Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. (1) Principal investigators should build (...) ‘true research teams’ where members of the team are meaningfully involved in decisions regarding the protocol and its implementation. (2)There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. (3) While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions (such as elaborated consent processes) and look for means to negotiate appropriate protections for those willing to participate. (4) In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. (5) Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist. (shrink)

Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review (...) of socio-empirical research on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent. (shrink)

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 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. (shrink)

Over the past few years, a growing number of people have called for reconceptualizing participation in health research as a moral obligation. John Harris argues that seriously debilitating diseases give rise to important needs, and since medical research is necessary to relieve those needs in many circumstances, people are morally obligated to act as research subjects.1 Rosamond Rhodes claims that research participation is a moral obligation for reasons of justice, beneficence, and self-development: because we (...) all benefit significantly from modern medicine, we are all required to do our part in advancing the state of medical knowledge.2 Individuals who reap the benefits of medical knowledge without contributing .. (shrink)

In standard medical care, physicians select treatments for patients based on clinical judgment, considering which treatment is best for the individual patient, given the patient's history and circumstances. In contrast, investigators conducting randomized clinical trials select treatments for participants based on a random selection process. Because this process represents a significant departure from the norms of standard medical care, it is widely assumed that potential research participants must understand randomization to give valid informed consent. This assumption, together with data (...) that many research participants do not understand randomization, implies that randomized clinical trials often fail to obtain adequately informed consent. Before accepting this conclusion, and before initiating extensive efforts to improve research participants' understanding of randomization, we should assess the plausible, but rarely analyzed assumption that participants need to understand randomization to give valid informed consent for randomized clinical trials. (shrink)

Objective: To examine current research payment practices and to inform development of clearer guidelines for researchers and ethics committees.Design: Exploratory email based questionnaire study of current research participant reimbursement practices. A diverse sample of organisations and individuals were targeted.Setting: Australia.Participants: Contacts in 84 key research organisations and select electronic listservers across Australia. A total of 100 completed questionnaires were received with representations from a variety of research areas .Main measurements: Open-ended and fixed alternative questions about type (...) of research agency; type of research; type of population under study; whether payment is standard; amounts and mechanisms of payment; factors taken into account when deciding on payment practices; and whether payment policies exist.Results: Reimbursement practice is highly variable. Where it occurs it is largely monetary and is for time and out-of-pocket expenses. Ethics committees were reported to be often involved in decision making around reimbursement.Conclusions: Research subject payment practices vary in Australia. Researchers who do provide payments to research participants generally do so without written policy and procedures. Ethics committees have an important role in developing guidelines in this area. Specific guidelines are needed considering existing local policies and procedures; payment models and their application in diverse settings; case study examples of types and levels of reimbursement; applied definitions of incentive and inducement; and the rationale for diverse payment practices in different settings. (shrink)

It is widely assumed that the use of deception in research is always inconsistent with obtaining valid consent. In addition, guidelines and regulations permit research without valid consent only when it poses no greater than minimal risk. Current practice thus prohibits studies that use deception and pose greater than minimal risk, including studies that rely on deceptive methods to evaluate experimental treatments. To assess whether these prohibitions are justified, the present paper evaluates five arguments that might be thought (...) to support the assumption that deception is always inconsistent with valid consent. Analysis of these arguments reveals that deception is frequently, but not always, inconsistent with obtaining valid consent for research. This conclusion suggests that, in order to avoid unnecessarily blocking valuable research, current policies and practice should be revised to recognize the conditions under which the use of deception can be consistent with obtaining research participants’ valid consent. (shrink)

Research concerned with human beings is always an interference of some kind, thus posing ethical dilemmas that need justification of procedures and methodologies. It is especially true in social work when facing mostly sensitive populations and sensitive issues. In the process of conducting a research on the emotional life histories of Israeli men who batter their partners, some serious ethical questions were evoked such as (a) Did the participants really give their consent? (b) What are the limits of (...) the researcher-participants relationship and who decides them? (c) For whom is the study beneficial? and (d) To what degree did the methodology fit with the participants? In this article, I discuss the Socratic idea of truth revealed through dialogue and the idea of reciprocity that was developed in Buber's (1949) ethics of dialogue and Habermas' (1990) communicative ethics. The 3 essential conclusions drawn from the ethical questions raised and the discussion of the thinkers that are mentioned previously are (a) dialogical methodology is ethically justified; (b) dynamic interactions give a more holistic perspective of the human nature, thus enriching the field; and (c) through dialogical methodology both researcher and participant profit from growth of knowledge, which is a key for empowerment and change. (shrink)

Researchers typically attempt to fulfill disclosure and informed consent requirements by having participants read and sign consent forms. The present study evaluated the reading levels of informed consent forms used in psychology research and other fields (medical research; social science and education research; and health, physical education, and recreation research). Two standardized measures of readability were employed to analyze a randomly selected sample (N = 108) of informed consent forms used in Institutional Review Board-approved research (...) projects at a midwestern university during the 1987-1988 academic year. Results indicate that informed consent forms are typically written at a higher reading level than is appropriate for the intended population and that there are no consistently significant differences in readability among areas of research or between college student and noncollege student participants. Due to the unacceptably high reading level of the consent forms, one must question whether participants can comprehend the information contained in the consent forms. (shrink)

Paying research subjects for their participation in biomedical studies is an increasingly common and acceptable practice. Nevertheless, it continues to raise numerous conceptual, ethical, and pract...

The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent-undermining coercion marks out certain actions as impermissible and certain agreements as (...) unenforceable. By contrast, coercion as subjection indicates a way in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment. (shrink)

Background: Despite potential benefits of the return of research results to research participants, the TriCouncil Policy Statement , which reflects Canadian regulatory ethical requirements, does not require this. The policies of Canadian research ethics boards are unknown.Objectives: To examine the policies of Canadian university based REBs regarding returning results to research participants, and to ascertain if the presence/absence of a policy may be influenced by REB member composition.Design: Email survey of the coordinators of Canadian university based (...) REBs to determine the presence/absence of a policy on return of research results to research participants both during an ongoing study and at conclusion. REB coordinators were asked to return a copy of the policy or guidelines and to describe the member composition of their REB.Findings: Of 50 REBs that were contacted 34 responded and 22 met the inclusion criteria. Two had a policy that governed the return of research results while on a study, and seven following the completion of a study. Presence of an ethicist or a lawyer on the REB did not influence the presence/absence of such policies. No REBs had specific guidelines describing how participants should be informed of results.Conclusions: Most REBs did not require researchers to disclose study results to research participants either during or following a study. Thus this study identifies an ethical shortcoming in the conduct of human research in Canada. It has also demonstrated that there are no clear recommendations by REBs to facilitate the return of results to participants following research projects. (shrink)

Background: Financial conflict of interest in clinical research is an area of active debate. While data exist on the perspectives and roles of academic institutions, investigators, industry sponsors, and scientific journals, little is known about the perspectives of potential research participants.Methods: The authors surveyed potential research participants over the internet, using the Harris Interactive Chronic Illness Database. A potential research participant was defined by: self report of diagnosis by a health care professional and willingness to participate (...) in clinical trials. Email invitations were sent to 20 205 persons with coronary artery disease, breast cancer, or depression; a total of 6363 persons were screened; of these, 86% or 5478 met inclusion criteria and completed the survey. The outcome measures were respondents’ ratings on: importance of knowing conflict of interest information, whether its disclosure ought to be required, and its effect on willingness to participate—across seven widely discussed scenarios of financial conflicts of interest .Results: Majority responded that knowing conflict of interest information was “extremely” or “very” important; a larger majority felt financial conflicts of interest should be disclosed as part of informed consent . In all seven scenarios, a majority was still willing to participate but in some scenarios a sizable minority would be wary of participation. Respondents were more wary of individual than institutional conflicts of interest. Illness group and sociodemographic factors had modest effects and did not affect the main trends.Conclusions: The prevailing practice of non-disclosure of financial conflicts of interest in clinical research appears contrary to the values of potential research participants. (shrink)

abstractBackground: Evidence shows both a tendency for research participants to conflate research and clinical care and a limited public understanding of research. Conflation of research and care by participants is often referred to as the therapeutic misconception. Despite this evidence, few studies have explicitly asked participants, and especially minors, to explain what they think research is and how they think it differs from regular medical care. Methods: As part of a longer semistructured interview evaluating assent (...) and parental permission for research, adolescent research participants (n = 177), including adolescents with illnesses and healthy volunteers, and their parents (n = 177) were asked to describe medical research in their own words and say whether and how they thought being in medical research was different from seeing a regular doctor. Qualitative responses were coded and themes were identified through an iterative process. Results: When asked to describe medical research, the majority described research in terms of its goals of helping to advance science, develop treatments and medicines, and help others; fewer described research as having the goal of helping particular research participants, and fewer still in terms of the methods used in research. The majority of teen and parent respondents said being in research is different than seeing a regular doctor and explained this by describing different goals, different or more procedures, differences in the engagement of the doctors/researchers, and differences in logistics. Conclusions: Adolescents participating in clinical research and their parents generally describe medical research in terms of its goals of advancing science and finding new medicines and treatments, sometimes in combination with helping the enrolled individuals. The majority perceive a difference between research and regular medical care and described these differences in various ways. Further exploration is warranted about how such perceived differences matter to participants and how this understanding could be used to enhance informed consent and the overall research experience. (shrink)

Payment for research participation has raised ethical concerns, especially with respect to its potential for coercion. We argue that characterising payment for research participation as coercive is misguided, because offers of benefit cannot constitute coercion. In this article we analyse the concept of coercion, refute mistaken conceptions of coercion and explain why the offer of payment for research participation is never coercive but in some cases may produce undue inducement.

In this article, I present a contractualist conception of human-participant research ethics, arguing that the most appropriate source of the rights and responsibilities of researcher and participant is the contractual understanding between them. This conception appears to explain many of the more fundamental ethical incidents of human-participant research. I argue that a system of contractual rights and responsibilities would allow a great deal of research that has often been felt to be ethically problematic, such as research (...) involving deception, concealed research, and research on dependent populations. However, in defining the conditions under which such research should be permissible, my contractualist theory also makes it clear that there are limits-and explains what those limits are-to the propriety of such research. (shrink)

Some are concerned about the possibility that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple influences leading to decisions, including decisions about research participation. The concept of undue influence is explored, as well as the question of whether or not there is something uniquely distorting (...) about money as opposed to a chance for treatment or medical care. An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make. (shrink)

Boundaries between research and clinical practice blur in health research conducted by clinician-researchers. We describe a typology, of clinician-researcher dual-role tensions, with two overarching catalysts: acting as a clinical resource for patient-participants and forming researcher–participant relationships mirroring clinician–patient relationships. Using the typology as an analytic template we explored blurred boundaries in five illustrative, non-clinician, critical studies. Like clinician-researchers, critical researchers act in ways that promote rapport and relationships with their participants, which can blur boundaries. While clinician-researchers see tension (...) between clinician and researcher roles, we ask what roles critical researchers attempt to distinguish: ethically minded citizen and researcher, socially conscious community member and researcher, or friend and researcher? Anticipating catalysts of dual-role tension may assist critical researchers in planning and conducting robust research. (shrink)

The study reported in this paper explored the ethical requirements of social research participants, an area where there is still little empirical research, by interviewing people who had participated in one of five recent social research studies. The findings endorse the conceptualization of informed consent as a process rather than a one-off event. Four different dynamics of decision-making were followed by participants in terms of the timing of decisions to participate and the information on which they were (...) based. Multiple information events were important, as was verbal as well as written information. Study participants reacted unfavourably to the idea of written consent. Although prior information was relevant to participant experience of the interview, what emerged more strongly as relevant was the behaviour of interviewers and the interviewing strategy used. The authors suggest that naturalistic, authentic approaches to information-giving are necessary, and that in scrutinizing them research ethics committees need to look not only at written information but also at verbal information giving, and how interviewer information-giving is supported by training and supervision. They suggest that committees also need to concern themselves more broadly with who will carry out interviews and the training, mentoring and monitoring in place to shape their conduct of interviews. In considering research instruments, research ethics committees need to consider not only whether interviewers will capture accurate and appropriate data but also whether they are likely to lead to a satisfactory interaction for participants. Given the impossibility of anticipating each individual participants information needs and their reaction to the interviewing strategy, the authors suggest that interviewers and participants need to be encouraged to negotiate the conduct of interviews jointly, and discuss how such negotiating roles might be supported. (shrink)

Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their preparticipation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may (...) be permissible to offer differential incentive payments if necessary to advance the goals of a study. We encourage investigators and Institutional Review Boards to think about whether to offer payment, in what amounts and for what purpose, and also to consider whether differential payment can help promote the scientific and ethical goals of clinical research. (shrink)

Recognizing that offers of payment to research participants can serve various purposes—reimbursement, compensation, and incentive—helps uncover differences between participants that can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their pre-participation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it (...) may be permissible to offer differential incentive payments if necessary to advance a study’s goals. We encourage investigators and Institutional Review Boards to think not only about whether to offer payment, in what amounts, and for what purpose, but also to consider whether differential payment can help promote the scientific and ethical goals of clinical research. (shrink)

Concepts such as ‘coercion’ and ‘inducement’ are often used within bioethics without much reflection upon what they mean. This is particularly so in research ethics where they are assumed to imply that payment for research participation is unethical. Wertheimer and Miller advance our thinking about these concepts and research ethics in a significant way, specifically by questioning the possibility of genuine offers ever being coercive. This commentary argues that they are right to question this assumption, however, (...) more needs to be said about the plausible coercive offer cases and to explain the normativity of these cases. (shrink)

It is widely held that individuals who are unable to provide informed consent should be enrolled in clinical research only when the risks are low, or the research offers them the prospect of direct benefit. There is now a rich literature on when the risks of clinical research are low enough to enroll individuals who cannot consent. Much less attention has focused on which benefits of research participation count as ‘direct’, and the few existing accounts (...) disagree over how this crucial concept should be defined. This disagreement raises concern over whether those who cannot consent, including children and adults with severe dementia, are being adequately protected. The present paper attempts to address this concern by considering first what additional protections are needed for these vulnerable individuals. This analysis suggests that the extant definitions of direct benefits either provide insufficient protection for research subjects or pose excessive obstacles to appropriate research. This analysis also points to a modified definition of direct benefits with the potential to avoid these two extremes, protecting individuals who cannot consent without blocking appropriate research. (shrink)

Background Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Aim Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Method Postal survey of all RECs in Ireland. Results Response rate was 62.5% (...) (n=50). 80% of RECs reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. Conclusions There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants. (shrink)

Background Seeking assent from children for participation in medical research is an ethical imperative of numerous institutions globally. However, none of these organizations provide specific guidance on the criteria or process to be used when obtaining assent. The primary objective of this scoping review was to determine the descriptions of assent discussed in the literature and the reported criteria used for seeking assent for research participation in pre-adolescent children. Methods Medline and Embase databases were searched until (...) November 2020 using the term “assent” in the title or abstract. Inclusion criteria were (1) studies enrolling children which specifically described operationalization of the assent process and (2) studies of the assent process which provided a description of assent. Data collected included participant information, patient criteria for seeking assent, guidelines referenced, description of assent reported, how assent was obtained and assent information presented, and reported assent rate. For qualitative articles focusing on the assent process, important themes were identified. Results A total of 116 articles were included of which 79 (68.9%) operationalized assent and 57 studies (%) described the assent process. The most commonly reported criterion used to determine the ability of a child to assent was age (35.4%, 28/79). The reported minimal age for obtaining pediatric assent varied considerably across and within jurisdictions (5–13 years; median 7.5 years, IQR 7.0, 9.75). Cognitive ability was reported as a criterion for obtaining assent in 5.1% (4/79) of studies. Assent rates were only reported in 17.7% (14/79) of citations and ranged from 32.0 to 100%. Analysis of the 57 studies describing the assent process identified several themes, including age thresholds, assessment of capacity, variable knowledge of pediatric assent and parental roles. Conclusion We found significant variation in criteria used for assessment of patient capacity, delivery of information used to obtain assent and documentation of the assent process. While we acknowledge that individual children, settings and jurisdictions may require different approaches to obtaining assent, there should be agreement on important principles to be followed with resulting common guidance on assessing capacity, delivering information and documentation of the assent process for publication. (shrink)

History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ (...) Michel Foucault’s ideas of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed — not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies. (shrink)

This paper reports an instructor and her students’ experiences with ethics in conducting action research in a university teacher-training class. The nature of educational action research suggests the dual roles of the instructor and students, the former as both a researcher and a practitioner, and the latter as both research participants and learners. However, in following an ethics procedure to allow students to opt out of the research project anonymously but, at the same time, not to (...) deny their access to learning opportunities, both the instructor and students experienced tensions as they tried to separate and switch roles for research and teaching/learning. Instead of benefiting from the research to explore and reflect on learning, many students complained about their sense of being used as research participants. The article suggests new ethics review procedures to support and help action research to generate valuable results in teaching and learning. (shrink)

Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.

People with dementia have commonly been excluded from research. The adverse impacts of this exclusion are now being recognized and research literature, position statements, and ethics guidelines increasingly call for inclusion of people with dementia in research. However, few published studies investigate the views of potential participants on taking part in research should they experience dementia-related cognitive impairment. This cross-sectional survey examined the views of people aged sixty and older attending hospital outpatient clinics about clinical (...) class='Hi'>research participation if they had dementia and impaired decision-making ability. Over 90 percent of respondents were agreeable to participating in a wide range of research activities, such as cognitive testing, physical measurements, imaging procedures, and blood draws. For drug studies, however, agreement dropped to 60 percent. Altruism was a strong motivator for research participation. In regard to who should be involved in decisions about their participation in research during periods of incapacity, respondents mostly preferred the person they appoint as their substitute decision-maker for healthcare matters or a doctor or health professional on the research team. Over three-quarters expressed interest in making an advance research directive. The study findings are discussed in relation to law reforms in Australia that aim to strengthen respect and inclusion for people with impaired decision-making capacity, especially by providing frameworks for advance planning for research participation. (shrink)

To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine (...) the validity of potential participants' informed consent. An analysis of individuals' interests suggests that potential participants need to understand three additional facts to understand that they are being invited to participate in research: 1) research contribution: those who enroll in the study will be contributing to a project designed to gather generalizable knowledge to benefit others in the future; 2) research relationship: the investigators will rely on participants' efforts to gather the generalizable knowledge to benefit others; and 3) research impact: the extent to which participating in the study will alter what participants do and what happens to them. (shrink)

Researchers studying at-risk and socially disenfranchised child and adolescent populations are facing ethical dilemmas not previously encountered in the laboratory or the clinic. One such set of ethical challenges involves whether to: (a) share with guardians research derived information regarding participant risk, (b) provide participants with service referrals, or (c) report to local authorities problems uncovered during the course of investigation. The articles assembled for this special section address the complex issues of deciding if, when, and how to report (...) or provide referrals for research participants who are minors (referred to hereafter as minor research participants). This paper focuses on two factors underlying these decisions: the validity of risk estimates and meta-ethical positions on scientific responsibility. It is suggested that, before sharing information about minor research participants investigators should do the following: critically examine the diagnostic validity of developmental measures, include the scope and limitations of information sharing in informed consent procedures, and become familiar with state reporting laws. I discuss the impact of the traditionally accepted act utilitarian meta-ethical position on the investigator-participant relationship, and I recommend consideration of alternative positions as a step toward developing a research ethic of scientific responsibility and care. (shrink)

Public participation and survivor research in mental health are widely recognized as vital to the field. At the same time, contributions of patient collaborators can present unique challenges to determining authorship. Using an unresolved dispute around research contributions to the American Psychiatric Association’s Psychiatric Services journal, authorship and contribution are addressed. Recommendations are suggested to prevent dilemmas and achieve responsible research credit inclusion, especially among researchers with different backgrounds and asymmetric power relations. Researchers and publishers can (...) prepare proactively for conflict through consensus on authorship criteria, prior agreements around author inclusion, arrangement for third party dispute resolution, transparency in communication and contracts, notification to prospective publications of pending disputes, a contributor-guarantor model of contribution, journal editor “expressions of concern” when authorship disputes go unresolved, and expectation of conflict as generative. (shrink)

A growing literature documents the existence of individuals who make a living by participating in phase I clinical trials for money. Several scholars have noted that the concerns about risks, consent, and exploitation raised by this phenomenon apply to many (other) jobs, too, and therefore proposed improving subject protections by regulating phase I trial participation as work. This article contributes to the debate over this proposal by exploring a largely neglected worry. Unlike most (other) workers, subjects are not paid (...) to produce or achieve anything but to have things done to them. I argue that this passivity is problematic for reasons of distributive justice. Specifically, it fails to enable subjects to realize what Gheaus and Herzog call “the goods of work”—a failure not offset by adequate opportunities to realize these goods outside of the research context. I also consider whether granting subjects worker-type protections would accommodate this concern. (shrink)

This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of (...) the Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ health research ethics committees in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs. (shrink)

BackgroundThe EU’s 2006 Paediatric Regulation aims to support authorisation of medicine for children, thus effectively increasing paediatric research. It is ethically imperative to simultaneously establish procedures that protect children’s rights.MethodThis study endeavours (a) to evaluate whether a template consent form designed by the Standing Working Group of the German-Research-Ethics-Committees (AKEK) adequately informs adolescents about research participation, and (b) to investigate associated phenomena like therapeutic misconception and motives for research participation. In March 2016 a questionnaire (...) study was conducted among 279 pupils (mean age 13.1 years) of a secondary school in northern Germany.ResultsA majority of participants showed a general good understanding of foundational research ethics concepts as understood from the AKEK consent form. Nevertheless, our data also suggests possible susceptibility to therapeutic misconception. Own health concerns and pro-social considerations were found to be significant motivational factors for participating in research, while anticipation of pain lessens likelihood of participation. Advice from trusted others is an important decisional influence, too. Furthermore, data security was found to be a relevant aspect of adolescents’ decision-making process.ConclusionBearing in mind adolescents’ generally good understanding, we infer the lack of knowledge about medical research in general to be one source of therapeutic misconception. To further improve the quality of consent we propose a multi-staged approach whereby general research education is completed before an individual becomes a patient or potential participant. To the best of our knowledge this is the first German questionnaire-study addressing issues of informed consent in a large under-age sample. (shrink)

ABSTRACT In this paper, I support the claim that placing certain restrictions on public access to possible new treatments is morally problematic under some exceptional circumstances. Very ill patients may find that all available standard treatments are unacceptable, either because they are ineffective or have serious adverse effects, and these patients may understandably be desperate to try something new even if this means stepping into the unknown. Faced with certain death, it is rational to want to try something new and (...) to chance a dire outcome. Restricting possible new treatments to research trials may put these treatments scientifically, geographically or economically out of reach of these patients. For those who can get access, research restrictions could weaken, though not necessarily eliminate, the value of consent participants of such trials are able to give. Some participants may therefore be exploited for scientific purposes in the name of public interest. There are nonetheless compelling reasons for keeping some restrictive regulation in this area. (shrink)

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

We thank the authors of the five commentaries for their careful and highly constructive consideration of our paper,1 which has enabled us to develop our proposal. Participation in research has traditionally been viewed as altruistic. Over time, payments for inconvenience and lost wages have been allowed, as have small incentives, usually in kind. The problem, particularly with controlled human infection model (CHIM) research or ‘challenge studies’, is that they are unpleasant and time-consuming. Researchers want to offer carrots (...) to incentivise participation (as Fernandez Lynch and Largent suggest2). We are proposing that research participation be viewed as a job with the full suite of financial entitlements of fairly remunerated work, including payment for risk and labour law protections. This would be a significant shift from current practice and standards. Ambuehl, Ockenfels and Roth have grasped this basic point and have beautifully elaborated how a fair price could be arrived at using economic theory. They build on our proposal helpfully and suggest ‘(1) salary for time involvement that is adjusted to account for the amount of discomfort experienced during participation, (2) insurance against ex post adverse outcomes and (3) ex ante compensation for risks that cannot be compensated ex post (such as death).’3 This effectively addresses Fernandez Lynch and Largent’s2 concern (echoed by Jamrozik and Selgelid4) that compensation for risk is inappropriate for harms which do not eventuate. However, because death cannot be compensated for, there must be payment for risk of death, as Ambuehl, Ockenfels and Roth convincingly argue.3 Indeed, the three-part model suggested by Ambuehl, Ockenfels and Roth makes us realise that job model would be a better title for our model than a payment for risk model. The alternative to a properly remunerated job model is the original altruistic model. However, this …. (shrink)