Ethical Considerations in Human Experimentation (original) (raw)

Journal of Oral Health and Community Dentistry

A n experiment is an attempt to discover something unknown or to test a supposition or principle, but we cannot be sure of the outcome. By definition, an experiment involves chance and it is because of this chance that ethics become paramount in the experiments, more so if they involve human subjects.(1) All innovative scientific interventions whether diagnostic, prophylactic or therapeutic should ultimately involve human subjects. The need of safeguards in human experimentation should incorporate several important codes and regulations for the protection of human subjects. The three human principles are(2) Beneficence, which requires that good should result, and harm should not result because of the experimentation. Respect for rights including the free choice of the subject and protection of the autonomy. Justice, which requires an equal distribution of burden and benefits.

Ethics and human experimentation

Physicians have conducted research on syphilis for centuries, seeking to understand its etiology and the means of transmission as well as find ways to prevent and cure the disease. Their research practices often strayed from today's ethical standards. In this paper we review ethical aspects of the long history of research on syphilis with emphasis on the experiments performed in the 20th century. The description of research around the time of World War II covers medical experiments carried out in US prisons and in the experimentation centers established by Japanese doctors in occupied territory, as well as experiments in Nazi Germany and the treatment of syphilitics there.

Research Involving Human Subjects- Ethical Perspective

Research involving human subjects are important to develop new therapeutics for the betterment of the human race. To take part in such research as volunteers is moral duty of any human. But such experiments should be justifiable and minimal risky for the participants. History of unethical research involving humans led to the development of many guidelines to make such research ethical as well as to gain maximum possible output. Several guidelines have been formulated to ensure research with human participants ethical. All the guidelines emphasize on one thing in particular- informed consent of the human subjects. Other considerations include rational benefit-harm ration, beneficence, justice, adequate research design and approval from proper authorities. All these guidelines aim to prevent any unethical research involving humans against their will.

Ethical codes of conduct and practices using human subjects

Procedia - Social and Behavioral Sciences, 2010

The objective of this exploratory study is to understand lecturers’ perception of ethics as it relates to the use of human subjects. Voluntary participation, protection from risks and cultural sensitivities are issues highlighted. Ten research course lecturers who were in-charge of academic research were interviewed. Study shows that lecturers are conversant with ethical procedures. However lack of clear ethical guidelines

The Evolution of Research Ethics: The Current International Configuration

The Journal of Law, Medicine & Ethics, 2004

propose in this essay to briefly describe some of the main current stakeholders who issue guidance on I the ethics of human subjects research. This will be preceded by a very brief historical introduction. Prior to World War 11, as far as I have been able to ascertain, there were no international efforts to regulate human experimentation. National activities were few and far between. One exception was a Directive on Human Experimentation issued in December 1900 by the then Prussian Minister of Religious, Educational and Medical Mairs. This was followed by a Circular on innovative therapy and scientific experimentation promulgated by the then Reich Minister of the Interior in February 1931. Just over five years later, in April 1936, the Bureau of the Medico-Scientific Council of the People's Commissariat for Health of the Russian Socialist Federated Soviet Republic (RSFSR), the main constituent Republic of the then Union of Soviet Socialist Republics, issued an Advisory Resolution on the procedures for testing new medicinal substances and methods which may present a hazard for the health and life of patients. And that is, I believe, the sum total of prewar efforts to regulate human experimentation. As you may well imagine, much has been written about the origins and impact of these early activities. These are no less crucial to the history of human experimentation than the nineteenth century Codes of Thomas Percival in England, William Beaumont in the USA, and Claude Bernard in France. And no less so than the well-known Nuremberg Code of 1947. The best source for material on the Code and its origins remains the 1992 book edited by George Annas and Michael Grodin, The N w ' Doctors and the Nuremberg Code: Human Rights in Human Experimentation. For those of you who do not know the details of this Code, I would remind you that it was promulgated by a U.S. Military Rbunal as part of the final judgement in the so-called "Doctors' Ral" (the "Medical Case") held in Nuremberg in 1946-1947. The Code has been the subject of much scholarly attention, notably at a series of Conferences convened to mark its 50th Anniversary in 1997, e.g. in Nuremberg and Freiburg-im-Breisgau. It is noteworthy that in 1946 the American Medical Association published its first principles of human experimentation, while in 1953 the US Department of Defence issued its then "top-secret" Memorandum on Sev S. Fluss, M.S., is a Senior Adviser at the Council for International Organizations ofMedical Sciences, a nongovernmental organization based at WTlO in Geneva. He was formerly Chief of WHO'S Health Legislation Unit, and is the author of numerous publications in thefields of health legislation and bioethics.

Chapter 4. Ethical Considerations

Harvard University Press eBooks, 2014

investigator is responsible for complying with the study protocol that was approved by the ethics committee and agreed by the sponsor and regulatory authority (if appropriate). A clinical trial legal and financial liability insurance, which is compulsory in some countries, provides the participants and sponsor financial protection against specific contingencies such as death, disability, or other health-related complications that may occur from the participation in a trial. In most cases, liability is product-related, and lawsuits against pharmaceutical companies have increased over the years, as more careful pharmaco-epidemiological studies have been able to identify adverse effects of new products when used in a large number of people or over a long period of time. Some ethics committees will not review a protocol without having a copy of the clinical trial insurance certificate. 2.8. Useful guidance documents Research involving human subjects is conducted in countries with widely varying socioeconomic , health, and research ethics infrastructure. However, irrespective of where the research is conducted, for the ethics infrastructure to be effective, it must have officially recognized regulations or guidelines, a system for oversight and monitoring, and well-functioning research ethics committees. Many LMICs lack laws or regulations governing ethics in research and face the challenge of deciding which international guidelines to use. These guidelines are increasing in number, are not harmonized, and require interpretation or adaptation to local circumstances. Many ethics committees also face the challenge of ensuring adequate ethical review of research protocols. The following is a selection of the most important guidance documents. 2.8.1. Operational guidelines for ethics committees that review biomedical research These were produced by the WHO Tropical Diseases Research Programme in 2000. They set out operational guidelines for ethics committees, in order to facilitate, support, and ensure quality of the ethical review of biomedical research in all countries of the world. Targeted for use by national and local bodies, these guidelines define the role and constituents of an ethics committee and detail the requirements for submitting an application for review. The review procedure and details of the decision-making process are provided, together with necessary follow-up and documentation procedures. They can be downloaded from http://www.who.int/tdr. 2.8.2. International conference on harmonisation/WHO good clinical practice standards This document (International conference on harmonisation, 1996) provides a unified standard for the European Union, Japan, the USA, Australia, Canada, the Nordic countries, and the WHO. Thus, any country that adopts this guideline technically follows this same standard. 2.8.3. The Declaration of Helsinki-ethical principles for medical research involving human subjects The Declaration of Helsinki is a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

ETHICS OF RESEARCH ON THE HUMAN SUBJECT

This work provides a framework for approaching ethical and policy predicaments in research with human subjects from the perception of trust. It explains how trust is important not only between plainclothesmen and subjects but also between and among other participants involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. Thus, research involving human subjects are important to develop new therapeutics for the betterment of the human race. Adopting an analytical method, one can argue that to take part in such research as a volunteer is the moral duty of any human. But such experiments should be justifiable and have minimal risk for the participants. The history of unethical research involving humans led to the development of many guidelines to make such research ethical as well as to gain the maximum possible output. Several guidelines have been formulated to ensure research with human participants is ethical. All the guidelines emphasize on one thing in particularinformed consent of the human subjects. Other considerations include rational benefit-harm ratio, beneficence, justice, adequate research design, and approval from proper authorities. All these guidelines aim to prevent any unethical research involving humans against their will.

Ethics in Research with Human Subjects - A Brief Review

Bangladesh Journal of Physiology and Pharmacology, 2010

Ethics in research involving humans were first codified in 1946 as Nuremberg code. Subsequently other ethical declarations and guide lines were developed to protect the research participants as well as the researchers. The basic research bioethics includes three principles-respects for person, beneficence, and justice. To make a research with human subjects ethically sound the research protocol should have social and scientific values, fair subject selection, favorable risk benefit ratio, independent review, and informed consent of and respect for the participants. Above all the researcher should be honest and responsible enough to safeguard the rights and welfare of the research subjects. DOI: 10.3329/bjpp.v24i1.5734Bangladesh J Physiol Pharmacol 2008; 24(1&2) : 24-26