Title: Three Scenarios Concerning Anonymous Donations
Author: Adrienne Carpenter
Description: This case study provides three scenarios concerning genetic research.
Keyword(s): Anonymity, Future Research on Stored Samples, Preexisting Data, Privacy/Confidentiality, Waiver of Consent
Based On: (Brody, 1998)
Case:
Scenario 1: Researchers plan to conduct a study on genetic samples that have already been stripped of identifiers, meaning that the samples are from anonymous donors (even if some demographic and clinical information has been maintained). The study would attempt to explore the possible health effects of the area’s water supply on certain demographic populations. However, since the samples are already anonymous, it would be impossible to inform the donors of any relevant results or to obtain their consent.
- How might one weigh the potential for scientific and medical gains against the lack of potential benefit for the individual donors?
- Is use of genetic material without consent acceptable in this study? Why or why not?
Scenario 2: The same study plans to use genetic material that has not yet been stripped of identifying information, but would be during the course of the research. Therefore, it is theoretically possible to obtain consent (even if impractical to do so).
- What factors should the researchers consider before determining whether or not they plan to obtain consent?
- What are the risks to the subjects in this research?
Scenario 3: Finally, the same study plans to use genetic material that has not and would not be stripped of identifiers; the material would be potentially used in future epidemiological research as well. Investigators plan to obtain informed consent to use the samples. There are several consent options: participants may allow their material to be 1) included in this study but not in future research, 2) used now and in related research in the future, 3) used only in anonymous research in the future (their samples would have to be stripped of identifiers in this case), or 4) used in other types of research in the future. The concern, though, is that offering these various consent options could affect the robustness of future epidemiological studies.
- Given the possible impact on potential future studies, do the researchers have the obligation to offer all of these consent options? Could the researchers specify that participants in the current study must also allow for their material to be used in future, non-anonymous research (or else not participate at all)?
- How can consent be informed regarding future research that has not yet even been designed?
- Should the investigator be obligated to inform the participants of the results of this study? Why or why not?
Source: Brody, B. (1998). Ethics of Biomedical Research. New York: Oxford University Press.