Research, Informed Consent, and the Limits of Disclosure

According to this paper, respect for informed consent implies that subjects should often be told a good deal more than ethical guidelines explicitly or implicitly require. Unless subjects are informed of the researchers' personal characteristics, views, and sponsors whenever they would be likely to consider them significant, their autonomy is being overridden. However, overriding subjects' autonomy is sometimes required by the interests of researchers in not being discriminated against or suffering intrusions into their privacy. This paper resolves the conflict between informed consent and the interests of researchers by recommending that (i) subjects generally should be told of the personal characteristics of researchers when relevant as part of the researchers' job and (ii) that subjects should be told of researchers' views when conceptually connected to the research and (iii) that subjects should almost always be told about sponsorship. While the paper explicitly limits the role of informed consent, these recommendations go significantly beyond most guidelines in their requirements about what information should be disclosed.     

Mind the gap: An empirical study of post‐trial access in HIV biomedical prevention trials

The principle of providing post‐trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post‐trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post‐trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post‐trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account.     

On the Alleged Right to Participate in High‐Risk Research

Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non‐minimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I address the question of whether there should be limits of permissible risks in non‐therapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have ‘a right to participate in high‐risk research’. I argue that this idea is ill‐founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees.     

Human Research Ethics Committees: Examining their Roles and Practices

considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.     

Consent for participating in clinical trials ‐ Is it really informed?

The article explores the challenges of ensuring voluntary and informed consent which is obtained from potential research subjects in the north‐eastern part of Romania. This study is one of the first empirical papers of this nature in Romania. The study used a quantitative survey design using the adapted Quality of Informed Consent (QuIC) questionnaire. The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The informed consent form must contain details regarding the potential risks and benefits, the aim of the clinical trial, study design, confidentiality, insurance and contact details in case of additional questions. Our study confirmed that although all required information was included in the ICF, few clinical trial participants truly understood it. We also found that the most important predictive factor for a good subjective and objective understanding of the clinical trial was the level of education. Our study suggests that researchers should consider putting more effort in order to help clinical trials participants achieve a better understanding of the informed consent. In this way they will ensure that participants’ decision‐making is meaningful and that their interests are protected.     

Combining efficiency and concerns about integrity when using human biobanks

In the debate about human bio-sampling the interests of patients and other sample donors are believed to stand against the interests of scientists and of their freedom of research. Scientists want efficient access to and use of human biological samples. Patients and other donors of blood or tissue materials want protection of their integrity. This dichotomy is reflected in the Swedish law on biobanks, which came into effect 1 January 2003. In this article I argue that if the basic interest of scientists using human biological samples is in increasing knowledge and developing better treatments, and if the concept 'integrity' is properly understood, then sample donors should also be interested in promotion of efficiency as well as in the protection of their integrity. The basic premise of this argument is that donors of samples have interests related to the donation and use of samples as well as to the use of the results of the research, that is, new medical products and treatments. They have a role both as donors or participants in research and as end users of the research. I conclude that if (i) access to information acquired through biobank research is strictly limited to researchers, (ii) the information is protected by secrecy safeguards through coding and (iii) the procedures governing the research are open to public and democratic control, then most research using human biobanks may be carried out on the basis of making general information available when collecting biological samples, without further contact with participants.     

涉及人的医学科研项目伦理审查实践体会

本文就国内涉及人的医学科研项目伦理审查现状进行了简要介绍,并结合武汉大学中南医院医学伦理委员会近年来伦理审查的工作实际,对涉及人的医学科研项目伦理审查中存在的共性问题进行了初步探讨,提出管理部门和伦理委员会应加强对研究人员伦理知识的宣传教育,加强科研项目伦理行为的过程监督,保护受试者权益,保证医学科研的健康发展。     

Biobank governance: a lesson in trust

Biobanks are controversial due to their ethical, legal, and social implications. Recent discussion has highlighted a central role for governance in helping to address these controversies. We argue that sustainable governance of biobanks needs to be informed by public discourse. We present an analysis of a deliberative public engagement to explore the public values, concerns, and interests underlying recommendations pertaining to biobank governance. In particular, we identify five themes underlying expressed goals and concerns of participants regarding the development, operation and application of biobank research. Ultimately, we argue that, for the deliberants, governance represented a way to achieve trust in biobanks through accountability, transparency and control. As discussion of biobank governance moves the conceptual to the specific, policy makers and researchers should acknowledge the importance of the public viewpoint in maintaining trust; this acknowledgement is of importance to the ultimate success and longevity of biobanks.     

Use and Misuse of Material Transfer Agreements: Lessons in Proportionality from Research,Repositories, and Litigation

Material transfer agreements exist to facilitate the exchange of materials and associated data between researchers as well as to protect the interests of the researchers and their institutions. But this dual mandate can be a source of frustration for researchers, creating administrative burdens and slowing down collaborations. We argue here that in most cases in pre-competitive research, a simple agreement would suffice; the more complex agreements and mechanisms for their negotiation should be reserved for cases where the risks posed to the institution and the potential commercial value of the research reagents is high.     

Study bystanders and ethical treatment of study participants—A proof of concept

The ethics of research on human subjects is often construed as a fine balance between the interests of patients in need of novel health interventions, and those of study participants who should remain safe in the process. But there is a third group in the mix. Some people belong to neither category, yet research can affect or jeopardize them. Call such people “bystanders.” This article shows that thinking about bystander protection can question whether there is an upper limit on the risks that studies may legitimately visit upon their participants. Thus, thinking about appropriate bystander protection can shed light on the appropriate protection of study participants. Core research ethics, which focuses on the latter, must consider the former as well.     

A Clinical Service to Support the Return of Secondary Genomic Findings in Human Research

Human genome and exome sequencing are powerful research tools that can generate secondary findings beyond the scope of the research. Most secondary genomic findings are of low importance, but some (for a current estimate of 1%–3% of individuals) confer high risk of a serious disease that could be mitigated by timely medical intervention. The impact and scope of secondary findings in genome and exome sequencing will only increase in the future. There is considerable agreement that high-impact findings should be returned to participants, but many researchers performing genomic research studies do not have the background, skills, or resources to identify, verify, interpret, and return such variants. Here, we introduce a proposal for the formation of a secondary-genomic-findings service (SGFS) that would support researchers by enabling the return of clinically actionable sequencing results to research participants in a standardized manner. We describe a proposed structure for such a centralized service and evaluate the advantages and challenges of the approach. We suggest that such a service would be of greater benefit to all parties involved than present practice, which is highly variable. We encourage research centers to consider the adoption of a centralized SGFS.     

IS PAYMENT A BENEFIT?

What I call ‘the standard view’ claims that IRBs should not regard financial payment as a benefit to subjects for the purpose of risk/benefit assessment. Although the standard view is universally accepted, there is little defense of that view in the canonical documents of research ethics or the scholarly literature. This paper claims that insofar as IRBs should be concerned with the interests and autonomy of research subjects, they should reject the standard view and adopt ‘the incorporation view.’ The incorporation view is more consistent with the underlying soft‐paternalist justification for risk‐benefit assessment and demonstrates respect for the autonomy of prospective subjects. Adoption of the standard view precludes protocols that advance the interests of subjects, investigators, and society. After considering several objections to the argument, I consider several arguments for the standard view that do not appeal to the interests and autonomy of research subjects.     

Research participation and the right to withdraw

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

The potential influence of Internet-based social networking on the conduct of clinical research studies

The rapid growth of internet usage has led to an explosion of social networking sites for discussion of health issues. This provides a forum for subjects to communicate with one another during the course of the studies. Previous studies have raised concerns about the quality of health information on social networking sites, although none have evaluated content related to ongoing clinical trials. We reviewed material posted in virtual communities by self-identified clinical trial participants. We identified material posted in online health forums that could introduce bias into clinical research studies; we believe that this issue warrants further study and discussion. Physicians and others who conduct clinical trials should be aware of this issue. Study investigators and research teams should also talk to their study subjects about where and how they are obtaining information in order to prevent behaviors and correct misinformation that could put a subject's safety or the study objectives at risk. Given the rapid increase in Internet use for health care, a broader evaluation of both the benefits and potential risks of social networking among research participants during the course of a clinical trial appears warranted.     

POST‐TRIAL ACCESS TO ANTIRETROVIRALS: WHO OWES WHAT TO WHOM?

Many recent articles argue that participants who seroconvert during HIV prevention trials deserve treatment when they develop AIDS, and there is a general consensus that the participants in HIV/AIDS treatment trials should have continuing post‐trial access. As a result, the primary concern of many ethicists and activists has shifted from justifying an obligation to treat trial participants, to working out mechanisms through which treatment could be provided. In this paper I argue that this shift frequently conceals an important assumption: that if there is an obligation to supply treatment, then any party who could provide it may be prevailed upon to discharge the obligation. This assumption is false. The reasons why trial participants should get ART affect who has the duty to provide it. We should not burden governments with the obligations of sponsors, nor researchers with the obligations of the international community. And we should not deprive a group of treatment because their need is less salient than that of research participants. Insisting otherwise may lead to people being wrongfully deprived of access to antiretrovirals.     

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

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

What do I want from health research and researchers when I am a patient?

I have attempted to adopt the perspective of a patient--albeit one with a rather atypical background--to explore what I want from health research and researchers. This has left me with the impression that health researchers could serve the interests of the public more effectively in a variety of ways, and that they would be helped to do so by greater lay involvement in planning and promoting health research.     

Impact of Open Data Policies on Consent to Participate in Human Subjects Research: Discrepancies between Participant Action and Reported Concerns

Research outlets are increasingly adopting open data policies as a requisite for publication, including studies with human subjects data. We investigated whether open data policies influence participants’ rate of consent by randomly assigning participants to view consent forms with and without discussion of open data policies. No participants declined to participate, regardless of condition, nor did rates of drop-out vs. completion vary between conditions. Furthermore, no significant change in potential consent rates was reported when participants were openly asked about the influence of open data policies on their likelihood of consent. However, follow-up analyses indicated possible poor attention to consent forms, consistent with previous research. Moreover, thematic analysis of participants’ considerations of open data policy indicated multiple considerations such as concerns regarding confidentiality, anonymity, data security, and study sensitivity. The impact of open data policies on participation raises complex issues at the intersection of ethics and scientific innovation. We conclude by encouraging researchers to consider participants as stakeholders in open data policy and by providing recommendations for open data policies in human subjects research.     

EXPLOITATION IN PAYMENTS TO RESEARCH SUBJECTS

Offering cash payments to research subjects is a common recruiting method but there is significant debate about whether and in what amount such payments are appropriate. This paper is concerned with exploitation and whether there should be a lower limit on the amount researchers can pay their subjects. When subjects participate in research as a way to make money, fairness requires that researchers pay them a fair wage. This call for the establishment of a lower limit meets resistance in two places: (1) denial that the payments offered by researchers are wages for participation; and (2) concern about undue inducement. This paper critically examines these arguments for and against a lower limit. It shows that the need for a lower limit cannot be avoided by adopting a non‐wage payment model and that concerns about undue inducement are unjustified in all trials except those that present greater than minimal risk. This analysis suggests the following compromise position: there should be an unconditional lower limit on payment amounts so that researchers cannot offer less than a fair wage, and when researchers cannot satisfy this limit because fairness requires a problematically large payment, then researchers should offer no payment at all.     

What can conservation strategies learn from the ecosystem services approach? Insights from ecosystem assessments in two Spanish protected areas

Biodiversity conservation strategies that overlook the interests of local people are prone to create conflicts. The ecosystem service approach holds potential for more comprehensively integrating the social dimension into decision-making in protected areas, but its implementation in conservation policies is still in its infancy. This research assesses the extent to which ecosystem services have been implemented in conservation strategies in protected areas. The study was conducted in two outstanding Spanish protected areas, covering a wetland (Doñana Natural and National Parks) and a Mediterranean mountain system (Sierra Nevada Natural and National Parks). Data were collected from deliberative workshops with managers and researchers, face-to-face surveys with users and a review of management plans. We found that, beyond intrinsic values of ecosystems and biodiversity, these areas provide multiple ecosystem services that deserve further attention to ensure their sustained delivery. Our research shows that environmental managers and researchers have different perceptions and priorities regarding ecosystem services management compared with ecosystem service users. Environmental managers and researchers in both protected areas perceived that human-nature relationships and ecosystem services are already widely included in management plans, if often not explicitly. We found that different ecosystem service categories receive uneven attention in management plans. These contained measures to manage provisioning and cultural services whereas measures for managing regulating services were perceived to be largely absent. We conclude by summarizing insights on how the ecosystem service approach may enhance the consideration of social interests in the management of management protected areas.