Increased research literacy to facilitate community ownership of health research in low and middle income countries

ABSTRACT

The expansion of health research to low and middle income countries has increased the likelihood of exploitation and undue influence in economically vulnerable populations. In behavioral research, “reasonable availability”, which was originally developed for biomedical research and advocates for the equitable provision of any product developed during the research process, cannot always prevent exploitation. In such cases and settings, the informed consent process may lack cross-cultural validity and therapeutic misconceptions may arise. This article advocates for a mutual learning framework where international researchers can gain cultural competence while training and empowering local partners, increasing community ownership of health research.     

Capacity to consent to research in schizophrenia: the expanding evidence base

Capacity to consent to research, fundamental to informed consent and thus vital to the ethical conduct of research, may be impaired among a variety of research populations. Until recently, relatively little empirical evidence has been available to inform discussion and policy-making regarding whose capacity should be assessed, what should be measured, and how it should be measured. Capacity to consent to research has emerged as a central topic in the field of "empirical ethics," an important area of biomedical research devoted to bringing evidence-based methods to the study of ethically salient issues in biomedical and biopsychosocial research. In this paper, empirical studies of capacity to consent to research are reviewed, with a particular focus on studies involving people with schizophrenia. These studies provide intriguing data regarding the nature, correlates, and modifiability of decisional abilities among potentially vulnerable research populations, including individuals with serious neuropsychiatric illnesses. Areas in need of further empirical ethics research are highlighted.     

Do Undergraduate Student Research Participants Read Psychological Research Consent Forms? Examining Memory Effects,Condition Effects,and Individual Differences

Although research has examined factors influencing understanding of informed consent in biomedical and forensic research, less is known about participants' attention to details in consent documents in psychological survey research. The present study used a randomized experimental design and found the majority of participants were unable to recall information from the consent form in both in-person and online formats. Participants were also relatively poor at recognizing important aspects of the consent form including risks to participants and confidentiality procedures. Memory effects and individual difference characteristics also appeared to influence recall and recognition of consent form information.     

Informed consent—Wishful thinking?

This article is concerned with the concept of “informed consent” as applied both in biomedical research involving human subjects and in clinical medicine in general. The current crisis over the elaboration and interpretation of the concept will be examined, along with the broader question of whether “informed consent” is any longer meaningful or viable as a criterion for complex bioethical policy-making. Finally, I will attempt to sketch a prognosis for the concept in doctor-patient relations, even if it is only wishful thinking.     

Sign on the Dotted Line: The Informed Consent Process (ICP) as Induced Compliance1

We investigated the social implications of signing an informed consent form (ICF) on participant behavior. ICF research fails to consider that the decision to participate in research is a process that occurs in a social and cultural context. Understanding the meaning of giving consent in this social context is critical. In separate experiments, we found significantly greater agreement to return to complete a study and persistence at a task in participants who signed the ICF versus those who did not. Signing the ICF may be putting participants at risk of induced compliance with study protocols, rather than empowering them to withhold consent or withdraw. Future research should investigate the psychosocial factors affecting participants' decision making in the informed consent process.     

Chronicles of communication and power: informed consent to sterilisation in the Namibian Supreme Court’s <Emphasis Type="Italic">LM</Emphasis> judgment of 2015

The 2015 judgment of the Namibia Supreme Court in Government of the Republic of Namibia v LM and Others set an important precedent on informed consent in a case involving the coercive sterilisation of HIV-positive women. This article analyses the reasoning and factual narratives of the judgment by applying Neil Manson and Onora O’Neill’s approach to informed consent as a communicative process. This is done in an effort to understand the practical import of the judgment in the particular context of resource constrained public healthcare facilities through which many women in southern Africa access reproductive healthcare. While the judgment affirms certain established tenets in informed consent to surgical procedures, aspects of the reasoning in context demand more particularised applications of what it means for a patient to have capacity and to be informed, and to appropriately accommodate the disruptive role of power dynamics in the communicative process.     

Goodness-of-fit ethic for informed consent to research involving adults with mental retardation and developmental disabilities

This article reviews current theory and research on informed consent policies for adults with mental retardation within a relational ethics framework that re-conceptualizes consent vulnerability in terms of the goodness-of-fit between participant decisional capacities and the specific consent context. Conceptualizing informed consent competence as a product of the relationship between person and consent context shifts assessment of decisional capacity away from an exclusive focus on a research participant's cognitive deficiencies to (a) an examination of those aspects of the consent setting that are creating or exacerbating consent vulnerability and (b) consideration of how the setting can be modified to produce a consent process that best reflects and protects the hopes, values, concerns, and welfare of adults with developmental disabilities.     

Informed Consent in Asymmetrical Relationships: an Investigation into Relational Factors that Influence Room for Reflection

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply.     

The therapeutic misconception and our models of competency and informed consent

The doctrine of informed consent rests on empirical claims. This is true particularly of what commentators have characterized as the "strong" model of informed consent. This model assumes that if adequate information is given to a competent individual, understanding will result and, permitted to make a voluntary decision, the individual will make a rational decision. However, the "therapeutic misconception" posits that individuals may confuse the goals of research with those of treatment and may make decisions that do not rest on adequate understanding. This article reviews research suggesting that this may in fact be true, and concludes that, as a result, traditional notions of informed consent may not yield results consistent with the assumptions on which the doctrine of informed consent rests.     

Exploring Understanding of “Understanding”: The Paradigm Case of Biobank Consent Comprehension

Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether consent comprehension is an ethical requirement or an ethical aspiration.     

The fair transaction model of informed consent: an alternative to autonomous authorization

The doctrine of informed consent in bioethics has relied on the view that consent is valid when it represents a patient or research subject's autonomous authorization. In this article we challenge this reigning conception of the validity of informed consent in clinical research, focusing in particular on the problem of the therapeutic misconception. We argue that the autonomous authorization model of informed consent suffers from four defects: (1) it fails to do justice to the relevance of risk-benefit considerations in shaping the criteria for the validity of consent, (2) it compromises the interests of subjects by preventing them from consenting to research participation with less than substantial understanding when doing so would likely be consistent with their preferences and beneficial to them or at least be unlikely to cause them harm, (3) it jeopardizes the interests of investigators by denying them fair notice regarding when the consent of research subjects can be considered valid and thus make it permissible for them to be enrolled in research, and (4) it threatens the reasonable limits on the responsibility of investigators to assure the adequacy of subjects' understanding of what research participation involves. In place of the autonomous authorization model, we present and defend a fair transaction model of informed consent, which better reflects the values served by consent.     

Conducting industrial and organizational psychological research: institutional review of research in work organizations

Although informed consent is a primary mechanism for ensuring the ethical treatment of human participants in research, both federal guidelines and American Psychological Association ethical standards recognize that exceptions to it are reasonable under certain conditions. However, agreement about what constitutes a reasonable exception to informed consent is sometimes lacking. We presented the same protocols to samples of respondents drawn from 4 populations: Institutional review board (IRB) members, managers, employees, and university faculty who were not members of IRBs. Differences in perceptions of IRB members from the other samples with respect to the risks of the protocols without informed consent and on the feasibility of conducting the research in employment organizations are discussed in terms of implications for industrial and organizational psychology research.     

Conducting Industrial and Organizational Psychological Research: Institutional Review of Research in Work Organizations

Although informed consent is a primary mechanism for ensuring the ethical treatment of human participants in research, both federal guidelines and American Psychological Association ethical standards recognize that exceptions to it are reasonable under certain conditions. However, agreement about what constitutes a reasonable exception to informed consent is sometimes lacking. We presented the same protocols to samples of respondents drawn from 4 populations: Institutional review board (IRB) members, managers, employees, and university faculty who were not members of IRBs. Differences in perceptions of IRB members from the other samples with respect to the risks of the protocols without informed consent and on the feasibility of conducting the research in employment organizations are discussed in terms of implications for industrial and organizational psychology research.     

Genetic Counseling Practice in Next Generation Sequencing Research: Implications for the Ethical Oversight of the Informed Consent Process

The potential for next generation sequencing research (NGS) to generate individual genetic results could have implications for the informed consent process and the provision of genetic counseling. We undertook a content analysis of informed consent templates and guidelines produced by Canadian institutional review boards, purposively sampling documents used by researchers to obtain consent from participants in genetics studies. Our goal was to examine the extent to which the informed consent documents addressed genetic counseling and the return of individual genetic results. Our analysis reveals that the majority of informed consent documents did not mention genetic counseling while several did not mention the return of results. We found differences in the ways in which documents addressed availability of counseling, eligibility criteria for referral to a genetic counselor, genetic counselor involvement, provision of services to family members of participants and incidental findings. From an ethical standpoint, consent documents should provide appropriate information so that participants may make an informed decision about their participation in research. The need to ensure adequate counseling for study populations in an NGS research context will necessarily involve adapting values that underlie care in genetic counseling practice. If the interests of research participants are to be truly promoted, the drafting and review of informed consent documents should give proper due to genetic counseling.     

探讨和完善生物医学期刊来稿中的伦理学问题

生物医学期刊来稿中最常见的伦理学问题就是受试者“知情同意”的问题。生物医学期刊通过提高编辑人员素质、加强医学伦理学宣传教育、对来稿严格把关以及协助科研机构建立和完善伦理学审查委员会,不断探讨和完善来稿中的伦理学问题,这不仅是对受试者负责,而且有利于医学科研人员素质的提高,有利于生物医学研究健康、有序的发展。     

Rethinking research ethics

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research.     

Rethinking research ethics

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research.     

Conducting Health Disparities Research with Criminal Justice Populations: Examining Research,Ethics, and Participation

This study explored the challenges of informed consent and understanding of the research process among Black and Latino men under community supervision (e.g., parole and/or probation). Between February and October 2012, we conducted cognitive face-to-face interviews using open-ended questions on the significant areas of research participation (i.e., the informed consent process, confidentiality, compensation, what is meant by human subject and clinical trials) among 259 men aged 35 to 67 under community supervision in Bronx, New York. Content analysis of the open-ended questions revealed limited knowledge concerning the understanding of research participation. The study participants appeared to generally understand concepts such as compensation after research participation and confidentiality. Participants demonstrated a lack of understanding of certain aspects of the research process—informed consent, human subject, Institutional Review Board, and clinical trials. These findings are informative to researchers conducting studies with criminal justice populations and Institutional Review Boards reviewing research studies.     

Rethinking Research Ethics

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research.     

论知情同意的中国本土化--中国文化视野中的知情同意走向

知情同意原产于西方,移植到中国后被"家文化"、"功利论"、"简单化"等中华传统文化彻底改造过以后,浓缩成了手术前一味要求病人家属或单位领导签字的行为模式,远离了知情同意的主旨,但曾一度非理性地普遍流行.现在,又出现了一种照搬欧美知情同意的倾向,在一线医务人员中引发了诸多困惑和不满.在实施知情同意时,离开中华文化语境,或者在本土化中化掉其本质的做法,都是不可行的.正确的取向只能是立足于中国当代医学实践,以正在形成中的中国现代文化去整合西方知情同意的本质、理念和规范,构建成一套适合中国国情的知情同意机制.