Title: The Follow-up Process: Obligations of Researchers to Anonymous Donors

Author: Adrienne Carpenter

Description: A small monetary incentive entices people to donate genetic material anonymously for Cystic Fibrosis research and future unspecified research. This case study considers researchers’ duties to anonymous subjects.

Keyword(s):  Anonymity, Informed Consent, Fair Subject Selection, Privacy/Confidentiality, Beneficence

Based On: (Brody, 1998)

Case: Dr. Gallardo is conducting genetic research on Cystic Fibrosis and CF-related liver disease. Since liver disease in CF patients does not seem to be related to specific CF gene-mutations, Dr. Gallardo wants to investigate the possibility of a relationship between liver disease and CF genetic modifiers or markers. The study requires participants to donate genetic material in exchange for small financial compensation. During the consent process and on the consent form, study participants are asked also to allow their samples to be used in future unspecified research and to allow investigators to access data from medical records in the future. Samples will be coded for confidentiality.

  1. Should the data ever be de-coded in order to inform participants of important findings?
  2. Given that the donors’ medical records will be retained for future use as well, how might participants be ensured that their information remain private if the nature of the future research is unknown?
  3. Can consent to future research ever truly be informed? If not, is this a concern?

Source: Brody, B. (1998). Ethics of Biomedical Research. New York: Oxford University Press.