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)

Medical and public health research includes surveys, interviews, and biospecimens — techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this (...) system, but has not yet specified the form that it will use instead. By examining the policies of the top 50 research institutions, this article assesses institutional practices surrounding exempt research, quantifies the extent of exempt-research review requirements, documents a problem of “over-compliance,” and makes recommendations for reform. (shrink)

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human (...) class='Hi'>subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust. (shrink)

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of (...) human subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of (...) human subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

Protection of human participants is a fundamental facet of biomedical research. We report the activities of a health service research study in which there were three institutional review boards (IRBs), three legal departments and one research administration department providing recommendations and mandating changes in the study methods. Complying with IRB requirements can be challenging, but can also adversely affect study outcomes. Multiple protocol changes mandated from multiple IRBs created a research method that was not reflective of how substance (...) use screening would be performed in a clinical setting. There was direct conflict between the IRBs' perceptions of participants' protection with the researchers' need to use research methodology that assures the clinical relevancy of results. (shrink)

Non-lethal weapons have become an increasingly important class of weapons. Creating these armaments requires examination of ethical issues in their research and development processes. Chief a...

Answering important public health questions often requires collection of sensitive information about individuals. For example, our understanding of how HIV is transmitted and how to prevent it only came about with people's willingness to share information about their sexual and drug-using behaviors. Given the scientific need for sensitive, personal information, researchers have a corresponding ethical and legal obligation to maintain the confidentiality of data they collect and typically promise in consent forms to restrict access to it and not to publish (...) identifying data.The interests of others, however, can threaten researchers' promises of confidentiality when legal demands are made to access research data. In some cases, the subject of the litigation is tightly connected to the research questions, and litigants' interest in the data is not surprising. Researchers conducting studies on tobacco or occupational or other chemical exposures, for example, are relatively frequent targets of subpoenas. (shrink)

Uses a social contingency analysis derived from behavioral psychology to compare research and practice. The components of a contingency (occasion, behavior, and consequence) present in a variety of research, treatment, and educational situations are discussed. Subjective terms such as intent, coercion, and consent are analyzed by means of a behavioral approach. Implications include the possible value of a collegial, symmetrical relationship between the professional and the individual in both research and practice domains. Such a relationship is consistent with current dissatisfaction (...) with the social fiduciary model of contractual relations between professionals and individuals. According to this model, one party exercises powers in fulfillment of a trust from the other party. There has been increasing rejection on the part of the public of this "let-us-do-the-driving," "you're-in-good-hands-with-Allstate" orientation adopted by some professionals. The suggested alternative approach, a social contractual model, has the advantage of recognizing this rejection. (39 ref) (PsycINFO Database Record (c) 2012 APA, all rights reserved). (shrink)

Here we identify approximately 40,000 healthy human volunteers who were intentionally exposed to infectious pathogens in clinical research studies dating from late World War II to the early 2000s. Microbial challenge experiments continue today under contemporary human subject research requirements. In fact, we estimated 4,000 additional volunteers who were experimentally infected between 2010 and the present day. We examine the risks and benefits of these experiments and present areas for improvement in protections of participants with respect to safety. (...) These are the absence of maximum limits to risk and the potential for institutional review boards to include questionable benefits to subjects and society when weighing the risks and benefits of research protocols. The lack of a duty of medical care by physician–investigators to research subjects is likewise of concern. The transparency of microbial challenge experiments and the safety concerns raised in this work may stimulate further dialogue on the risks to participants of human experimentation. (shrink)

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research (...) on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities. (shrink)

In recent years, to protect the rights and welfare of human subjects, institutions in the USA have begun to set up programmes to monitor ongoing medical research. These programmes provide routine, onsite oversight, and thus go beyond existing oversight such as investigating suspected misconduct or reviewing paperwork provided by investigators. However, because of a lack of guidelines and evidence, institutions have had little guidance in setting up their programmes. To help institutions make the right choices, we used interviews (...) and document analysis to study how and why 11 US institutions have set up their monitoring programmes. Although these programmes varied considerably, we were able to distinguish two general types. ‘Compliance’ programmes on the one hand were part of the institutional review board office and set up to ensure compliance with regulations. Investigators’ participation was mandatory. Monitors focused on documentation. Investigators could be disciplined, and could be obliged to take corrective actions. ‘Quality-improvement’ programmes on the other hand were part of a separate office. Investigators requested to be monitored. Monitors focused more on actual research conduct. Investigators and other parties received feedback on how to improve the research process. Although both types of programmes have their drawbacks and advantages, we argue that if institutions want to set up monitoring programmes, quality improvement is the better choice: it can help foster an atmosphere of trust between investigators and the institutional review board, and can help raise the standards for the protection of human subjects. (shrink)

A collaborative team of environmental sociologists, community psychologists, religious studies scholars, environmental studies/science researchers and engineers has been working together to design and implement new training in research ethics, culture and community-based approaches for place-based communities and cultural groups. The training is designed for short and semester-long graduate courses at several universities in the northeastern US. The team received a 3 year grant from the US National Science Foundation’s Ethics Education in Science and Engineering in 2010. This manuscript details the (...) curriculum topics developed that incorporate ethical principles, particularly for group protections/benefits within the field practices of environmental/engineering researchers. (shrink)

A broad consensus affirms the concept that all human beings have equal moral worth (Beauchamp and Childress 1994; Rawls 1971). Translating this ethical norm into practice requires careful attention...

“Public health practice” consists of activities and Programs managed by public health agencies to promote health and prevent disease, injury, and disability. Some of these activities might be deemed to fit within the broad definition of “research” under federal regulations, known as the Common Rule, designed to protect human research subjects. The Common Rule defines research as “a systeniatic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Public health activities that might (...) under some circumstances be considered research include disease reporting, review of medical records, surveys, interviews, focus groups, specimen collection, and laboratory testing.There are questions about the extent to which the Common Rule applies or was intended to apply to public health practice: and it has been suggested in any case that Common Rule regulation of public health practice may not be socially optimal for both practical and principled reasons. (shrink)

“Public health practice” consists of activities and Programs managed by public health agencies to promote health and prevent disease, injury, and disability. Some of these activities might be deemed to fit within the broad definition of “research” under federal regulations, known as the Common Rule, designed to protect human research subjects. The Common Rule defines research as “a systeniatic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Public health activities that might (...) under some circumstances be considered research include disease reporting, review of medical records, surveys, interviews, focus groups, specimen collection, and laboratory testing.There are questions about the extent to which the Common Rule applies or was intended to apply to public health practice: and it has been suggested in any case that Common Rule regulation of public health practice may not be socially optimal for both practical and principled reasons. (shrink)

If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.BackgroundIn the past two decades, the involvement of non-academic sponsors of biomedical research, particularly clinical trial research, has increased exponentially. The value of such sponsored research is difficult to ascertain. However, it is estimated that, between 1980 and 2003, overall research and development expenditures by US (...) pharmaceutical companies increased from $2 billion to $33 billion and that, in 2001, clinical trial research expenditures in Canada totaled $800 million to $1 billion.The source of funding for biomedical research has shifted significantly from predominantly government and private foundations to industry. By 2002,70% of funding for clinical trials came from industry. These factors have affected the conduct of research, particularly clinical trial research, in a variety of ways. (shrink)

If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.BackgroundIn the past two decades, the involvement of non-academic sponsors of biomedical research, particularly clinical trial research, has increased exponentially. The value of such sponsored research is difficult to ascertain. However, it is estimated that, between 1980 and 2003, overall research and development expenditures by US (...) pharmaceutical companies increased from $2 billion to $33 billion and that, in 2001, clinical trial research expenditures in Canada totaled $800 million to $1 billion.The source of funding for biomedical research has shifted significantly from predominantly government and private foundations to industry. By 2002,70% of funding for clinical trials came from industry. These factors have affected the conduct of research, particularly clinical trial research, in a variety of ways. (shrink)

A broad consensus affirms the concept that all human beings have equal moral worth (Beauchamp and Childress 1994; Rawls 1971). Translating this ethical norm into practice requires careful attention...

A broad consensus affirms the concept that all human beings have equal moral worth (Beauchamp and Childress 1994; Rawls 1971). Translating this ethical norm into practice requires careful attention...

A broad consensus affirms the concept that all human beings have equal moral worth (Beauchamp and Childress 1994; Rawls 1971). Translating this ethical norm into practice requires careful attention...

Volume 19, Issue 10, October 2019, Page 99-101.

Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.