Post-trial Access Research Articles

Pharmaceutical Companies vs. The State: Who Is Responsible for Post-Trial Provision of Drugs in Brazil?

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system.

Pharmaceutical Companies vs. the State: Who is Responsible for Post-Trial Provision of Drugs in Brazil?

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system.

Reasons Why Post-Trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review.

Background: researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial drug and the uses of such reasons. Data sources: databases in science/medicine, law and ethics, thesis databases, bibliographies, research ethics books and included publications’ notes/bibliographies. Publication selection: a publication was included if it included a reason as above. See article for detailed inclusion conditions. Data extraction and analysis: two reviewers extracted and analyzed data on publications and reasons. Results: of 2060 publications identified, 75 were included. These mentioned reasons based on morality, legality, interests/incentives, or practicality, comprising 36 broad (235 narrow) types of reason. None of the included publications, which included informal reviews and reports by official bodies, mentioned more than 22 broad (59 narrow) types. For many reasons, publications differed about the reason’s interpretation, implications and/or persuasiveness. Publications differed also regarding costs, feasibility and legality of PTA. Limitations: reason types could be applied differently. The quality of reasons was not measured. Conclusion: this review captured a greater variety of reasons and of their uses than any included publication. Decisions based on informal reviews or sub-sets of literature are likely to be biased. Research is needed on PTA ethics, costs, feasibility and legality and on assessing the quality of reason-based literature.

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.

Ethics in clinical research: the Indian perspective.

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

GOING FROM PRINCIPLES TO RULES IN RESEARCH ETHICS

In research ethics there is a canon regarding what ethical rules ought to be followed by investigators vis-à-vis their treatment of subjects and a canon regarding what fundamental ethical principles apply to the endeavor. What I aim to demonstrate here is that several of the rules find no support in the principles. This leaves anyone who would insist that we not abandon those rules in the difficult position of needing to establish that we are nevertheless justified in believing in the validity of the rules. I conclude by arguing that this is not likely to be accomplished. The rules I call into question are the rules requiring: - that studies be designed in a scientifically valid way - that risks to subjects be minimized - that subjects be afforded post-trial access to experimental interventions - that inducements paid to subjects not be counted as a benefit to them - that inducements paid to subjects not be 'undue' - that subjects must remain free to withdraw from the study at any time for any reason without penalty. Both canons, the canon on principles and the canon on rules, are found in the overlap among ethical pronouncements that are themselves canonical: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, CIOMS's International Ethical Guidelines for Biomedical Research Involving Human Subjects, and NBAC's 2001 report, Ethical Issues in International Research: Clinical Trials in Developing Countries.

Conducting ethical clinical trials for L. donovani in the Bihar region of India

Visceral leishmaniasis is a severe disease that disproportionally afflicts the Bihar state in India with 40% of the worldwide disease burden. Drug resistance, poor adherence, extreme poverty, malnutrition and certain living conditions have made control and treatment of the disease difficult. There is a great need for new drugs and control programs to reduce the disease burden of this debilitating and potentially fatal disease. Drug discovery research on leishmaniasis is being conducted in the USA and this raises issues concerning the ethical conduct of international clinical trials. Ethical principles dictate that the Bihari who need these drugs should be included in clinical trials. Additional safeguards for the ethical conduct of clinical trials on developing countries by developed countries have been formulated elsewhere. These include collaborative partnership, social value, scientific validity, fair selection of study population, favorable risk-benefit ratio, independent review, informed consent, and respect for recruited participants and study communities. These principles are applied to the Bihari context, and issues of ancillary care and post-trial access are also addressed. The socio-cultural context of the region is discussed in order to give researchers the tools to obtain meaningful informed consent. A description of the Bihari context and relevant ethical considerations should facilitate the design and conduct of ethical clinical trials for L. donovani.

SHAH AND GRADY RESPOND

Onyeabor's letter highlighted some of the ethical complexities inherent in posttrial access. Although we agree that ethically, individuals benefiting from antiretroviral therapy should continue to receive it, the challenge for all of us involved in the ethical conduct of research is to be clear about how this should occur. Many study participants in developing countries, including those in the studies cited, understandably feel that antiretroviral treatment should be continued for life.1 Yet, in other studies, participants appeared to expect national programs to provide treatment, not necessarily the researchers themselves.2 Similar to other influential ethical guidance documents,3–6 the National Institutes of Health guidelines that apply to the studies in our sample recognize that researchers have an obligation to address the provision of posttrial antiretroviral therapy, but not an obligation to directly provide it.7 Onyeabor seems to suggest that researchers have greater obligations—namely, that researchers should provide posttrial access for participants themselves in recognition of the contributions that participants make to advancing science. Though we agree with Onyeabor that research participants certainly deserve recognition for their contributions, the nature and extent of this recognition might justifiably vary according to the contribution made, and we would argue that participants are owed a fair share of the benefits.8 However, we do not agree that researchers necessarily bear long-term obligations to provide care after their research is over. In conducting research, researchers have many important obligations, including those to maintain scientific integrity and protect research participants. Although the relationship between a researcher and a research participant cannot last forever, researchers' obligations to participants do not end when the last pieces of data are collected. Just as hospital physicians should engage in careful discharge planning when patients are being released from their care, we would argue that researchers have obligations to end their relationships with research participants responsibly. This obligation to help participants transition to local sources of care might increase or decrease in intensity depending on several factors, including the extent of participants' need for assistance and dependence on the researchers, whether local sources of care exist, and how long the research relationship has lasted. More work needs to be done in this area, but we hope the findings from our study help advance a more careful understanding of what it means to conduct and conclude responsible research.

ETHICAL IMPERATIVE OF POSTTRIAL ACCESS TO ANTIRETROVIRAL TREATMENT

Shah et al.’s article was of great interest to me because of my experience of having lived and worked as a physician caring for patients with HIV/AIDS in a developing country. Shah et al. examined whether the National Institutes of Health's (NIH's) guidance was being implemented in NIH-funded antiretroviral treatment trials conducted in developing countries from July 2005 to June 2007. They reported that 70% of the 18 studies they reviewed “had specific mechanisms for posttrial medication access, but none guaranteed long term sponsor funding after the trials.”1(p1556) The NIH requires that researchers make adequate plans for participants of antiretroviral research trials in developing countries to be given the option of continuing medication following the study's completion.2 I appreciate the authors’ work in estimating the degree of compliance with NIH guidance based on their review of study protocols, but the research would have been even more informative and adaptive had they also surveyed the experiences of local participants of these research trials. I salute the addition of posttrial guidance into the NIH ethical guidance document for antiretroviral research trials. These requirements should help ensure that researchers adequately address their ethical obligation to providing clinical trial participants with antiretroviral drugs after the completion of research studies. While there have been improvements in the way research is conducted, particularly in poor, uneducated communities in developing countries, much remains to be done in terms of properly acquiring informed consent from participants, addressing cultural understanding on the part of the research team, and the continuing provision of care for study participants. Most of the participants in HIV/AIDS research in developing countries expect compensation through provision of either antiretroviral drugs or funds to purchase the drugs3; unfortunately, these expectations are not always met. As one participant put it, “I have been used like a guinea pig, so how does he just leave me without compensation?”4(p904) Most participants interviewed by MacQueen et al.5 viewed the provision of antiretroviral treatment by researchers to HIV-infected research participants as unfair if treatment is not sustained beyond the end of trial. The issue of trust and fairness must be taken seriously for meaningful research to continue in these communities. This includes the ethical imperative that antiretroviral treatment be continued for the vulnerable populations who volunteer to help advance science with the hope of also prolonging or saving their own lives. One of hundreds of new residential buildings being constructed in Dhaka, Bangladesh, whose explosive population growth has left this capital city with a scarcity of housing for the millions of working class and poor. Photograph by Spencer Platt. Printed with permission of Getty Images.

Social and Behavioral Challenges of HIV Vaccines: Implications for Social Work and Social Science

A safe and efficacious HIV vaccine would be a tremendous asset to halting the spread of HIV. Nevertheless, HIV vaccines face a range of social and behavioral challenges that will determine their ultimate contribution to prevention. HIV vaccine development and clinical trials raise thorny social, behavioral, and ethical issues around resource allocation, recruitment and enrollment, trial implementation, and post-trial follow-up and access to services. Furthermore, the success of future HIV vaccines is contingent on access and acceptability. Involvement of social work and social service providers and engagement of social science research across the continuum of HIV vaccine development and dissemination are central to successful community engagement and advocacy, mitigation of social harms of clinical trials, support for fair and ethical conduct of trials, acceptability and access to future vaccines, and integration of HIV vaccines with behavioral HIV prevention.

Ulf Schmidt, Andreas Frewer (eds), History and theory of human experimentation: the Declaration of Helsinki and modern medical ethics, History and Philosophy of Medicine, vol. 2, Stuttgart, Franz Steiner, 2007, pp. 370, €54.00 (hardback, 978-3-515-08862-6).

Although the Declaration of Helsinki (1964) of the World Medical Association (WMA) is internationally recognized as a code of ethics for medical research on human subjects, its origins and the circumstances of its various revisions (Tokyo 1975, Venice 1983, Hong Kong 1989, Somerset West 1996, Edinburgh 2000, Seoul 2008) have received relatively little historical attention. The present volume therefore constitutes a welcome addition to the literature on this important “living document”. Several contributions to this volume provide historical background, especially Ulf Schmidt’s essay on the Nuremberg Doctors’ Trial and the Nuremberg Code as the most influential precursor document for the principles contained in the Helsinki Declaration, or discuss from various perspectives the issues that have shaped the different versions of the WMA document. Compared with the stringency of the rules for voluntary informed consent and the strength of the protection for human subjects in the Nuremberg Code (1947), the Declaration of Helsinki reflected the start of a “watering down process”, as the editors observe (p. 15), which has made allowances for the practical needs of medical researchers and which has continued to the present day. As Susan Lederer’s discussion of the origins of the 1964 version makes clear, American pharmaceutical interests and financial power prevailed over attempts within the WMA to ban experimentation on children in institutions and on so-called captive subjects (inmates of mental asylums, prisons and reformatories). These groups of human subjects were too important for the testing of new vaccines and for drug development. While the insertion of the requirement for independent review of research projects through ethics committees in the Tokyo version of 1975 (discussed by one of its authors, Povl Riis) could be seen as a step that increased safeguards for subjects, the controversies surrounding the Declaration’s revision in 2000 illustrated again the conflicts between research interests and wishes to strengthen protections for vulnerable subjects. The debates about the key issues then, the use of placebo controls even when a standard therapy exists for comparison, and the guaranteeing of post-trial access of the participants to the best treatment identified by the study, are analysed from different viewpoints. Kati Myllymaki, as a member of the WMA’s committee of “three wise women” in charge of this revision, provides an insider’s recollections; Robert Carlson, Kenneth Boyd and David Webb examine the complex process of re-drafting the Declaration in 2000 through the relevant archive materials of the WMA; and David Willcox reviews the comments in the medical and general press that accompanied this revision process. Although I found these essays the most interesting in this collection, I missed a more thorough ethical and historical discussion of the relevant trials in developing countries that formed the background to these debates and of the attempts, since then, to provide guidelines for human subject research in those countries, such as the report of the relevant Working Party of the Nuffield Council on Bioethics in 2002. One might also wish for a clearer assessment of the intentions and effects of the WMA’s Notes of Clarification on the Declaration’s controversial paragraphs 29 (placebos) and 30 (post-trial access), that were issued in 2002 and 2004, respectively. On the other hand, readers interested in the legal and ethical significance of the Helsinki Declaration are well served by Dominique Sprumont, Sara Girardin and Trudo Lemmens’ discussion of how its principles have influenced United States, Canadian, European Union, Swiss, German, French, and UK legislation (tellingly, most legal references are made to the 1996 rather than the controversial 2000 version of the Declaration), and by Ulrich Trohler’s documentation of the plethora of bioethics codes, including codes on human experimentation, that have been issued since the 1980s. Moreover, contributions by Ulf Schmidt (on the nerve gas experiments at Porton Down in the 1950s) and by Andreas Frewer (referring to his research on forced labourers at the Gottingen university clinics during National Socialism) remind us of the important practical dimensions, in the form of facilitating compensation claims of victims, that historical research in this area may have. An appendix including an English translation of the German Reich Guidelines for New Therapy and Human Experimentation of 1931 and reprints of the Nuremberg Code (1947), of the 1964, 1975 and 2000/2004 versions of the Helsinki Declaration and of the 1997 Council of Europe Convention on Human Rights and Biomedicine further enhances the usefulness of this volume.

Planning for posttrial access to antiretroviral treatment for research participants in developing countries.

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.

Subjects’ views of obligations to ensure post-trial access to drugs, care and information: qualitative results from the Experiences of Participants in Clinical Trials (EPIC) study

Objectives:To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and...

Ethical Responsibility of Phase 0 Trials

To the Editor: We read with great interest the article by Abdoler et al. (1) on the ethics-based interpretation of phase 0 trials in cancer patients. In our opinion, drugs that consistently show favorable toxicity profile and beneficial therapeutic activity in preclinical models should be tested in anima nobile. This is particularly important for molecular targeted therapies, in which impressive responses are sometimes seen in particular subpopulations.As pointed out by the authors, the reconceptualization of the investigator-subject relationship and a deep evaluation of the subjects' understanding of phase 0 trials are essential for subject enrollment. Paying modest quantities was also recommended. This must be seriously considered especially in the developing countries where most participants are in a vulnerable condition due to lower per capita incomes (2, 3).Whereas recruitment of terminally ill cancer patients in phase 0 trials is controversial, the issues of indirect and/or direct benefits such as access to therapy once successful are also equally disputed. Paragraph 30 of Declaration of Helsinki and its clarification note emphasize the needed assurance of post-trial access by study participants to the best therapeutic method identified as beneficial during the drug development. This is particularly important for subjects enrolled in phase III trials. However, because cancer patients that are eligible to phase 0 trials are end-staged, their chances of direct clinical benefits from proven therapy are highly limited. In this context, the nontherapeutic nature of such trials will always raise ethical and/or moral-based discussions (4). Therefore, access to identified beneficial therapy should be expanded to subjects enrolled in earlier trials on which phase III were based.Paragraph 19 of the Declaration of Helsinki states that medical research is ethically justified only if there is a reasonable chance that the population on which it is conducted will benefit from the results. It is expected that subsequent trials using information derived from phase 0 would lead to fewer toxicities and higher probability of clinical benefits. Therefore, the community or population from which the subjects are derived may benefit from data originated in phase 0 trials, if the emphasis of subsequent trials is placed to the same tested population. Importantly, by extending the access of subsequent trials where phase 0 was conducted, the population, and not only the tested individuals per se, may benefit from the proven therapy.No potential conflicts of interest were disclosed.

Clinical development of new prophylactic antimalarial drugs after the 5th Amendment to the Declaration of Helsinki

Malaria is of continuing concern in nonimmune traveling populations. Traditionally, antimalarial drugs have been developed as agents for dual indications (treatment and prophylaxis). However, since 2000, when the 5th Amendment to the Declaration of Helsinki (DH2000) was adopted, development of new malaria prophylaxis drugs in this manner has ceased. As a consequence, there may not be any new drugs licensed for this indication in the foreseeable future. Major pharmaceutical companies have interpreted DH2000 to mean that the traditional development paradigm may be considered unethical because of doubt over the likelihood of benefit to endemic populations participating in clinical studies, the use of placebo, and the sustainability of post-trial access to study medications. In this article, we explore the basis of these concerns and suggest that the traditional development paradigm remains ethical under certain circumstances. We also consider alternative approaches that may be more attractive to sponsors as they either do not use placebo, or utilize populations in endemic countries who may unambiguously benefit. These approaches represent the way forward in the future, but are at present unproven in clinical practice, and face numerous regulatory, logistical and technical challenges. Consequently, in the short term, we argue that the traditional clinical development paradigm remains the most feasible approach and is ethical and consistent with the spirit of DH2000 under the appropriate circumstances.

Clinical research in India

India is considered as a preferred site for conducting global clinical trials. Existence of a large treatment-naïve population, availability of English-speaking, skilled doctors, plenty of clinical material, and cost-savings are obvious advantages for carrying out clinical research in India. However, challenges exist at various levels. Lack of formal training in bioethics and research methodology, heavy burden of clinical duties and sub-optimal administrative support restrict investigators. Absence of oversight of functioning of ethics committees (ECs) and lack of mechanisms for ensuring quality of ethics review heighten societal concerns about safety of participants. Conducting research on issues not relevant to local needs and failure to ensure post-trial access further enhance society's cynicism. These issues need to be tackled through capacity building, training of investigators and EC members, strengthening of EC functioning and encouraging greater community participation.

Abstract 3622: End of Trial Period for Randomized Controlled Cardiology Trials: Is patient safety monitored and protected?

Background: The post trial period is the period after the end of study drug administration. The Declaration of Helsinki (DOH) states that “at the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.” It further adds that “post trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review.” Therefore our objectives were: to determine whether research trial protocols systematically consider post trial period issues including planned follow-up and patient surveillance in the post trial period; and to assess if consent forms addressed end of trial issues. Methods: We searched the research ethics board (REB) databases at 2 academic institutions in Toronto from 1995 to 2006 to identify approved randomized clinical trials of chronic medical therapies for cardiac conditions. Results: Fourty-two studies were identified including 18 heart failure and 15 coronary artery disease trials. Thirty-eight of these trials were industry funded. Almost all trials (n=37) ended study drug abruptly at the last clinic visit, while only 4 studies offered a clinical visit post trial termination, and an additional 3 reported a telephone contact after trial completion. Only 5 trials submitted consent forms to the REB with a discussion of the post trial period. After REB review, no additional consent forms addressed the post trial period. When comparing the time period before and after the updated version of the DOH in 2000, there was a trend towards a decline in addressing post trial care (p=0.08). Conclusion: The majority of cardiac trials end study drug abruptly with unknown and potentially negative consequences, and most patients have no systematic post trial follow up from trial investigators. Study patients are also not made aware of the post trial period, as the majority of study consent forms do not discuss post trial care. Therefore, an important aspect of clinical trial design, the post trial period, could be improved by systematic follow-up described in the protocol, and full discussion of this aspect of trial participation in the consent form.

Reciprocity and post-trial access for participants in antiretroviral therapy trials

Rationing antiretroviral therapy (ART) when need exceeds available supply raises many important and challenging questions [1–8]. Here, we focus on a particular ethical question that faces research sponsors, investigators, and policy-makers in various settings. Should research participants in ART trials have preference for further treatment over compatriots who have not participated, but who have a similar need and clinical eligibility for ART?

Multinational clinical trials in oncology and post-trial benefits for host countries: where do we stand?

International collaboration has undoubtedly played a key role in the extraordinary progress we have witnessed in some areas of oncology in recent years. It has allowed us, for instance, to design trials large enough to depict very small benefits, as well as high-quality trials in less incident types of cancer. For different reasons, developing countries have also shown growing interest in this international effort and have been participating in many international trials. However, the ever-growing costs of novel anti-cancer treatments and technologies have created unprecedented difficulties for health economies in developing countries. Although the issue of individual benefit for patients must also be taken into account, the actual benefit for their society may be minimal. This paper discusses the ethics of including patients from non-developed countries in clinical trials evaluating the role of treatments that are unlikely to be made available to them after the trial because of prohibitive costs. Upfront arrangements ensuring post-trial access to interventions that have been proven successful might be the best alternative to exclusion from the research.

Post-trial Access to Tested Interventions: The Views of IRB/REC Chair, Investigators, and Research Participants in a Multinational HIV/AIDS Study

Controversy exists regarding an ethical requirement to make products proven effective in research available after the trial. Little is known about the views of several stakeholders. Phone or self-administered questionnaires were completed by 65 IRB/REC chairs, 117 investigators, and 500 research participants in a multinational HIV trial to assess their views about posttrial access to interventions proven effective in the study. A total of 83% of research participants, 29% of IRB/REC chairs, and 42% of researchers (p = 0.046) thought IL-2 should be guaranteed for every HIV-infected person in the world if proven effective. Most European and Latin American research participants thought IL-2 should be provided free, while North American, Australian, and Thai participants commonly said at a price the average person could afford (p < 0.001). Most IRB/REC chairs and researchers thought the CIOMS "reasonable availability" requirement applied to people in the country where the study was conducted and meant a drug should be available at a price the average person could afford and that host country governments had primary responsibility for making it available. Most research participants believe an HIV drug proven effective in research should be made available to everyone in the world who needs it. IRB/REC chairs and researchers were less expansive both in who and how they thought a drug should be guaranteed.