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I. INTRODUCTION II. SCOPE OF THE PROBLEM A. Why Is Taking Human Subject Research and Clinical Drug Trials Overseas a Problem? B. Why Are Companies Taking Human Subject Research Overseas? [...]

I assume all the risks of this experiment and declare that I absolve the University of Chicago and all the technicians and researchers who take part in the experiment, as [...]

Genesis In the beginning, there was the Nuremberg Code. But in 1964, the recently established World Medical Association saw that Code, that it was not good. So World Medical Association [...]

"... no aspect of research, from formulation of initial hypothesis down to final clinical acceptance, is devoid of ethical significance." (1) In Canada, as well as elsewhere, governments, sponsors, institutions, [...]

The only way to justify clinical research is when the participants are protected from excessive risks; however, the main problem lies in the absence of any proper system to assess the risks. The benefits and advantages offered by the systematic evaluation of research risks (SERR) for evaluating the risks of research interventions are highlighted.

Despite recognition of the importance of posttrial access to antiretroviral therapy (ART), the implementation process has not been studied. We examined whether the National Institutes of Health (NIH) guidance document was being implemented in NIH-funded ART trials conducted in developing countries between July 2005 and June 2007. All of the 18 studies we identified had posttrial access plans for trial participants. More than 70% had specific mechanisms for posttrial access, but none guaranteed long-term sponsor funding after the trials. The plans reflected variation in local contexts and the uncertainty of predicting local conditions in the long term. The strength of the NIH guidance document may be that it encourages investigators to formulate plans in advance and to work with other stakeholders to provide access to ART. (doi:10.2105/AJPH.2008.157982)

Respondent-driven sampling is especially useful for reaching hidden populations and is increasingly used internationally in public health research, particularly on HIV. Respondent-driven sampling involves peer recruitment and has a dual-incentive structure: both recruiters and their peer recruits are paid. Recent literature focusing on the ethical dimensions of this method in the US context has identified integral safeguards that protect against ethical violations. We analyzed a study of 3 groups in Lebanon who are at risk for HIV (injection drug users, men who have sex with men, female sex workers) and the ethical issues that arose. More explicit attention should be given to ethical issues involved in research implementing respondent-driven sampling of at-risk populations in developing countries, where ethical review mechanisms may be weak. (doi: 10.2105/AJPH.2008.144832)

Composed of scientific and technical experts and lay members, thousands of research ethics committees--Institutional Review Boards (IRBs) in the United States--must identify and assess the potential risks to human research subjects, and balance those risks against the potential benefits of the research. IRBs handle risk and its uncertainty by adopting a version of the precautionary principle. To assess scientific merit, IRBs use a tacit 'sanguinity principle,' which treats uncertainty as inevitable, even desirable, in scientific progress. In balancing human subjects risks and scientific benefits, IRBs use uncertainty as a boundary-ordering device that allows the mediation of the science and ethics aspects of their decisions. One effect is the entangling of methodological and ethical review. Some have suggested these should be more clearly separated, but decisions by research ethics committees depend in part on the negotiating space created by incommensurable approaches to uncertainty. Keywords: uncertainty; risks; human subjects research, ethics; benefits of science

In 'Replicating Milgram: Would People Still Obey Today?' Jerry M. Burger (2009) reported a high base rate of obedience, comparable to that observed by Stanley Milgram (1974). Another condition, involving a defiant confederate, failed to significantly reduce obedience. This commentary discusses the primary contributions of Burger' s study in terms of (a) its novel methodological variation on Milgram's original paradigm (the '150-volt solution') and (b) its attention to ethical concerns so as to minimize participant discomfort and ensure institutional review board approval. Burger's technique could unlock research on behavioral aspects of obedience, which has been essentially muted for several decades. However, Burger's intensive efforts to improve the ethics of the study may be exaggerated, are uncertain in their effectiveness, and pose impractical demands. Different procedures used by Milgram and Burger in the modeled refusal condition preclude a clear explanation for the results and challenge Burger's emphasis on the comparability of his and Milgram's experiments. This study documents the complexities of extending research on destructive obedience in the context of contemporary ethical guidelines. Keywords: Milgram obedience experiments, ethical issues in research with human participants, methodological aspects of obedience research, institutional review boards and the Milgram experiment

This article discusses the issue of assent of school-age bilingual children to participate in a research study. The article reviews cognitive, cultural, and linguistic factors influencing verbal and nonverbal concept formation in bilingual children. At the applied level, the focus of the article is on methodological considerations in using this information to obtain assent from a child who is bilingual and speaks English as a second language. Recommendations for the assessment of the child's language dominance, language proficiency, and the development of the assent form are provided. Language diversity and its potential effects on the assent process need to be formally acknowledged and appropriately addressed. Keywords: bilingual; assent; school-age children

Recruiting participants for research studies is often a challenging task. Recruitment requires careful planning, collaboration, and flexibility on the part of researchers and health care providers at the recruitment sites. This article describes six major barriers to recruiting study participants as identified from a review of the literature and from the coauthors' research experiences. These barriers include challenges related to regulations of the Health Insurance Portabililty and Accountability Act (HIPAA), health care providers' work burden, providers' financial disincentives, competition, health care provider concerns regarding research, and provider protection of patients. Each barrier is described, and specific strategies are suggested based on the empirical literature. In some instances, the coauthors' experiences are also shared. Keywords: clinical research; HIPAA; recruitment barriers; participant recruitment

Institutional Review Boards (IRB) infringe on academic freedom by regulating who is required to consent to research, by stipulating the type of questions allowed and location of research interactions, and by limiting research design. This trend places academic freedom and human subject protection principles under increasing conflict with one another.

This article argues that lingering uncertainty about the normative foundations of research ethics is perpetuated by two unfounded dogmas of research ethics. The first dogma is that clinical research, as a social activity, is an inherently utilitarian endeavor. The second dogma is that an acceptable framework for research ethics must impose constraints on this endeavor whose moral force is grounded in role-related obligations of either physicians or researchers. This article argues that these dogmas are common to traditional articulations of the equipoise requirement and to recently articulated alternatives, such as the non-exploitation approach. Moreover, important shortcomings of these approaches can be traced to their acceptance of these dogmas. After highlighting these shortcomings, this article illustrates the benefits of rejecting these dogmas by sketching the broad outlines of an alternative called the 'integrative approach' to clinical research. Keywords: common good, common rule, equipoise, nonexploitation, reasonable risk, therapeutic obligation.

Results of a study conducted to establish whether patients were affected by a conflict of interests including financial indicated that for most it did not matter. It is very important to preserve faith and trust in research.

A study was conducted to establish whether patients undergoing cancer research trials are disturbed by financial conflicts of interest between researchers and medical companies conducting the tests. Results indicated that most patients were not concerned about conflicts of interest while a substantial minority wanted to be informed of the same before the trial.

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.

Objective: This paper aims to examine whether university human research ethics committees (HRECs) proactively seek to protect members of the research team as well as study subjects in their written documentation. Methods: A content analysis of 37 Australian university HREC application forms and attachments was undertaken. Each form was allocated to one of four predetermined categories. Results: Of the 37 forms, only three included an explicit request for the applicant to reflect on all possible aspects of safety of the researchers (physical, psychological and emotional). Conclusion: Few HRECs have taken issues of possible harm to researchers into account in their documentation. It is recommended that HRECs explicitly recognise potential risks to researchers, especially those engaged in exploration of sensitive topics, in their processes of approving human research. It is also recommended that researchers consider the possible implications of undertaking this type of research and ensure strategies are in place to minimise these risks.

This paper aims to show that to reduce the level of exploitation present in (some) international clinical trials, research sponsors must aim to provide both an ex-ante expected gain in utility and a fair ex-post distribution of benefits for research subjects. I suggest the following principles of fair risk distribution in international research as the basis of a normative definition of fairness: (a) Persons should not be forced (by circumstance) to gamble in order to achieve or protect basic goods; (b) In cases where one party is gambling with basic goods and the other party is not, the distribution of benefits and burdens must be arranged so that they are of greatest benefit to the worst off; (c) In relationships where one party is gambling for basic goods and the other party is not, the party gambling for basic goods must be assured of some guaranteed benefits in addition to the chance of gaining some potential benefits. These principles are applied to the case of HIV international research. I conclude that the research (as described) is mutually advantageous but still exploitative because the distribution of surplus benefits is unfair. It is unfair because research subjects are gambling with and for basic goods but they are not assured of a fair ex-post distribution of benefits. Principles (b) and (c) are not satisfied. Research participants are not accorded enough guaranteed benefits to outweigh the risks they undertake.

Consensus and controversy in clinical research ethics are discussed focusing on substantive, rather than procedural concerns. The state of research ethics reflects consensus on many issues but substantive controversies remains about the foundations of the consensus system and the need to supplement it with community involvement, rules for special populations and rules for special types of research, which involves both conceptual and empirical components.

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.

Human research conducted at institutions receiving funding from any of the three federal Canadian funding agencies must be reviewed and approved in advance by a human research ethics board (REB). [...]

I. Introduction The purpose of Canada's Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans (1) is to promote only research that is conducted according to the highest [...]

Objectives: the purpose of this study is to explore laypersons' attitudes towards and experiences of medical research, and to compare them with those of physicians in Japan. Designs and Participants: fourteen Japanese adults from the general public and seven physicians participated in one of three focus interviews. Setting: Osaka, Japan. Results: trust and distrust in the physician by whom the participants were invited to participate in research played a considerable role in their decisions about participation. That the participants felt an obligation to participate was also expressed. The lay participants perceived medical research as something entirely outside of their world. A greater willingness to volunteer for research was expressed if there were direct benefits to themselves or their families. Research methods such as use of placebos, double blinds, and randomisations seemed to cause negative attitudes to medical research. All physicians were convinced of the need for medical research, including double-blinded randomised control trials, and its significant role in medical progress. Most physicians thought that the greater awareness of the need for medical research in the community and a better understanding of the psychology of potential research participants were necessary and urgent. Conclusions: there is a good possibility that the lay public and medical professionals have sharply different beliefs about and attitudes towards every aspect of medical research. Building up a better and equal patient-doctor relationship based on trust is a key issue in medical research, and it is mandatory to fill the gap in perception regarding medical research between them through fully informed debates.

Radical proposal to conduct 'human challenge' studies could dramatically speed up vaccine research. Should scientists infect healthy young people with coronavirus? Radical proposal to conduct 'human challenge' studies could dramatically speed up vaccine research., Author(s): Ewen Callaway Author Affiliations: Should scientists infect healthy people with the coronavirus to test vaccines? The SARS-CoV-2 virus imaged by an electron microscope. [see PDF for image] Credit: NATIONAL [...]

What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. The type of multinational research likely to raise the most ethical concerns is that in which the investigators or sponsors are from a powerful industrialised country or a giant pharmaceutical company and the research is conducted in a developing country. Second is the situation of women, who are made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. In the face of cultural values and practices, or governmental policies, these women suffer serious consequences for their health and even lives. Examples are provided, and it is suggested that in some cases vulnerable individuals can be harmed but not exploited. On the positive side, recent developments reveal a new awareness of exploitation and efforts to enhance the ability of developing countries to protect themselves and their citizens from exploitation at the hands of powerful sponsors of research. In addition, human rights principles are increasingly being used to monitor the actions (or inaction) of governments regarding women's reproductive rights and vulnerability with respect to HIV/AIDS, and to take remedial actions.

Human beings are essentially vulnerable in the view that their existence qua humans is not given but construed. This vulnerability receives basic protection from the State, expressed in the form of the universal rights all citizens are meant to enjoy. In addition, many individuals fall prey to destitution and deprivation, requiring social action aimed at recognising the specific harms they suffer and providing remedial assistance to palliate or remove their plights. Citizens receive protection against their biologic vulnerability by means of an in rem right to health [care], which is more an attitude of protection than a specific programme. When individuals become susceptible, that is, biologically weak or diseased, they also increase their predisposition to additional harm, and require social actions to treat their demeaned condition. Such assistance takes the form of positive healthcare rights. Research on human beings has been slow to observe that the subjects recruited are susceptible, especially so if research is done in less developed countries. By mislabelling them as vulnerable u a characteristic they share with all humans u sponsors avoid registering the deprivation these people suffer, and the ethical obligation to offer them remedial help. The distinction between vulnerability and susceptibility also marks the difference between being intact but fragile u vulnerable u and being injured and predisposed to compound additional harm u susceptible. Awareness of this difference should give additional force to the rejection of double standards in research ethics.

Editor's Note: In keeping with the theme of stroke research for this issue, we felt that it was an appropriate time to devote some attention to the changing world of [...]

Bioethicists are setting up consultancies for research -- but some scientists question whether they are needed., Author(s): Elie Dolgin [sup.1] Author Affiliations: (1) Elie Dolgin is a science writer in Somerville, Massachusetts., Nlshop/Shutterstock Stacy Hodgkinson and Amy Lewin had the best of intentions when they enrolled [...]

Recruiting patients into clinical research is essential for the advancement of medical knowledge. However, when the physician undertaking the care of the patient is also responsible for recruitment into clinical research, a situation arises of an inter-role breach of confidentiality which is distinguishable from other conflicts of interest. Such discord arises as the physician utilizes confidential information obtained within the therapeutic relationship beyond its primary objective, and safeguards ought to be observed in order to avert this important, and generally overlooked, problem. The moral worth of the pledge of confidentiality is based not on its innate value but on its being a promise on which subsequent interactions and disclosures are founded. Within the patient-doctor interaction, confidentiality is an important facet of the promised fidelity and, as such, a loose interpretation of the notion threatens the essence of the relationship, and any violation thereof requires compelling moral justification. To avoid conflict, patients' confidential information ought not be used for the purpose of recruitment, which needs to be undertaken through general education and non-directed appeals, and a preliminary consent to be approached for research should be obtained from the patient prior to her being identified as a suitable research subject. Securing this prior consent would avoid one source of potential, albeit unintended, coercion. Keywords: clinical research, confidentiality, consent

Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drag studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, dialogue, and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature. Keywords: homeless persons, informed consent, pharmaceutical research, vulnerable populations