Research participation and the right to withdraw

Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute 'right' of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw. This does not imply that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self-defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to 'push' participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to 'screen out' people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on-going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account.     

Attitudes toward Post‐Trial Access to Medical Interventions: A Review of Academic Literature,Legislation, and International Guidelines

There is currently no international consensus around post‐trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post‐trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post‐trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post‐trial access and participants and community members. Given that clinical trials conducted in low‐income countries will likely continue, there is an urgent need for consideration of post‐trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available.     

Limiting Factors Impacting on Voluntary First Person Informed Consent in the Philippines

How well can institutional guidelines help ensure the dignity, rights, safety and well being of research participants in an underdeveloped country? In this paper I describe the limits of informed consent as an instrument for the protection of participants in the context of the Philippines. I bring to this paper my experiences as an advocate of rights, a member of an ethics review board, a researcher on the ethics of research and as an observer of the dynamics of clinical practice in an academic public teaching hospital of the University of the Philippines where I am professor.     

Sleep and dream patterns of political liberals and conservatives.

In this study the author examined the dreams of American liberals and conservatives to highlight patterns that might correlate with their opposing political views. A total of 234 participants (134 self-described liberals and 100 self-described conservatives) completed a lengthy sleep and dream survey, and their answers revealed several notable patterns. People of both political persuasions shared a common substrate of basic human sleep and dream experience. Conservatives slept somewhat more soundly, with fewer remembered dreams. Liberals were more restless in their sleep and had a more active and varied dream life. In contrast to a previous study, liberals reported a somewhat greater proportion of bad dreams and nightmares. Consistent with earlier research, the dreams of conservatives were more mundane, whereas the dreams of liberals were more bizarre. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Informed Consent in Health Research: Challenges and Barriers in Low‐and Middle‐Income Countries with Specific Reference to Nepal

Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low‐and middle‐income countries (LMICs) in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent.     

Ethical and epistemological insights: a case study of participatory action research with young people

Debates over how to determine age of consent for youth to participate in research feature prominently in the practice of researchers, research ethics boards (REBs), and community decision makers working with youth. In particular, tensions can arise over how the ethical principles of beneficence, autonomy, and justice are interpreted and applied in research involving young people. We discuss our experiences obtaining ethical approval to conduct a participatory action research project involving youth and the differences of opinion we encountered regarding underage youth's capability to make informed consent. We suggest that researchers, REBs, and community decision makers all share a responsibility to conduct proactive outreach to youth participants, so that they are adequately informed of their rights related to research.     

Medical research: civil liability and compensation for personal injury--a discussion paper. Ciba Foundation Study Group.

The Ciba Foundation Study Group has considered the most appropriate means of compensating participants (or their relatives) for injuries received as a consequence of medical research. The group recognises that injury may occur despite the exercise of the highest degree of skill and care by the investigator and that compensation through an action for negligence is therefore not available. At present injured participants have to rely on ex gratia payments. The group considers this unsatisfactory and recommends the establishment of a centrally operated fund with authority to provide compensation on a no-fault basis. These recommendations do not diminish the rights of the participant to bring an action in the event of negligence on the part of the investigator or an action under the law relating to product liability against the manufacturers of defective equipment or drugs.     

Interest in dream interpretation: A gender difference.

Although several studies reported a significant effect with regard to the gender difference in an interest in dreams, the generalizability of these studies is limited because mainly students were recruited as participants. In this study, gender differences with regard to interest in dream interpretation as an indicator of interest in dreams in general have been demonstrated in a representative sample. There was, however, a significant age-gender interaction, indicating that interest in dreams might not be a potent variable for explaining gender differences in dream recall. In future studies, the course of interest in dreams over the life span and any associated gender differences should be investigated using carefully designed scales. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The impact of insomnia and sleep disturbances on depression and suicidality.

Previous research has demonstrated an association between suicidality and sleep, suggesting that sleep disturbances may exacerbate mood dysregulation in participants suffering from mood disorders. The purpose of this study was to investigate the impact of sleep disturbances and insomnia on depression and suicidality in a nontreatment seeking sample of college students. Results indicated that insomnia and nightmares were significant predictors of symptoms of depression, while only nightmares significantly predicted suicidal ideation. Further analysis indicated that participants with elevated scores on insomnia, nightmares, or both experienced differing levels of depression and suicidal ideation. Future directions and treatment implications are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Muslim immigrants and religious group feelings: self-identification and attitudes among Sunni and Alevi Turkish-Dutch

Affective ratings of multiple religious (sub)groups (Muslims, Christians, Jews and non-believers, as well as Sunni, Alevi and Sjiit Muslims), the endorsement of Islamic minority rights and religious group identification were examined among Sunni and Alevi Turkish-Dutch participants. The findings show that both groups differ in important ways. Some Alevi participants considered themselves Muslims but others interpreted Alevi identity in a secular way. The Sunnis were quite negative towards Jews and non-believers, they more strongly endorsed Islamic minority rights and they had very high Muslim group identification. Furthermore, the Sunnis were negative towards Alevis and the Alevis were negative towards the Sunnis. Muslim group identification was positively and strongly related to feelings towards Muslims and to the endorsement of Islamic group rights.     

Support for Kurdish language rights in Turkey: the roles of ethnic group,group identifications,contact, and intergroup perceptions

The question of Kurdish language rights has been a central issue in the Turkish–Kurdish conflict. The current study examined endorsement of Kurdish language rights in relation to intergroup factors (i.e. group identifications, cross-group friendships, perceived discrimination, and perceived out-group beliefs about state unity) among self-identified Turkish and Kurdish participants. The results indicate that Turks were much less in favour of these rights than the Kurds. In addition, for the Turks, higher national and ethnic identification were associated with lower support for Kurdish language rights, while cross-group friendship, perceived discrimination of Kurds and the belief that Kurds endorse national unity were associated with more support for rights. For the Kurdish participants, stronger national identification seems to undermine the mobilizing meaning that Kurdish group identification has for language rights support. Furthermore, friendship with Turks can undermine the support for rights because it strengthens national identification and reduces ethnic identification.     

Transnational Human Rights and Local Activism: Mapping the Middle

How do transnational ideas such as human rights approaches to violence against women become meaningful in local social settings? How do they move across the gap between a cosmopolitan awareness of human rights and local sociocultural understandings of gender and family? Intermediaries such as community leaders, nongovernmental organization participants, and social movement activists play a critical role in translating ideas from the global arena down and from local arenas up. These are people who understand both the worlds of transnational human rights and local cultural practices and who can look both ways. They are powerful in that they serve as knowledge brokers between culturally distinct social worlds, but they are also vulnerable to manipulation and subversion by states and communities. In this article, I theorize the process of translation and argue that anthropological analysis of translators helps to explain how human rights ideas and interventions circulate around the world and transform social life.     

Human genome diversity: Ethics and practice in Australia

Researchers who propose projects about the human past frequently fail to distinguish between scientific value and the impact of both the proposal and the possible outcome for participant groups. It is only in recent years, and still in relatively few cases, that Aboriginal Australians have been directly involved in projects about themselves. The legacy of previous research experiences is a lingering distrust of ‘white’ researchers who visit communities briefly, take material/information, publish papers, and are rarely seen again. This distrust is understandable but in turn becomes a barrier which many well-intentioned researchers are unable or unwilling to overcome. The expectations of the scientific community, particularly in the field of molecular biology, simply do not make allowances in terms of time or funding to build a trusting relationship between the researchers and the researched. Sensitivity to indigenous rights and expectations with regard to scientific research brings obligations to scientific investigators with which few are well prepared to deal. The direct involvement of indigenous people in research about themselves is essential to the development of trusting working relationships likely to result in valuable outcomes for all participants and increased opportunities for ongoing research. Well negotiated, co-operative research can provide information of value to both scientific investigators and local participants, but adequate and ongoing consultation, as well as the return of results to the communities in an accurate and appropriate form must be part of research strategy. For example, information about mitochondrial DNA studies may assist Indigenous Australian people, whose families were dispersed during colonisation by Europeans, to trace links with the past, find ‘stolen children’ and by association with other anthropological, linguistic and archaeological data, repossess some remnants of traditional knowledge, but researchers must ensure that participants have a realistic understanding of the limitations of the research.     

Anti-Semitism and opposition to Israeli government policies: the roles of prejudice and information

Past research on the link between anti-Semitism and criticism of the Israeli government has revealed a partial correlation between the two. However, among the political arguments that have inspired such research, one has gone unaddressed: that criticism of the Israeli government along with silence about more egregious human rights abuses committed elsewhere can only arise from anti-Semitism. This article investigates the link between knowledge of conflicts around the world, anti-Semitism, Islamophobia, and criticism of the Israeli and Saudi governments, among US participants. Using a deeper index of anti-Israel opinions than prior research, the results indicate that some criticisms of the Israeli government are more reliable indicators of anti-Semitic sentiment than others. The findings are discussed with regard to how legitimate political criticism can be distinguished from prejudice in the context of the Israeli–Palestinian conflict.     

Return of Genomic Results to Research Participants: The Floor,the Ceiling,and the Choices In Between

As more research studies incorporate next-generation sequencing (including whole-genome or whole-exome sequencing), investigators and institutional review boards face difficult questions regarding which genomic results to return to research participants and how. An American College of Medical Genetics and Genomics 2013 policy paper suggesting that pathogenic mutations in 56 specified genes should be returned in the clinical setting has raised the question of whether comparable recommendations should be considered in research settings. The Clinical Sequencing Exploratory Research (CSER) Consortium and the Electronic Medical Records and Genomics (eMERGE) Network are multisite research programs that aim to develop practical strategies for addressing questions concerning the return of results in genomic research. CSER and eMERGE committees have identified areas of consensus regarding the return of genomic results to research participants. In most circumstances, if results meet an actionability threshold for return and the research participant has consented to return, genomic results, along with referral for appropriate clinical follow-up, should be offered to participants. However, participants have a right to decline the receipt of genomic results, even when doing so might be viewed as a threat to the participants’ health. Research investigators should be prepared to return research results and incidental findings discovered in the course of their research and meeting an actionability threshold, but they have no ethical obligation to actively search for such results. These positions are consistent with the recognition that clinical research is distinct from medical care in both its aims and its guiding moral principles.     

Sharing the Knowledge: Sharing Aggregate Genomic Findings with Research Participants in Developing Countries

Returning research results to participants is recognised as an obligation that researchers should always try to fulfil. But can we ascribe the same obligation to researchers who conduct genomics research producing only aggregated findings? And what about genomics research conducted in developing countries? This paper considers Beskow's et al. argument that aggregated findings should also be returned to research participants. This recommendation is examined in the context of genomics research conducted in developing countries. The risks and benefits of attempting such an exercise are identified, and suggestions on ways to avoid some of the challenges are proposed. I argue that disseminating the findings of genomic research to participating communities should be seen as sharing knowledge rather than returning results. Calling the dissemination of aggregate, population level information returning results can be confusing and misleading as participants might expect to receive individual level information. Talking about sharing knowledge is a more appropriate way of expressing and communicating the outcome of population genomic research. Considering the knowledge produced by genomics research a worthwhile output that should be shared with the participants and approaching the exercise as a ‘sharing of knowledge’, could help mitigate the risks of unrealistic expectations and misunderstanding of findings, whilst promoting trusting and long lasting relationships with the participating communities.     

Our social genome?

Apocalyptic views on the natural order, chimeras and genetic engineering should not detract from the fact that medical research, similar to the promotion of health, is a public good. Genomics crosses all species, thereby requiring a global approach that respects human rights and public health priorities. Public trust and public participation in research demand clear stewardship as well as transparent and accountable oversight. Characterizing fundamental genomic data as a public resource might counterbalance the current overemphasis on individual rights but this will not be simple. It is only through an attachment to justice and solidarity that the dignity and well-being of persons, both as humans and as citizens, can truly be fostered.     

Attachment styles and emotional content, stress, and conflict in dreams of romantic partners.

Expanding on previous research investigating the link between dreams and attachment, participants in committed dating relationships were recruited to fill out dream diaries for 1 week. It was hypothesized that when dreaming about romantic partners (attachment figures), dream content would vary by attachment style, such that insecurely attached individuals would experience a different quality of dream, emotionally and cognitively. At Time 1, participants completed a self-report measure of attachment style, and then completed a dream diary at home each morning for 7 days. Dreams that contained romantic partners were coded by double-blind research assistants for emotional content, with a focus on attachment-related emotions and stressful expressions. Anxious-attached and avoidant-attached participants experienced significantly more stress and conflict, and scored significantly higher on specific emotions such as anxiety and jealousy in such dreams. Secure scores did not correlate with any specific or general emotion. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

At the Crossroads of Human Rights and Anthropology: Toward a Critically Engaged Activist Research

In this article, I consider anthropology's engagement with human rights today. Through the lens of my experience in a case brought before the International Labor Organization by a community in Chiapas, Mexico, I consider the ethical, practical, and epistemological questions that arise in research defined by rights activism. I argue that the critical engagement brought about by activist research is both necessary and productive. Such research can contribute to transforming the discipline by addressing the politics of knowledge production and working to decolonize our research process. Rather than seeking to avoid or resolve the tensions inherent in anthropological research on human rights, activist research draws them to the fore, making them a productive part of the process. Finally, activist research allows us to merge cultural critique with political action to produce knowledge that is empirically grounded, theoretically valuable, and ethically viable.     

The right to withdraw from controlled human infection studies: Justifications and avoidance

The right to withdraw from research without penalty is well established around the world. However, it has been challenged in some corners of bioethics based on concerns about various harms—to participants, to scientific integrity, and to research bystanders—that may stem from withdrawal. These concerns have become particularly salient in emerging debates about the ethics of controlled human infection (CHI) studies in which participants are intentionally infected with pathogens, often in inpatient settings with extensive follow-up. In this article, I provide support for preserving the right to withdraw from research without penalty and demonstrate that it is also typically justified in the specific context of CHI studies. The right is well aligned with individual freedoms outside the research setting, where autonomous individuals are permitted to engage in behaviors that will foreseeably cause them harm; where they cannot be compelled to satisfy contracts for their services, nor penalized for failure to do so; and where their behavior is not constrained by public health authorities except in extreme circumstances. These freedoms are supported by U.S. law, as well as by ethical analysis that is more globally relevant. The problems associated with the right to withdraw, however, remain. The best approach to addressing them is not to restrict the right but rather to avoid initiating research when withdrawal would be especially problematic. If research proceeds, steps can still be taken to minimize participant withdrawal without infringing the right. Investigators can avoid participant surprise through informed consent focused on a study’s most burdensome aspects and promote study completion through financial incentives. Should participants nonetheless seek to withdraw, investigators may attempt to persuade them not to do so by encouraging consideration of the range of potential harms that may result. Researchers conducting CHI studies and other research from which withdrawal might be especially problematic should prepare for the possibility of participant withdrawal, respect participant requests to withdraw without penalty, and incorporate various measures to avoid such requests.