Have you ever tried to find an old friend from school? Where did they move? Did they change their name? It is not always easy, is it? Well, imagine that you are trying to find a few hundred research subjects to get consent to use their pediatric data or tissue in a research study. Sure, their mom or dad said that it was fine to use this sample or this medical information for research, but that was decades ago when the subject was a child. Now that the child is an adult, perhaps the subject has their own ideas about whether or not researchers should be using these resources for science. Finding them, however, could be a problem. Who are they? Where are they? Do you really have to go through the trouble and expense to find them? What would these “donors” think if you just skipped that step?
To shed some light on some of these questions, the authors of a new article (Goldenberg AJ, Chandros Hull S, Botkin JR, Wilfond BS. Pediatric biobanks: approaching informed consent for continuing research after children grow up. J Pediatr. 2009 Jul 10. PMID: 19595370.) conducted a survey based on a hypothetical scenario:
“When you were an infant, your parents gave their permission for a blood sample of yours to be used in research on children’s health. Your doctor collected samples from hundreds of infants this way. Since then, your blood sample has been stored in a freezer along with a unique identification number and some background medical information about you. Several decades have passed and all of the infants whose blood samples were collected are adults. The researcher now wishes to continue to use your sample for research.”
The survey asks four questions to measure the level of concern about using this data in research. The final question asks: “Suppose that the researcher could not locate you. Would it be acceptable to you for the researcher to use your sample anyway?”
The survey of 1186 patients at 5 academic medical centers found that 54% of the respondents did not think that researchers should have to ask the adult for consent to continue using their pediatric samples. Of the 543 (46%) people responding that researchers should have to ask for consent, 228 found it “acceptable” for a researcher to use the samples if the subject could not be located. While these numbers might be encouraging to researchers using pediatric samples, one must remember that 310 people would NOT find it acceptable for the researchers to use the samples without consent. The survey also gathered valuable information about trust in researchers, attitudes regarding genetic research in general, and privacy about medical information.
In the discussion, the authors observe that contacting every subject “may not be feasible for those studies that lack the funding and administrative support to keep track of children years after the initial participation.” Therefore, the authors recommend increased public engagement. By using focus groups, community meetings, and other engagement methods, the authors suggest that the public might become more comfortable with the concept of ongoing use of pediatric samples without explicit consent from adults. Researchers would also be better equipped to identify communities and studies in which the subjects would absolutely expect to be contacted as adults for explicit consent for ongoing research with their pediatric samples. Further research, the authors suggest, could go beyond hypothetical scenarios and explore what actually patients enrolled in pediatric biobanks think (as children and later as adults) about these issues.
Goldenberg AJ, Chandros Hull S, Botkin JR, Wilfond BS. Pediatric biobanks: approaching informed consent for continuing research after children grow up. J Pediatr. 2009 Jul 10. PMID: 19595370.
Haas DM, Renbarger JL, Meslin EM, Drabiak K, Flockhart D. Patient attitudes toward genotyping in an urban women’s health clinic. Obstet Gynecol. 2008 Nov;112(5):1023-8. PMID: 18978101.
Hull SC, Sharp RR, Botkin JR, Brown M, Hughes M, Sugarman J, Schwinn D, Sankar P, Bolcic-Jankovic D, Clarridge BR, Wilfond BS. Patients’ views on identifiability of samples and informed consent for genetic research. Am J Bioeth. 2008 Oct;8(10):62-70. PMID: 19003716.
Neidich AB, Joseph JW, Ober C, Ross LF. Empirical data about women’s attitudes towards a hypothetical pediatric biobank. Am J Med Genet A. 2008 Feb 1;146(3):297-304. PMID: 18205141.
Tarini BA, Goldenberg A, Singer D, Clark SJ, Butchart A, Davis MM. Not without my permission: parents’ willingness to permit use of newborn screening samples for research. Public Health Genomics. 2009 Jul 11. PMID: 19602864.
For more on the ethics of pediatric biobanks, read about the Predictive Health Ethics Research (PredictER) program of the Indiana University Center for Bioethics or follow PredictER Blog.
Other Recent Research Ethics Articles (July 2009)