This article argues that we could improve the design of research protocols by developing an awareness of and a responsiveness to the social contexts of all the actors in the research enterprise, including subjects, investigators, sponsors, and members of the community in which the research will be conducted. ?Social context? refers to the settings in which the actors are situated, including, but not limited to, their social, economic, political, cultural, and technological features. The utility of thinking about social contexts is (...) introduced and exemplified by the presentation of a hypothetical case in which one central issue is limitation of the probability of injury to subjects by selection of individuals who are not expected to live long enough for the known risks of the study to become manifest as harms. Benefits of such considerations may include enhanced subject satisfaction and cooperation, community acceptance, and improved data quality, among other desirable consequences. (shrink)

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important changes (...) in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. (shrink)

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important changes (...) in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. (shrink)

Children and individuals with developmental disabilities compared to typical participants are disadvantaged not only by virtue of being vulnerable to risks inherent in research participation but also by the higher likelihood of exclusion from research altogether. Current regulatory and ethical guidelines although necessary for their protection do not sufficiently ensure fair distributive justice. Yet, in view of disproportionately higher burdens of co-occurring physical and mental disorders in individuals with DD, they are better positioned to benefit from research by equitable participation. (...) Greater elucidation of this ethical dilemma is called for by researchers, institutional review boards, and funding agencies to urgently redress the imbalance. This article discusses many of the regulatory principles to ensure better research participation of children and individuals with DD: human rights, validity, distributive justice, beneficence/nonmaleficence, and autonomy. (shrink)

With the development of visual prostheses research from the engineering phase to clinical trials, volunteer recruitment for the early visual prosthesis trials needs to be carefully considered. In this article, we mainly discuss several issues related to volunteer recruitment that had posed serious challenges to the visual prosthesis trials, such as low rates of participants, high expectations and underlying motivations to participate in the visual prosthesis trials as well as the importance of informed consent. When recruiting volunteers for visual prosthesis (...) implants, it is critical that the visual prosthesis researchers should not only take into account the patient’s expectations and motivations, but also make the patients fully aware of the possible benefits and risks involved with their participation, and help patients establish realistic expectations for the early phase of visual prosthesis implantation. Based on these considerations to the challenges, eligible volunteers may be recruited in the preliminary stages of visual prosthesis trials. (shrink)

The main goal in this paper is to present the legal rules connected with medical experiment on human beings in emergency medicine and to explain the scope, significance, and meaning of these rules, especially with regard to their interpretation. As the provisions about medical experiments truly make sense only if they can be observed by the whole “civilised” international community, they are presented in the context of international law with reference to Polish law. By considering the appropriate regulations of research (...) contained in legal documents, it is possible to formulate a catalogue of doctors’ duties and patients’ rights. This general catalogue refers to all kinds of medical research involving human beings. In the field of emergency medicine, general provisions are sometimes involved, and they are sometimes limited. The main and most important conclusion is that a medical experiment in emergency medicine is admissible only if previously indicated conditions based on general rules of conducting research are fulfilled. (shrink)

University of North Carolina at Greensboro Most approaches to the philosophy of the natural and social sciences are basedon completed scientific investigations. However, there are many importantcases in science in which testing is incomplete. These cases are termed suspendedtrials and are particularly significant in biomedical and allied health fields. Initially,the authors' interest in suspended trials was piqued by a controversialmethod for assisting autistic children known as facilitated communication. Thisarticle examines facilitated communication and other examples of suspendedtrials from the perspective of (...) an economics of science and game theory. Themodel is consistent with recent evolutionary approaches to the philosophy ofthe natural and social sciences and with recent contributions to an economicunderstanding of science. Key Words: clinical trials • innovative therapies • economics of science • suspended trials • facilitated communication • economics of clinical research. (shrink)

Institutional Review Boards and their federal overseers protect human subjects, but this vital work is often dysfunctional despite their conscientious efforts. A cardinal, but unrecognized, explanation is that IRBs are performing a specific function – the management of risk – using a flawed theoretical and practical approach. At the time of the IRB system’s creation, risk management theory emphasized the suppression of risk. Since then, scholars of governance, studying the experience of business and government, have learned that we must distinguish (...) pure from opportunity risks. Pure risks should be suppressed. Some opportunity risks, in contrast, must be accepted if the institution is to meet its goals. Contemporary theory shows how institutions may make these decisions wisely. It also shows how a sound organizational understanding of risk, a proper locus of responsibility, and appropriate institutional oversight all contribute to effective risk management. We can apply this general theory, developed in other contexts, to the problems of the IRB system. Doing so provides a unifying explanation for IRBs’ disparate dysfunctions by spotlighting five related deficiencies in IRB theory and structure. These deficiencies are inability to focus on greater risks, loss of balanced theory, inaccessibility to guidance from senior leadership, unbalanced federal oversight, and inflexibility. These flaws are deeply rooted in the system, and superficial reform cannot resolve them. Congress should overhaul the system to meet contemporary standards of risk management; this would benefit subjects, scientists, and the public that needs the fruits of research. (shrink)

One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to (...) subjects” be “reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge” to be gained from the .. (shrink)

In this issue of the Journal of Law, Medicine & Ethics Peter Clark provides a comprehensive and sound ethical analysis of clinical trials examining the treatment of advanced Parkinson's disease with fetal tissue transplantation. These studies raise profound questions about how clinical trials of surgical interventions ought to be conducted. At stake is not only the ethical basis of such trials, but differing views as to the proper role of science in medicine and its limitations.Experience with the broader debate on (...) the ethical permissibility of placebo controls has taught us that the choice of control treatment is an aspect of trial design in which ethical and scientific issues overlap. Accordingly, I will highlight, and perhaps expand upon, three issues raised by Clark: What scientific questions ought clinical trials of surgical interventions ask? How should the ethical analysis of risk for such trials be conceived? And, are surgical patients a vulnerable population? (shrink)

In this issue of the Journal of Law, Medicine & Ethics Peter Clark provides a comprehensive and sound ethical analysis of clinical trials examining the treatment of advanced Parkinson's disease with fetal tissue transplantation. These studies raise profound questions about how clinical trials of surgical interventions ought to be conducted. At stake is not only the ethical basis of such trials, but differing views as to the proper role of science in medicine and its limitations.Experience with the broader debate on (...) the ethical permissibility of placebo controls has taught us that the choice of control treatment is an aspect of trial design in which ethical and scientific issues overlap. Accordingly, I will highlight, and perhaps expand upon, three issues raised by Clark: What scientific questions ought clinical trials of surgical interventions ask? How should the ethical analysis of risk for such trials be conceived? And, are surgical patients a vulnerable population? (shrink)

For a few decades, patients with Parkinson's disease have been treated with intracerebral transplantations of fetal mesencephalic tissue. The results of open trials have been variable. Double blind, placebo-controlled studies have recently been started in order to further investigate the efficacy of this new medical technique. In this paper we challenge the need for sham surgery in neurotransplantation research on PD patients. Considerations regarding the research subjects' informed consent, therapeutic misconception, the integrity of the human body, and the assessment of (...) risks and benefits argue against sham surgery for patients with PD. Moreover, there is an alternative, less harmful mode of research that can provide the same or comparable scientific evidence. A plea is made for intrapatient research based on quantitative measurements of the patient's pre- and post-operative condition combined with similar research on a reference group of patients who have received the standard treatment. (shrink)

Vulnerability has become a popular though controversial topic in bioethics, notably since 2000. As a result, a common body of knowledge has emerged distinguishing between different types of vulnerability, criticizing the categorization of populations as vulnerable, and questioning the practical implications. It is argued that two perspectives on vulnerability, i.e., the philosophical and political, pose challenges to contemporary bioethics discourse: they re-examine the significance of human agency, the primacy of the individual person, and the negativity of vulnerability. As a phenomenon (...) of globalization, vulnerability can only be properly addressed in a global bioethics that takes the social dimension of human existence seriously. (shrink)

Este artículo estudia la justificación normativa de la adopción de los ensayos clínicos aleatorizados por parte de las autoridades sanitarias británicas como estándar metodológico en 1946. A partir de un análisis de los distintos intereses de los participantes en el proceso (pacientes, médicos, farmacéuticas y el propio Estado) argumentamos que la aleatorización se adoptó como mecanismo de asignación imparcial de tratamientos, aunque sus propiedades estadísticas no fueran bien comprendidas. Tal justificación permanece aún vigente.

Moral status is the moral value that something has in its own right, independently of the interests or concerns of others. Research using human embryonic stem cells implicates issues about moral status because the current method of extracting hESCs involves the destruction of a human embryo, the moral status of which is contested. Moral status issues can also arise, however, when hESCs are transplanted into embryonic or fetal animals, thereby creating human/ nonhuman stem cell chimeras. In particular, one concern about (...) chimera research is that it could confer upon an animal the moral status of a normal human adult, but then impermissibly fail to accord the animal the protections it merits in virtue of its enhanced status. Understanding the public policy implications of this ethical conclusion is complicated by the fact that certain views about the moral status of the embryo cannot legitimately be used to justify public policy decisions. Arguments like those employed in the abortion debate for the conclusion that abortion should be legally permissible even if abortion is not morally permissible also support, to a more limited degree, a liberal policy on hESC research involving the creation of chimeras. (shrink)

The use of deception in research is generally permitted so long as participants are debriefed at the conclusion of their participation. Several authoritative research ethics guidelines allow investigators to omit debriefing under certain circumstances, however. Here we examine various justifications for forgoing debriefing in deceptive research, including concerns about subject pool contamination, the risk that revealing the deception will be harmful or distressing to participants, and issues of practicability. We conclude that, contrary to current practice, omitting debriefing is ethically acceptable (...) only when debriefing is impracticable, the deception is innocuous, and no reasonable person would object to involvement in the research. (shrink)

Mandatory reporting laws, which vary slightly from state to state, require reporting by helping professionals when there is reasonable cause to suspect child abuse. Institutional Review Boards (IRBs) require researchers to warn subjects of this duty to report, which may have a chilling effect on subject rapport and candor. Certificates of confidentiality, in conjunction with other precautions, may reduce some barriers to valid research. Attempts to resolve problems created by reporting laws must produce the most valid research, while minimizing harm (...) and distress to research participants, their families, and the researcher and meeting local and federal legal requirements. (shrink)

The physician-researcher conflict of interest, a long-standing and widely recognized ethical challenge of clinical research, has thus far eluded satisfactory solution. The conflict is fairly straightforward. Medical research and medical therapy are distinct pursuits; the former is aimed at producing generalizable knowledge for the benefit of future patients, whereas the latter is aimed at addressing the individualized medical needs of a particular patient. When the physician-researcher combines these pursuits, he or she serves two masters and cannot — no matter how (...) well-intentioned — avoid the risk of compromising the duties owed in one of the professional roles assumed. Because of the necessary rigidity of a research protocol, the more demanding of the two masters is frequently the research.The problem of the physician-researcher conflict has been evident since the first attempts to regulate human research in the United States. Otto E. Guttentag, a physician at the University of California School of Medicine in San Francisco, addressed the conflict in a 1953Sciencemagazine article. (shrink)

In preparation for the development of a rapid tissue donation programme, we surveyed healthcare providers in our institution about knowledge and attitudes related to RTD with lung cancer patients. A 31-item web based survey was developed collecting data on demographics, knowledge and attitudes about RTD. The survey contained three items measuring participants’ knowledge about RTD, five items assessing attitudes towards RTD recruitment and six items assessing HCPs’ level of agreement with factors influencing decisions to discuss RTD. Response options were presented (...) on a 5-point Likert scale. Ninety-one HCPs participated in the study. 66% indicated they had never heard of RTD prior to the survey, 78% rated knowledge of RTD as none or limited and 95.6% reported not having ethical or religious concerns about discussing RTD with patients. The majority were either not comfortable or not sure if they felt comfortable discussing RTD with cancer patients . 56.1% indicated their knowledge of RTD would play an integral role in their decision to discuss RTD with patients. 71.4% reported concerns with RTD discussion and the emotional state of the patient. Physicians and nurses play an important role in initiating conversations about recruitment and donation to research that can ultimately influence uptake. Increasing HCP knowledge about RTD is a necessary step towards building an RTD programme. Our study provides important information about characteristics associated with low levels of knowledge and practice related to RTD where additional education and training may be warranted. (shrink)

The articles by Brooks-Gum, Fisher, Hoagwood, Liss, and Scott-Jones (all this issue) present a panoply of real-world ethical issues in conducting scientific research on risky behaviors of children, adolescents, and their parents, particularly those from vulnerable populations. The universal, ethical principles of beneficence, justice, and respect for others are always applicable, but they do not resolve issues of child assent, parental consent, legal reporting requirements for illegal behaviors, and the special problems of studying risky behaviors in risky populations. Taken as (...) a group, the articles raise some of the most interesting ethical problems that arise in developmental research. My discussion elaborates some issues and fails to resolve others. I hold the view that both science and ethics can be served by thoughtfully designed and implemented research on important social issues, but that the studies themselves cannot simultaneously solve the many societal problems of participants and be scientifically credible. (shrink)

When lethal injection was first legalized in the late 1970s, many people viewed it as safe, reliable, and humane. Today, however, lethal injection does not always perform as promised. Due to difficulties with sourcing lethal injection drugs, states are utilizing untested lethal injection protocols, with little knowledge or experience to guide them. This article argues that lethal injection reform requires regulation similar to that for human subject research, and that the practice of utilizing untested lethal injection methods comes very close (...) to falling under the federal statutory definition of “human subject research“ formulated in the Common Rule. This article argues further that even if one decides that it does not, the practice of lethal injection today is the type of conduct that the human subject research regulations were designed to correct. Moreover, society has an interest in ensuring that executions are conducted in a way that reduces pain and suffering to the lowest extent possible. As such, lethal injection ought to receive further review and oversight to ensure that it comports with reasonable notions of humanity. (shrink)

Since modern medicine is based substantially in clinical medical research, the flaws and ethical problems that arise in this research as it is conceived and practiced in the United States are likely to be reflected to some extent in current medicine and its practice. This paper explores some of the ways in which clinical research has suffered from an androcentric focus in its choice and definition of problems studied, approaches and methods used in design and interpretation of experiments, and theories (...) and conclusions drawn from the research. Some examples of re-visioned research hint at solutions to the ethical dilemmas created by this biased focus; an increased number of feminists involved in clinical research may provide avenues for additional changes that would lead to improved health care for all. (shrink)

Little is known about how researchers view ethically salient aspects of human studies. As part of a National Institutes of Mental Health-funded study, the authors performed a confidential written survey to assess the attitudes, views, and experiences of researchers with institutional review board approved protocols at the University of New Mexico. A total of 363 researchers (57% response rate) participated. Investigators overall held favorable views of general ethical aspects of research and ethics-based safeguards, and they identified a positive role of (...) ethics training. Investigators with more experience encountering ethical problems (p < .001), more ethics training (p = .001), and a PhD or MD/PhD (p = .003) held more favorable general ethical perspectives. Women investigators (p < .03), nonphysician investigators (p < .001), those whose training had been helpful in resolving ethical dilemmas (p = .006), and those for whom spirituality is important (p = .008) more strongly endorsed ethical safeguards. Investigators perceive the scientific and ethical aspects of their work as valuable and linked, and they affirm the role of safeguards in human studies. Formal ethics preparation and training initiatives were also viewed positively by investigators. (shrink)

One of the fundamental ethical concerns about biomedical research is that it frequently exposes participants to risks for the benefit of others. To protect participants’ rights and interests in this context, research regulations and guidelines set out a mix of substantive and procedural requirements for research involving humans. Risk thresholds play an important role in formulating both types of requirements. First, risk thresholds serve to set upper risk limits in certain types of research. Second, risk thresholds serve to demarcate risk (...) categories that streamline risk-adapted systems of ethical oversight. But although risk thresholds play such an important role in research governance, there is a need both to better define the existing risk thresholds and to delineate new thresholds in order to develop more risk-adapted systems of research oversight. The present paper examines the existing minimal risk threshold and the surrounding debates with the goal of deriving a systematic approach to setting thresholds of research risk. (shrink)

Unequal treatment of human research subjects is a significant ethical concern, because justice in research involving human subjects requires equal protection of rights and equal protection from harm and exploitation. Disputes sometimes arise concerning the issue of unequal treatment of research subjects. Allegedly unequal treatment occurs when subjects are treated differently and there is a genuine dispute concerning the appropriateness of equal treatment. Patently unequal treatment occurs when subjects are treated differently and there is not a genuine dispute about the (...) appropriateness of equal treatment. Allegedly unequal treatment will probably always occur in research with human subjects due to disagreements about fundamental questions of justice. The best way to deal with allegedly unequal treatment is to promote honest and open discussions of the issues at stake. Research regulations can help to minimize patently unequal treatment by providing rules for investigators, ethical review boards, institutions, and sponsors to follow. However, patently unequal treatment may still occur because the regulations are subject to interpretation. Federal agencies have provided interpretive guidance that can help promote consistent review and oversight of human subjects research. Additional direction may be needed on topics that are not adequately covered by current guidance or regulations. International guidelines can help promote equal treatment of human subjects around the globe. While minor variations in the treatment of research subjects should be tolerated and even welcomed, major ones (i.e. those that significantly impact human rights or welfare) should be avoided or minimized. (shrink)

The idea that research with human participants should benefit society has become firmly entrenched in various regulations, policies, and guidelines, but there has been little in-depth analysis of this ethical principle in the bioethics literature. In this paper, I distinguish between strong and weak versions and the social benefits principle and examine six arguments for it. I argue that while it is always ethically desirable for research with human subjects to offer important benefits to society, the reasonable expectation of substantial (...) public benefit should be a necessary condition for regarding research as ethical only when it imposes more than minimal risks on non-consenting subjects; or it is supported by public resources. (shrink)

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits (...) of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

Deception is a useful methodological device for studying attitudes and behavior, but deceptive studies fail to fulfill the informed consent requirements in the U.S. federal regulations. This means that before they can be approved by Institutional Review Boards, they must satisfy the four regulatory conditions for a waiver or alteration of these requirements. To illustrate our interpretation, we apply the conditions to a recent study that used deception to show that subjects judged the same wine as more enjoyable when they (...) believed it had a higher price. (shrink)

Recruiting participants from underserved and marginalized communities for behavioral research is an essential yet challenging task. We examined participants' motivation to participate in a focus group about health communication and their beliefs about appropriate remuneration for participation. Twelve focus groups were conducted with low-income African American and Latina adolescent girls and African American women. We utilized a grounded theory approach and thematic analysis to examine views about research participation and remuneration. This study can inform important considerations about the consent process, (...) study recruitment, and remuneration. (shrink)

The term therapeutic misconception was coined by Paul Appelbaum and his colleagues to describe the tendency of patients enrolled in clinical trials to confuse research participation with the personal clinical attention characteristic of medical care. It has not been recognized that an analogous therapeutic misconception pervades ethical thinking about clinical research with patient-subjects. Investigators and bioethicists often judge the ethics of clinical research based on ethical standards appropriate to the physician-patient relationship in therapeutic medicine. This ethical approach to clinical research (...) constitutes a misconception because it fails to appreciate the ethically significant differences between clinical research and clinical care.In this article I argue that the assumption that the ethical principles governing the practice of therapeutic medicine should also apply to clinical research with patient- subjects produces incoherence in research ethics and erroneous guidance concerning certain controversial research designs. (shrink)

Volume 20, Issue 7, July 2020, Page 80-82.

The protection of human subjects in biomedical research relies on two principal mechanisms: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects' informed consent. While these have been discussed extensively in the literature, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual appearance, performance, or capability rather than to prevent, cure, or mitigate disease . This essay examines this question (...) in order to ensure that subjects in biomedical enhancement research receive adequate protection. (shrink)

There are two critical steps in determining whether a medical experiment involving human subjects can be conducted in an ethical manner: assessing risks and potential benefits and obtaining potential subjects’ informed consent. Although an extensive literature on both of these aspects exists, virtually nothing has been written about human experimentation for which the objective is not to prevent, cure, or mitigate a disease or condition, but to enhance human capabilities. One exception is a 2004 article by Rebecca Dresser on preimplantation (...) genetic modification — one of the most controversial enhancement technologies — in which she states, “Under existing research ethics principles, it would be unethical for investigators to perform modifications exposing embryos expected to develop into healthy children to significant risk in exchange for a possible physical or mental enhancement.” But Dresser does not explain why such an experiment would be unethical under existing principles, and her conclusion is not self-evident. (shrink)

The vulnerability of participants in Substance Abuse and Mental Health Services Administration (SAMHSA) programs is a consequence of the illnesses that they are experiencing; ethical guarantees must be in place that ensure the dignity of the persons involved in such programs. Dignity is more than an individual concern; it has individual, institutional, and societal dimensions. An ethical framework is proposed that involves the interrelated vulnerabilities and needs of individuals and communities and our societal response to them. Among the issues given (...) particular attention are individual and community stigmatization, target population involvement in program planning, balance with regard to confidentiality and privacy, the place of proportionality grounded in a rich sense of community as a guiding ethical principle, and guidelines for SAMHSA programs. (shrink)

Amid continuing social unrest from the Great East Japan Earthquake and subsequent Fukushima nuclear accident of 2011, the Japanese government announced plans for a major biobanking project in the disaster-stricken areas, to be administered by the ‘Tohoku Medical Megabank Organization’ (ToMMo). This project differs from previous biobanking projects in that it 1) was initiated mainly to boost post-disaster recovery and reconstruction; and 2) targets the area’s survivors as its primary subjects. Here, we review the ethics of the ToMMo biobanking project (...) within the wider context of disaster remediation. (shrink)

In this paper, I reflect on an important article by Bob Veatch in the inaugural issue of the Hastings Center Report, entitled “Experimental Pregnancy.” It is a report and elegant analysis of the Goldzieher Study, in which nearly 400 women were randomized to receive hormonal contraception or placebo absent consent or disclosure about placebo use, resulting in several pregnancies. Noting the study’s limited notoriety, I first consider the narratives that have instead dominated bioethics’ approach to pregnancy and research: thalidomide and (...) diethylstibesterol. These narratives have facilitated a narrow focus on avoiding fetal risk, to the exclusion of other ethically relevant considerations. I then revisit “Experimental Pregnancy” and offer two ways in which Bob’s analysis serves as an important corrective, first, by foregrounding research subjects, and second, by normalizing pregnancy and thus foregrounding foundational ethical considerations that are sometimes lost amidst pregnancy’s presumed exceptionalism. (shrink)

The aim of this article is to examine whether informational manipulation, used intentionally by the researcher to increase recruitment in the research study, can be morally acceptable. We argue that this question is better answered by following a non-normative account, according to which the ethical justifiability of informational manipulation should not be relevant to its definition. The most appropriate criterion by which informational manipulation should be considered as morally acceptable or not is the researcher’s special moral duties towards their subjects. (...) We also propose that a broader definition of manipulation of information should be adopted (than that already existing in the literature) since informational manipulation can affect not only a person’s beliefs but also their desires in decision-making. We conclude that manipulation of information can either be used to protect the potential subject and facilitate the informed consent process or be used to exploit and merely use a person for scientific goals. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)