Principles of biomedical ethics pdf

Background Research ethics govern the standards of conduct for scientific researchers. It is important to adhere principles of biomedical ethics pdf ethical principles in order to protect the dignity, rights and welfare of research participants. As such, all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld. Discussion of the ethical principles of beneficence, justice and autonomy are central to ethical review.

Council for International Organizations of Medical Sciences. The ERC ensures that WHO only supports research of the highest ethical standards. The ERC reviews all research projects, involving human participants supported either financially or technically by WHO. Before creating a program of instruction or education in the responsible conduct of research, it is essential to first ask: What are the goals for teaching responsible conduct of research? Before addressing these goals, it is important to recognize that many scientists are skeptical about the value of explicit education in RCR.

While this skepticism is healthy and sometimes appropriate, many arguments against instruction are based on some of the misconceptions described below. Isn’t responsible conduct just a matter of following regulations? Although there are explicit regulations that govern some aspects of scientific practice — for instance, the treatment of human subjects — these regulations are insufficient to determine every choice a scientist will need to make. Moreover, scientists must always interpret regulations in their scientific practice. Treating human subjects responsibly involves more than just knowing regulations, and so too with other issues of RCR. Where trainees learn by example, they must discern which features are important and which are not. For instance, they might learn that the reagents used are more critical than the style of music played in the lab.

Even if they are trained to do research responsibly, then, they may or may not distinguish the elements that are matters of responsibility and integrity from those that are matters of style or manners. It is rarely the case that people are intent on doing wrong. Failures of research integrity that result from ignorance or carelessness might be averted by even a modicum of attention to RCR issues. Furthermore, even though a course in research ethics may not set straight a scientist who is intent on falsifying data or mistreating research subjects, such a scientist will interact with peers and coauthors who will be in a position to recognize misconduct. It’s wrong to think that RCR is distinct from the demand to do good science.

Promoting the integrity of science is one of the demands of responsible conduct. There may be times when it would be possible to learn something new only by acting irresponsibly, and that knowledge would then come at too high a price. Since science is self-policing, it may be tempting to think that the scientific community can handle any matters of responsibility by its own methods. This is already rebutted by the creation of regulations to govern scientific research due to past failures of the scientific community to minimize and mitigate misconduct by some scientists. The need for research ethics education is specified, in part, by federal requirements from the NIH and NSF, and so some extent by institutions. Some of the rationale behind these requirements is discussed below as well. With increasing federal requirements, and increasing attention to the need for research ethics education, more and more institutions or individual programs and departments are making such education a requirement for all students or even all researchers.

The purpose of teaching research ethics is to promote integrity in the work of scientists, scholars, and professionals involved in the field of scientific and scholarly inquiry and practice. Responsible and ethical research behavior of researchers, research institutions, and government agencies has historically relied on a system of self-regulation based on shared ethical principles and generally accepted practices. Blatant forms of research misconduct have included cases of fabrication, falsification or plagiarism, resulting in political attention and intense reaction. The consequences of such wrongdoing are not only lost opportunities in science, but also a risk for decreasing public trust. Shattuck lecture summarized high profile cases of medical research misconduct that resulted in political scrutiny in the 1980s and 1990s, leading to federal policies and guidelines requiring RCR instruction.

Following implementation by the NIH of a requirement that training grant programs provide training in the responsible conduct of research, many formal RCR training programs have now been established. Knowledge about the responsible conduct of research would include the facts, guidelines, policies, data and other sources of information that answer “what” questions. Unwritten standards such as principles that guide opinions on unresolved ethical issues and standards of practices that make up RCR. RCR as “the achievement of a satisfactory level of proficiency in mastering a specified knowledge base or skill. Additionally they recommended that students gain “a fuller understanding of ethical issues that may arise in research careers. Appreciation for accepted, normative scientific practices for conducting research.

Awareness of the gray areas and ambiguities of ethical issues, including differences between compliant and ethical behavior in the conduct of research, or the range of acceptable and unacceptable practices. It is important, therefore, that students develop skills and habits that prepare them to effectively resolve ethical conflicts they may encounter in professional life. Attitudes that promote RCR can be defined by an acceptance and understanding of the value of acting in ways which foster responsible conduct. Attitudes are closely related to opinions and beliefs, and are based upon personal experiences, and can be influenced by interactions with others.

An intrinsic assumption for discussing the goals and core competencies for teaching RCR is that ethics can be taught. One must first believe that RCR instruction can influence the thinking processes that underlie behavior, and that students can learn the conventions and rules for appropriate research conduct, to reflect on choices and decisions regarding RCR, to develop ethical sensitivity and critical thinking skills, and can learn to effectively resolve ethical conflicts in new situations. There has been increased focus on developing moral awareness about ethical issues in scientific research. They proposed a Four-Component Model of Morality, posing the question: When a person is behaving morally, what must we suppose has happened psychologically to produce the behavior? Ideally, RCR instruction changes not only attitudes, but also behavior. Many believe that ethics instruction can influence the thinking processes that relate to behavior.

A hope of many has been that training in the responsible conduct of research would decrease the incidence of serious research misconduct. This study supports organizational efforts to foster ethical behavior. Ultimately the goal is to cultivate thinking processes that develop moral behavior, which in turn leads to professionally ethical behavior. 99 of the largest graduate departments in chemistry, civil engineering, microbiology and sociology to measure the rates of exposure to perceived misconduct in academic research. Science itself is fundamentally grounded in ethical values, notably truthfulness and benefiting others. Involvement of an individual in producing knowledge creates an ethical responsibility for its outcome.

21st Century Competitiveness Act of 2007: Responsible Conduct of Research. Reminder and Update: Requirement for Instruction in the Responsible Conduct of Research in National Research Service Award Institutional Training Grants. Required Education in the Protection of Human Research Participants. Update on the Requirement for Instruction in the Responsible Conduct of Research. Proposal and Award Policies and Procedures Guide. Medical ethics: some uses, abuses, and limitations. New England J of Medicine, 293, 384-487.