Examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi

Abstract Background The participant recruitment process is a key ethical pivot point when conducting robust research. There is a need to continuously review and improve recruitment processes in research trials and to build fair and effective partnerships between researchers and participants as an important core element in ensuring the ethical delivery of high-quality research. When participants make a fair, informed, and voluntary decision to enroll in a study, they agree to fulfill their roles. However, supporting study participants to fulfill study requirements is an important ethical obligation for researchers, yet evidenced as challenging to achieve. This paper reports on participants’ motivations to volunteer and remain part of a dietary study conducted in Kasungu District, Malawi. Methods We conducted twenty in-depth interviews (with chiefs, religious leaders, trial participants, and health surveillance assistants), five systematic ethnographic observations, and fourteen focus group discussions with trial participants and their partners. Interviews were audio-recorded and transcribed verbatim. We used a grounded theory methodology to analyse data that included coding, detailed memo writing, and data interpretation. Findings The findings reveal that many participants had concerns during the trial. Thematically, experiences included anxieties, mistrust of researchers, rumours, fears of exploitation, and misconceptions. Anonymous concerns collected from the participants were reported to the trial team which enabled the researchers to appropriately support participants. Despite initial concerns, participants described being supported and expressed motivation to take up their role. Conclusion These findings highlight a diverse map of multiple notions of what is ethically relevant and what can impact participation and retention within a study. The study has revealed how embedding a responsive approach to address participants’ concerns and ethical issues can support trust relationships. We argue for the need to employ embedded ethics strategies that enhance informed consent, focus on participants’ needs and positive experiences, and support researchers to fulfill their roles. This work highlights the need for research ethics committees to focus on the risks of undue influence and prevent exploitation especially in settings with a high asymmetry in resources and power between researcher and participant groups. Trial Registration: The Addressing Hidden Hunger with Agronomy (Malawi) trial was registered on 5th March 2019 (ISCRTN85899451).

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Ethical Issues for Control-Arm Patients After Revelation of Benefits of Experimental Therapy: A Framework Modeled in Neuroblastoma

Journal of Clinical Oncology ◽

10.1200/jco.2012.47.1227 ◽

2013 ◽

Vol 31 (5) ◽

pp. 641-646 ◽

Cited By ~ 8

Author(s):

Yoram Unguru ◽

Steven Joffe ◽

Conrad V. Fernandez ◽

Alice L. Yu

Keyword(s):

Ethical Issues ◽

Controlled Trial ◽

Phase Iii ◽

Experimental Therapy ◽

Ethical Challenges ◽

Randomized Controlled ◽

Improved Outcomes ◽

Post Trial ◽

Study Participants ◽

Trial Participants

In 2009, the Children's Oncology Group (COG) phase III randomized controlled trial, ANBL0032, found that adding immunotherapy (Ch14.18) to standard therapy significantly improved outcomes in patients with high-risk neuroblastoma when administered within 110 days after autologous stem-cell transplantation (SCT). After careful deliberation and consultation, the COG Neuroblastoma Committee decided to offer Ch14.18 to prior trial participants who had been randomly assigned to the control arm (no immunotherapy), regardless of the time that had elapsed since SCT. This decision occurred in the context of a limited supply of Ch14.18 and no data regarding its role when administered beyond 110 days. In this article, we analyze the numerous ethical challenges highlighted by the ANBL0032 trial, including the limits of researchers' reciprocity-based obligations to study participants, post-trial access to beneficial therapies, and the balance between scientific knowledge and parental hope. These deliberations may be useful to other researchers when considering their ethical obligations to control-arm participants in the wake of a positive randomized trial.

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Experiment on identical siblings separated at birth: ethical implications for researchers, universities, and archives today

Journal of Medical Ethics ◽

10.1136/medethics-2019-105983 ◽

2020 ◽

pp. medethics-2019-105983

Author(s):

Robert L. Klitzman ◽

Adam M. Kelmenson

Keyword(s):

Ethical Issues ◽

Ethics Committees ◽

Institutional Review Boards ◽

Yale University ◽

Ethical Problems ◽

Ethical Implications ◽

Nature Versus Nurture ◽

Institutional Review ◽

Study Participants

Several films, including Three Identical Strangers, examined ethical problems in an experiment that involved identical siblings who were adopted as infants and separated into different families to examine the effects of nature versus nurture. The study was primarily designed and directed by Dr Peter Neubauer. The experiment, conducted in the 1960’s through 1980’s, serves as an important cautionary case study, raising several critical and ongoing ethical issues faced by researchers, universities and archives today. The organisation coordinating the study donated the research records to Yale University under the condition that they remain sealed until 2065, and has impeded study participants’ full access to research material. This case raises questions of what investigators, their descendants, research ethics committees or institutional review boards (IRBs), universities and archives should do with study records when researchers retire or die—whether universities should accept researchers’ donations of archival records that may contain patient or participant data, and if so, under what conditions. This study also poses crucial issues for IRBs—for example, whether researchers themselves or their designates should control all access to study records, particularly if controversy or lawsuits ensue. These questions will become increasingly crucial since the amount of research has burgeoned over recent decades, and investigators, on retirement or death, may want to donate their archives to universities. This experiment thus highlights ethical questions to which researchers, IRBs, universities, healthcare institutions, archivists and libraries should attend.

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Can we decrease the duration of basal thumb joint distraction for early osteoarthritis from 8 to 6 weeks? Study protocol for a non-inferiority randomized controlled trial

Trials ◽

10.1186/s13063-021-05283-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Janna S. E. Ottenhoff ◽

Teun Teunis ◽

Assa Braakenburg ◽

Aebele B. Mink van der Molen

Keyword(s):

Physical Function ◽

Human Subjects ◽

Controlled Trial ◽

Central Committee ◽

Ethics Committees ◽

Randomized Controlled ◽

Joint Distraction ◽

New Treatment ◽

Thumb Carpometacarpal ◽

Medical Research Ethics

Abstract Background To our knowledge, to date, 52 patients with thumb carpometacarpal osteoarthritis (CMC1 OA) were treated with joint distraction. So far, most patients experienced improved physical function and less pain. After 2 years, only 1 patient proceeded to trapeziectomy. This study assesses if we can safely lower the distraction duration from 8 to 6 weeks for CMC1 joint distraction, maintaining the improvement in physical function and pain. Methods This is a monocenter randomized controlled non-inferiority trial that includes patients younger than 65 years of age with ongoing symptoms of CMC1 OA and an established indication for surgery. All patients will be treated with CMC1 joint distraction. The primary outcome is to assess whether 6 weeks of joint distraction is not inferior to 8 weeks in terms of physical function at 1 year after surgery. Secondary outcomes will identify differences between groups at 1 year in pain intensity, patient satisfaction, hand health status, adverse event rates, treatment failure, differences in thumb strength and range of motion, and radiographic changes. Discussion If safe, the duration of basal thumb joint distraction can be reduced to 6 weeks, reducing patient burden. Because this is a relatively new treatment, this trial will provide greater knowledge of potential adverse events. This knowledge allows for more informed decision making for patients considering CMC1 distraction treatment. Future studies can directly compare joint distraction to other treatments of CMC1 joint arthritis like splinting and trapeziectomy. Trial registration Central Committee on Research Involving Human Subjects (CCMO), NL68225.100.18; registered on 9 August 2019. Medical Research Ethics Committees United (MEC-U), R19.003; registered on 9 August 2019. Netherlands Trial Register, NL8016; registered on 15 September 2019.

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Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264618824921 ◽

2019 ◽

Vol 14 (2) ◽

pp. 107-116 ◽

Cited By ~ 3

Author(s):

Blessing Silaigwana ◽

Douglas Wassenaar

Keyword(s):

South Africa ◽

Research Ethics ◽

South African ◽

Biomedical Research ◽

Ethical Issues ◽

Ethics Committees ◽

Financial Contracts ◽

Scientific Validity ◽

Participant Selection ◽

Education And Awareness

In South Africa, biomedical research cannot commence until it has been reviewed and approved by a local research ethics committee (REC). There remains a dearth of empirical data on the nature and frequency of ethical issues raised by such committees. This study sought to identify ethical concerns typically raised by two South African RECs. Meeting minutes for 180 protocols reviewed between 2009 and 2014 were coded and analyzed using a preexisting framework. Results showed that the most frequent queries involved informed consent, respect for participants, and scientific validity. Interestingly, administrative issues (non-ethical) such as missing researchers’ CVs and financial contracts emerged more frequently than ethical questions such as favorable risk/benefit ratio and fair participant selection. Although not generalizable to all RECs, our data provide insights into two South African RECs’ review concerns. More education and awareness of the actual ethical issues typically raised by such committees might help improve review outcomes and relationships between researchers and RECs.

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Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

BMC Medical Ethics ◽

10.1186/s12910-020-00536-9 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Daria Kim ◽

Joerg Hasford

Keyword(s):

Clinical Trials ◽

Health Risks ◽

Ethics Committees ◽

Medical Community ◽

Significant Extent ◽

Regulatory Requirements ◽

Trial Participants ◽

Clinical Trials Regulation ◽

Clinical Trial Regulation ◽

The Eu

Abstract The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

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DigiKnowIt News: Educating youth about pediatric clinical trials using an interactive, multimedia educational website

Journal of Child Health Care ◽

10.1177/13674935211003774 ◽

2021 ◽

pp. 136749352110037

Author(s):

Alison E. Parker ◽

Tracy M. Scull ◽

Abigail M. Morrison

Keyword(s):

Clinical Trials ◽

Interactive Multimedia ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Wait List ◽

Wait List Control Group ◽

Wait List Control ◽

Satisfaction Questionnaire ◽

Study Participants

Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.

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Commentary 1: Research with Persons Under Involuntary Commitment—Ethical Issues Surrounding Competence and Voluntariness

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264619847322a ◽

2019 ◽

Vol 14 (5) ◽

pp. 475-478

Author(s):

Matthé Scholten ◽

Jochen Vollmann

Keyword(s):

Informed Consent ◽

Ethical Issues ◽

Research Participation ◽

Research Participant ◽

Involuntary Commitment ◽

Proxy Consent ◽

Undue Influence ◽

Research Participants ◽

Manic Symptoms ◽

Prospective Research

In this case commentary, we analyze ethical concerns that were raised in response to an interview with a woman with bipolar disorder who was under involuntary commitment. We focus on competence and voluntariness as two prerequisites for valid informed consent. We recommend that judgments of competence be based on whether prospective research participants sufficiently possess certain decision-making abilities. Based on this functional approach, we argue that manic symptoms need not undermine competence and that, even if we were to assume that the research participant became incompetent during the interview, this would not invalidate her consent retroactively. It would, however, compromise her ability to revoke her consent. We furthermore show that obtaining additional proxy consent for research participation may compromise the autonomy of service users who are competent to consent. Then we turn to the issue of voluntariness. Arguing that neither the great strength nor the external etiology of a desire compromises voluntariness, we propose that the voluntariness of a decision instead depends on whether the decision-maker endorses it on reflection. The researchers disclosed that prospective research participants’ decision about study participation would have no influence on the duration of the commitment or the quality of care. We contend that because of this neither coercion nor undue influence was exerted in the informed consent process. Nevertheless, there is an increased likelihood of perceived coercion and undue influence under conditions of involuntary commitment, and we close by suggesting some safeguards to prevent this.

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Commentary: Mrs. J—Culture and Healthcare Ethics Committees

Cambridge Quarterly of Healthcare Ethics ◽

10.1017/s0963180110000472 ◽

2010 ◽

Vol 19 (4) ◽

pp. 537-540

Author(s):

John R. Stone

Keyword(s):

Ethical Issues ◽

Ethics Committees ◽

Healthcare Ethics ◽

Healthcare Ethics Committees

The heart-rending story of Mrs. J raises many complex ethical issues. Key elements include suffering, disagreement, culture, religion, perspective, and facts. Overarching concerns include whose voices and stories should count, the connection of pain with suffering, and how healthcare ethics committees should respond.

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Ethical and Social Issues in Medicine

10.2310/tywc.1222 ◽

2019 ◽

Author(s):

Roberta Springer Loewy ◽

Erich H. Loewy ◽

Faith T. Fitzgerald

Keyword(s):

Ethical Issues ◽

Social Issues ◽

Ethics Committees ◽

Daily Basis ◽

Moral Authority ◽

Health Care Ethics ◽

Good Medicine ◽

Personal Morality ◽

Online Access

So rapidly has the field of health care ethics continued to grow that, when recently “googled,” the term produced 28.2 million hits. The challenge is to address the ethical and social issues in medicine in this very limited article space. It remains an impossible task to present more than a superficial discussion of these complex issues and the complicated cases in which they are to be found. Like good medicine, good ethics cannot be practiced by algorithm. The authors have opted to provide an operational guide to help clinicians sort through the ethical and social quandaries they must face on a daily basis. To that end, the authors have chosen to divide this chapter into the following sections: 1. A brief description of the biopsychosocial nature of ethics and how it differs from personal morality 2. A method for identifying and dealing with ethical issues 3. A discussion of the role of bioethicists and ethics committees 4. The professional fiduciary role of clinicians 5. Listings of some of the common key bioethical and legal terms (online access only) 6. A very brief discussion of the terms cited in the above listings (online access only) This reviews contains 4 tables, 8 references, 1 appendix, and 20 additional readings. Keywords: Ethical, social, right, wrong, good, bad, obligation, moral authority, critically reflective, and multiperspectival activity, Curiosity, Honesty, Patience, Open-mindedness

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