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Introduction: Those aged 80 years and over are the fastest-growing sector of the Australian population but are often excluded from research. Oldest old people living alone, in disadvantaged neighbourhoods, and with ill health or dementia, face additional barriers that may hinder their participation in research., Methods: This paper contributes timely critical commentary on methodological and ethical approaches to engaging under-represented people in research. We draw on our experiences and reflections from a study of social exclusion of people aged 80 years and older living alone in government housing in Melbourne, Australia., Results and Discussion: We suggest key factors to facilitate representation of this population group in future research. These factors include using doorknocking to gain access, cultivating trust with participants and gatekeepers, and conducting face-to-face home interviews. We also interrogate ethical and safety issues for researchers and oldest old participants including the potential for informed consent protocols to exclude this population group., Conclusion: To avoid unintentionally excluding the oldest old, researchers need to consider older persons' self-determination and advocate for methods that ensure oldest old perspectives inform future healthy ageing planning and reduce possible health and well-being inequities., (© 2024 The Author(s). Australasian Journal on Ageing published by John Wiley & Sons Australia, Ltd on behalf of AJA Inc’.)

This paper explores some of the ethical considerations of working collaboratively with people with dementia within research based upon the experiences, challenges and learning from three doctoral research studies. Focus is on the research relationship with participants and gatekeepers, the importance of setting and access, the power relations within the research and ways in which people with dementia can be supported to be active and have a voice in research. This sits within an ethical framework of principalist ethics and ethics of care to guide not only how research is planned ethically and with consideration of participants, but also how this can support decisions made in situ. The aim is to share, based upon these three studies, ways of managing and working through some of the ethical consideration to support researchers in their decisions in planning and conducting research with people with dementia as active collaborators.

During the past years, co-production in medical and health related research has gained more focus. The purpose is to ensure that researchers - and the individuals that the research is relevant and has consequences for - will develop and produce the research, and accordingly also, the results together. In our understanding, the eventual success of co-production in research has to be based on some sort of sensitivity to and negotiation as to the perspectives and categories describing the research theme. In this article, based on empirical data from interviews with adolescents participating in treatment for lifestyle change, we explore the significance of the researchers' sensitivity for adolescents' resistance during the interview process. We argue that this sensitivity is embodied and requires ethical reflection helping the researcher to discover ethical moments. By being sensitive as to participants' resistance in the interview situation, we argue that new knowledge is thereby developed.

Objective: Non-native English speaking workers with a mild work-related traumatic brain and/or head injury are a vulnerable and underrepresented population in research studies. The researchers present their experiences with recruiting and performing qualitative interviews with non-native English speaking individuals with a work-related mild traumatic brain injury, and provide recommendations on how to better include this vulnerable population in future research studies. This paper presents considerations regarding ethics, recruitment challenges, interview preparation and debriefing, sex & gender and language and cultural issues must be made when working with this vulnerable population., Results: The researchers discuss critical issues and provide recommendations in recruiting and engaging with non-native English language workers including ethics, recruitment challenges, interview preparation and debriefing, sex & gender and language, and cultural considerations that must be made when working with this population. The study recommendations advise investigators to spend more time to learn about the non-native English participants in the mild wrTBI context, to be familiar with the vulnerabilities and specific circumstances that these workers experience. By increasing their awareness of the challenging facing this vulnerable population, the intention is to provide better care and treatment options through evidence-based research and practice.

Background: Genomic research can reveal 'unsolicited' or 'incidental' findings that are of potential health or reproductive significance to participants. It is widely thought that researchers have a moral obligation, grounded in the duty of easy rescue, to return certain kinds of unsolicited findings to research participants. It is less widely thought that researchers have a moral obligation to actively look for health-related findings (for example, by conducting additional analyses to search for findings outside the scope of the research question)., Main Text: This paper examines whether there is a moral obligation, grounded in the duty of easy rescue, to actively hunt for genomic secondary findings. We begin by showing how the duty to disclose individual research findings can be grounded in the duty of easy rescue. Next, we describe a parallel moral duty, also grounded in the duty of easy rescue, to actively hunt for such information. We then consider six possible objections to our argument, each of which we find unsuccessful. Some of these objections provide reason to limit the scope of the duty to look for secondary findings, but none provide reason to reject this duty outright., Conclusions: We argue that under a certain range of circumstances, researchers are morally required to hunt for these kinds of secondary findings. Although these circumstances may not currently obtain, genomic researchers will likely acquire an obligation to hunt for secondary findings as the field of genomics continues to evolve.

Consent to any experimental procedure, even when offered as therapeutic, involves extensive discussion between patient-subjects and clinician-researchers. Decision making should be shared with a focus on potential risks and benefits of enrolling in a protocol. Just as patients who underwent nonexperimental interventions might experience regret or reconsider autonomously made choices, patient-subjects who are undergoing or who have undergone experimental therapies should be afforded latitude to reconsider their decisions. Although clinician-researchers tend to be deeply invested in gathering data about patient-subjects' experiences, they are obligated to express respect for patient-subjects' fundamental right to stop being enrolled in research., (© 2019 American Medical Association. All Rights Reserved.)

Objective: To study the relationship between cancer patient/research participants' perceptions of communication with their research nurse and doctor and (1) participants' thoughts of dropping out from their cancer clinical trials (CCTs), (2) how informed they felt before and during their clinical trial participation, and (3) trust in their researchers. Methods: We surveyed 110 adult cancer patients who were enrolled in cancer clinical trials by using 15 modified items from the Medical Communication Competence Scale measuring information exchange and relational communication. Retention was measured by two items: ever thought about dropping out (yes/no) and likelihood of remaining enrolled in the clinical trial (5-point Likert item). We asked how well informed about the trial participants felt at enrollment, at the date they filled out the survey, and about changes in the trial. Results: Patient-participants with thoughts of dropping out from their CCTs rated their communication with research doctors lower than those who did not have thoughts of dropping out (4.14 versus 4.46, t  = 2.22, p  = 0.03). Patient-participants' intention to remain enrolled was correlated with more favorable scores on relational communication (such as contributing to a trusting relationship and showing compassion) with research doctors ( r  = 0.20, p  = 0.04) and nurses ( r  = 0.25, p  = 0.01). Communication with doctors was also associated with how informed patient-participants felt during their clinical trials. Conclusions: Relational communication with research doctors and nurses was significantly related to thoughts about remaining enrolled or dropping out of a clinical trial among adult participants in cancer treatment clinical trials. Practice Implications : Relational communication with cancer patients advances retention in research.

In this article, we explore how narrative accounts of trauma are co-constructed through the interaction between researcher and participant. Using a narrative multiple-case study with Kurdish refugee families, we address how this process takes place, investigating how researcher and participants were engaged in relational, moral, collective, and sociopolitical dimensions of remembering, and how this led to the emergence of particular ethical questions. Case examples indicate that acknowledging the multilayered co-construction of remembering in the research relationship profoundly complicates existing deontological guidelines that predominantly emphasize the researcher's responsibility in sensitively dealing with participants' alleged autobiographical trauma narratives. Instead, our analysis invites qualitative researchers to engage in a continued, context-specific ethical reflection on the potential risks and benefits that are invoked in studies with survivors of collective violence.

Research ethics is often understood by researchers primarily through the regulatory framework reflected in the research ethics review process. This regulatory understanding does not encompass the range of ethical considerations in research, notably those associated with the relational and everyday aspects of human subject research. In order to support researchers in their effort to adopt a broader lens, this article presents a "person-oriented research ethics" approach. Five practical guideposts of person-oriented research ethics are identified, as follows: (1) respect for holistic personhood; (2) acknowledgement of lived world; (3) individualization; (4) focus on researcher-participant relationships; and (5) empowerment in decision-making. These guideposts are defined and illustrated with respect to different aspects of the research process (e.g., research design, recruitment, data collection). The person-oriented research ethics approach provides a toolkit to individual researchers, research groups, and research institutions in both biomedical and social science research wishing to expand their commitment to ethics in research.

The field of paleogenomics (the study of ancient genomes) is rapidly advancing, with more robust methods of isolating ancient DNA and increasing access to next-generation DNA sequencing technology. As these studies progress, many important ethical issues have emerged that should be considered when ancient Native American remains, whom we refer to as ancestors, are used in research. We highlight a 2017 article by Kennett et al., "Archaeogenomic evidence reveals prehistoric matrilineal dynasty," that brings to light several ethical issues that should be addressed in paleogenomics research. The study helps elucidate the matrilineal relationships in ancient Chacoan society through ancient DNA analysis. However, we, as Indigenous researchers and allies, raise ethical concerns with the study's scientific conclusions that can be problematic for Native American communities: (1) the lack of tribal consultation, (2) the use of culturally insensitive descriptions, and (3) the potential impact on marginalized groups. Further, we explore the limitations of the Native American Graves Protection and Repatriation Act, which addresses repatriation but not research, because clear ethical guidelines have not been established for research involving Native American ancestors, especially those deemed "culturally unaffiliated." Multiple studies of "culturally unaffiliated" remains have been initiated recently, so it is imperative that researchers consider the ethical ramifications of paleogenomics research. Past research indiscretions have created a history of mistrust and exploitation in many Native American communities. To promote ethical engagement of Native American communities in research, we therefore suggest careful attention to ethical considerations, strong tribal consultation requirements, and greater collaborations among museums, federal agencies, researchers, scientific journals, and granting agencies.

Background Interviews are widely used in qualitative research to collect data. However, little has been written about interviewing people with severe mental illness (SMI). Aim To report and analyse an experience of addressing the ethical and practical challenges of interviewing people with SMI. Discussion Semi-structured interviews were conducted as part of a doctoral study to explore how service users and healthcare professionals built relationships with each other. Conclusion Although interviewing participants with SMI was challenging, rich data illustrating their experiences were gathered. Careful planning around ethical considerations, such as obtaining informed consent, was required to maximise the opportunities to gather in-depth information during the interviews. The relationship established between researcher and the participants assisted with sensitive disclosures and allowed participants to tell their stories. Implications for research This paper provides strategies to help guide researchers planning interviews with vulnerable populations, including those with SMI. These strategies include how to discuss sensitive issues and promote engagement. Listening to participants' life stories is an intense experience, requiring support for the interviewer to stay neutral during interviews. It is also important to be aware of the differences between the roles of nurse and nurse researcher before undertaking in-depth qualitative interviews, particularly with vulnerable participants.

Background When conducting qualitative research, participants usually share lots of personal and private information with the researcher. As researchers, we must preserve participants' identity and confidentiality of the data. Objective To critically analyze an ethical conflict encountered regarding confidentiality when doing qualitative research. Research design Case study. Findings and discussion one of the participants in a study aiming to explain the meaning of living with HIV verbalized his imminent intention to commit suicide because of stigma of other social problems arising from living with HIV. Given the life-threatening situation, the commitment related to not disclosing the participant's identity and/or the content of the interview had to be broken. To avoid or prevent suicide, the therapist in charge of the case was properly informed about the participant's intentions. One important question arises from this case: was it ethically appropriate to break the confidentiality commitment? Conclusion confidentiality could be broken if a life-threatening event is identified during data collection and participants must know that. This has to be clearly stated in the informed consent form.

In biomedical research lack of trust is seen as a great threat that can severely jeopardise the whole biomedical research enterprise. Practices, such as informed consent, and also the administrative and regulatory oversight of research in the form of research ethics committees and Institutional Review Boards, are established to ensure the protection of future research subjects and, at the same time, restore public trust in biomedical research. Empirical research also testifies to the role of trust as one of the decisive factors in research participation and lack of trust as a barrier for consenting to research. However, what is often missing is a clear definition of trust. This paper seeks to address this gap. It starts with a conceptual analysis of the term trust. It compares trust with two other related terms, those of reliance and trustworthiness, and offers a defence of Baier's attribute of 'good will' a basic characteristic of trust. It, then, proceeds to consider trust in the context of biomedical research by examining two questions: First, is trust necessary in biomedical research?; and second, do increases in regulatory oversight of biomedical research also increase trust in the field? This paper argues that regulatory oversight is important for increasing reliance in biomedical research, but it does not improve trust, which remains important for biomedical research. It finishes by pointing at professional integrity as a way of promoting trust and trustworthiness in this field.

In this paper we focus on important considerations when planning and conducting qualitative interviews on sensitive topics. Drawing on experiences of conducting interviews with dementia caregivers, a framework of essential elements in qualitative interviewing was developed to emphasize study participants' needs while also providing guidance for researchers. Starting with a definition of sensitive research, the framework includes preparing for interviews, interacting with gatekeepers of vulnerable groups, planning for interview timing, and location, building relationships and conducting therapeutic interactions, protecting ethically vulnerable participants, and planning for disengagement. This framework has the potential to improve the effectiveness of sensitive interviewing with vulnerable groups. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Traditional Informed Consent is becoming increasingly inadequate, especially in the context of research biobanks. How much information is needed by patients for their consent to be truly informed? How does the quality of the information they receive match up to the quality of the information they ought to receive? How can information be conveyed fairly about future, non-predictable lines of research? To circumvent these difficulties, some scholars have proposed that current consent guidelines should be reassessed, with trust being used as a guiding principle instead of information. Here, we analyse one of these proposals, based on a Participation Pact, which is already being offered to patients at the Istituto Europeo di Oncologia, a comprehensive cancer hospital in Milan, Italy., (© 2015 John Wiley & Sons Ltd.)

Confidentiality is one of the cornerstones of research involving human participants. Researchers are the frontline gatekeepers of their participants' right to confidentiality, and situations can arise that challenge this responsibility. This is the case when individuals who have shared a common experience (i.e., dyads) are interviewed separately, but interview results are disseminated within the context of dyads. Based on our experience of conducting research with dyads and given how little literature is available to serve as guide, we set out to write this article to share the knowledge we acquired and the solutions we found. We will describe both the ethical challenges and the methodological decisions involved in conducting qualitative research with dyads. The article also describes different modalities of dyadic analysis, their benefits and drawbacks. This endeavor seems especially relevant as research with dyads is emerging in several domains involving couples, families, caregivers and health., (© The Author(s) 2016.)

Photovoice methodology is growing in popularity in the health, education and social sciences as a research tool based on the core values of community-based participatory research. Most photovoice projects state a claim to the third goal of photovoice: to reach policy-makers or effect policy change. This paper examines the concerns of raising false hopes or unrealistic expectations amongst the participants of photovoice projects as they are positioned to be the champions for social change in their communities. The impetus for social change seems to lie in the hands of those most affected by the issue. This drive behind collective social action forms, what could be termed, a micro-social movement or comparative interest group. Looking to the potential use of social movement theory and resource mobilisation concepts, this paper poses a series of unanswered questions about the ethics of photovoice projects. The ethical concern centres on the focus of policy change as a key initiative; yet, most projects remain vague about the implementation and outcomes of this focus.

The researcher's body in qualitative research is often absented, an absence that can render deceptively tidy research accounts. In this article, I reflect on the interplay of embodiment and disclosure in the interview dynamic and the way in which my body became an object of inquiry in the research process. Three qualitative studies inform the article: the first exploring the experiences of 40 people living with hepatitis C in New Zealand and Australia, the second comprising life-history interviews with 38 people who inject drugs in London, and the third following 27 people through hepatitis C treatment in London. Bodily and verbal disclosures of my history, as someone with/without hepatitis C and a former heroin user, affected the energy of the interview dynamic, also embodied understandings of illness and drug use. Disclosure can enhance researcher vulnerability and I close with reflection on the ethical implications of "enhanced rapport" in the research situation., (© The Author(s) 2015.)

Background: Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa., Discussion: Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both child participant and parent. Where appropriate, alternatives to prospective informed consent should be considered to ensure that important paediatric critical care research can be undertaken in South Africa, whilst being cognisant of research risk. This document could provide a basis for debate on consent options in paediatric critical care research and contribute to efforts to advocate for South African law reform.

Researchers need a decision-making framework about disclosing a finding of misattributed parentage that accounts for nonclinical factors like the effects of personal identity and familial relationships.

This paper seeks to analyze the construction of ethics in sexuality research in which qualitative methods are employed in the field of social sciences. Analyses are based on a bibliographic review of current discussions on research methods of queer theory and on the authors' own experiences of past research on sexuality. The article offers a theoretical perspective on the ways ethnography and in-depth interviews become methods that can rely on a consensual method and create a politics of intimacy between the researchers and research participants. The politics of intimacy may contribute to the production of a politically engaged knowledge while escaping from the moral matrix that usually governs the relationship between researchers and research participants. It is argued here that the researcher's sexed and gendered body matters for fieldwork; that the consensual method among participants may be employed in sexuality research as a fruitful tool; and that the relationships created among researchers and participants can pose a challenge to predetermined ethical guidelines in research. As a result, discussions problematize the existence of a politics of intimacy in sexuality research that is characterized by ethical relations among research participants., (© 2014 John Wiley & Sons Ltd.)

Consent is a foundational principle of medical and dental ethics. The importance of the concept has changed over time and it is now viewed as more important than it has ever been, both within the profession and by wider society. This article looks at the nature of consent historically, the changes it has undergone, and some of the contemporary challenges in this area. The philosophical basis of consent is considered, looking at two lines of thought relating to autonomy and prevention of harm. The difficulty and appropriateness of providing 'fully-informed' consent is then considered along with some of the modern problems relating to consumerist culture, and the social changes that have caused them. By looking at consent from a social and philosophical standpoint, we can broaden our thinking to give context to the day-to-day practicalities of obtaining consent in practice. These practicalities are addressed in subsequent articles within this issue of the Primary Dental Journal.

Anthropological research with street-related children, adolescents, and young adults raises epistemological, methodical, and ethical predicaments. In this article, I illustrate the advantages of an anthropology that acknowledges the ethnographer's emotions as valuable data when conducting research with marginalized communities. By drawing on my own experiences when conducting long-term fieldwork, I argue that systematic self-reflexivity and an emotionally aware epistemology enhance both the anthropologist's emotional literacy and his or her understanding of informants and interlocutors. The integration of the ethnographer's emotions in the analysis and interpretation of ethnographic data can assist in formulating anthropological theory, challenging the limits of traditional empiricism, and raising emotions to a category of epistemic value.

Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.

Aim: To explore the methodological and ethical issues of conducting qualitative telephone interviews about personal or professional trauma with critical care nurses., Background: The most common method for conducting interviews is face-to-face. However, there is evidence to support telephone interviewing on a variety of sensitive topics including post-traumatic stress disorder (PTSD). Qualitative telephone interviews can limit emotional distress because of the comfort experienced through virtual communication. Critical care nurses are at increased risk of developing PTSD due to the cumulative exposure to work-related stress in the intensive care unit. We explored the methodological and ethical issues of conducting qualitative telephone interviews, drawing on our experiences communicating with a group of critical care nurses., Data Sources: Qualitative research interviews with 27 critical care nurses. Fourteen of the nurses met the diagnostic criteria for PTSD; 13 did not and had scores consistent with high levels of resilience., Review Methods: This is a methodology paper on the authors' experiences of interviewing critical care nurses on sensitive topics via the telephone., Discussion: The authors found that establishing rapport and connections with the participants and the therapeutic use of non-verbal communication were essential, and fostered trust and compassion. The ethical issues of this mode of communication include protecting the privacy and confidentiality associated with the disclosure of sensitive information, and minimising the risk of psychological harm to the researcher and participants., Conclusion: Qualitative telephone interviews are a valuable method of collecting information on sensitive topics., Implications for Research/practice: This paper explores a method of interviewing in the workplace. It will help inform interventions to promote healthy adaptation following trauma exposure in the intensive care unit.

Background: In this manuscript, we argue that within the context of phase IV, physician-researchers retain their fiduciary obligation to treat the patient-participants., Discussion: We first clarify why the perspective that research ethics ought to be differentiated from clinical ethics is not applicable in phase IV, and therefore, why therapeutic orientation is most convivial in this phase. Next, assuming that ethics guidelines may be representative of common morality, we show that ethics guidelines see physician-researchers primarily as physicians and only secondarily as researchers. We then elaborate on what a fiduciary obligation is and how some of the obligations are default duties. Lastly, we look at the fiduciary obligation of the physician-researcher in phase IV interventional trials., Conclusion: The fiduciary obligation to treat is not as easily waived as in earlier trials. Assuming the entwinement of research and practice in phase IV, physician-researchers, in collaboration with other researchers, investigators, and research ethics committees, should ensure that in terms of study design, methodology, and research practice, the therapeutic value of the research to the patient-participants is not diminished.

Background: Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs' perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently., Methods: A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels., Results: A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement., Conclusions: Research ethics committees identified a clear need for ethics guidelines for CRTs and education about distinct ethical issues in CRTs. There is disagreement among committees, even within the same countries, with respect to key questions in the ethics review of CRTs. This disagreement reflects variability of opinion and practices pointing toward possible gaps in knowledge, and supports the need for explicit guidelines for the ethical conduct and review of CRTs.

Nurse researchers engaged in qualitative interviews with patients and spouses in healthcare may often experience being in unforeseen ethical dilemmas. Researchers are guided by the bioethical principles of justice, beneficence, non-maleficence, respect for human rights and respect for autonomy through the entire research process. However, these principles are not sufficient to prepare researchers for unanticipated ethical dilemmas related to qualitative research interviews. We describe and discuss ethically challenging and difficult moments embedded in two cases from our own phenomenological interview studies. We argue that qualitative interviews involve navigation between being guided by bioethics as a researcher, being a therapist/nurse and being a fellow human being or even a friend. The researchers' premises to react to unexpected situations and act in a sound ethical manner must be enhanced, and there is a need for an increased focus on the researchers' ethical preparation and to continually address and discuss cases from their own interviews.

This paper introduces the term "structural coercion" to underscore the ways in which broader social, economic, and political contexts act upon individuals to compel them to enroll as subjects in clinical research. The paper challenges the adequacy of the concepts of "coercion" and "undue influence" in determining when research participation is voluntary. Acknowledging structural coercion shifts the frame of ethical deliberation away from specific individuals and specific studies to see important patterns in research participation by salient demographic characteristics. The effects of structural coercion manifest themselves in particular research settings, but unlike the conventional form of coercion, it is not rooted in the researcher-participant relationship or linked to particular study protocols. By extracting voluntariness from entrenched conceptions of the researcher-participant dyad, this paper proposes approaches to minimize the effects of structural coercion while creating new ethical imaginaries for review boards and researchers alike.

Observational research has a history of controversy, particularly when the research is conducted in a clinical setting. Existing ethical approval processes focus on protecting participants and the researcher's responsibilities, in particular where vulnerable populations are concerned. In this study, the authors explored the less overt and often understated ethical challenges that can arise when conducting observational research in a clinical setting. Reflecting on two recent studies conducted in different clinical settings, the authors described the challenges of blurring role boundaries, the risk of collecting redundant data, and the impact of reverse power relationships between researchers, clinicians, and managers. From their experiences, the authors suggested that the preparatory work undertaken with clinicians and managers onsite, which typically focuses on how the researchers will maintain the ethical robustness of the research and protect the rights of participants and the vulnerable, should also highlight the sometimes overlooked ethical issues associated with participatory research. This can help ensure that participants and managers understand the scope and limitations of the research, and consider the ways in which the observed can influence the researcher and the findings., (© 2013 Wiley Publishing Asia Pty Ltd.)

In this article, we examine the ethical and methodological tensions entailed in doing qualitative research in obesity studies. Framing our own embodied engagements through critical social theory, we consider how cultural meanings associated with obesity are silenced and negotiated in the research process. This negotiation is fraught with linguistic and corporeal challenges, beginning with the decision to use (or not use) the word obesity in research materials. Obesity is a visible stigma, and we argue that silencing language does not erase the tacit judgments that accompany discursive categorization. It is in a broader context of power relations that we examine the relationship between researcher and participant bodies and the ways in which collective knowingness about fat bodies underpins methodological engagement. The simultaneous presence and absence of obesity have a significant impact on the research process, in shaping both participants' experiences and the researcher's actions and interpretations.

One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered 'emerging biotech' locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of 'global bioethics'. Such a 'global', 'Western' or 'universal' bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four 'spheres' - deliberation, regulation, oversight and interaction - as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

The most contentious, unresolved issue in biomedicine in the last twenty-five years has been how to best address compensated partnerships between academic researchers and the pharmaceutical industry. Law and policy deliberately promote these partnerships through intellectual property law, research funding programs, and drug and device approval pathways while simultaneously condemning them through conflict-of-interest (COI) regulations. These regulations have not been subjected to the close scrutiny that is typically utilized in administrative law to evaluate and improve regulatory systems. This Article suggests that the solution to this standoff in biomedical law and policy lies in an informed, empirical approach. Such an approach must both recognize such partnerships' legal and practical variations, as well as classify them based on their benefit to innovation and their harm to research biases. Ultimately, this approach must facilitate administrative reforms that would convert what is now an inherently arbitrary, yet widespread, regulatory regime into an epistemically rich mechanism for distinguishing between harmful and beneficial partnerships.

The creation of socially and technically robust biobank privacy regimes presupposes knowledge of and compliance with legal rules, professional standards of the biomedical community, and state-of-the-art data safety and security measures. The strategies in privacy management and data protection presented in this review show a trend that goes beyond searching for compromises or efforts of balancing scientific demands for efficiency and societal demands for effective privacy regimes. They focus on developing synergies that facilitate cooperative use of biomaterials and data and enhance sample search efficiency for researchers on the one hand, and protect rights and interests of donors and citizens on the other hand. Among the issues covered are: a) ethical sensitivities and public perceptions on privacy in biobanking b) tools and procedures that allow maintenance of the rights and dignity of donors, without jeopardizing legitimate information needs of researchers and autonomy of biobanks, and c) a privacy sensitive framework for sharing of data and biomaterials in the research context.

Background: This study is the first to examine the understandings that participants have of the consent process in a pharmacogenetic trial of anti-depressant medication., Methods: This was a qualitative cross sectional study. There were 76 participants residing in London, Mannheim, Arhuus and Poznan., Results: Only one quarter of participants (none in Poznan) could articulate the concept of pharmacogenetics. Heritability and testing medication were also given as the purpose of the trial. Most participants had not appreciated harms that could derive from the trial. Even when shown the consent sheet, participants were confused about DNA profiling. There was evidence that participants appreciated weekly contact with researchers. Most said they would participate in a trial again but would like choice over the intervention they were assigned to., Conclusion: Participants in this study showed a poor level of informed consent. Although this is not the first time this argument has been made, it is in the case of a pharmacogenetic trial. Further work should investigate the associations between extraneous factors such as information and social support on beneficial or untoward outcomes of antidepressant treatment.

Research on immigrant communities has often been reductionist, stereotypical, and simplistic, and even the most well-intentioned researchers are susceptible to using cultural deficit models. This chapter critically evaluates some of the dominant tensions and problem areas with respect to researching immigrant communities. Specifically, we analyze three primary challenges that researchers encounter: the heterogeneity of immigrant lives, adequate representations of immigrant communities, and researcher privilege. In addition to identifying these unique theoretical, methodological, and ethical concerns, we draw from critical theory, feminist scholarship, and cultural psychology to provide an interdisciplinary solution. For researchers investigating immigrant communities, we advocate the following: (a) grounding of intersectional frameworks; (b) reliance on a risk and resilience framework; (c) phenomenological understanding of immigrants' everyday lives; (d) inclusion of immigrant participants' voices; and (e) cultivation of negative capability. Finally, we briefly review selected studies that address three recurring challenges that researchers face and heed our five recommendations., (Copyright © 2013 Wiley Periodicals, Inc., A Wiley Company.)

Community Engagement (CE) has been presented by bio-ethicists and scientists as a straightforward and unequivocal good which can minimize the risks of exploitation and ensure a fair distribution of research benefits in developing countries. By means of ethnographic fieldwork undertaken in Kenya between 2007 and 2009 we explored how CE is understood and enacted in paediatric vaccine trials conducted by the Kenyan Medical Research Institute and the US Centers for Disease Control (KEMRI/CDC). In this paper we focus on the role of paid volunteers who act as an interface between villagers KEMRI/CDC. Village Reporters' (VRs) position of being both with the community and with KEMRI/CDC is advantageous for the conduct of trials. However it is also problematic in terms of exercising trust, balancing allegiances and representing community views. VRs role is shaped by ambiguities related to their employment status and their dual accountability to researchers and their villages. VRs are understandably careful to stress their commitment to self-less community service since it augments their respectability at community level and opens up opportunities for financial gain and self-development. Simultaneously VRs association with KEMRI/CDC and proximity to trial participants requires them to negotiate implicit and explicit expectations for material and medical assistance in a cultural setting in which much importance is placed on sharing and mutuality. To ensure continuity of productive interactions between VRs, and similar community intermediaries, and researchers, open discussion is needed about the problematic aspects of relational ethics, issues concerning undue influence, power relations and negotiating expectations., (© 2013 Blackwell Publishing Ltd.)

Fieldworkers (FWs) are community members employed by research teams to support access to participants, address language barriers, and advise on culturally appropriate research conduct. The critical role that FWs play in studies, and the range of practical and ethical dilemmas associated with their involvement, is increasingly recognised. In this paper, we draw on qualitative observation and interview data collected alongside a six month basic science study which involved a team of FWs regularly visiting 47 participating households in their homes. The qualitative study documented how relationships between field workers and research participants were initiated, developed and evolved over the course of the study, the shifting dilemmas FWs faced and how they handled them. Even in this one case study, we see how the complex and evolving relationships between fieldworkers and study participants had important implications for consent processes, access to benefits and mutual understanding and trust. While the precise issues that FWs face are likely to depend on the type of research and the context in which that research is being conducted, we argue that appropriate support for field workers is a key requirement to strengthen ethical research practice and for the long term sustainability of research programmes., (© 2013 Blackwell Publishing Ltd.)

There is wide agreement that community engagement is important for many research types and settings, often including interaction with 'representatives' of communities. There is relatively little published experience of community engagement in international research settings, with available information focusing on Community Advisory Boards or Groups (CAB/CAGs), or variants of these, where CAB/G members often advise researchers on behalf of the communities they represent. In this paper we describe a network of community members ('KEMRI Community Representatives', or 'KCRs') linked to a large multi-disciplinary research programme on the Kenyan Coast. Unlike many CAB/Gs, the intention with the KCR network has evolved to be for members to represent the geographical areas in which a diverse range of health studies are conducted through being typical of those communities. We draw on routine reports, self-administered questionnaires and interviews to: 1) document how typical KCR members are of the local communities in terms of basic characteristics, and 2) explore KCR's perceptions of their roles, and of the benefits and challenges of undertaking these roles. We conclude that this evolving network is a potentially valuable way of strengthening interactions between a research institution and a local geographic community, through contributing to meeting intrinsic ethical values such as showing respect, and instrumental values such as improving consent processes. However, there are numerous challenges involved. Other ways of interacting with members of local communities, including community leaders, and the most vulnerable groups least likely to be vocal in representative groups, have always been, and remain, essential., (© 2013 Blackwell Publishing Ltd.)

Identities ascribed to research staff in face-to-face encounters with participants have been raised as key ethical challenge in transnational health research. 'Misattributed' identities that do not just deviate from researchers' self-image, but obscure unequivocal aspects of researcher identity - e.g. that they are researchers - are a case of such ethical problem. Yet, the reasonable expectation of unconcealed identity can conflict with another ethical premise: confidentiality; this poses challenges to staff visiting participants at home. We explore these around a case study of 'follow-up' staff, observed during an ethnographic study of a Kenyan HIV 'trial community', which included participant observation, conversations, and interviews with staff (n = 79) and participants (n = 89). We found that because of the need to maintain confidentiality and because of some suspicions towards researchers, research staff drew upon alternative identities - presenting themselves to non-participants as relatives or friends, rather than as researchers. Several staff experienced this as necessary but uncomfortable. Simultaneously, staff and participants forged close relations in line with their fictional identities, which however also posed challenges because they entailed personal responsibilities that were difficult to live up to, due to limited resources, and the trial's limited duration. Similar challenges may arise in transnational HIV treatment programmes and should be explored further in that context., (© 2013 Blackwell Publishing Ltd.)

In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research participant. This tension is exacerbated in HIV research in low and middle income countries, which frequently uncovers comorbidities other than the condition under study. Some bioethicists argue that as the goals of medicine and those of research are distinct, it is a mistake for researchers to assume therapeutic responsibilities while engaging in research. Others propose that there is a duty of care, but disagree as to how this is limited and specified. In this qualitative study, principal investigators from HIV prevention trials discuss their experience of providing medical benefits to participants within the context of conducting research into HIV biomedical prevention technologies. They describe the limitations imposed at times by funders and at times by infrastructure constraints, and canvass the importance of ancillary care provision and capacity building in trial communities. The views of the principal investigators are compatible with the perspective that there is a duty of care, limited by the nature of the research, the depth of the relationship between research and participant, and the capacity of the research site. The therapeutic orientation in HIV prevention trial appears to be indivisible from competent research practise by making concrete and appropriate benefits available to trial participants and their communities that support rather than compete with local infrastructure.

Background: Persons with intellectual and developmental disabilities have had regrettably few opportunities to voice their opinions on aspects of research with which they have had direct experience. Understanding and responding to these views can contribute to policies and practices that increasingly treat people as they desire to be treated., Methods: We conducted individual interviews and focus groups with 16 adults with intellectual and developmental disabilities to examine their perspectives on participating in research., Results: Our analysis indicates that adults with intellectual and developmental disabilities want to engage in research to improve their quality of life and to have greater access to a worthwhile activity through more active participation. Our results also highlight trust as a critical ingredient in the success of research with this group., Conclusions: Our findings suggest that despite ethical challenges, researchers can and should pursue research that has the potential to improve the lives of persons with intellectual and developmental disabilities. Such research is more likely to be both ethical and successful if researchers pay attention to enhancing autonomy and person-centredness, while at the same time engendering participant trust., (© 2012 The Authors. Journal of Intellectual Disability Research © 2012 Blackwell Publishing Ltd.)

In this article we suggest a theoretical framework of knowledge construction by employing the concept of dialectics to power relationships between researcher and participants. Power distribution in research is perceived as dichotomous and asymmetrical in favor of the researcher, creating unequal power relations that make exploitation possible. Acknowledging such exploitation has led to a critical stance and attempts to bridge gaps through egalitarianism and empowerment of participants. Some scholars have focused on shifting expert knowledge differentials between researcher and participants throughout the research project. Others have evaluated such gaps as a source of knowledge construction. In the present work we applied a dialectical approach to understanding research relationships, suggesting reciprocity as their defining attribute, regardless of symmetry or asymmetry and as a source of knowledge construction. In this article we recommend avoiding a taken-for-granted attitude, because we see it as a direct obstacle to the construction of knowledge.