What is Ethics in Research & Why is it Important?

SM Kalantar

Prof. Molecular Cytogenetics

Member of Heart Ethical Board

Bioethics

• Bioethics is the study of controversial ethics brought about by advances in biology and medicine.

• Bioethicists are concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, and philosophy

• The term Bioethics (Greek bios, life; ethos, behavior) was coined in 1927 by Fritz Jahr, who "anticipated many of the arguments and discussions now current in biological research involving animals" in an article about the "bioethical imperative," as he called it, regarding the scientific use of animals and plants

• Although bioethical issues have been debated since ancient times, and public attention briefly focused on the role of human subjects in biomedical experiments following the revelation of Nazi experiments conducted during World War II, the modern field of bioethics first emerged as an academic discipline in Anglophone societies in the 1960s.

• Technological advances in such diverse areas as organ transplantation and end-of-life care, including the development of kidney dialysis and respirators, posed novel questions regarding when and how care might be withdrawn

• Purpose and scopeThe field of bioethics has addressed a broad swath of human inquiry, ranging from debates over the boundaries of life (e.g. abortion, euthanasia), Surrogacy to the allocation of scarce health care resources (e.g. organ donation, health care rationing) to the right to turn down medical care for religious or cultural reasons

• Medical ethics is the study of moral values and judgments as they apply to medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.

• Medical ethics tends to be understood narrowly as an applied professional ethics, whereas bioethics appears to have worked more expansive concerns, touching upon the philosophy of science and issues of biotechnology.

• Still, the two fields often overlap and the distinction is more a matter of style than professional consensus.

• Medical ethics shares many principles with other branches of healthcare ethics, such as nursing ethics.

• A Bioethicist assists the health care and research community in examining moral issues involved in our understanding of life and death, and resolving ethical dilemmas in medicine and science

• Many religious communities have their own histories of inquiry into bioethical issues and have developed rules and guidelines on how to deal with these issues from within the viewpoint of their respective faiths. The Jewish, Christian and Muslim faiths have each developed a considerable body of literature on these matters

What are the main ethical issues in human subjects research?

• There are several ethical issues that must be considered when designing research that will utilize participants who are human beings.

• The primary concern of the investigator should be the safety of the research participant.

• This is accomplished by carefully considering the risk/benefit ratio, using all available information to make an appropriate assessment and continually monitoring the research as it proceeds.

• The scientific investigator must obtain informed consent from each research participant.

• This should be obtained in writing (although oral consents are sometimes acceptable) after the participant has had the opportunity to carefully consider the risks and benefits and to ask any pertinent questions.

• Informed consent should be seen as an ongoing process, not a singular event or a mere formality.

• The investigator must enumerate how privacy and confidentiality concerns will be approached.

• Researchers must be sensitive to not only how information is protected from unauthorized observation, but also if and how participants are to be notified of any unforeseen findings from the research that they may or may not want to know.

• The investigator must consider how adverse events will be handled; who will provide care for a participant injured in a study and who will pay for that care are important considerations.

• In addition, before enrolling participants in an experimental trial, the investigator should be in a state of "equipoise," that is, if a new intervention is being tested against the currently accepted treatment or diagnostic, the investigator should be genuinely uncertain which approach is superior.

• In other words, a true null hypothesis should exist at the onset regarding the outcome of the trial.

• the obligation on the part of the investigator to respect each participant as a person capable of making an informed decision regarding participation in the research study.

• The investigator must ensure that the participant has received a full disclosure of the nature of the study, the risks, benefits and alternatives, with an extended opportunity to ask questions.

• The second ethical principle is beneficence, which refers to the obligation on the part of the investigator to attempt to maximize benefits for the individual participant and/or society, while minimizing risk of harm to the individual. An honest and thorough risk/benefit calculation must be performed.

• The third ethical principle invoked in research with human subjects is justice, which demands equitable selection of participants, i.e., avoiding participant populations that may be unfairly coerced into participating, such as prisoners and institutionalized children.

• The principle of justice also requires equality in distribution of benefits and burdens among the population group(s) likely to benefit from the research

What are the components of an ethically valid informed consent for research?

• Disclosure: The potential participant must be informed as fully as possible of the nature and purpose of the research, the procedures to be used, the expected benefits to the participant and/or society, the potential of reasonably foreseeable risks, stresses, and discomforts, and alternatives to participating in the research. There should also be a statement that describes procedures in place to ensure the confidentiality or anonymity of the participant. The informed consent document must also disclose what compensation and medical treatment are available in the case of a research-related injury. The document should make it clear whom to contact with questions about the research study, research subjects' rights, and in case of injury.

• Understanding: The participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by one of the investigators. The informed consent document must be written in lay language, avoiding any technical jargon

• Voluntariness: The participant's consent to participate in the research must be voluntary, free of any coercion or promises of benefits unlikely to result from participation.

• Competence: The participant must be competent to give consent. If the participant is not competent due to mental status, disease, or emergency, a designated surrogate may provide consent if it is in the participant's best interest to participate. In certain emergency cases, consent may be waived due to the lack of a competent participant and a surrogate

• Consent: The potential human subject must authorize his/her participation in the research study, preferably in writing, although at times an oral consent or assent may be more appropriate.

Prinicple

• Institutional Ethic of Board

• University (local) Ethical Board

• National Ethical Board

Case 1

• Investigator (s) has to remove all teeth of a cat (teethless’ cat).

• The experiment finished successfully & do not need any more to do

• What should be done?

Case 2

During the conduct of a large clinical trial of an investigational drug, preliminary analysis of results show that there were three times as many participants in the experimental group who experienced severe nausea and vomiting compared to the control group. Two of the cases were severe enough to require that the participants be hospitalized. This is despite the fact that the preliminary analysis shows that there may be a moderate benefit with the drug. What should be done?

Case 3

• A women undergoing IVF, she had 15 eggs.

• 3 eggs were been transferred

• 10 eggs were been frozen for future

• 2 more eggs do not good quality for treatment

• We need for training, research

• What should be done?

Case 4

• Patients went to the central lab.

• She or he donated 10 ml Blood sample for blood analysis as physician required & went away

• Technician used 7 ml

• A research needs to use 1 ml.

• What should be done?

• What is Plagiarism?

• Many people think of plagiarism as copying another's work, or borrowing someone else's original ideas. But terms like "copying" and "borrowing" can disguise the seriousness of the offense: