Is consent for research genuinely informed? Using decision aid tools to obtain informed consent in the global south

Gaining informed consent among marginalized groups that include decisionally incapacitated individuals and those outside of the researcher's own geo-social and ethnic background still challenges many researchers. We suggest that there is a need for consideration of a different approach to research ethics in international settings. Based on extensive field work in West Africa on medical knowledge transfers and patient–healer relationships, this paper will discuss the challenges posed in obtaining informed individual consent in international settings. It is argued that while being on the whole convincing, the top-down approach of the proposed solutions, which clearly dominates the participative approach, fails in building sustainable capacity, decision-making competency, and empowerment in the communities in which the research is conducted. Using appropriate decision aids can help resolve these issues.     

国际合作中知情同意面临的难题及思考

目前在医学研究的国际合作中,知情同意原则在实施中出现了许多争议和难题.结合一些典型案例,对知情同意的跨文化研究、知情同意表格的误解以及保护受试者与自由研究之间的权衡等问题进行了深入地分析.指出:加强交流、相互尊重、求同存异是解决跨文化研究的必由之路;严格审查、加强监管是避免知情同意流于形式的重要手段;鼓励与防范并举才能达到双赢的局面.     

美国与知情同意有关的一些问题

知情同意是医疗保健和医学研究的一个基本的伦理学要求。这两种情况中,当医学研究的知情同意标准比医疗保健要求更加严格时,知情同意包含了3种要素：（1）告知病人或受试者该研究的性质。包括益处,危险和其他有关内容;（2）确保病人受试者理解所提供的信息;（3）得到病人或受试者自愿的同意,没有能力参与知情同意的病人包括患痴呆和危重病等无决断 能力的病人,这些病人属弱势病人。如要获许对他们的疾病进行研究,我们必须制定保护弱势受试者有效的伦理政策,提出了关于对痴呆病人、危重病人,脑死亡病人研究的伦理学政策。     

Suicidal Ideation in First‐Episode Psychosis (FEP): Examination of Symptoms of Depression and Psychosis Among Individuals in an Early Phase of Treatment

First‐episode psychosis (FEP) is a particularly high‐risk period for suicide, in which risk elevates by 60% within a first year of treatment as compared to later stages of illness. To date, much of the literature has focused on individuals with a longer duration of psychosis; thus, there is an urgency for research to examine suicide risk among individuals in FEP in the beginning stage of treatment. This study aimed to identify the relationships between demographic characteristics, symptoms of depression, psychosis (particularly positive symptoms of psychosis), and suicidal ideation among individuals in FEP. Secondary data were obtained from National Institute of Mental Health's Early Treatment Program of the Recovery After an Initial Schizophrenia Episode project (N = 404). Consistent with prior research, participants who experienced suicidal ideation during the study period reported having a longer duration of untreated psychosis and greater symptoms of depression. Further, positive symptoms of psychosis, namely hallucinations and delusions, were found to increase the odds of experiencing suicidal ideation. Findings point toward the implication that depression and positive symptoms of psychosis relate to the experience of suicidal ideation among individuals with a FEP and should be evaluated for and treated in the early stages of treatment.     

Ethical Considerations of Screening and Early Intervention for Clinical High-Risk Psychosis

Research on individuals at clinical high risk for psychological and physical disorders has grown exponentially in recent years, with a variety of new screening tools and early intervention techniques being implemented. One recent example is Attenuated Psychosis Syndrome, a diagnosis for individuals who are at clinical high risk for psychosis, which was recently included in Section III of the Diagnostic and Statistical Manual of Mental Disorders (5th ed.). Given the focus on prevention at early stages, at-risk individuals will continue to be a topic of significance not only in psychosis research but also in other illnesses. This document provides a comprehensive summary of the ethical dilemmas that clinicians or researchers may encounter in this domain, and possible actions consistent with the current Canadian Code of Ethics for Psychologists. We use clinical high risk for psychosis and the Canadian Code of Ethics for Psychologists as a way to illuminate these ethical issues; however, application to other jurisdictions and disciplines, as well as other high-risk populations, is also of relevance.     

Diverse Perceptions of the Informed Consent Process: Implications for the Recruitment and Participation of Diverse Communities in the National Children’s Study

We examined the experiences, perceptions, and values that are brought to bear when individuals from different ethnic and cultural backgrounds consider participating in health research. Fifty-three women from Latino, Asian American, Middle Eastern, or Non-Latino, White backgrounds participated in seven English or Spanish focus groups facilitated by trained investigators using a standard protocol. Investigators described the National Children’s Study (NCS) and then asked questions to elicit potential concerns, expectations, and informational needs. Group sessions were audio-recorded, transcribed verbatim, and analyzed using qualitative thematic methods. A major theme that emerged during focus groups was participant self-identification as a member of a cultural group or community when raising issues that would influence their decision to participate in research. A related theme was the belief by some that communities may differ in the ease of participation in the NCS. Identified themes related to the informed consent process included perceived risks, anticipated burden, perceived benefits, informational needs, and decision-making strategies. Although themes were shared across groups, there were cultural differences within themes. Findings indicated that individuals from diverse backgrounds may have different perspectives on and expectations for the research process. To effectively recruit representative samples, it will be important to address a range of issues relevant for informed consent and to consider the impact of participation on both individuals and communities.     

A Study of the Impact of Informed Consent Procedures on Participant Responses in Trauma-Related Research

Researchers and ethics board members are often concerned about the possibility of adverse reactions to trauma-related research. While research has shown that participants in trauma-related studies rarely experience adverse reactions, mild short-term emotional distress is common. While a number of protections have been suggested to minimize risks for more vulnerable subgroups of participants, no research to date has tested how modifications to informed consent procedures may affect the data collected and participant reactions to the research. One-hundred and forty-five college students were separated into five conditions with different modifications to the informed consent procedures. Participants completed surveys on trauma experience, posttraumatic stress, coping, and reactions to research participation. The results showed no differences among the conditions on all outcome measures. It appears that modifications to informed consent procedures geared toward minimizing risk do not affect the quality of the data collected nor change reactions to participating in trauma-related research.     

美国对受试者研究中特殊挑战的观点:遗传研究中的伦理问题

虽然基因研究比其他任何时候更有望了解人类疾病及其在世界各类人群中的表现形式,并且对预防和治疗疾病产生了深远影响,但是它的应用也会极大地改变我们对个体及群体特征。从个体属性及群体意识的角度来看,特别是关于知情同意这个议题,我们会非常清楚地看到遗传研究所面临的挑战。阐述了在美国遗传研究所面临的挑战,讨论了遗传研究进行过程中出现的一系列伦理问题,如：如何正确执行知情同意;研究中可能对受试者产生的标签和歧视行为;遗传流行病研究中出现的伦理问题以及需要关注的社区和民族的伦理问题;对人类组织样本的储存和使用中所出现的伦理问题。强调了知情同意和社区参与遗传研究及在研究中社区代表性的重要性;强烈主张在遗传研究中建立多民族的合作是确保研究的顺利进行的基础。     

Effectively Obtaining Informed Consent for Child and Adolescent Participation in Mental Health Research

With the recent expansion of child mental health research, more attention is being paid to the process of informed consent for research participation. For the consent to be truly informed, it is necessary that the relevant information be both disclosed and actually understood. Traditionally, much effort has gone to ensuring the comprehensiveness of consent/assent documents, which have progressively increased in length and complexity, whereas less attention has been paid to the comprehensibility of these documents. Available data indicate that many parent and children have difficulties appreciating the research nature of treatment studies and that a higher level of formal education among the parents is associated with a greater degree of understanding. Promising approaches to achieving truly informed research participation have emerged, such as additional time for parents to meet with the researchers and using postexplanation questionnaires for identifying issues in need of further clarification. Research is needed to develop and test strategies for improving the effectiveness of the informed consent process in child mental health.     

“Not Tied Up Neatly with a Bow”: Professionals’ Challenging Cases in Informed Consent for Genomic Sequencing

As the use of genomic technology has expanded in research and clinical settings, issues surrounding informed consent for genome and exome sequencing have surfaced. Despite the importance of informed consent, little is known about the specific challenges that professionals encounter when consenting patients or research participants for genomic sequencing. We interviewed 29 genetic counselors and research coordinators with considerable experience obtaining informed consent for genomic sequencing to understand their experiences and perspectives. As part of this interview, 24 interviewees discussed an informed consent case they found particularly memorable or challenging. We analyzed these case examples to determine the primary issue or challenge represented by each case. Challenges fell into two domains: participant understanding, and facilitating decisions about testing or research participation. Challenges related to participant understanding included varying levels of general and genomic literacy, difficulty managing participant expectations, and contextual factors that impeded participant understanding. Challenges related to facilitating decision-making included complicated family dynamics such as disagreement or coercion, situations in which it was unclear whether sequencing research would be a good use of participant time or resources, and situations in which the professional experienced disagreement or discomfort with participant decisions. The issues highlighted in these case examples are instructive in preparing genetics professionals to obtain informed consent for genomic sequencing.     

Research without Consent: Exception from and Waiver of Informed Consent in Resuscitation Research

The ethical concept of Informed Consent provides individuals with the right and the opportunity to approve of events that will occur regarding his or her own person. In medicine, informed consent is obtained for treatment and for research participation. However, under some circumstances, prospective informed consent cannot be obtained because of the devastating clinical condition of the patient. In emergency circumstances, treatment is never withheld if obtaining informed consent from a critically ill person is not possible or if a delay while seeking surrogates would further endanger life. In emergency research circumstances, waiving informed consent for study participation is fraught with additional ethical considerations. This article will review a presentation given at the June 2, 2006 conference entitled “The Ethics of Research in Emergency Medicine”. An earlier version of this paper was presented at: The 7th International Conference on Bioethics on “The Ethics of Research in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland.     

Emergency Research without Consent under Polish Law

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.     

Trauma‐Informed Care for Individuals with Serious Mental Illness: An Avenue for Community Psychology's Involvement in Community Mental Health

Individuals with serious mental illness are at particularly high risk for trauma; however, service environments with which they interact may not always be trauma‐informed. While community mental health and other human services settings are moving toward trauma‐informed care (TIC) service delivery, a variety of TIC frameworks exist without consensus regarding operationalization, thereby leading to challenges in implementation. TIC is principle‐driven and presents substantial overlap with community psychology values and competencies, including ecological frameworks, second‐order change, empowerment, and citizen participation. One way to address barriers to TIC implementation is to draw on the strengths of the field of community psychology. With a particular emphasis on the applicability of TIC to individuals with serious mental illness, this paper identifies key implementation issues and recommends future directions for community psychologists in clarifying the service framework, its adaptation to specific service contexts, and improving delivery through consultation and evaluation. Community psychologists may work with various disciplines involved in the TIC field to together promote a more conscious, actionable shift in service delivery.     

Informed consent as a prescription calling for debate between analysts and researchers(1)

This article is a review of the international scientific literature on informed consent and its use in some of the constituent organizations of the International Psychoanalytical Association (IPA). Because psychoanalysis comprises a theory based on practice, the dearth of clinical material for study, training and research purposes is a serious problem for analysts. Supervisions, presentations at scientific societies and congresses, publications and teaching material involve patients to an extent that goes beyond the work done in their sessions. Should consent be requested in these cases? This contribution addresses controversial and long‐standing issues such as informed consent and confidentiality, audio recording of treatments, knowledge production, the ambivalence of participating subjects over time and the perspective of analysts and patients respectively. The authors consider the various alternative approaches available for the handling of these ethical dilemmas without losing sight of the patient’s dignity and personal rights, while also taking account of the position of the analyst.     

The Ethics of Conducting Community-Engaged Homelessness Research

This paper focuses on some of the ethical issues which may arise when conducting research in the context of homelessness. These issues are considered from the viewpoints of researchers, research coordinators and interviewers, drawing from their extensive real world experience. In addition to negotiating the complex context of homelessness, community-based homelessness researchers need to address a number of ethical issues in research conception, design, implementation and dissemination. Although these issues are commonly considered in community-engaged research, research with people who are homeless may raise exceptional challenges. Such challenges include determining the nature of informed consent; protecting research participants and researchers, and determining appropriate compensation for participation. Understanding the context of homelessness to conduct ethical research will require sharing information and joint decision-making, processes that must include members of communities within which the research participants live. Furthermore, researchers should be sensitive to the changing context of homelessness, and vigilant for new ethical challenges.     

‚Mirroring‘ the Ethics of Biobanking: What Analysis of Consent Documents Can Tell Us?

Biobanks have been recognized as a key research infrastructure and how to approach ethical questions has been a topic of discussion for at least a decade by now. This article explores the characteristics of donors’ participation in European biobanks as reflected in the consent documents of a selection of different biobanks from various European countries. The primary aim of this study is to understand how donors are informed about their participation in biobanking. Also the paper discusses what the most important thematic issues of information are to be given to the biobank participants and how this information should be presented in the consent documents. For these purposes, we analyse consent documents from 14 biobanks in 11 countries for six ethically relevant issues: (1) model of consent, (2) scope of future research, (3) access to medical data, (4) feedback to the participants, (5) consent withdrawal, and (6) role of research ethics committee. In order to compare different trends of informing donors of human biological material and medical data, we interpret the six analysed issues in the context of respect to donor’s autonomy paradigm. Although the results of the paper reflect the heterogeneity of biobank consent document policies applied in different European countries, we uncovered some trends and suggested several examples of good practices to balance the interests of the donors with those of the researchers and future patients.     

The Art of Recruitment: The Foundation of Family and Linkage Studies of Psychiatric Illness

Family and linkage studies of psychiatric illness involve special benefits and challenges in the field of scientific investigation. The success of a family or linkage study is dependent on the recruitment process. The most informative and reliable method of data collection in this field of investigation is through direct interviews with as many family members as possible. Although there are circumstances when direct interviewing is not possible, there are other circumstances, such as refusal of relatives to participate, that deserve closer scrutiny. The complexities involved in the recruitment process while conducting medical investigations have been explored in the literature. However, special issues relevant to the recruitment process merit further exploration for working with families in the context of family and linkage studies of psychiatric illness. Careful understanding of this critical topic may minimize the incidence of family nonparticipation in such research endeavors. This article addresses these issues as they relate to recruiting individuals and their families in this field of investigation. These issues include the role of attitudes, values and beliefs, family interaction and the identification of influential members, informal communication networking, informed consent while promoting the research, and ethical concerns.     

Psychologische Interventionen bei Personen mit erhöhtem Psychoserisiko

Indicated prevention in individuals at clinical high risk for first episode psychosis is hoped to delay the onset of the disorder or even prevent the transition to full-blown psychosis. Remission of at-risk symptoms, psychosocial functioning and quality of life are secondary outcomes. According to current evidence cognitive behavioral therapy can be considered the best evaluated stand alone therapy approach for the prevention of psychosis. The treatment of persons at risk for first episode psychosis is associated with the risk of exposing falsely identified persons to potential side effects; therefore, treatment with the best risk-benefit ratio should be chosen. Consequently, monitoring within specialized early recognition centers should be considered first, followed by a customized psychoeducation. The data on psychoeducation of people at risk for psychosis are encouraging but still not sufficient. Methodological issues and differences of the evaluated approaches are discussed.     

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.