Regulation Of Biomedical Research Research Articles

The Political Life of Research Ethics Committees And What It Means for Ethnographic Research

This review discusses three pieces of work, that is, a conference panel and two books, that deal with the role of research ethics committees (RECs) in regulating biomedical research and medical anthropological research. We summarise the papers and conversations of a panel we convened on this topic during the 2020 European Association for Social Anthropologists (EASA) conference. We review two relatively recent books which discuss the role of RECs in biomedical research: Adam Hedgecoe’s (2020) Trust in the System: Research Ethics Committees and the Regulation of Biomedical Research, and Salla Sariola and Bob Simpson’s (2019) Research as Development: Biomedical Research, Ethics, and Collaboration in Sri Lanka. Finally, we consider how the review that RECs outside academic institutions perform is inadequate for ethnographic research, including that involving prospective participants who may lack capacity to consent. We conclude that undertaking the research ethics review internally (i.e., under university RECs) would be a first step forward in reclaiming ethnographic research ethical conversations.

Certificates of confidentiality: privileging research data.

With the Supreme Court's decision in Dobbs, reproductive research now joins other sensitive research topics that present legal risks to research participants, underscoring the role of Certificates in protecting them. Yet, stakeholders question whether Certificates will hold up in court. In this article, we describe the essential arguments supporting Congress's regulation of biomedical research and, thus, Certificates, under its authority to regulate interstate commerce. Our analysis should reassure researchers and Institutional review boards who rely on Certificates to protect the confidentiality of research participants' data. We conclude with recommendations for stakeholders based on our analysis.

Trust in the system: Research Ethics Committees and the regulation of biomedical research. By AdamHedgecoe, Manchester: Manchester University Press. 2020. pp. 224. £85 (hardcover). ISBN: 978‐1‐5261‐5291‐6

Trust in the system: Research Ethics Committees and the regulation of biomedical research. By AdamHedgecoe, Manchester: Manchester University Press. 2020. pp. 224. £85 (hardcover). ISBN: 978‐1‐5261‐5291‐6

Biomedical Research Regulation Challenges in Countries in Transition: Georgian Experience

Regulation of biomedical research is a complex task, including ethical aspects subdivided into issues related to research on humans and laboratory animals. Involvement of human subjects is under the strict guidance of relevant regulatory documents common to most countries. Regarding animals, these aspects may vary significantly in nations with different socio political and economic factors of transition. From the other side, contemporary biomedical research suggests, amongst other, close collaboration of scientific and educational institutions from different countries. In Georgia-like countries in transition, this process requires significant amendments to the legislation of biomedical research, as international state-of-the-art regulations require, on one hand, compliance with proper guidelines for use of laboratory animals involved in the research process, and on the other — relevant vivarium infrastructure and qualified staff. The current study aimed to collect opinions and experiences from the corresponding Georgian institutions and identify and propose step-by-step solutions to overcome existing challenges. To achieve the goal, we compiled a questionnaire about the management, conduction, and monitoring of biomedical research and sent it to relevant organizations. Questions concerning an institutional policy on the use of laboratory animals, staff qualifications, and infrastructure of units for animal housing/breeding (vivariums or similar), were included as well. The survey revealed the major gaps, among which yet absent national legislative framework appeared of greatest importance, as it allows most institutions’ authorities not to perceive the need to adopt accepted standards at their level. This leads to a decreased credibility of the research, and forces scientists to use international regulations that are quite challenging because of the current state of scientific infrastructure in countries in transition. To overcome the identified problems, we have proposed several solutions, such as a universal package of institutional regulations and a draft amendment to the existing legislation to form a national policy on animal welfare.

BLACK HOLES IN LEGISLATION AND GRAY ZONES OF ETHICS: ETHICAL COMMITTEES IN THE STRUCTURE OF LEGAL REGULATION OF GENETIC STUDIES

The article examines the world experience in the legal regulation of biomedical research, in which people are participants and during which problems of an ethical nature arise. The situation in the process of dissemination of foreign practices in the fi eld of legal institutionalization of bioethics in the Russian Federation is analyzed. Based on the material of Russian legislation, basic concepts of bioethics are explicated, such as the “gray zone of ethics”, “ethics committee”, etc. An example of the organization of bioethical examination to assess the possibility of genetic research is considered, for which geneticists, philosophers, and managers combine their eff orts , journalists, and the examination itself and its results are covered in detail in the media. The necessity of adapting foreign experience to Russian realities both in the fi eld of law and in other areas of social life is substantiated.

Ética, derecho y regulación de la investigación biomédica en Chile

Resumen El presente trabajo analiza la relación entre ética y derecho en la regulación de la investigación biomédica en Chile. Para ello, se lleva a cabo un estudio comparativo entre el marco legal chileno y las principales normativas éticas internacionales ( Declaración de Helsinki y Pautas del Consejo de Organizaciones Internacionales de las Ciencias Médicas), teniendo como referente los requisitos para evaluar una investigación biomédica propuestos por Emanuel, Wendler y Grady. Se examinan y comentan tensiones e inconsistencias entre estos ámbitos regulatorios, en particular aquellas donde la legislación chilena tiene vacíos, falencias o es más exigente que el estándar ético internacional. Se concluye con sugerencias para mejorar la regulación jurídica chilena, entre las que se incluyen fortalecer el rol deliberativo de los comités ético-científicos y sistematizar el marco relacionado con investigación con el fin de lograr un cuerpo legal más orgánico y completo.

Η βοηθική και το επιστημολογικό παράδειγμα της πολυπλοκότητας

Nearly half a century now, the regulation of biomedical research and its technological applications, particularly in medical practice, takes place through a novel combination of positive sciences with humanities, philosophy and social theory of science. However, their combination is still a challenge both practically and theoretically. The practical challenge is how scientific and technological progress combined to the economic and social development it brings is harmonized with the protection of natural and social goods as well as the respect for individual freedoms. Besides, the regulation of biomedicine consists an epistemological challenge for philosophy and theory of science. The work of the deceased Thanassis Papachristou, Professor of Law School of the National and Kapodistrian University in Athens and a former member of the National Bioethics Committee, has been a pioneer precisely because he perceived the dual challenge being simultaneously a civilist and a sociologist of law.The article explains first the reasons why his work opens up to a dynamic view of the regulation of biomedicine. Second, it proceeds further and after quoting the basic theoretical assumptions of the epistemological example of complexity, it develops arguments in favor of its adoption for the interpretation and description of bioethics with bio-law and their combination in the modern model of regulation of biomedicine. Thirdly, the article exposes some thoughts about the implementation of the complexity paradigm in the case pf the Greek model of regulation of biomedicine and the dynamics of bioethics development within it.

医学研究規制政策の新たな展開 : 分裂から統合へ?( 制度・政策の現在において問う)

医学研究規制政策の新たな展開 : 分裂から統合へ?( 制度・政策の現在において問う)

Challenges in regulation of biomedical research: The case of Kenya.

Unregulated biomedical research has previously caused untold suffering to humankind. History is full of examples of abuse of animal and human subjects for research. Several codes and instruments have been formulated to regulate biomedical research. In Kenya, the Science, Technology and Innovation Act, 2014, together with the Constitution of Kenya, 2010, provide a fairly robust legal framework. Possible challenges include capacity building, overlap of functions of institutions, monitoring and evaluation, scientific/technological advances, intellectual property rights, funding for research, and dispute resolution. It is hoped that the new legislation will adequately address these challenges.

Research governance in placebo-controlled trials

The European Medicines Agency and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use are powerful international institutions for the regulation of biomedical research. Although not directly concerned with the ethical aspects of research, both institutions have disseminated position papers on ethical issues relating to the use of placebos in clinical trials. What appears initially to be guidance on the methodology of placebo-controlled trials (with very technical content) clearly has some far-reaching implications for the extent of risk patients can be expected to be subjected to in such trials. On the basis of this guidance, this article questions how much additional harm to patients would be acceptable in placebo-controlled trials in comparison with active-control trials. The article will show that the instruments provided in the guidance are unsuitable, remaining unclear on vital points and thereby leaving patients, researchers and research ethics committees without appropriate direction. In conclusion, placebo-controlled trials urgently need more appropriate regulation to ascertain an acceptable level of risk for participating patients in relation to additional harm.

Student Projects in Medicine: A Lesson in Science and Ethics

Regulation of biomedical research is the subject of considerable debate in the bioethics and health policy worlds. The ethics and governance of medical student projects is becoming an increasingly important topic in its own right, especially in the U.K., where there are periodic calls to change it. My main claim is that there seems to be no good reason for treating student projects differently from projects led by qualified and more experienced scientists and hence no good grounds for changing the current system of ethics review. I first suggest that the educational objectives cannot be met without laying down standards of good science, whatever they may be. Weak science is unnecessary for educational purposes, and it is, in any case, unlikely to produce good researchers in the future. Furthermore, it is curious to want to change the system of ethics review specifically for students when it is the science that is at stake, and when the science now falls largely outside the ethics remit. I further show that ethics review is nevertheless important since students carry a new potential conflict of interests that warrants independent oversight which supervisory support does not offer. This potential conflict may become more morally troublesome the greater the risks to the subjects of the research, and students may impose greater risks on their subjects (relative to professional researchers) by virtue of being inexperienced, whatever the nature of the project. Pragmatic concerns may finally be allayed by organizing the current system more efficiently at critical times of the university calendar.

Managing scientific uncertainty in health legislation

Legislation and regulation of biomedical research is seldom a one-off process since biomedical science evolves rapidly, dynamically and often unpredictably. This paper discusses the challenges faced by regulators who need to produce legislation and policy in rapidly changing fields and outlines some practical suggestions for managing law reform and policy-making under these circumstances.

Aspectos éticos de la investigación biomédica: Conceptos frecuentes en las normas escritas

Most codes and declarations pertaining to the ethics of research involving human subjects have been formulated in response to specific events mostly of a painful or embarrassing nature. Several concepts appearing repeatedly in their texts are highlighted in this paper: principles of respect for persons, beneficence and justice, vulnerability and research propriety. Along with some comments on current revisions of many international guidelines and the role of bioethics committees, a plea is made to have a proactive rather than a reactive stance in ethical regulation of biomedical research.

Genes and Embryos (review)

well be that his vigorous and articulate stands are partially responsible for the fact that science and academic scholars remain as free as they are in 1990. The Excitement andFascination ofScience: Reflections by Eminent Scientists. Vol. 3, pts. 1 and 2. Compiled by Joshua Lederberg. Palo Alto, Calif.: Annual Reviews, Inc., 1990. Pp. 2,317. $90.00. Teaching potential scientists has become less humanistic as more information has to be presented in shorter semesters and quarters. Students are infrequently informed about the eminent scientists whose names identify an observation, experiment, or concept. When my students interested in more than accumulating facts ask how these scientists achieve eminence, I refer them to a prefatory chapter in a pertinent volume of the Annual Reviews. In these chapters, senior scientists often use autobiography to present views of the development of their disciplines during long careers and personal involvement. The Annual Reviews previously published two volumes of prefatory chapters. In the third volume, TL· Excitement andFascination ofScience: Reflections by Eminent Scientists, 106 scientists representing 16 disciplines in the biological and physical sciences present their unique backgrounds, experiences, contributions and views of their disciplines. The chapters glow with the excitement of discovery and, after long careers, the scientists are still fascinated with their disciplines. I had the distinct impression that almost all were pleased with their career choices. No lecturer can match the flavor of these autobiographies that illuminate dry textbooks. This collection should be in every college and university library as required reading for undergraduates interested in a scientific, and perhaps academic, career. E. D. Garber Department of Ecology and Evolution, University of Chicago Chicago, Illinois 60637 Genes andEmbryos. Edited by D. M. Glover and B. D. Hames. New York: Oxford University Press, 1989. Pp. 228. $59.00; (paper) $38.00. Two factors have been responsible for the explosive advances in developmental biology, née embryology: (1) rapid progress in the technology of molecular biology and (2) the isolation ofdevelopmental mutants in genetically favored species. Genes and Embryos considers only four species to present the latest advances in developmental biology. Two species with numerous developmental mutations are a nematode (Caenorhabditis elegans) and a fly (Drosophila mefanogasUr ). One has only a few such mutations, a mammal (the mouse). Technical advantages are responsible for the attention given to an amphibian (Xenopus laevis). Two chapters are devoted to the fly, the genetically most sophisticated species, Perspectives in Biology and Medicine, 34, 2 - Winter 1991 \ 305 and one chapter to each of the other species. Each chapter has a lengthy list of appropriate and current references. Clear diagrams and photographs illustrate the straightforward text. The authors seem to be aware that the volume will be read by advanced undergraduate and graduate students to keep abreast of the latest advances in a "hot" field of biology. Note the interesting error (typo?) on page 166. I will recommend Genes and Embryos as collateral reading for my own classes in genetics and to colleagues not likely to become professional developmental biologists. E. D. Garber Department of Ecology and Evolution University of Chicago Chicago, Illinois 60637 TITLES THAT MAY INTEREST YOU As a service to our readers whose specific interests span the full spectrum of the fields of biology and medicine, we are providing the titles of and relevant information about some of the books sent to us by the publishers that will not receive full review treatment. Whenever possible we will add a short description of each book. AIDS and the Health Care System. Edited by Lawrence O. Gostin. New Haven, Conn.: Yale University Press, 1990. Pp. 299. $35.00; (paper) $12.95. This comprehensive and timely review of the healdi care aspects of the AIDS epidemic comprises 19 papers grouped into eight parts, namely, policies and priorities planning for the 1990s; prevention, treatment, care, and dignity; patients ' rights and public health: confidentiality, duty to warn, and discrimination; die threat to health care workers: assessment and response; professional responsibility ; balancing hope and risk: regulation of biomedical research; the price: financing, reimbursement systems, and the financial effect on providers; and the international perspective. Alzheimer's Disease: Treatment and Long-Term Management. Edited by Jeffrey L. Cummings and Bruce L. Miller. New York...

Titles That May Interest You

and one chapter to each of the other species. Each chapter has a lengthy list of appropriate and current references. Clear diagrams and photographs illustrate the straightforward text. The authors seem to be aware that the volume will be read by advanced undergraduate and graduate students to keep abreast of the latest advances in a "hot" field of biology. Note the interesting error (typo?) on page 166. I will recommend Genes and Embryos as collateral reading for my own classes in genetics and to colleagues not likely to become professional developmental biologists. E. D. Garber Department of Ecology and Evolution University of Chicago Chicago, Illinois 60637 TITLES THAT MAY INTEREST YOU As a service to our readers whose specific interests span the full spectrum of the fields of biology and medicine, we are providing the titles of and relevant information about some of the books sent to us by the publishers that will not receive full review treatment. Whenever possible we will add a short description of each book. AIDS and the Health Care System. Edited by Lawrence O. Gostin. New Haven, Conn.: Yale University Press, 1990. Pp. 299. $35.00; (paper) $12.95. This comprehensive and timely review of the healdi care aspects of the AIDS epidemic comprises 19 papers grouped into eight parts, namely, policies and priorities planning for the 1990s; prevention, treatment, care, and dignity; patients ' rights and public health: confidentiality, duty to warn, and discrimination; die threat to health care workers: assessment and response; professional responsibility ; balancing hope and risk: regulation of biomedical research; the price: financing, reimbursement systems, and the financial effect on providers; and the international perspective. Alzheimer's Disease: Treatment and Long-Term Management. Edited by Jeffrey L. Cummings and Bruce L. Miller. New York: Marcel Dekker, 1990. Pp. 390. $125.00 (U.S. and Canada); $150.00 (all other countries). "Designed as a practical handbook of therapy, it is intended for family physicians , geriatricians, internists, neurologists, nurses, psychologists, social workers, and family members engaged in the care of DAT (Dementia of the Alzheimer Type) patients or their families." It purports to include all the new treatment and management approaches in a single volume. The 25 papers are grouped into four major areas of treatment interest, namely, disease-specific therapies (five papers), treatment of behavioral symptoms (four), long-term care (eight), 306 Book Reviews and future treatment directions (seven). In addition, the introductory chapter deals with the clinical diagnosis of Alzheimer's disease. TL· Animal Estate. The English and Other Creatures in the Victorian Age. By Harriet Ritvo. Cambridge and London: Harvard University Press, 1987. Pp. 347. $25.00. The author presents "a vivid picture of how animals figured in English thinking during the nineteenth century and, by extension, how they served as metaphors for human psychological needs and sociopolitical aspirations." The book combines rhetorical analysis with historical research to produce an unusual perspective on Victorian culture. Information about "people and organizations concerned with agricultural breeding, veterinary medicine, the world of pets, vivisection and other human causes, zoos, hunting at home and abroad, all revealing underlying assumptions and deeply held convictions—for example, about Britain 's imperial enterprise, social discipline, and the hierarchy of orders, in nature and human society." The Black Skimmer: Social Dynamics of a Colonial Specks. By Joanna Burger and Michael Gochfeld. New York: Columbia University Press, 1990. Pp. 355. $45.00. There has been increasing curiosity why animals form groups, and investigations have been intensifying to determine "the benefits and costs of colonial breeding in many different animals." Individual benefits include decreased time for predator detection and increasing opportunities for mate selection and predator defense. However, colonies "increase the potential for competition for mates, nest sites, and food and enhance the spread of disease and the likelihood of detection by predators." The authors have spent 15 years studying "the colonial dynamics, social behavior , and reproductive success of more than 30 black skimmer colonies." Black skimmers usually nest in mixed-species colonies with various species of terns on sandy beaches, salt marshes, and other habitats. These data should prove valuable in ensuring conservation of their habitats and their protection. TL· Dread Disease: Cancer and Modern American Culture. By James T...

Informed consent in psychiatric research: Preliminary findings from an ongoing investigation

Preliminary findings from an investigation of informed consent processes in four psychiatric research projects (two being carried out at a university medical center and two at a public psychiatric hospital) are reported. Study methods include the systematic observation of investigator/subject information disclosure sessions using audio and videotape, as well as the use of standardized interaction rating forms and subject understanding interviews. In an attempt to determine if subjects' understanding of research can be improved through increased subject education, several modes of information disclosure are compared. Partial results from the public psychiatric hospital portion of the investigation suggest low subject understanding in many areas with subjects often demonstrating difficulty differentiating between treatment and biomedical research. Subjects' problematic understanding of research purposes and methodology was compounded by investigator disclosures which often emphasized the therapeutic, personalistic and nonresearch-oriented aspects of the project. Nevertheless, even when information disclosures were significantly improved, subject understanding in many cases continued to be low— suggesting that additional factors aside from the quality of investigator disclosure are involved in psychiatric subjects' comprehension and understanding of research. The implication of these findings for informed consent, regulation of biomedical research and the protection of human subjects are discussed.

Ethical and Legal Problems in Resuscitation Research

Medicine has made great advances in the past decade, and is now opening the frontiers of brain resuscitation. Coinciding with the advances in medicine, society has witnessed great changes. There is an increasing awareness of patients' rights, an increasing desire for self determination, a rejection of the once-accepted paternal role of the physician, and an increasing willingness to challenge physicians in the courts. At the same time, government regulation of biomedical research has been expanding rapidly. The origin of this regulation dates back to the post-World War II Nuremburg trials. In 1974, the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The evolving concern about human experimentation has led to the current Department of Health and Human Services (DHHS) and the Federal Drug Administration (FDA) regulations which became effective July 27,1981. All biomedical research supported by federal funds must conform to these legal requirements. One aspect of these regulations is that all research protocols be approved by an institutional review board (IRB) established at the institution where the research is conducted.