Informed Consent: A Monthly Review
This digest aggregates and distills key content addressing 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_March 2022
Informed Consent and Protection of Personal Data in Genetic Research on COVID-19
Piergiorgio Fedeli, Roberto Scendoni, Mariano Cingolani, Marcelo Corrales Compagnucci, Roberto Cirocchi, Nunzia Cannovo
Healthcare, 11 February 2022; 10(349)
The particular characteristics of COVID-19 demand the careful biomedical study of samples from patients who have shown different symptomatology, in order to understand the genetic foundations of its phenotypic expression. Research on genetic material from COVID-19 patients is indispensable for understanding the biological bases for its varied clinical manifestations. The issue of “informed consent” constitutes the crux of the problem in regulating research biobanks, because it concerns the relationship between the person and the parts separated from the body. There are several consensus models that can be adopted, varying from quite restricted models of specific informed consent to forms that allow very broad authorization (open consent). Our current understanding of COVID-19 is incomplete. Thus, we cannot plan, with precision, the research to be conducted on biological samples that have been, or will be, collected from patients infected by the novel coronavirus. Therefore, we suggest utilizing the “participation pact” between researchers and donors, based on a new form of participation in research, which offers a choice based on the principles of solidarity and reciprocity, which represent the communication of “values”. In the last part of this paper, the general data protection regulation concerning the matter is discussed. The treatment of personal data must be performed with explicit goals, and donors must be provided with a clear, transparent explanation of the methods, goals and time of storage. The data must not be provided to unauthorized subjects. In conclusion, open informed consent forms will be necessary for research on individual patients and on populations.
Ethical Aspects of the Informed Consent During COVID-19 Vaccination
Zorin KV , Gurevich KG
Medical Ethics, 31 March 2021
The main tactics used for COVID-19 prevention should be both quarantine measures and the large scale vaccination of the population. This does raise many ethical issues related to obtaining informed consent in biomedical research and clinical practice. The full and adequate ethical review of vaccination against the novel coronavirus infection can be provided only subject to ethical aspects of voluntary informed consent. Without that, it would be impossible to control the quality, efficiency and safety of the vaccine, and, consequently, the patients’ vaccination and its results.
Transparency informed consent related to patient dishonesty amid COVID-19 pandemic in Indonesia: In law perspective
Tiwuk Herawati, Fifik Wiryani, M. Nasser, Mokhammad Najih
Diponegoro Law Review, 2021; 6(2) pp 279-288
To break the chain of transmission of COVID-19 outbreak, the public is expected to be honest in explaining chronological physical contact when treating to health facilities, especially if the patient experiences symptoms of COVID-19. Honesty of patients indicated by COVID-19 is very important so that the chain of transmission of COVID-19 does not expand and facilitate health workers in data collection. Denial, lies, even like the refusal of COVID-19 corpses if it continues to be left, does not mean the countermeasures of COVID-19 are increasingly stretched. This article tries to review the transparency of informed consent in relation to patient dishonesty, where transparent communication is expected by the patient to be honest and not to cover the perceived symptoms or various things related to COVID-19. This research is normative juridical research. In normative legal research, library material is the basic data that in research science is classified as secondary data.
Editor’s note: Diponegoro Law Review is published by the Faculty of Law, Diponegoro University, Indonesia.
Evaluation of a blockchain-based dynamic consent platform (METORY) in a decentralized and multicenter clinical trial using virtual drugs
Ki Young Huh, Seol Ju Moon, Sang-Un Jeong, Min-Ji Kim, Wooseok Yang, Myeonggyu Jeong, Min-Gul Kim, SeungHwan Lee
Clinical and Translational Science, 14 February 2022
Blockchain is a novel data architecture characterized by a chronological sequence of blocks in a decentralized manner. We aimed to evaluate the real-world feasibility of a blockchain-based dynamic consent platform (METORY) in a decentralized and multicenter trial. The study consisted of three visits (i.e., screening and 2 follow-up visits) with a 2-week interval. Each subject was required to report the self-measured body temperatures and take a virtual investigational drug by entering the unique drug code on the application. To simulate real-world study settings, two major (i.e., changes in the schedule of body temperature measurement) and three minor protocol amendments (i.e., nonsignificant changes without any changes in the procedures) were set. Overall study completion rates, proportion of consent, and response time to each protocol amendment and adherence were evaluated. A total of 60 subjects (30 in each center) were enrolled in two study centers. All subjects completed the study, and the overall proportion of consent to each protocol amendment was 95.7 ± 13.7% (mean ± SD), with a median response time of 0.2 h. Overall, subjects took 90.8% ± 19.2% of the total drug, whereas compliance with the schedule was 69.1% ± 27.0%. Subjects reported 96.7% ± 4.2% of the total body temperature measurements whereas the adherence to the schedule was 59.0% ± 25.0%, which remarkably decreased after major protocol amendments. In conclusion, we evaluated a blockchain-based dynamic consent platform in real clinical trial settings. The results suggested that major changes should be avoided unless subjects’ proper understanding is warranted.
How to obtain valid consent for research?
Manel Ben Fredj
International Journal of Research and Ethics, 1 February 2022; 5(1)
There is a broad agreement on the need to protect humans participating in biomedical research. Research ethics encompasses three fundamental principles: autonomy, beneficence, and justice. In practice, valid consent from participants is considered as the main tool to protect the participants and to ensure their rights. Obtaining a valid consent for research requires the voluntariness and the capacity of participants with disclosing an adequate and clear information. Nevertheless, in some circumstances, the institutional review board (IRB) may make an exception and approve the waiver of consent. An approval by the IRB is always needed. This workshop introduces candidates to fundamental principles in ethics research and to the rules of consent writing in research. It addresses also the specific situations under which a waiver consent may be acceptable. The workshop proceeds in two sessions in which we: present the principles of research ethics with explaining the steps of obtaining a valid consent for research and organize work groups.
Recruitment, consent and retention of participants in randomised controlled trials : a review of trials published in the National Institute for Health Research (NIHR) Journals Library (1997–2020)
Richard M Jacques, Rashida Ahmed, James Harper, Adya Ranjan, Isra Saeed, Rebecca M Simpson, Stephen J Walters
BMJ Open, 30 January 2022; 12(2)
To review the consent, recruitment and retention rates for randomised controlled trials (RCTs) funded by the UK’s National Institute for Health Research (NIHR) and published in the online NIHR Journals Library between January 1997 and December 2020.
RCTs funded by the NIHR and published in the NIHR Journals Library.
Information relating to the trial characteristics, sample size, recruitment and retention.
Primary and secondary outcome measures
The primary outcome was the recruitment rate (number of participants recruited per centre per month). Secondary outcomes were the target sample size and whether it was achieved; consent rates (percentage of eligible participants who consented and were randomised) and retention rates (percentage of randomised participants retained and assessed with valid primary outcome data).
This review identified 388 individual RCTs from 379 reports in the NIHR Journals Library. The final recruitment target sample size was achieved in 63% (245/388) of the RCTs. The original recruitment target was revised in 30% (118/388) of trials (downwards in 67% (79/118)). The median recruitment rate (participants per centre per month) was found to be 0.95 (IQR: 0.42–2.60); the median consent rate was 72% (IQR: 50%–88%) and the median retention rate was estimated at 88% (IQR: 80%–97%).
There is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Although the majority of (6 out of 10) trials in this review achieved their final target sample; 3 out of 10 trials revised their original target sample size (downwards in 7 out of 10 trials). Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections.
Patient-centred consent in women’s health: does it really work in antenatal and intra-partum care?
Jacqueline Nicholls, Anna L David, Joseph Iskaros, Anne Lanceley
BMC Pregnancy and Childbirth, 25 February 2022; 22(156)
Legal and social changes mean that information sharing and consent in antenatal and intrapartum settings is contentious, poorly understood and uncertain for healthcare professionals. This study aimed to investigate healthcare professionals’ views and experiences of the consent process in antenatal and intrapartum care.
Qualitative research performed in a large urban teaching hospital in London. Fifteen healthcare professionals (obstetricians and midwives) participated in semi-structured in-depth interviews. Data were collectively analysed to identify themes in the experiences of the consent process.
Three themes were identified: (1) Shared decision-making and shared responsibility –engaging women in dialogue is often difficult and, even when achieved, women are not always able or do not wish to share responsibility for decisions (2) Second-guessing women – assessing what is important to a woman is inherently difficult so healthcare professionals sometimes feel forced to anticipate a woman’s views (3) Challenging professional contexts – healthcare professionals are disquieted by consent practice in the Labour ward setting which is often at odds with legal and professional guidance.
Results suggest that there is a mismatch between what is required of healthcare professionals to effect an antenatal or intrapartum consent process concordant with current legal and professional guidance and what can be achieved in practice. If consent, as currently articulated, is to remain the barometer for current practice, healthcare professionals need more support in ways of enabling women to make decisions which healthcare professionals feel confident are autonomous whatever the circumstances of the consultation.
Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions
Original Research Article
Astrid Berner-Rodoreda, Shannon McMahon, Nir Eyal, Puspita Hossain, Atonu Rabbani, Mrittika Barua, Malabika Sarker, Emmy Metta, Elia Mmbaga, Melkizedeck Leshabari, Daniel Wikler, Till Bärnighausen
Journal of Empirical Research on Human Research Ethics, 10 February 2022
Individual informed consent is a central requirement for clinical research on human subjects, yet whether and how consent requirements should apply to health policy experiments (HPEs) remains unclear. HPEs test and evaluate public health policies prior to implementation. We interviewed 58 health experts in Tanzania, Bangladesh and Germany on informed consent requirements for HPEs. Health experts across all countries favored a strong evidence base, prior information to the affected populations, and individual consent for ‘risky’ HPEs. Differences pertained to individual risk perception, how and when consent by group representatives should be obtained and whether HPEs could be treated as health policies. The study adds to representative consent options for HPEs, yet shows that more research is needed in this field – particularly in the present Covid-19 pandemic which has highlighted the need for HPEs nationally and globally.
Experiences and practices of key research team members in obtaining informed consent for pharmacogenetic research among people living with HIV: a qualitative study
Nabukenya Sylvia, Ochieng Joseph, Kaawa-Mafigiri David, Munabi Ian, Nakigudde Janet, Nakwagala Frederick Nelson, Barugahare John, Kwagala Betty, Ibingira Charles, Twimwijukye Adelline, Sewankambo Nelson, Mwaka Erisa Sabakaki
Research Ethics, 7 February 2022
This study aimed to explore experiences and practices of key research team members in obtaining informed consent for pharmacogenetics research and to identify the approaches used for enhancing understanding during the consenting process. Data collection involved 15 qualitative, in-depth interviews with key researchers who were involved in obtaining informed consent from HIV infected individuals in Uganda for participation in pharmacogenetic clinical trials. The study explored two prominent themes: approaches used to convey information and enhance research participants’ understanding and challenges faced during the consenting process. Several barriers and facilitators for obtaining consent were identified. Innovative and potentially effective consenting strategies were identified in this study that should be studied and independently verified.