In 2006, the University of Chicago Institutitonal Review Board was given a protocol that would set up a pediatric biobank. The IRB desired greater pediatric ethics expertise and asked the PI (principal investigator) to meet with the research ethics consultation service. Specifically, the IRB raised the issue of whether a Pediatric biobank presents at most minimal risk. This is important as research on healthy children that does not offer the prospect of direct benefit is permissible with local review only if it poses at most minimal risk. The IRB also asked the Ethics Committee to consider 1) What additional information beyond the traditional consent requirements should be included to ensure that parents are giving meaningful informed consent?; and 2) What additional safeguards, if any, should be in place to protect newborns whose parents authorize their enrollment into a biobank?

After several meetings between the PIs and the research ethics consultation service and a review of the biobank literature, there was consensus that the research posed minimal risk. Although the REC believed that the consent requirements were adequate, the REC felt that additional privacy safeguards were important to protect the enrolled children, and suggested that the researchers in charge of the new pediatric biobank obtain a Certificate of Confidentiality (COC) from the National Institutes of Health. The PIs and the IRB agreed and a COC was obtained before parents were asked to enroll their child in the biobank.

In addition, the REC decided to use this opportunity for a broader purpose. One member of the REC decided to collect data from mothers of healthy infants about their attitudes towards a pediatric biobank in order to examine empirically the questions asked by the IRB. We also decided to collect data from these women about their own decision about enrolling in an obstetrics biobank program that was already enrolling women at our institution (CLIPP, or the Chicago Lying-in Pregnancy Program) as well as hypothetical enrollment into the pediatric biobank. What we found was that 47% of women stated that they would enroll their child in the hypothetical pediatric biobank. Another 66 (28%) were not sure. The rest (57 or 24%) stated that they would not enroll their child. When women were asked the open-ended question of why they would or would not enroll their child into the hypothetical biobank, 207 provided an explanation. Fifty three women (26%) explained that they did not feel that they had enough information and another 21 (10%) and 17 (8%) expressed concerns about risks and privacy respectively. Sixteen women (8%) expressed concerns about consent: either that they would want to include the infant’s father or that the decision should be made by the child when he or she could consent for him/herself. Of the 90 women who explained why they would enroll their children, 48 (53%) expressed altruistic reasons to benefit society and 18 women (20%) described the potential benefit to their own child or family.[3]

One hundred and seventy-six of 233 (76%) women perceived their child’s enrollment into a pediatric biobank as minimal risk. An additional 38 women were not sure leaving only 19 women (8%) considering enrollment to be more than minimal risk. The assessment of risk did not correlate with enrollment.

The University of Chicago research ethics committee was very concerned about the privacy risks of a pediatric biobank and how it would be interpreted by the community. However, we found that virtually all of our respondents (over 80% African American) expressed trust that the researchers would keep their information private. Thus, the concern that led to a COC application appears to be more palpable to the ethics committee than to the women we interviewed.

The decision to publish both the hypothetical pediatric data [3] and the obstetric data [4] was to share with our colleagues both the utility of research ethics consultation and to show how ethics issues raised by a scientific project can lead to an empirical ethics investigation in its own right. In this case, then, our consultation served the PI, the IRB and the broader research community.

History of Research Ethics Consultation at the University of Chicago

Research Ethics Consultation began at the University of Chicago in 1988 when the transplant surgeons decided to explore with the faculty of the MacLean Center for Clinical Medical Ethics a living donor liver transplantation between a parent and child. The transplant surgeons were frustrated by the inadequate supply of livers for children and wanted to increase access for children. The literature showed that healthy adults could live without their right hepatic lobe and this was believed to be an adequate quantity of liver for a young child.

In consultation with the Ethics faculty, 3 major issues were raised. First, who were the appropriate patients? The surgeons and ethicists agreed that they wanted to give parents the right to renege from this first-of-its-kind procedure. In that vein, the decision was to limit this procedure initially to children who had a chronic progressive cause of liver failure, namely biliary atresia. This way, the issue could be raised at diagnosis (usually around 6-8 weeks) although a transplant would often not be necessary for 6-8 more months. The transplant team explained to the parents that the child could be listed for a deceased liver or that the parent could undergo elective partial hepatectomy which would be transplanted into the child. Parents who wanted to be listed and only undergo the surgery if a liver did not become available in a timely manner were excluded on the grounds that the living donor option was a procedure of lsat resort and raised issues of true voluntariness. Thus, the decision was to enroll only children with chronic liver disease whose parents were willing to undergo the experimental procedure as a first option.

The second major issue was what to tell the parents about the risks and benefits of the procedure. In truth, an elective hepatectomy in a healthy person had never been done before and that was clearly stated in the consent form. The consent was quite detailed.

The third major decision was to perform these procedures as a research project and to seek IRB approval. In addition, both the transplant team and the ethicists agreed it would be wise to publicly raise the issue before the first living liver donor transplant was performed. The manuscript was published in the New England Journal of Medicine.[1] There were no concerns expressed by the medical community and the procedure was performed later that year and heralded as a huge success.

Both the ethics team and the transplant team were quite pleased with the concept of research ethics consultation for innovative practice and wrote a more analytical manuscript discussing this process that was published a year later in Theoretical Medicine.[2] As the authors explain in the abstract:

Our purpose was to analyze the ethics of liver transplants using living donors and to propose guidelines for the procedure before it was introduced in the United States. We used a process of "research ethics consultation" that involves a collaboration between clinical investigators and clinical ethicists. We concluded that it was ethically appropriate to perform liver transplantation using living donors in a small series of patients on a trial basis, and we published our ethical guidelines in a medical journal before the procedure was introduced. We recommend this prospective, public approach for the introduction of other innovative therapies in medicine and surgery. [2]

Thus, this case example shows 2 clear differences between IRB review and research ethics consultation. First, research ethics consultation can be useful to the broader research community in discussing methodologies for working with clinicians to ensure a scientifically sound ethically appropriate research methodology. While IRBs often work behind closed doors, the research ethics consultation provides an opportunity to share best practices with colleagues around the world. Second, research ethics consultation served to facilitate passage of the proposed surgery as a research endeavor with the IRB.