Informed Consent and Ethical Issues in Military Medical Research

Abstract Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of research participants, and communication of research results. Ethical issues known to be associated with genomic research in general, such as privacy risks and informed consent/assent, seem especially pressing for NDD participants because of their potentially decreased cognitive abilities, increased vulnerability, and stigma associated with mental health problems. Additionally, there are informational risks: learning genetic information about NDD may have psychological and social impact, not only for the research participant but also for family members. However, there are potential benefits associated with research participation, too: by enrolling in research, the participants may access genetic testing and thus increase their chances of receiving a (genetic) diagnosis for their neurodevelopmental symptoms, prognostic or predictive information about disease progression or the risk of concurrent future disorders. Based on the results of our review, we developed an ethics checklist for genomic research involving children affected by NDDs. Conclusions In setting up and designing genomic research efforts in NDD, researchers should partner with communities of persons with NDDs. Particular attention should be paid to preventing disproportional burdens of research participation of children with NDDs and their siblings, parents and other family members. Researchers should carefully tailor the information and informed consent procedures to avoid therapeutic and diagnostic misconception in NDD research. To better anticipate and address ethical issues in specific NDD studies, we suggest researchers to use the ethics checklist for genomic research involving children affected by NDDs presented in this paper.

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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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Human Physiology: A Very Short Introduction

10.1093/actrade/9780198869887.001.0001 ◽

2021 ◽

Author(s):

Jamie A. Davies

Keyword(s):

Human Physiology ◽

Medical Research ◽

Human Body ◽

Ethical Issues ◽

Physiological Mechanisms ◽

Short Introduction ◽

Process Information ◽

Internal Parameters ◽

The Creation

Human Physiology: A Very Short Introduction explores how the human body works, senses, reacts, and defends itself. Physiology is the science of life. It considers how human bodies are supplied with energy, how they maintain their internal parameters, the ways in which they gather and process information or take action, and the creation of new generations. This VSI examines the experiments undertaken to understand the interplay of the vast variety of physiological mechanisms and principles within us, and analyses the ethical issues involved. It also looks at how enhanced understandings of physiological knowledge can help inform medical research and care.

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Ethical Issues Surrounding High-Risk Kidney Recipients: Implications for the Living Donor

Progress in Transplantation ◽

10.1177/152692480701700304 ◽

2007 ◽

Vol 17 (3) ◽

pp. 180-182 ◽

Cited By ~ 3

Author(s):

Jerome F. O'Hara ◽

Katrina Bramstedt ◽

Stewart Flechner ◽

David Goldfarb

Keyword(s):

Informed Consent ◽

High Risk ◽

Ethical Issues ◽

Family Members ◽

Transplant Recipients ◽

Kidney Donor ◽

Living Kidney Donor ◽

Kidney Recipients ◽

Medical Issues ◽

Donor Transplant

Evaulating patients for living kidney donor transplantation involving a recipient with significant medical issues can create an ethical debate about whether to proceed with surgery. Donors must be informed of the surgical risk to proceed with donating a kidney and their decision must be a voluntary one. A detailed informed consent should be obtained from high-risk living kidney donor transplant recipients as well as donors and family members after the high perioperative risk potential has been explained to them. In addition, family members need to be informed of and acknowledge that a living kidney donor transplant recipient with pretransplant extrarenal morbidity has a higher risk of a serious adverse outcome event such as graft failure or recipient death. We review 2 cases involving living kidney donor transplant recipients with significant comorbidity and discuss ethical considerations, donor risk, and the need for an extended informed consent.

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The ethical concerns of seeking consent from critically ill, mechanically ventilated patients for research – A matter of possessing capacity or surrogate insight

Clinical Ethics ◽

10.1177/1477750918762350 ◽

2018 ◽

Vol 13 (3) ◽

pp. 107-111 ◽

Cited By ~ 2

Author(s):

Avelino C Verceles ◽

Waqas Bhatti

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Informed Consent ◽

Critically Ill ◽

Ethical Issues ◽

Mechanically Ventilated ◽

Mechanically Ventilated Patients ◽

Ethical Concerns ◽

Multiple Factors ◽

Ventilated Patients

Conducting clinical research on subjects admitted to intensive care units is challenging, as they frequently lack the capacity to provide informed consent due to multiple factors including intensive care unit acquired delirium, coma, the need for sedation, or underlying critical illness. However, the presence of one or more of these characteristics does not automatically designate a potential subject as lacking capacity to provide their own informed consent. We review the ethical issues involved in obtaining informed consent for medical research from mechanically ventilated, critically ill patients, in addition to the concerns that may arise when a legally authorized representative is asked to provide informed consent on behalf of these patients.

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