Many are new or revised
The Council for International Organizations of Medical Sciences (CIOMS) published in October 2002 its revised and updated International Ethical Guidelines for Biomedical Research Involving Human Subjects. Here is a brief look at the new and revised guidelines:
1. Ethical justification and scientific validity of biomedical research involving human subjects. Sponsors and investigators need to ensure that all of the investigators and others involved in a study are qualified by education and experience to perform competently, and these qualifications need to be reviewed by a scientific and ethical review committees.
2. Ethical review committees. Review committees must be independent and have no financial dependence on the research. Investigators need to obtain their approval, and the committee should review new studies and monitor studies that have already been approved. Also, these review committees need to be local and invite the views of people representing patients with the diseases or impairments being studied.
3. Ethical review of externally sponsored research. Reviews of research protocols should be as stringent in examining ethical and scientific standards for studies conducted in a host country as they are for the sponsoring country, and the health authorities of the host country should be involved in ensuring that the proposed research is responsive to the public’s health needs.
4. Individual informed consent. Prospective subjects or their legally authorized representatives will need to provide voluntary informed consent for all biomedical research involving humans. The consent process should include language and comprehension provisions and be subject to renewal during the course of a study. A special consideration needs to be made to accommodate cultural concerns. In some communities, the investigator may need to obtain permission from a community leader or council before approaching prospective subjects and obtaining their individual consent.
5. Obtaining informed consent: Essential information for prospective research subjects.
6. Obtaining informed consent: Obligations of sponsors and investigators. Investigators need to ensure the adequacy of informed consent, be capable of answering all of subjects’ questions, and provide counseling when appropriate.
7. Inducement to participate. While reimbursement for travel and expenses are permitted, medical care may be provided at no charge, and payments may be made to subjects, these payments should not be so large as to induce prospective subjects to consent against their better judgment.
8. Benefits and risks of study participation.
9. Special limitations on risk when research involves individuals who are not capable of giving informed consent. The risks from research interventions that do not hold out the prospect of direct benefit for the individual who is not capable of giving informed consent should not be more likely or greater than the risk attached to routine medical or psychological examination of such persons.
10. Research in populations and communities with limited resources.
11. Choice of control in clinical trials.
12. Equitable distribution of burdens and benefits in the selection of groups of subjects in research.
13. Research involving vulnerable people. Investigators need special justification for inviting vulnerable people to serve as research subjects.
14. Research involving children.
15. Research involving individuals who by reason of mental or behavioral disorders are not capable of giving adequately informed consent.
16. Women as research participants. Women of reproductive age should not be excluded from research, but a thorough discussion of the risks in the event of pregnancy should be discussed.
17. Pregnant women as research participants.
18. Safeguarding confidentiality. Investigators should inform subjects of the limits in their ability to safeguard confidentiality and of the possible adverse social consequences of breaches of confidentiality.
19. Right of injured subjects to treatment and compensation. Research subjects who suffer injury due to their participation in a study should receive free medical treatment and other assistance that would compensate them equitably for any resultant impairment, disability, or handicap, and their dependents are entitled to compensation in the event of the subject’s death.
20. Strengthening capacity for ethical and scientific review and biomedical research.
21. Ethical obligation of external sponsors to provide health care services. External sponsors are ethically obliged to ensure that the host country has health care services essential to the safe conduct of the research, treatment for subjects who suffer an injury resulting from the research, and a commitment that the sponsor will make a beneficial intervention or product, developed as a result of the research, reasonably available to the host country’s population.