(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.
Contact AFROEAST RESEARCH AND BUSINESS WRITING CENTRE at (+255)0653 620 781 /
0655 831 885 or afroeastinvestment@yahoo.com
