Opinion 2.10 - Fetal Research Guidelines
The following guidelines are offered as aids to physicians when they are engaged in fetal research:
(1) 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.
(2) If appropriate, properly performed clinical studies on animals and nongravid humans should precede any particular fetal research project.
(3) 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.
(4) All valid federal or state legal requirements should be followed.
(5) There should be no monetary payment to obtain any fetal material for fetal research projects.
(6) 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.
(7) Research on the so-called dead fetus, macerated fetal material, fetal cells, fetal tissue, or fetal organs should be in accord with state laws on autopsy and state laws on organ transplantation or anatomical gifts.
(8) In fetal research primarily for treatment of the fetus:
(a) Voluntary and informed consent, in writing, should be given by the gravid woman, acting in the best interest of the fetus.
(b) 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.
(9) In research primarily for treatment of the gravid female:
(a) Voluntary and informed consent, in writing, should be given by the patient.
(b) Alternative treatment or methods of care should be carefully evaluated and fully explained to the patient. If simpler and safer treatment is available, it should be pursued.
(c) If possible, the risk to the fetus should be the least possible, consistent with the gravid female’s need for treatment.
(10) In fetal research involving a fetus in utero, primarily for the accumulation of scientific knowledge:
(a) Voluntary and informed consent, in writing, should be given by the gravid woman under circumstances in which a prudent and informed adult would reasonably be expected to give such consent.
(c) The purpose of research is the production of data and knowledge which are scientifically significant and which cannot otherwise be obtained.
(d) In this area of research, it is especially important to emphasize that care and concern for the fetus should be demonstrated. (I, III, V)