Data collection during the prenatal period is important to ascertain aspects of the fetal environment that may contribute to congenital anomalies or later diseases related to maternal exposure to environmental toxicants. Agents investigated can include aspects of the physical environment of which the pregnant woman is unaware or that are unknown, such as air pollutants or lead contaminants, or agents the mother has intentionally ingested, such as antibiotics, antiallergens, hair dyes, illicit drugs, or high levels of alcohol for which prenatal risks are or are not known. Umbilical cord blood (UCB) is a frequently used source of information for identifying infant biologic markers and prenatal exposure to toxicants. Women are often asked to contribute UCB soon after delivery when they may not be fully informed about the type of personal data that will be stored in UCB banks (Sugarman et al. 1998
). After consent, mothers may be asked about their sexual and medical history or their blood may be tested for infectious diseases, such as HIV and hepatitis. Prenatal studies may intrude on maternal privacy by asking whether pregnancies were conceived through reproductive technologies or provide information on a child’s paternity that was either unknown by the woman or that she did not wish to be revealed.
Private information about both the mother and fetus collected during the prenatal period may be stored in registries used in epidemiologic studies to monitor temporal or geographic patterns. To be of scientific and social value, registries must include minimal demographic information about the mother (i.e., age, ethnicity, and type of employment if it is relevant to potential exposure to environmental toxicants) and geographic region, as well as linkages between various sources of information about the mother and the fetus or newborn that at some point in the process must include a unique identifier that may pose privacy risks for the mother.
Investigators and IRBs need to be aware that risks to pregnant women outlined in this section raise issues of distributive social justice because the risks are assumed primarily by women rather than men. Thus, calculations of the ratio of scientific benefit to the confidentiality and privacy risks associated with such studies need to consider whether it is fair to burden one segment of the population with such risk.
Maternal privacy risks during prenatal testing
Collection of maternal urine samples or amniotic fluid to identify toxicants that may be associated with congenital anomalies may uncover maternal use of illicit drugs or illegal use of prescription drugs that can lead to criminal investigation, a child welfare complaint, loss of food stamps, or loss of Supplemental Security Income. Identification of toxicants in biologic samples from the mother or infant may also lead to disqualifications regarding maternal employment opportunities, social stigma, legal risk, or self-recrimination (Harvey et al. 2002
). For example, Grandjean and Sorsa (1996)
describe an instance in which a manufacturing company excluded smokers from work sites with asbestos exposure because of data indicating smoking might increase susceptibility to asbestos-related lung cancer.
Another threat to privacy can arise when, for recruitment purposes, physicians are alerted to the need for research on a suspected teratogenic agent unique to a specific maternal demographic. In these circumstances, whether or not the mother agrees to participate in the study, her physician may ask questions or conduct invasive tests that would not otherwise be required, and her refusal to take such tests may stigmatize her as a neglectful or incompetent mother (Marshall et al. 2003
). Additional privacy risks can emerge when women give permission for data from amniocentesis to be collected and the results of the amniocentesis lead to a decision to terminate the pregnancy—a decision that may be included in the data record.
Maternal rights versus the information rights of other family members
Data on maternal exposure to or ingestion of teratogenic agents also raise questions regarding the rights of other family members to this information. Does the child’s biologic or legal father have the right to maternal environmental exposure information hypothesized to be linked to fetal or child health? Does the decision depend on the extent to which the hypothesized link has been empirically demonstrated? Although physicians may not be legally required to share such information, their participation in recruitment and data collection may be judged within a different set of ethical and legal medical principles.
Do adult children with congenital anomalies or other health problems associated with maternal exposures or ingestion of environmental toxicants have the right to know about their mother’s environmental history if the information is available in data banks? The answer to this question may rest on the source of information. For example, if information on the mother’s exposure or ingestion of the teratogen was acquired through analysis of amniotic fluid, fetal tissue, or UCB, one might conclude that the child, not the mother, was the data donor, with all the informational privileges attached to donor status. Ethical decisions regarding these complex issues must be made during the design phases of the research so that IRBs can help investigators ensure that mothers are adequately informed about the immediate or future risks to privacy they may face.
Environmental health research involving teenage participants raise additional challenges in the arena of child and maternal rights. First, whether or not a pregnant teenager can provide legal independent consent to research participation depends on individual state laws governing the age and circumstances under which teenagers are considered mature or emancipated minors. In some states, for example, teenage mothers can provide consent for their infant’s participation in research but not for their own participation. Thus, in some instances, family members as legal guardians may have access to information about the adolescent mother’s exposure to or ingestion of teratogenic agents that would not be accessible if the mother were legally recognized as an adult (English 1995
; Santelli et al. 1995
A second concern arises in developmental studies of child and adolescent exposure to environmental toxicants. For such studies, adolescents may with parental permission assent to blood tests or other biologic assays to determine the presence of such toxicants. In some instances, these tests may indicate that the adolescent is pregnant, when the adolescent is not aware of the pregnancy and/or she does not want her parents to be notified. Disclosing such information to the adolescent may be perceived as a violation of privacy if the informed consent information did not include the possibility that a pregnancy could be detected. In other instances, the pregnancy may disqualify adolescents from continued participation in the study, leading to questions about the discontinuation from her parents. Is telling the parents the reason for discontinuation a violation of the adolescent’s confidentiality? Should investigators engage in deceptive explanations to parents about the reason for withdrawing the child from study participation? Should they continue to maintain the participant in the protocol with the intention of disqualifying the data, which in turn may violate their obligation to the agency funding the research? The best way to protect the privacy and confidentiality of female adolescent participants in these contexts is to plan in advance the disclosure procedures that will be most appropriate and least harmful to participants and their families and communicate what these procedures will be to both parents and adolescents during informed consent.