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.
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.
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
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
Regenerative Medicine, 1 July 2020
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
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.
Analyses of the compliance with the checklists of 21 PIS and ICFs reviewed/approved during 2016‐2017 by a medicinal Research Ethics Committee.
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.
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
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.