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Case 35. Enforcement Agencies and the Protection of Human Subjects


Enforcement Agencies and the Protection of Human Subjects (Summarized from documents presented to ASA by Judith Levy)
Judith Levy was the Principal Investigator (PI) on a research demonstration project funded by the National Institute of Drug Abuse (NIDA). The study, the Neighborhood Outreach Demonstration Project (NODP), was designed to implement and evaluate the efficacy of providing community-based case management and peer support to reduce drug-use and HIV transmission among active street addicts. Levy received full Institutional Review Board (IRB) approval and maintained a rigorous set of procedures designed to minimize harm to research participants. She also obtained a Federal Certificate of Confidentiality issued under Public Health Service Act, 42, U.S.C. Section 242 (qa) as further protection. Levy became embroiled in an FBI investigation when two of the study's participants kidnaped their child from a Department of Child and Family Services shelter and fled across state lines.  Media coverage included on-the-sidewalk news reports, un-authorized by the project, which showed the study's field station and staff. Local police, cooperating with the FBI, proposed to hide in the field station to apprehend the couple and threatened project staff with prosecution for non-cooperation. The University lawyers were not able to stop the surveillance but were able to shift the police's site of their "stake-out" to cars on the street. 


  1. What are the ethical issues at stake here?
  2. What kinds of guarantees are really offered by either IRBs or the Federal Certificate of Confidentiality?
  3. Does the notion of vulnerable populations include or extend to research staff as well as research subjects?

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