2.1 The major principles:
All research involving human subjects should be conducted in accordance with three basic ethical principles, namely respect for persons, beneficence and non-malificence and justice. It is generally agreed that these principles, which in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies (1.4).
· Respect for persons incorporates at least two fundamental ethical considerations, namely:
a. Respect for autonomy which requires that those who are capable of
deliberation about their personal choices should be treated with
respect for their capacity for self-determination.
b. Protection of persons with impaired or diminished autonomy, which
requires that those who are dependent or vulnerable be afforded
full security against harm or abuse.
· Beneficence and non-malificence refers to the ethical obligation to maximize benefits and to minimize harms. This gives rise to norms requiring that the risks of research to be reasonable in the light of the expected benefits, that the research design to be sound, and that the investigators to be competent to conduct the research and to safeguard the welfare of the research subjects.
· Justice refers to the ethical obligation to treat each person in accordance with what is morally right and proper; to give each person what is due to him or her. In the ethics of research involving human subjects the principle refers primarily to distributive justice, which requires equitable distribution of both the burdens and the benefits of participation in research.
Table (1):Ethical Principles of Research
2.2 Other principles: (5-11)
1. Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a knowledge of the related scientific literature.
2. Every proposal for health and medical research on human subjects must be reviewed and approved by an independent nationally-recognised ethics committee before it can proceed.
3. The ethics committee may approve the project as presented, require changes before it can start, or refuse approval altogether.
4. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol, which should be transmitted for consideration, comment, guidance and approval of the nationally-recognised research ethics committee.
5. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person as decided by the relevant committee.
6. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.
7. The right of the research subject to safeguard his / her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical and mental health and integrity and on the personality of the subject.
8. Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits.
9. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results.
10. In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw her consent to participation at any time. The physician should then obtain the subject's freely given informed consent, preferably in writing.
11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the legally responsible person/authority replaces that of the subject in accordance with national legislation.
12. In any study, every patient- including those of a control group, if any- should be assured of the best proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists.
13. The refusal of the patient to participate in a study must never interfere with the physician-patient relationship.
14. The physician can combine medical research with professional care, the objective being the acquisition of new knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.
15. It is necessary for the researcher to demonstrate that the risks to the research subjects are not unreasonable or disproportionate to the expected benefits of the research, which may not even go to the research subjects. A risk is the potential for an adverse outcome (harm) to occur. It has two components: (1) the likelihood of the occurrence of harm (from highly unlikely to very likely), and (2) the severity of the harm (from trivial to permanent severe disability or death). A highly unlikely risk of a trivial harm would not be problematic for a good research project. At the other end of the spectrum, a likely risk of a serious harm would be unacceptable unless the project provided the only hope of treatment for terminally ill research subjects. In between these two extremes, paragraph 17 of the DOH requires researchers to adequately assess the risks and be sure that they can be managed. If the risk is entirely unknown, then the researcher should not proceed with the project until some reliable data are available, for example, from laboratory studies or experiments on animals.
16. Paragraph 11 of the declaration of Helsinki (DoH) requires that medical research involving human subjects must be justifiable on scientific grounds. This requirement is meant to eliminate projects that are unlikely to succeed, for example, because they are methodologically inadequate, or that, even if successful, will likely produce trivial results.
17. In the purely scientific application of medical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health well-benig of that person on whom biomedical research is being carried out.
18. Paragraphs 18 and 19 of the DoH clearly favor the consideration of social value in the evaluation of research projects. The importance of the project’s objective, understood as both scientific and social importance, should outweigh the risks and burdens to research subjects.
19. In research on humans, the interest of science and society should never take precedence over considerations related to the well-being of the subject.
References:
http://www.nhmrc.gov.au/issues/humanlpreamble.htm. Produced by NHMRC
1- Council for International Organizations of Medical Sciences (CIOMS): Ethical Guidelines for Biomedical Research Involving Human Subjects, World Health Organization, Geneva, Switzerland 2002.
2- World Medical Association: WMA declaration of Helsinki, Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964.
3- World Medical Association (2005): Medical Ethics Manual, The World Medical Association, B.P. 63, 01212 Ferney-Voltaire Cedex, France.
4- National Health and Medical Research Council: National Statement on Ethical Conduct in Research Involving Preamble: 28 June 1999:URL:
Date created by NHMRC. Accessed May 2005.
5- Operational Guidelines for Ethics Committees That Review Biomedical Research, WHO 2000.
6- International guidelines for Ethical Review of Epidemiological Studies, CIOMS, 1991
7- Serour G I, Implementation of ethics Review Committee in WHO Workshop[ on Ethical Issues in Research in Reproductive Health), Cairo 2001.
8- Langat S K, The role of Ethics Review in Health Research, in The Africa Malaria Vaccine Testing Network Workshop on Ethics in Health Research in Africa, Kisumu, Kenya 2001.
9- Botha J, The Role of Ethical Review in Health Research, Workshop on Ethics in Health Research in Africa, Kisumu, Kenya 2001.
10- World Association Declaration of Helsinki, Ethical Principle for Medical Research Involving Human Subjects, 2000
11- TDR,WHO, Scientific and Ethical Review group Terms of Reference and Procedures, 1999.
Major Principles
1. Autonomy
2. Beneficence and non-maleficence
3. Justice
Others
1. Accepted Scientifically
2. Accepted qualified researchers
3. Ethics committee review
4. Accuracy of published results……etc