RESEARCH ETHICS & CONSENT FOR MEDICAL RESEARCHES

(1)When conducting medical research involving human subjects, investigators should remember their obligations with respect to individual patients. Ethical conduct of research requires that a human subject must participate willingly, having been adequately informed about the research and given consent; that there is a favorable balance between the potential benefit and harm of participation; and that protection of vulnerable people is ensured. The validity of findings must address questions of sufficient importance to justify any risks to participants. In any clinical trial there must be genuine uncertainty as to which treatment arm offers the most benefit, and placebo controls should not be used if equally effective standard therapies exist. When doubt exists, researchers should consult the existing literature and seek the advice of experts in research ethics.

(2)1 All research projects involving human subjects, whether as individuals or communities, or the use of fetal material, embryos and tissues from the recently dead, should be reviewed and approved by an Ethical Review Committee of the institution before the study begins.

(3)It is essential that written consent be obtained if patients are to be involved in clinical trials. The aims and methods of the proposed research, together with any potential hazards or discomfort, should be explained to the patient. The Consent document must be clearly written using non-technical language as to be understandable to subjects and use local language in addition wherever applicable.

(4) In situations where study subjects are too young or too incapacitated, as well as the mentally ill or unconscious person, consent to take part in research may be unobtainable. Research is best avoided unless it can be shown to be relevant and potentially beneficial to the patient and there is no objection from parents or relatives.

(5) Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person.

(6) The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy of the subject, and the confidentiality of the patient’s information.

(7) Research results must always preserve patient anonymity unless permission has been given by the patient to use his or her name.

(8) Volunteers and patients may be paid for inconvenience and time spent, but such payment should not be so large as to be an inducement.

(9) Refusal to participate in research must not influence the care of a patient in any way.

(10) Declaration of Helsinki the PMDC supports the resolutions and draws attention to the Declaration of Helsinki adopted by the 18th World Medical Assembly and revised by the 48th World Medical Assembly.

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