Case 64. Data Sharing, Informed Consent and Confidentiality

Situation

Professor Randall Stillwell's research on family ties among the homeless participating in a demonstration project was funded by a federal agency and has passed through all the appropriate human subjects reviews regarding safeguards on confidentiality, risks and benefits. At the end of the project, Professor Stillwell is asked by a colleague at another university if he would provide his data for a secondary analysis on a related topic. Professor Stillwell becomes concerned that his informed consent statement did not notify the respondents that the data would be passed on to other researchers. He knows that the information was shared with him because the respondents in the program came to trust him as a researcher and, while he does not know for certain, suspects that they would have been skeptical if they were aware that data would be passed on to others. He deliberates the sensitive nature of the data since the site for the study was small and could lead to the identification of particular individuals. 

Questions

1.    Are Professor Stillwell's concerns justified? 
2.    How can he resolve issues of informed consent and protection of subjects with both federal mandates that encourage data sharing and that require that data collected under federal funds be made public after five years? 
3.    If such concerns and situations are common, how can informed consent procedures be developed which takes this and other possible future uses of the data (e.g., in data archives such as the ICPSR) into account?


     Reflect on the above questions and form your own answers before clicking the Discussion key to review the commentary provided with this case.

Discussion

Ethical principles and scientific standards have to be anticipated by researchers, whatever the federal regulations are. In this case, if Professor Stillwell does not make the data available to others, then the data cannot be verified and the results subjected to scrutiny by others. At the onset of the project, Professor Stillwell needed to match the feasibility of the research with the ability to make the data available for scrutiny. If he is convinced that key issues remain, then Professor Stillwell should raise them with both his local Institutional Review Board (IRB) and other colleagues with experience in these matters. Respondents need to be informed about every possible use of the data as long as they are consonant with scientific objectives and they have been obtained with ample consent for the research from respondents.