of assessing the uptake of the agent in fetal organs and tissues. Autopsy following pregnancy termination would permit suchexamination of fetal tissue.
Examples include phase I gene transfer studies that have asendpoints the measurement of levels of the new gene or the geneproduct in target tissues. In both scenarios B and C, investigatorswould have good reasons to want a decision to terminate thepregnancy as an inclusion criterion. In all three scenarios, it is tobe understood that the woman
s decision about abortion is madebefore any discussion of research. In this way, the abortion deci-sion is separated from the decision about participation in research.In this paper I attempt to identify the justi
able role, if any,that abortion decisions have as inclusion and exclusion criteriafor research participation. To pursue this, I shall identify andcritically examine the arguments for and against using abortiondecisions as inclusion or exclusion criteria.
ARGUMENTS SUPPORTING THE PERMISSIBILITY OF ABORTIONDECISIONS AS INCLUSION AND EXCLUSION CRITERIA
Let us consider the main arguments for the justi
ability of having abortion decisions as inclusion criteria.
First, taking intoconsideration scenario A, long-term follow-up will be an integralpartofsomeresearch.AsDoris TZallennoted atameeting oftheUS Recombinant DNA Advisory Committee (RAC), accom-plishment of such follow-up would be promoted by recruitingonly women who have a
rm intention to carry the pregnancy toterm (RAC, p. 56).
Such an inclusion criterion would reducethe likelihood of dropouts and the associated loss of ef
ciency inuse of time and resources by investigators. Explicitly having suchan inclusion criterion would also promote the informed consentof subjects, by emphasising that the purpose of the researchincludes long-term follow-up. Whether the woman
rm can be assessed in an interview in which she is invitedto discuss her intention to continue the pregnancy.Second, for types of research that potentially are harmful tofuture children, Amy Patterson points out that the likelihood of such harm can be reduced by restricting the research to womenwho intend to abort (RAC, p. 55).
Similarly, Robert Levinenotes that the risk of preterm birth and its potential harm toa future child can be diminished by such a research design. Headds that there has been a history of innovative research inwhich this has been recognised as an acceptable approach:
in the early stages of development of such techniques asamniocentesis, fetoscopy, chorionic villus biopsy and intrauterineumbilical cord blood sampling, researchers have preferred trialsperformed shortly before initiation of a procedure to terminatepregnancy (Levine, p. 302).
To give an example, in 1979 the Ethics Advisory Board of theUS Department of Health, Education and Welfare approveda research protocol designed to test the safety of fetoscopy. Inthat study, the new technique of fetoscopy was carried out onpregnant women at 16
gestational age who hadelected to undergo abortion (Anon, p 8).
Another RACmember, Alexander M Capron, agrees with the argument inquestion, stating:
The relevance of abortion is to avoid harm to a born person. Abortion is a relevant criterion for phase I or even phase II trials. If there is any harm known, it should not be passed on to a bornperson (RAC, p 57).
Third, it can be noted that, for some types of research, theobjectives cannot be achieved without examining the fetus afterthe in utero intervention. This could be done through additionaltransuterine interventions such as obtaining fetal blood or tissuesamples, but such approaches would add to the risks of spon-taneous abortion and preterm birth. Potential injury to a futurechild can be avoided by performing the research upon fetuses tobe aborted. Robert Levine points out that research examiningthe fetus after in utero interventions is necessary for establishingproper dosages of drugs used to treat fetuses and that failure topermit such research would exacerbate the
problem (Levine, p. 301).
A fourth argument has been given by Ray Noble and CharlesH Rodeck. They claim that when a gene transfer has unprovedef
cacy, it should not be offered as an alternative to abortionbecause the woman might be misled into thinking that it isa treatment. Rather, recruitment should occur
only aftera decision has been made not to terminate
(Noble and Rodeck,p. 226).
Underlying this argument is a recognition of the
a tendency of research partici-pants to overestimate a study
s potential for therapeuticbene
By separating the abortion decision from theresearch participation decision, investigators can avoid thetherapeutic misconception
uencing a woman
s decision tocontinue her pregnancy. As these arguments illustrate, good reasons can be given forhaving abortion decisions as inclusion criteria. But we alsoshould consider the arguments against such criteria.
ARGUMENTS AGAINST THE PERMISSIBILITY OF ABORTIONDECISIONS AS INCLUSION AND EXCLUSION CRITERIA
Some who object to abortion decisions as inclusion and exclu-sion criteria are concerned that the woman
s right to make herown decision about abortion would be infringed. For example, ina conference report by the RAC, the authors state:
as is the case for any in utero intervention, the pregnantwoman
s decision not to have an abortion cannot be used as aninclusion criterion for participation and she must be told that shecan end her participation and decide to have an abortion at any time (RAC, p. 1222).
The RAC statement implies that having a decision not toabort as an inclusion criterion entails that the woman
s right tochange her mind about abortion is infringed. In reply, there isa problem with this view that can be seen by distinguishing twointerpretations of what is involved in having decisions aboutabortion as inclusion criteria.
Interpretation 1: The prospective subject is asked by theinvestigator whether she plans to continue or terminate thepregnancy. Depending on her answer, she either meets or fails tomeet an inclusion criterion. If she meets the criterion, she is toldthat, if she enters the study, she will have a right to end her
In what follows, I focus primarily on inclusion criteria. If a particular decision aboutabortion is an inclusion criterion, then the absence of that decision can be regardedas an exclusion criterion. Thus, in this context, the concepts of inclusion criterion andexclusion criterion are directly related.
Zallen’s comment was made during a discussion of ethical issues in prenatal genetransfer. The view in question also was stated by Karen Rothenberg (RAC, p. 52).
For discussion of research involving fetuses to be aborted, see Mahoney.
Seealso John C Fletcher and Joseph D Schulman, who discuss the development ofchorionic villus sampling in research involving fetuses to be aborted (Fletcher andSchulman, p. 9).
See also Mirkin.
For a similar argument, see Fletcher and Richter, p. 1612,
and Chervenak andMcCullough, p. 13.
J Med Ethics