As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair (...) inclusion and vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. (shrink)

Background. Responsible clinical research drives the advancement of healthcare. Despite tremendous improvements in the globalresearch and development environment since the 1950s, low- and middle-income countries (LMICs) are often left behind. There are several reasons for this. Firstly, operational, social, ethical and regulatory challenges in LMICs make it difficult for researchers to conduct clinical studies in those settings in line with international requirements. Secondly, many people living in low-resource settings distrust research because some past studies have not benefited the participants or (...) the communities involved.Objectives. To present the consensus recommendations by a Council for International Organizations of Medical Sciences (CIOMS) Working Group on how to advance good-quality, ethical clinical research in resource-limited settings.Methods. CIOMS convened a Working Group of senior scientists from drug regulatory authorities, the pharmaceutical industry, publicprivate partnerships for product development, and academia.Results. This article summarises the Working Group’s report.Conclusion. The report recommendations can foster the creation of a more enabling ecosystem for clinical research and promotecollaboration between policymakers, regulators, researchers and funders. (shrink)

Based on worldwide consultations with experts in science and ethics the revised CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects provide guidance on when the use of placebo as a comparator in clinical research is ethically acceptable. The article reviews the main points of the CIOMS Guidelines and commentaries including the use of placebo in situations where the best current method is available and the relation of placebo to established effective intervention. It discusses the use (...) of placebo in externally sponsored research in low-resource countries and requirements for informed consent related to placebo studies. (shrink)

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair (...) inclusion and vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. (shrink)

In November 2016, the Council for International Organizations of Medical Sciences published its revised International Ethical Guidelines for Health-related Research Involving Humans. In relation to earlier versions, the scope of the new guidelines has been expanded to include public-health research. While successful to some extent, the document does not take into sufficient account the differences between public-health research and other types of health research. It is silent on some issues of importance to public-health research, such as its definition, health inequities (...) and novel research methodologies. Its treatment of some other issues, including the need for researchethics committee approval, consent, community involvement and dissemination of research results, are deficient in some respects. The guidelines that are particularly applicable to and useful for public-health research deal with social value, the health needs of communities and populations, community engagement, disasters and disease outbreaks, cluster randomised trials and data sharing. Much further development of the foundations and applications of public-health research ethics is needed to inform future revisions of the guidelines and of other international and national research-ethics documents. (shrink)

The theme of the 10th Annual Research Ethics Conference organized by the Uganda National Council for Science and Technology (2018) was “Evolution of Research Ethics in Uganda and the Region: Past, Present and Future”. We were asked to address the topic: “The History of CIOMS and the recent changes in the international ethics guidelines: implications for local research”. The thrust of the conference was to track progress in ensuring ethical conduct of research, highlight challenges encountered, and to propose strategies (...) for effective and meaningful implementation of international ethical guidelines in local contexts. Consequently, the purpose of this paper is to comment on the implications of the history of CIOMS ethical guidelines and suggest strategies for their effective and meaningful implementation in the East African region, and perhaps the whole of Sub‐Saharan Africa. Inferring from the ‘evolutionary’, ‘flexible’, and ‘general’ nature of the CIOMS guidelines, we proposed a six‐point strategy for ensuring their effective and meaningful implementation in local contexts. This strategy is in the form of obligations for local research regulators and researchers, the fulfillment of which will go a long way towards their smooth and meaningful implementation in local contexts. These obligations are: ensuring evidence‐based adaptation of each individual guideline; ensuring sufficiently judicious and motivated RECs membership; acting proactively to ensure harmony between bioethics and local legal regimes; cultivating a ‘bioethics culture’ among the public; moving towards regional bioethics governance; and playing an active and meaningful role in future revisions of these guidelines. (shrink)

Records the main presentations of an international conference convened to identify the ethical concerns that need to be addressed as WHO renew its health for all policy for the 21st century. The meeting was attended by more than 150 experts in the fields of ethics, human rights, philosophy, medicine, and public health. Their contributions illustrate the many complex issues that need to be addressed when formulating global health policies for the future, particularly in view of striking recent changes in health (...) care, disease patterns, market forces, and political systems. The report opens with a description of the WHO policy framework for achieving four goals in the 21st century: attainment by all of health rights, achievement of global health equity, increase in healthy life expectancy, and access for all to essential quality health services. Against this background, the first section traces the evolution of bioethics to its present concern with the health of populations and identifies some of the most important inequalities that confront contemporary society. Papers in section two discuss key policy issues, including the definition of essential public health functions and their relationship to primary health care, ethical issues raised by the use of Disability-Adjusted Life Years (DALYs) to prioritize health resources, and the potential conflict between policies aimed at reaching vulnerable groups and those seeking to achieve aggregate health benefits. Ethical issues are discussed in subsequent sections, which explore policy implications at global, regional, and national levels. The remaining sections consider the actions needed to ensure that ethical analysis plays a role in the renewal of the health for all strategy and discuss some of the practical requirements for gaining commitment to equity as an essential public health goal for the 21st century. (shrink)

The 2016 CIOMS International ethical guidelines for health‐related research involving humans states that ‘health‐related research should form an integral part of disaster response’ and that, ‘widespread emergency use [of unproven interventions] with inadequate data collection about patient outcomes must therefore be avoided’ (Guideline 20). This position is defended against two lines of criticism that emerged during the 2014 Ebola outbreak. One holds that desperately ill patients have a moral right to try unvalidated medical interventions (UMIs) and that it is (...) therefore unethical to restrict access to UMIs to the clinical trial context. The second holds that clinical trials in contexts of high‐mortality diseases are morally suspect because equipoise does not exist between a standard of care that offers little prospect of clinical benefit and a UMI that might offer some clinical advantage. (shrink)

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population‐level research and big data because it results in a primary focus on consent (meta‐, broad, dynamic and/or specific consent). Two recent guidelines – the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health‐related research involving humans – both focus on the growing reliance on health (...) data for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision‐making capacity? I propose that a public health ethics framework – based on public benefit, proportionality, equity, trust and accountability – provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest. (shrink)

In democratic theory, “legitimacy” refers to the set of conditions that must be in place in order for the claims to authority of somebody to be deemed appropriate, and for their claims to compliance to be warranted. Though criteria of legitimacy have been elaborated in the context of democratic states, there is no reason for them not to be drawn up, with appropriate amendments, for other kinds of authority structures. This paper examines the claims to authority made over researchers by (...) international bodies governing research ethics, who exercise their authority by the research ethics guidelines they produce (including recent revisions to the Declaration of Helsinki and CIOMS Guidelines). We argue that discussions of such bodies and sets of guidelines often elide questions of justification and questions of legitimacy, and that the grounds that might allow us to mount a strong case for the latter are at present sorely underdeveloped. (shrink)

CIOMS has been criticised for not adequately consulting stakeholders about its revised ethical guidelines regarding medical research.

The World Medical Association has announced that a new revision process of the Declaration of Helsinki has been started. This article will identify the criticisms that have been made in the bioethics literature, particularly since the last revision. In addition, criticisms are discussed that were made in the literature even before the last revision and have not fallen silent. The plausibility of the recommendation for a change in the Declaration of Helsinki is examined.

This paper explores the legal and ethical concept of human subject research in order to determine whether genetic research with already available biosamples and data falls within this concept. Although the ethical concept seems to have evolved to recognize research based on data as human research, from a supranational legal perspective this form of research is not considered human subject research. Thus human subject research regulations do not apply and therefore do not invoke the requirement of obtaining consent prior to (...) using an individual’s biosample or genetic data in research. Furthermore, it remains ambiguous in both the legal and ethical realm whether the use of biosamples or genetic data without additional links to the individual would invoke the same safeguards as research involving additional or specific identifiers. Seeing that research based on already available biosamples and genetic data is not governed by rules concerning human subject research, the second part of the paper analyses whether any consent requirements apply for the further use of already available bio‐samples or genetic data in research. Whereas further use of biosamples is subject to considerably lax consent requirements under Article 22 of the Oviedo Convention, under the General Data Protection Regulation further use of genetic data might not be subject to a prior consent requirement at all, unless it is stipulated in national laws. When it comes to clinical trials, however, sponsors will have the possibility under Article 28(2) of Regulation 536/2014 to obtain open consent for further use of data in any kind of future research. (shrink)

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold out (...) direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of “minimal risk” are untenable. The “absolute” interpretation of the “routine examination” standard is defended as best. (shrink)

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: the data protection regime which follows the application of the European Union General Data Protection Regulation, and the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore (...) has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper. (shrink)

In this paper we argue that Aristotle operates with a particular theoretical model in his explanation of animal locomotion, what we call the ‘centralized incoming and outgoing motions’ model. We show how the model accommodates more complex cases of animal motion and how it allows Aristotle to preserve the intuition that animals are self-movers, without jeopardizing his arguments for the eternity of motion and the necessary existence of one eternal unmoved mover in Physics VIII. The CIOM model helps to elucidate (...) Aristotle’s two central yet problematic claims, namely that the soul is the efficient cause of animal motion and that it is the internal supporting-point necessary for animal motion. Moreover, the CIOM model helps us to explain the difference between voluntary, involuntary and non-voluntary motions, and to square Aristotle’s cardiocentrism with his hylomorphism, but also, more generally, it provides an interesting way of thinking about the place of intentionality in the causal structure of the world. (shrink)

Biomedical research is so important that there is a positive moral obligation to pursue it and to participate in itScience is under attack. In Europe, America, and Australasia in particular, scientists are objects of suspicion and are on the defensive.i“Frankenstein science”5–8 is a phrase never far from the lips of those who take exception to some aspect of science or indeed some supposed abuse by scientists. We should not, however, forget the powerful obligation there is to undertake, support, and participate (...) in scientific research, particularly biomedical research, and the powerful moral imperative that underpins these obligations. Now it is more imperative than ever to articulate and explain these obligations and to do so is the subject and the object of this paper.Let me present the question in its starkest form: is there a moral obligation to undertake, support and even to participate in serious scientific research? If there is, does that obligation require not only that beneficial research be undertaken but also that “we”, as individuals and “we” as societies be willing to support and even participate in research where necessary?Thus far the overwhelming answer given to this question has been “no”, and research has almost universally been treated with suspicion and even hostility by the vast majority of all those concerned with the ethics and regulation of research. The so called “precautionary approach”9 sums up this attitude, requiring dangers to be considered more likely and more serious than benefits, and assuming that no sane person would or should participate in research unless they had a pressing personal reason for so doing, or unless they were motivated by a totally impersonal altruism. International agreements and protocols—for example, the Declaration of Helsinki10 and the CIOMS Guidelines11—have been directed principally at …. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.4 (2004) 411-425 [Access article in PDF] Vulnerability, Vulnerable Populations, and Policy Mary C. Ruof "Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied."Guideline 13: Research Involving Vulnerable Persons International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for International Organizations of (...) Medical Sciences (CIOMS) and World Health Organization (WHO) Geneva, Switzerland, 2002 Within medical research and healthcare certain groups are afforded special protections and services because of their designation as vulnerable. The vulnerable require special justification to participate in human subject research in order to eliminate potential human rights abuses. The Nuremberg Code of 1947 was written in response to the extreme human subject abuses that occurred under the Nazi regime, and, although the intent of the 1947 Code was to protect human rights, rigid voluntary consent requirements deprived some individuals of the right to participate in clinical trials. Recent human research guidelines, such as the CIOMS/WHO guidelines referenced above and the guidelines referenced in Section V of this Scope Note, attempt to balance both protection from abuse in research and access to new, experimental treatments for the vulnerable.Although various protective guidelines stipulate special protections for vulnerable populations, the concept of vulnerability and consequently the criteria designating vulnerable populations remain vague. Precisely who are the vulnerable? The word "vulnerability" stems from the Latin vulnerare, "to wound." (Oxford Encyclopedic English Dictionary 1995). In clinical research, the term [End Page 411] vulnerable generally is applied to individuals who are unable to give informed consent or who are susceptible to coercion. The Common Rule (45 CFR 46, Subpart A) includes as vulnerable research subjects: children, prisoners, pregnant women, and persons who are handicapped, mentally disabled, economically disadvantaged, or educationally disadvantaged. Although the Common Rule specifies certain vulnerable categories, the guidelines were not intended to be exclusive, leaving open the interpretation of vulnerability.In medical research and health policy, vulnerability is an abstract concept that has concrete effects both for those labeled vulnerable and for those not. Clinical researchers, healthcare workers, ethical reviewers, and policymakers must be able to identify vulnerable subjects to establish how healthcare resources will be allocated and who will qualify for special protections and socialized benefits. Attempts to quantify vulnerability in clear, measurable ways have met little if any consensus. As Alexander Morawa (II, 2003, p. 150) states, "There is no single approach to definition of vulnerability. In fact, there is no purposeful categorisation at all."Difficulties in defining vulnerability have prompted discourse surrounding its utility as a qualifying factor in the allocation of health resources and its appropriateness as a guiding principle in bioethics. Some of the authors cited in this Scope Note argue against the labeling and categorization of vulnerable individuals and populations. "Labeling individuals as 'vulnerable' risks viewing vulnerable individuals as 'others' worthy of pity, a view rarely appreciated" (III, Danis and Patrick 2002, p. 320). The categories of vulnerable groups listed under the Common Rule have been the source of controversy, "for example, many find the suggestion that pregnant women are vulnerable to be quite sexist" (IV, DeBruin 2001, p. 7). Instead of creating categories of vulnerable populations, would it not be better to derive an account of just treatment from a just social policy at large that encompasses human vulnerabilities (II, Brock 2002, p. 283).For some of the authors listed here, the concept of vulnerability is essential to bioethics. Robert Goodin (I, 1985, p. 107) writes that the vulnerability of other human beings is the source of our special responsibilities to them. In contrast to the four American principles of biomedical ethics—autonomy, nonmaleficence, beneficence, and justice—the four principles of European bioethics and biolaw include vulnerability along with autonomy, dignity, and integrity. According to, Jacob Dahl Rendtorff and Peter Kemp (I, 2000, p. 274) "the principle of vulnerability is ontologically prior to the other [European] principles, it expresses better than all of the other ethical principles... the finitude of the human condition."Some of the... (shrink)

Several influential ethical guidelines and frameworks endorse the view that research with human participants is ethically acceptable only when it has “social value,” meaning that it generates knowledge which can be used to benefit society. For example, the Nuremberg Code requires that medical experiments on human beings “yield fruitful results for the good of society, unprocurable by other methods or means of study”. The Council for International Organizations of Medical Sciences guidelines hold that “health-related research with humans... must have social (...) value” or the “prospect of generating the knowledge and the means necessary to protect and promote people’s health” (CIOMS... (shrink)

The revision of the Council of International Organizations of Medical Sciences (CIOMS) International ethical guidelines for health‐related research (2016) heralds a paradigm shift from the ‘protectionist’ policies that emerged following historical research atrocities of the 20th century, towards a more nuanced and inclusive approach to research participation. Adopting this modified approach will enable countries to secure the benefits of research for individuals and for society as a whole, while at the same time minimizing the potential for exploitation and research‐related (...) harms. This article considers the potential impact of Guideline 16 of the CIOMS 2016 from a New Zealand perspective, with respect to research involving adults with impaired capacity and who are incapable of giving informed consent. While the CIOMS 2016 apply a ‘minimal risk’ threshold to guide research involving adults who lack capacity to consent, New Zealand law currently adopts a ‘best interests’ standard which significantly restricts the scope of permissible research that may be performed in this context. This article argues that the CIOMS 2016 should influence change to New Zealand’s legal framework for ethical review of research. CIOMS 2016 provides useful guidance for the necessary standards and processes to enable the responsible and ethical inclusion of adults with impaired capacity in research. (shrink)

One of the arguments against conducting human subject trials in the Third World adopts a distributive justice principle found in a commentary of the CIOM'S Eighth Guideline for international research on human subjects. Critics argue that non-participant members of the community in which the trials are conducted are exploited because sponsoring agencies do not ensure that the products developed have been made reasonably available to these individuals. I argue that the distributive principle's wording is too vague and ambiguous to be (...) used to criticize any trial. Furthermore, the mere fact that an experiment does not fulfill this particular distributive justice principle does not entail that it is unethical. (shrink)

The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. For (...) example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. (shrink)

In exploring the concept of vulnerability, we do not begin with a blank slate. In research involving human subjects, ethics guidelines typically provide a rough definition of the concept. For example, the commentary on Guideline 13 in the International Ethical Guidelines for Biomedical Research Involving Human Subjects, issued by the Council for International Organizations of Medical Sciences (CIOMS), says that "vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have (...) insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests" (CIOMS 2002). Because the CIOMS guidelines .. (shrink)

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 penaltyBoth 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. (shrink)

ABSTRACT The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. (...) For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Religious Perspectives on Bioethics, Part ILaura Jane Bishop (bio) and Mary Carrington Coutts (bio)This is Part One of a two part Scope Note on Religious Perspectives on Bioethics. Part Two will be published in the December 1994 issue of this Journal. This Scope Note has been organized in alphabetical order by the name of the religious tradition.Contents for Parts 1 and 2Part 1Part 2I.GeneralI.Native AmericanII.African Religious TraditionsReligious TraditionsIII.Bahá'í FaithII.Protestantism—willIV.Buddhism (...) and Confucianisminclude a general sectionV.Eastern Orthodoxyand sections focused onVI.Hinduismspecific denominations.VII.IslamIII.Roman CatholicismVIII.JainismIX.JudaismIntroductionThe many religions of the world bring diverse, and occasionally divergent, attitudes to bioethical issues. These beliefs may guide patients and health care professionals as they seek or provide health care. In an attempt to facilitate understanding of and access to information about these beliefs in our pluralistic and global society, this Scope Note identifies literature by the world's major religious groups on topics relating to bioethics.Topics covered by this Scope Note include general attitudes to health and [End Page 155] health care, the physician-patient relationship, treatment refusal, abortion, contraception, sterilization, reproductive technologies, genetics, mental health, human experimentation, organ transplantation and donation, death, euthanasia, suicide, and prolongation of life. Material was not available on all of these topics for each religion.The literature gathered here represents only a small portion of the available writing on religion and medicine, and is limited to that which comments explicitly on bioethical issues. Some faiths have a rich tradition of writing in bioethics; for others the literature is more limited. Variation in coverage is not intended to indicate the relative importance of a faith, but reflects accessibility and space constraints. Individuals interested in obtaining additional information are encouraged to contact the National Reference Center for Bioethics Literature.Specific citations about a region or country were chosen because of the predominance of a religious tradition within the population. In all cases, variation in spelling represents author usage. This Scope Note treats only the literature published in English, and every attempt has been made to identify English language sources for these faiths.It is important to remember that doctrinal and theological differences exist even within the same denomination and that views of individual patients, family members, and health care providers should be sought.Dictionaries and EncyclopediasMelton, J. Gordon, ed. Encyclopedia of American Religions. Fourth edition. Detroit: Gale Research, 1993. 1217 p. Basic information about the history, sacred texts, membership, educational facilities, publications, and North American addresses are provided for 1,730 churches, denominations, sects, and cults. Bibliographies for many faiths supplement this extensive resource.Reich, Warren T., ed. Encyclopedia of Bioethics. New York: Free Press, Macmillan, 1978. 4 volumes. Articles on all the major religions as they relate to bioethics are included in this highly-regarded encyclopedia. In addition, many of the topical essays feature a section on the views of various faiths on the topic under discussion. For the best use of the Encyclopedia, see the subject index in volume 4. (Note: a revised, second edition is due to be published by Macmillan in late 1994.)GeneralAmerican Psychiatric Association. Committee on Religion and Psychiatry. Guidelines Regarding Possible Conflict Between Psychiatrists' Religious Commitment and Psychiatric Practice. American Journal of Psychiatry 147 (4): 542, April 1990. The American Psychiatric Association recommends that psychiatrists respect their patients' religious beliefs and that they not impose their own [End Page 156] beliefs on their patients.Bankowski, Z., and Bryant, J. H. Health Policy, Ethics and Human Values: Proceedings of the XVIIth CIOMS Round Table Conference, Athens Greece. Geneva: Council for International Organizations of Medical Sciences, 1985. 336 p. Many sections of this volume address issues where religion impacts health policymaking. Africa, the Middle East, Europe, Latin America, and Asia are highlighted for the varied ways in which their religions and cultures are integrated into the provision of health care.Batchelor, Edward, ed. Abortion: The Moral Issues. New York: Pilgrim Press, 1982. 246 p. Batchelor compiles a collection of essays by experts on religious ethics as they relate to abortion. Includes... (shrink)

Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs in developing (...) countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)

The effort to revise the Declaration of Helsinki and the CIOMS Guidelines has sparked a sometimes vitriolic debate centering on the use of placebo controls.

Health‐related data uses and data sharing have been in the spotlight for a while. Since the beginning of the big data era, massive data mining and its inherent possibilities have only increased the debate about what the limits are. Data governance is a relevant aspect addressed in ethics guidelines. In this context, the European project BRIDGE Health (BRidging Information and Data Generation for Evidence‐based Health policy and research) strove to achieve a comprehensive, integrated and sustainable EU health‐information system. One of (...) the aims of the project was to evaluate the requirements to construct a data‐linkage infrastructure for the secure management of health information. In a blueprint provided for this infrastructure, the topics ethics and the intimately related governance occupied a whole section, where the recent ethics guidelines by the Council for International Organizations of Medical Sciences (CIOMS) and the World Medical Association (WMA) were referenced. We explore what has changed in the latest versions of the ethics documents adopted by CIOMS and WMA regarding the management of health data and human tissues, the appropriateness of their application in new forms of research and infrastructures as the proposed in the BRIDGE Health project, and whether society should be so concerned about this topic, in the digital era of social exchange. (shrink)

The concept of vulnerability has been hotly debated in research ethics literature. Some critics considered it a useless concept. In 2009—against some of those criticisms—I defended the importance of understanding this concept in terms of layers instead of applying it as a label given to certain subpopulations. In this paper, I present some of the limits of this analysis and I also explore the similarities and differences this approach has when compared to using a taxonomy as another answer on how (...) to assess vulnerability. I present the notion of cascade vulnerability and underscore the dispositional character of layers and their relevance to identify and evaluate layers of vulnerability. Finally, I show how this layered account has been incorporated in important documents such as the new 2016 CIOMS-WHO Guidelines. (shrink)

Four key guidance points in the UNAIDS guidance document, Ethical Considerations in HIV Preventive Vaccine Research, are compared with analogous statements in three other recently issued documents dealing with international research. Those documents are: the Declaration of Helsinki, as revised in 2000; the report of the U.S. National Bioethics Advisory Commission, issued in 2001; and a current (2001) draft revision of the 1993 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The four guidance points compared with statements (...) on similar issues in the other three documents are Guidance Point 2, which deals with making available a safe and effective vaccine after trials are completed; the second half of Guidance Point 4, which requires that the desired outcome should potentially benefit the population from which research participants are drawn; Guidance Point 11, which discusses what should be provided to a control group in a vaccine trial; and Guidance Point 16, which addresses the care and treatment to be provided for trial participants who become infected with HIV during the trial. The analysis and comparison concludes that the UNAIDS guidance points are at least as ethically sound as analogous points in these other documents, and for the most part are ethically superior in providing greater benefits to research participants and to others. Nevertheless, they are subject to the criticism that they are too ‘aspirational’ and not sufficiently ‘pragmatic’. (shrink)

IntroductionExtended decision -making through the use of proxy decision -makers has been enshrined in a range of International Codes, Professional Guidance and Statute,For example, the UK Mental Capacity Act section 9.1; The General Medical Council ; the US National Guardianship Association ; Nuffield Council on Bioethics ; CIOMS-WHO section 6. Court cases such as Re Quinlan in the US have also contributed to establishing the groundings for the legal status of the proxy, albeit in terms of who might be (...) suitable as a proxy in cases where there was no clear appointment of them by a still competent individual. and is now widely seen as a useful means through which we can exercise control over decisions that affect our lives when we have lost capacity to make these decisions for ourselves.I will here limit myself to discussion of proxy consent for adults appointed prior to the loss of competence by the person they are acting as proxy for. The issue of p. (shrink)

Guideline 20 of the updated International Ethics Guidelines for Health‐related Research Involving Humans (2016) by the Council for International Organizations of Medical Sciences (CIOMS) provides guidance on research in disasters and disease outbreaks against the background of the need to generate knowledge quickly, overcome practical impediments to implementing such research, and the need to maintain public trust. The guideline recommends that research ethics committees could pre‐screen study protocols to expedite ethical reviews in a situation of crisis, that pre‐arrangements be (...) made regarding data sharing and biomedical sample sharing, and that sponsors and research ethics committees seek to minimize risk to researchers conducting research during a disaster. This paper critiques these recommendations against the background of the findings of a survey of public health officials and chairs of research ethics committees in the Caribbean during 2016, which sought to determine the best template for the expeditious ethical review of research proposals in emergency and epidemic situations in the Caribbean, and whose findings can serve as a model for other low‐ and middle‐income countries. (shrink)

The discussion on ethical issues, it is said, should not be confined to experts but should be extended to patients and local communities, because of the real need to engage stakeholders and non‐stakeholders alike not only in carrying out any biomedical research project, but also in the drafting and legislation of bioethics instruments. Several local and inter‐country consultations have already been conducted in furtherance of this goal, but there is much left to be desired in them. The consultations may have (...) helped in articulating local principles, but not in making the instruments embody these principles. As such, instruments turn incompossible, i.e. the principles and actions they legitimate are not performable. In an ethnographic study conducted in the Philippines, for example, paragraphs 29 and 30 of the Declaration of Helsinki and CIOMS guidelines 8 and 15 are construed as not only contradictory to one another but also to local principles. This problem can be solved by taking deliberate steps to ensure that consultations are grounded in ethnographic data about local principles, which the instruments would embody. A steering committee can be of help in gathering ethnographic data, in conducting consultations at the local level, and in providing a venue for discourse on various bioethical issues. (shrink)

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations (...) of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. (shrink)

In October 2005, UNESCO (the United Nations Educational, Scientific and Cultural Organization) adopted the Universal Declaration on Bioethics and Human Rights. This was the culmination of nearly 2 years of deliberations and negotiations. As a non-binding instrument, the declaration must be incorporated by UNESCO’s member states into their national laws, regulations or policies in order to take effect. Based on documentary evidence and data from interviews, this paper compares the declaration’s universal principles with national bioethics guidelines and practice in Kenya (...) and South Africa. It concentrates on areas of particular relevance to developing countries, such as protection of vulnerable persons and social responsibility. The comparison demonstrates the need for universal principles to be contextualised before they can be applied in a meaningful sense at national level. The paper also assesses the ‘added value’ of the declaration in terms of biomedical research ethics, given that there are already well-established international instruments on bioethics, namely the World Medical Association Declaration of Helsinki and the CIOMS (Council for International Organizations of Medical Sciences) guidelines on biomedical research. It may be that the added value lies as much in the follow-up capacity building activities being initiated by UNESCO as in the document itself. (shrink)

The enrolment of children and adolescents in health research requires that attention to be paid to specific assent and consent requirements such as the age range for seeking assent; conditions for parental consent (and waivers); the age group required to provide written assent; content of assent forms; if separate assent and parental consent forms should be used, consent from emancipated young adults; reconsent at the age of adulthood when a waiver of assent requirements may be appropriate and the conditions for (...) waiving assent requirements. There is however very little available information for researchers and ethics committees on how to navigate these different issues. To provide guidance to research initiatives, the SickleInAfrica consortium conducted a thematic analysis of a sample of research ethics guidelines and procedures in African countries, to identify guidance for assent requirements in health research. The thematic analysis revealed that 12 of 24 African countries specified the age group for which assent is required. The minimum age for written assent varied across the countries. Five countries, Algeria, Botswana, Cameroon, Nigeria and The Democratic Republic of Congo require consent from both parents/family council in certain circumstances. Botswana, Nigeria, South Africa and Uganda have specific assent/consent requirements for research with emancipated minors. South Africa and Algeria requires re-consent at onset of adulthood. Five countries (Botswana, Cameroon, Nigeria, South Africa and Tanzania) specified conditions for waiving assent requirements. The CIOMS and the ICH-GCP guidelines had the most comprehensive information on assent requirements compared to other international guidelines. An interactive map with assent requirements for different African countries is provided. The results show a major gap in national regulations for the inclusion of minors in health research. The SickleInAfrica experience in setting up a multi-country SCD registry in Africa highlights the need for developing and harmonising national and international guidelines on assent and consent requirements for research involving minors. Harmonisation of assent requirements will help facilitate collaborative research across countries. (shrink)