Guidelines for Fetal Research
In order to aid physicians in fulfilling their ethical responsibilities when they engage in fetal research, the WSMA has established the following guidelines for fetal research:
- Physicians may participate in fetal research when their activities are part of a competently designed program, under accepted standards of scientific research, to produce data which are scientifically valid and significant.
- If appropriate, properly performed clinical studies on animals and nongravid humans should precede any particular fetal research project.
- In fetal research projects, the investigator should demonstrate the same care and concern for the fetus as a physician providing fetal care or treatment in a non-research setting.
- All valid federal or state legal requirements should be followed.
- There should be no monetary payment to obtain any fetal material for fetal research projects.
- Competent peer review committees, review boards, or advisory boards should be available, when appropriate, to protect against the possible abuses that could arise in such research.
- Research on the so-called "dead fetus", macerated fetal material, fetal cells, fetal tissue, fetal organs, or the placenta should be in accord with state laws on autopsy and state laws on organ transplantation or anatomical gifts. Informed and voluntary consent, in writing, should be obtained from a legally authorized representative of the fetus.
- In fetal research primarily for treatment of the fetus:
- Voluntary and informed consent, in writing, should be given by the gravid woman, acting in the best interest of the fetus.
- Alternative treatment or methods of care, if any, should be carefully evaluated and fully explained. If simpler and safer treatment is available, it should be pursued.
- In research primarily for the treatment of the gravid female:
- Voluntary and informed consent, in writing, should be given by the patient.
- Alternative treatment of methods of care should be carefully evaluated and fully explained to the patient. If simpler and safer treatment is available, it should be pursued.
- If possible, the risk to the fetus should be the least possible, consistent with the gravid female's need for treatment.
- In fetal research involving a viable fetus, primarily for the accumulation of scientific knowledge:
- Voluntary and informed consent, in writing, should be given by the gravid woman under circumstances which a prudent and informed adult would reasonably be expected to give such consent.
- The risk to the fetus imposed by the research should be the least possible.
- The purpose of research is the production of data and knowledge which are scientifically significant, and which cannot otherwise be obtained.
- In this area of research, it is especially important to emphasize that care and concern for the fetus should be demonstrated. There should be no physical abuse of the fetus.
(JC 2.09-87) (Reaffirmed A-17)
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Abbreviations for House of Delegates report origination:
EC – Executive Committee; BT – Board of Trustees; CPA – Council on Professional Affairs; JC – Judicial Council; CHS – Community and Health Services