Informed Consent: A Monthly Review

April 2019

This digest is intended to aggregate and distill 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 GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:

Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation

David R. Curry
President & CEO
GE2P2 Global Foundation

PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_April 2019

HPV vaccination and sexual health in France: Empowering girls to decide

HPV vaccination and sexual health in France: Empowering girls to decide
Hervé Lefevre, Stéphanie Samain, Nour Ibrahim, Christine Fourmaux, Anne Tonelli, Sébastien Rouget, Emmanuelle Mimoun, Renaud De Tournemireci, Marie Devernav, Marie Rose Morp, Jonathan Lachal
Vaccine, 22 March 2019; 37(13) pp 1792-1798
Vaccination coverage against HPV in France is among the lowest in the industrialized world, although the public authorities have recently become aware of this issue. Few studies have looked at teenaged girls’ representations of this vaccination, even though they are the most concerned by it. This qualitative study explored the experiences and representations of HPV vaccination by adolescent girls seeing doctors at least occasionally.
Study Design
We used a written essay question to explore this issue among 101 adolescent girls at six urban medical centers and a semi-structured interview to discuss it in further depth with five of them. The analysis was lexicometric (ALCESTE®) and phenomenological (Interpretative Phenomenological Analysis).
These results are organized around four superordinate themes: the teenage girls’ factual knowledge about this vaccine, their motives for and obstacles to vaccination, their involvement in this decision, and finally the need for information about and solutions to this issue.
Teenage girls know little about this vaccine and are more sensitive to the emotional discourse that surrounds it than to rational knowledge about it. The requirement for parental authorization for this vaccine reinforces the girls’ lack of investment. Vaccination programs should integrate the HPV vaccine more thoroughly into general prevention concerning sexual health and should send a strong signal by offering minors anonymous vaccination free of charge, as is already the case in France for requests for contraception, the morning-after pill, elective abortion, and screening and treatment of sexually transmitted infections.

Communication with children and adolescents about the diagnosis of their own life-threatening condition

Communication with children and adolescents about the diagnosis of their own life-threatening condition
Alan Stein, Louise Dalton, Elizabeth Rapa, Myra Bluebond-Langner, Lucy Hanington, Kim Fredman Stein, Sue Ziebland, Tamsen Rochat, Emily Harrop, Brenda Kelly, Ruth Bland
The Lancet, 16 March 2019; 393(10176) pp 1150-1163
When a child is diagnosed with a life-threatening condition, one of the most challenging tasks facing health-care professionals is how to communicate this to the child, and to their parents or caregivers. Evidence-based guidelines are urgently needed for all health-care settings, from tertiary referral centres in high-income countries to resource limited environments in low-income and middle-income countries, where rates of child mortality are high. We place this Review in the context of children’s developing understanding of illness and death. We review the effect of communication on children’s emotional, behavioural, and social functioning, as well as treatment adherence, disease progression, and wider family relationships. We consider the factors that influence the process of communication and the preferences of children, families, and health-care professionals about how to convey the diagnosis. Critically, the barriers and challenges to effective communication are explored. Finally, we outline principles for communicating with children, parents, and caregivers, generated from a workshop of international experts.

Informed Consent in Biomedical Research

Informed Consent in Biomedical Research
Fida K.Dankar, MartonGergely, SamarDankar
Computational and Structural Biotechnology Journal, 25 March 2019
Informed consent is the result of tumultuous events in both the clinical and research arenas over the last 100 years. Throughout this time, the notion of informed consent has shifted tremendously, both due to advances in medicine, as well as the type of data being gathered. As such, informed consent has misaligned with the goals of medical research. It is becoming more and more vital to address this chasm, and begin building new frameworks to link this disconnect. Thus, we address three goals in this paper. First, we discuss the history of informed consent and unify the varying definitions of the term. Second, we evaluate the current research on the topic, classify them into themes, and attend to the problems therein. Lastly, we employ these themes of informed consent research mentioned previously to provide guidance and insight for future research in the arena.

Factors associated with refusal or acceptance of older patients (≥ 65 years) to provide consent to participate in clinical research in cardiology: a qualitative study

Factors associated with refusal or acceptance of older patients (≥ 65 years) to provide consent to participate in clinical research in cardiology: a qualitative study
Fiona Ecarnot, Nicolas Meunier-Beillard, Jean-Pierre Quenot, Nicolas Meneveau
Aging Clinical and Experimental Research, 21 March 2019; pp 1–8
Clinical research is an essential step in the successful translation of knowledge from basic research into concrete clinical applications, yet many people are reluctant to provide consent when actually approached to actively participate in clinical trials.
We investigated the factors that influence older patient’s (≥ 65 years) decisions to accept or refuse to participate in a prospective randomized clinical trial in secondary prevention after acute coronary syndrome.
Qualitative approach based on individual semi-structured interviews with patients who were approached for consent to participate in a currently ongoing clinical trial was adopted. Patients were interviewed after the consent process (8 accepted; 8 refused the trial). Interviews were analysed using grounded theory methodology.
Sixteen patients aged ≥ 65 years participated. The main concept to emerge from these interviews is that the actual trial itself does not appear to be the primary determinant in the decision to participate in clinical research. Rather, patients’ decisions to participate (or not) in clinical research appear to be primarily determined by their capacity to deal with the current health event that has disrupted their life, and by their available mental and physical resources.
Discussion and conclusion
Older patients display varying levels of engagement in their own health, ranging from low engagement with high trust in the medical profession, to high engagement mirrored by distrust of the medical profession. Structural conditions, such as personal benefit from trial participation, or logistic barriers to participation, seem to affect both accepters and refusers in the same manner.

Informed Consent for Genetics Research in Italy

Informed Consent for Genetics Research in Italy
Piergiorgio Fedeli, Nunzia Cannovo, Rosa Guarino, Vincenzo Graziano
Open Medicine Journal, 28 February 2019; 6 pp 6-12
Genetic research has become an indispensable instrument for medical research, and the subjects involved have both divergent and convergent interests.
The possibility of having more detailed genetic information undoubtedly offers benefits for the health of the subject, but could also pose risks and make the subject vulnerable to discrimination. The scientific community has viewed very favorably the public health utility of family history, in which data from a family whose members suffer from chronic pathologies is collected and filed, in order to develop a sort of “stratification of family risk.” Even though in the last decade the scientific and juridical literature has contributed greatly to the topic of biobanks, the perplexities that continue to surround this theme give the idea that current ethical protocols on research are inadequate.
Genetic data must be used not to exploit, but to serve the person. Freedom and responsibility must be the twin guiding lights for establishing parameters for the use of biological samples. An evaluation of how this technology impacts the various aspects of the future of society is urgently needed.

Clinical applications of machine learning algorithms: beyond the black box [Analysis]

Clinical applications of machine learning algorithms: beyond the black box [Analysis]
David S Watson, Jenny Krutzinna, Ian N Bruce, Christopher EM Griffiths, Iain B McInnes, Michael R Barnes, Luciano Floridi
British Medical Journal, 12 March 2019; 364 
Machine learning algorithms are an application of artificial intelligence designed to automatically detect patterns in data without being explicitly programmed. They promise to change the way we detect and treat disease and will likely have a major impact on clinical decision making. The long term success of these powerful new methods hinges on the ability of both patients and doctors to understand and explain their predictions, especially in complicated cases with major healthcare consequences. This will promote greater trust in computational techniques and ensure informed consent to algorithmically designed treatment plans.

Unfortunately, many popular machine learning algorithms are essentially black boxes—oracular inference engines that render verdicts without any accompanying justification. This problem has become especially pressing with passage of the European Union’s latest General Data Protection Regulation (GDPR), which some scholars argue provides citizens with a “right to explanation.” Now, any institution engaged in algorithmic decision making is legally required to justify those decisions to any person whose data they hold on request, a challenge that most are ill equipped to meet. We urge clinicians to link with patients, data scientists, and policy makers to ensure the successful clinical implementation of machine learning (fig 1). We outline important goals and limitations that we hope will inform future research.

The willingness to participate in biomedical research involving human beings in low‐ and middle‐income countries: a systematic review

The willingness to participate in biomedical research involving human beings in low‐ and middle‐income countries: a systematic review
Joyce L. Browne, Connie O. Rees, Johannes J. M. van Delden, Irene Agyepong, Diederick E. Grobbee, Ama Edwin, Kerstin Klipstein‐Grobusch, Rieke van der Graaf
Tropical Medicine & International Health, March 2019; 24(3) pp. 264-279
To systematically review reasons for the willingness to participate in biomedical human subjects research in low‐ and middle‐income countries (LMICs).
Five databases were systematically searched for articles published between 2000 and 2017 containing the domain of ‘human subjects research’ in ‘LMICs’ and determinant ‘reasons for (non)participation’. Reasons mentioned were extracted, ranked and results narratively described.
Ninety‐four articles were included, 44 qualitative and 50 mixed‐methods studies. Altruism, personal health benefits, access to health care, monetary benefit, knowledge, social support and trust were the most important reasons for participation. Primary reasons for non‐participation were safety concerns, inconvenience, stigmatisation, lack of social support, confidentiality concerns, physical pain, efficacy concerns and distrust. Stigmatisation was a major concern in relation to HIV research. Reasons were similar across different regions, gender, non‐patient or patient participants and real or hypothetical study designs.
Addressing factors that affect (non‐)participation in the planning process and during the conduct of research may enhance voluntary consent to participation and reduce barriers for potential participants.

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration
Rami Tadros, Gillian E Caughey, Sally Johns, Sepehr Shakib
Clinical Trials, 28 February 2019
A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer’s autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process.
The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer.
A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8–6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to repeat the aims of the study correctly.
The poor performance of our study volunteers raises concerns about recall of information prior to study drug administration. This has implications for the volunteer’s safety and ability to provide true informed consent. Interventions to improve recall prior to dosing should be undertaken.

Ethical Issues in Substance-Use Prevention Research

Ethical Issues in Substance-Use Prevention Research
Celia B. Fisher, Rimah Jaber
Prevention of Substance Use, 2 March 2019; pp 281-299
Substance use and dependency among individuals living in the United States has been recognized as a public health crisis. Substance-use prevention scientists are at the forefront of identifying current and continually evolving individual and social factors contributing to the misuse of prescription and illegal drugs and for designing and empirically validating preventive and treatment approaches that can inform public health policy. Along with the benefits of a substance-use science agenda are the ethical challenges associated with conducting socially sensitive research involving participants whose daily lives are vulnerable to psychological, social, legal, and economic harms. Given these vulnerabilities, investigators often encounter roadblocks to the conduct of scientifically valid and socially valuable research as a result of IRB requirements that may be the result of overestimation of participant risk and lack of information on the adequacy of risk protections developed specifically for this population. IRB concerns often include questioning whether monetary compensation will condone or increase illicit substance use, if street recruitment will draw police attention to illegal behaviors, whether cravings or withdrawals are indications of incapacity to consent, and if questions regarding factors associated with substance use such as sexual risk behaviors, depression, and interpersonal violence will in themselves cause emotional distress or internalized stigma. This chapter discusses these challenges through examination of four domains essential for the responsible conduct of addiction science: balancing of research risks and benefits, informed consent, confidentiality and disclosure policies, and fair and noncoercive compensation. We conclude with a discussion of the importance of community perspectives and the applicability of the goodness-of-fit ethics model for enhancing participant protections in substance-use prevention research.