Informed Consent: A Monthly Review

February 2019

This digest is intended to aggregate and distill key content around informed consent from a broad spectrum of peer-reviewed and grey literature, practice domains and organization types including key agencies/IGOs, NGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this spectrum/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_February 2019

The psychology of “cure” – unique challenges to consent processes in HIV cure research in South Africa

The psychology of “cure” – unique challenges to consent processes in HIV cure research in South Africa
Keymanthri Moodley, Ciara Staunton, Theresa Rossouw, Malcolm de Roubaix, Zoe Duby, Donald Skinner
BMC Medical Ethics, 24 January 2019; 20(9)
Consent processes for clinical trials involving HIV prevention research have generated considerable debate globally over the past three decades. HIV cure/eradication research is scientifically more complex and consequently, consent processes for clinical trials in this field are likely to pose a significant challenge. Given that research efforts are now moving toward HIV eradication, stakeholder engagement to inform appropriate ethics oversight of such research is timely. This study sought to establish the perspectives of a wide range of stakeholders in HIV treatment and research to inform consent processes for cure research.
In total, 68 South African stakeholders participated in two qualitative research modalities. In-depth interviews (IDIs) were conducted with a purposive sample of 42 individuals – audiotaped with consent. Twenty-six stakeholders participated in three focus group discussions (FGDs). Thematic analysis of transcribed IDIs and FGDs was conducted.
The majority of respondents indicated that there could be unique challenges in HIV cure research requiring special attention. In particular, given the complexity of cure science, translation of concepts into lay language would be critical for potential participants to adequately appreciate risks and benefits in early phase research with experimental interventions. Furthermore, to aid understanding of risks and benefits against a background of desperation for a cure, specially trained facilitators would be required to assist with a psychological assessment prior to consent to avoid curative misconceptions. Long-term participant engagement to assess durability of a cure would mean that the consent process would be prolonged, necessitating annual re-consent. Building trust to maintain such long-term relationships would be critical to retain study participants.
Unique consent requirements for cure research in South Africa would include significant efforts to maximise understanding of trial procedures, risks and the need for long-term follow-up. However, the psychological dimension of cure must not be underestimated. Beyond an understanding of cure science, the emotional impact of HIV cure advances the discourse from cure to healing. Consequently, the consent process for cure research would need to be enhanced to include psychological support and counselling. This has several important implications for research ethics review requirements for consent in HIV cure research.

Emergency Consent: Patients’ and Surrogates’ Perspectives on Consent for Clinical Trials in Acute Stroke and Myocardial Infarction

Emergency Consent: Patients’ and Surrogates’ Perspectives on Consent for Clinical Trials in Acute Stroke and Myocardial Infarction
Neal W. Dickert, Victoria M. Scicluna, Opeolu Adeoye, Dominick J. Angiolillo, James C. Blankenship, Chandan M. Devireddy, Michael R. Frankel, Sara F. Goldkind, Gautam Kumar, Yi‐An Ko, Andrea R. Mitchell, Raul G. Nogueria, Ruth M. Parker, Manesh R. Patel, Michele Riedford, Robert Silbergleit, Candace D. Speight, Ilana Spokoyny, Kevin P. Weinfurt, Rebecca D. Pentz
Journal of the American Heart Association, 19 January 2019; 8(2)

Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients’ and surrogates’ experiences.
Methods and Results
We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016. Primary domains included trial recall, consent experiences, and preferences
regarding involvement. Descriptive and test statistics were used to characterize responses and explore relationships between key domains and characteristics. Multivariable logistic regression was used to examine associations between key covariates and consent preferences. There were 176 (84 stroke, 92 AMI) completed interviews. Most stroke respondents (82%) were surrogates; all AMI respondents were patients. Average time from trial enrollment to interview was 1.9 years (stroke) and 2.8 years (AMI); 89% of stroke and 62% of AMI respondents remembered being in the trial, and among these respondents, 80% (stroke) and 44% (AMI) remembered reading some of the consent form. Over 90% reported not feeling pressure to enroll, being treated in a caring way, and being treated with dignity. A minority (16% stroke and 26% AMI) reported they would have preferred not to be asked for consent. Just over half (61% stroke and 53% AMI) recalled a postenrollment conversation about the study.
Most respondents felt they were treated respectfully and were glad they had been asked for consent. Trial recall was relatively low, and many respondents recalled little postenrollment discussion. Further development of context‐sensitive approaches to consent is important.

Myth or Magic? Towards a Revised Theory of Informed Consent in Medical Research

Myth or Magic? Towards a Revised Theory of Informed Consent in Medical Research
Bert Heinrichs
The Journal of Medicine and Philosophy, 14 January 2019; 44(1) pp 33–49
Although the principle of informed consent is well established and its importance widely acknowledged, it has met with criticism for decades. Doubts have been raised for a number of different reasons. In particular, empirical data show that people regularly fail to reproduce the information provided to them. Many critics agree, therefore, that the received concept of informed consent is no more than a myth. Strategies to overcome this problem often rest on a flawed concept of informed consent. In this paper, it is suggested that informed consent is a communicative act between two persons. The challenge is to elucidate the norms and constraints for successfully performing such a communicative act. The view developed here has major consequences with regard to the standards for information disclosure as well as for the general scope of informed consent.

Informed Consent: No Longer Just What the Doctor Ordered? Revisited

Informed Consent: No Longer Just What the Doctor Ordered? Revisited
Marc D. Ginsberg
Akron Law Review, January 2019; 52(2) pp 49-90
The law of informed consent in medicine has evolved from the original doctrine which required the physician’s disclosure of the risks, benefits, and complications of (and alternatives to) a proposed procedure or treatment. The doctrine now implicates the disclosure of matters personal to the physician. Questions regarding the breadth of the doctrine in other respects have developed as well. This paper represents the author’s second examination of the unconventional aspects of the law of informed consent.

Consent in the face of death

Consent in the face of death
Camilla L. Scanlan, Cameron Stewart, Ian Kerridge
Ethics in Medicine, 24 January 2019; 49(1) pp 108-110
While the traditional model of consent is supported by codes and theories of ethics, is enshrined in law, and provides the core of health policy and clinical governance, it is unclear how accurately it reflects clinical practice and in particular how accurately it accounts for edition‐making in ‘high‐risk’ situations where patients are critically ill and facing death.

Should I Agree? Delegating Consent Decisions Beyond the Individual

Should I Agree?: Delegating Consent Decisions Beyond the Individual
Bettina Nissen, Victoria Neumann, Mateusz Andrzej Mikusz, Rory Gianni, Sarah Clinch, Chris Speed, Nigel Andrew Justin Davies
Lancaster University, 7 January 2019
Obtaining meaningful user consent is increasingly problematic in a world of numerous, heterogeneous digital services. Current approaches (e.g. agreeing to Terms and Conditions) are rooted in the idea of individual control despite growing evidence that users do not (or cannot) exercise such control in informed ways. We consider an alternative approach whereby users can opt to delegate consent decisions to an ecosystem of third-parties including friends, experts, groups and AI entities. We present the results of a study that used a technology probe at a large festival to explore initial public responses to this reframing focusing on when and to whom users would delegate such decisions. The results reveal substantial public interest in delegating consent and identify differing preferences depending on the privacy context, highlighting the need for alternative decision mechanisms beyond the current focus on individual choice.

Improving the informed consent process among HIV‐infected undisclosed minors participating in a biomedical research: insights from the multicentre nutritional SNACS study in Senegal

Improving the informed consent process among HIV‐infected undisclosed minors participating in a biomedical research: insights from the multicentre nutritional SNACS study in Senegal
Fabienne Hejoaka, Marie Varloteaux, Caroline Desclaux‐Sall, Sidy Mokhtar Ndiaye, Karim Diop, Aminata Diack, Fatou Niasse, Cécile Cames
Tropical Medicine & International Health, 9 January 2019
Providing research information in a manner accessible to minors participating in biomedical research is a major challenge. Guidance is dramatically lacking regarding best practices for seeking informed consent among undisclosed minors enrolled in HIV‐related research. We implemented an improved informed consent process (IICP) and identified factors associated with understanding of the information presented to HIV‐infected minors prior to their enrolment in a study.
We enrolled study participants attending 12 paediatric HIV clinics in Senegal. Children ≥7 years were provided with standardised research information using the IICP, which involves viewing a video and taking part in extended group discussions. Understanding was assessed by seven basic questions scored 1 or 2 points, with a maximum score of 11 points. A score of 9 or more points was defined as satisfactory understanding. Factors associated with understanding were identified using a stepwise logistic regression model.
Overall, 112 children, with a median age of 12.9 years (IQR: 10.2–15.0), participated in the IICP, of whom 37% were HIV disclosed. 71% achieved a satisfactory understanding score and all gave consent to participate in the research. HIV‐disclosed children were more likely to demonstrate satisfactory understanding than undisclosed children (aOR = 3.2, 95% CI: 1.1–9.6). Age, study setting and education level were not associated with satisfactory understanding.
These findings provide practical guidance for the development of improved and friendly informed consent processes in research involving minors. The implementation of the paediatric HIV research agenda will require a standardised and operational definition of informed consent, integrating the issue of HIV disclosure.

Ethical complexities in child co-research

Ethical complexities in child co-research
Merle Spriggs, Lynn Gillam
Research Ethics, January 2019; 15(1) pp 1–16
Child co-research has become popular in social research involving children. This is attributed to the emphasis on children’s rights and is seen as a way to promote children’s agency and voice. It is a way of putting into practice the philosophy, common amongst childhood researchers, that children are experts on childhood. In this article, we discuss ethical complexities of involving children as co-researchers, beginning with an analysis of the literature, then drawing on data from interviews with researchers who conduct child co-research. We identify six ethical complexities, some of which are new findings which have not been mentioned before in this context. In light of these possible ethical complexities, a key finding is for researchers to be reflexive – to reflect on how the research may affect child co-researchers and participants before the research starts. A separate overriding message that came out in responses from the researchers we interviewed was the need for support and training for child co-researchers. We conclude by providing a list of questions for reflexive researchers to ask of themselves when they use child co-research methodology. We also provide important questions for human research ethics committees to ask when they review projects using child co-research.

Who Speaks for Me?: Addressing Variability in Informed Consent Practices for Minimal Risk Research Involving Foster Youth

Who Speaks for Me?: Addressing Variability in Informed Consent Practices for Minimal Risk Research Involving Foster Youth
MV Greiner, SJ Beal, A Allen, V Patel, J Meinzen-Derr, AH Matheny Antommaria
Journal of Health Disparities Research and Practice, Winter 2018; 11(4) pp 111-131
Youth in protective custody (i.e., foster care) are at higher risk for poorer physical and mental health outcomes compared with those who are not in custody. These differences may be due in part to the lack of research on the population to create evidence-based recommendations for health care delivery. A potential contributor to this lack of research is difficulties in obtaining informed consent for empirical studies in this population. The objective of this study was to describe the approaches to obtaining informed consent in minimal risk studies of foster youth and provide recommendations for future requirements.
We conducted a systematic review of the literature to characterize the informed consent approaches in published minimal risk research involving youth in foster care. We searched PubMed, CINAHL, PsychINFO, Embase, ERIC, Scopus, and EBMR. Inclusion criteria were: studies conducted in the United States, included current foster youth, minimal risk, peer reviewed, and published in English. Full text was reviewed, and individuals required to consent and assent were extracted.
Forty-nine publications from 33 studies were identified. Studies required 0 to 3 individuals to consent. Individuals required to give consent included case workers (16, 48%), foster caregivers (12, 36%), biological parents (7, 21%), judges (5, 15%), and guardian ad litems (2, 6%). Twenty-nine (88%) studies required the youth’s assent. The studies used 14 different combinations of individuals. One (3%) study utilized a waiver of consent.
There is no consistent approach for obtaining informed consent for foster youth to participate in minimal risk research. Consent should ideally involve individuals with legal authority and knowledge of the individual youth’s interests and should not be burdensome. Consensus regarding consent requirements may facilitate research involving foster youth.