FIMA Year Book 2009 - Federation of Islamic Medical Associations

Ethics of Clinical Researchis preferable for a married woman toobtain her husband’s consent. (20) Nosuch point is included in the CIOMSguidelines.Guideline 17. Pregnant Women asResearch SubjectsResearch involving pregnant womenis complicated by the fact that it maypresent potential benefits and risksto two beings; the woman and herfetus. However, pregnant womenshould be presumed to be eligiblefor participation in biomedicalresearch as long as they are adequatelyinformed about the benefits and risksto themselves, their pregnancies, theirfetuses, their subsequent pregnanciesand their fertility. The research shouldbe relevant to the particular healthneeds of pregnant women in general.Investigators should include in theirprotocols a plan to monitor theoutcome of the pregnancy with regardto both the health of the woman andthe short- and long-term health of thenewborn.Islamically, there is no objection tothe participation of pregnant womenin biomedical research because of thepotential benefit to them and to theirfetuses that can be derived from suchresearch. Ideally, before enrollingpregnant women in biomedicalresearch, the investigators should ruleout any harm to the fetus. Howeverthat is almost impossible to achieve.The safety of new medications can notbe assumed from animal experimentsor from the study of the pharmacologyof the used medication. There willalways be some risk. Islamically,accepting the possibility of such harmwould nevertheless be permissible ifthe mother or the fetus is likely to gainan absolute or outweighing benefit.When there are potential risks for thefetus, even when they are minor oroutweighed, the investigator shouldalso obtain the consent of the father.This is not a requirement of the CIOMSguidelines. It states “..it is desirable inresearch directed at the health of thefetus to obtain the father’s opinion also,when possible.” (20)In some instances, the clinical trials aremeant for the treatment of the fetus andnot the mother. In these cases there aremore risks to the mother without anybenefit to her. In my opinion the mostobvious example is in utero (prenatal)fetal surgery to correct a fetal birthdefect. In these cases, the maternalinstinct may unduly influence herto agree to such trials. Ethically andIslamically, the investigators shouldmake an extra effort to explain the trial,the potential benefit to the fetus and thepotential complications in the neonatalmanagement, the short and long termprognosis for the fetus/neonate/childand especially the short- and long-termcomplications for the mother beforeshe agrees to participate in the trial.Safeguards should be established toprevent undue inducement to pregnantwomen to participate in the researchfor the sole benefit of the fetus. In thesecircumstances I recommend that theethics review committee establishes aFIMA YearBook 2009148