141110P - ETHICAL ISSUES IN RESEARCH

Presentation at a training program for family medicine resident s at the National Guard Madina 9-10 November 2014 by Professor Omar Hasan Kasule Sr. MB ChB (MUK). M{H (Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical City.

INTRODUCTION

·        Medical research is a form of ijtihad inspired by the teaching of the prophet that there is a cure for every disease that must be searched for, li kulli daai dawaau.

·        Modern ethics arose as a reaction to ethical violations by Nazi Germany and Japan who cruelly experimented on prisoners of war without consent

·        Post World War Ethical Codes: Nurenberg 1946, Helsinki 1964, Belmont Report 1979

·        The 4 Western principles of ethics (autonomy, beneficence, nonmalefacence, and justice) are subsumed under just one principle of fiqh, qa’idat al dharar.

·        The maqasid and qawa’id provide a comprehensive guideline for research ethics

RESEARCH ETHICS FROM MAQASID AL SHARI’AT

·        The Islamic ethical theory on research is based on the 5 purposes of the Law, maqasid al shari’at (hifdh al ddiin, hifdh al nafs, hifdh al nasl, hifdh al aql, & hifdh al maal)

·        If any of the five is at risk permission is given to undertake human experiments that would otherwise be legally prohibited.

·        Therapeutic research fulfills the purpose of protecting health and life. Infertility research fulfils the purpose of protecting progeny.

·        Psychiatric research fulfills the purpose of protecting the mind.

·        The search for cheaper treatments fulfills the purpose of protecting wealth.

RESEARCH ETHICS FROM QAWA”ID AL FIQH..1

·        The 5 principles of the Law, qawa’id al shari’at, resolve conflicts between and among the maqasid.

·        Under the principle of intention, qa’idat al qasd, research is judged by its underlying and not expressed intentions.

·        Under the principle of certainty, qa’idat al yaqeen, research on new treatment modalities is permitted if there are doubts about existing modalities.

·        Under the principle of injury, qa’idat al dharar, research is allowed if benefit expected from the experimental therapy outweighs the potential risks.

·        The principle of custom, qa’idat al ‘aadat, is used to define standards of good clinical practice (GCP) as what the majority of reasonable physicians consider as reasonable.

RESEARCH ETHICS FROM QAWA'ID AL FIQH..2

·        Under the doctrine of istishaab, an existing treatment is continued until there is evidence to the contrary.

·        Under the doctrine of istihsaan a physician can ignore results of a new experiment because of some inclination in his mind based on clinical intuition.

·        Under the doctrine of istislaah medical research can be carried out in the public interest although it causes inconvenience to individuals.

THE SHARI’AT BASIS FOR INFORMED CONSENT

·        Informed consent by a legally competent research subject is mandatory for research. Informed consent, an expression of autonomy, is based on qa’idat al dharar .

·        Of all the persons involved in research, the research subject who consents has the purest intentions because he is at risk. Others involved in the research may have selfish motives that are not in the best interests of the research subject.

·        The doctrine of informed consent is derived from the principle of preventing harm, qa’idat al dharar, already mentioned above

·        Informed consent does not legalize risky non-therapeutic research with no potential benefit.

·        It is illegal to force participation of the weak (prisoners, children, the ignorant, mentally incapacitated, and the poor) in research even if they sign informed consent forms.

RESEARCH PUBLICATION

·        Findings of research should be widely disseminated either by teaching or by publication for universal benefit.

·        Islam enjoins dissemination of knowledge and prohibits hiding or monopolizing knowledge, kitman al ‘ilm.

·        Violations / fraud in research occur because of reputation, and the pressure to publish or perish

RESEARCH ON ANIMALS…1

·        Islam enjoins kindness to animals and prohibits any cruelty. Animal experimentation is therefore allowed only under very strict conditions

·        In general animal experimentation is allowed under the doctrine of taskhiir

·         Animal experiments are allowed if a prima facie case can be established that the result of the research is a necessity, dharuurat. Dharuurat under the Law is what is necessary for human life. The regulations of necessity require that no more than the absolute minimum necessary should be done.

·         Animal research has definite risks for the animals that are not balanced by any benefits: pain, suffering, permanent injury, inhumane treatment and operations, and being killed (sacrificed). Thus use of animals in justifiable on the basis of benefiting humans and not any benefits that accrue to the animals.

·         The risks to humans from animal research are minimal in the short term; long-term effects are difficult to fathom.

RESEARCH ON ANIMALS…2

·         If the results of animal experimentation will lead to protection of human life, then research is allowed to proceed because then it is a necessity. This is similar to killing animals for food, a necessity for human life.

·      Use of animals that are haram like the pig should be avoided as much as possible and should be considered only in cases of dharurat.

·         Animals, like humans, have rights to enjoyment of life and good health. The researcher must therefore minimize animal suffering. The animals must be shown kindness and respect. They should not be subjected to the psychological pain of seeing other animals in pain or being sacrificed. Pain must be minimized both during the experiment and when the animal is being terminally sacrificed.