Case 35. Enforcement Agencies and the Protection of Human Subjects

Last Updated: July 12, 2016

Situation

(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.

Questions

  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?

Discussion

As Levy points out, research designed to implement and evaluate services for individuals engaged in criminal activity placed the project at multiple risk for problems. These include the ability to protect the confidentiality (e.g., anonymity and location) of research participants, the protection of subordinates and the clash between law and ethics. Levy’s experience with the Certificate of Confidentiality (COC) is not encouraging. She contacted the Office of the U.S. General Council on the recommendation of the federal officer who issued the certificate and was advised to see University attorneys because Council could not be of any assistance. Similarly, her case suggested that IRBs have little in place to handle challenges from state agents. She discovered, by consulting the Federal Register, that she did not have the legal right to withhold research data in a criminal investigation if the a court has found “good cause” to investigate or pursue a serious crime. In addition, the Register made clear that she was subject to legal penalty, even under these circumstances, for revealing confidential information (e.g. fines from $500 for first offense to $5,000 for subsequent offenses). Finally, her experience pointed out that on-site staff, rather than the PI, are likely to be presented with challenges to confidentiality. In this case, using former drug addicts as peer supports, meant that the notion of vulnerable population could be extended to staff since police threatened staff with contempt of court penalties (which for this population with significant prison histories) would likely result in harsh judgements.

In general, the COC is very misunderstood. It has limitations and does not protect researchers and research projects from federal scrutiny. The researcher is still obligated to put all of the necessary protection in place (e.g., separation of names and data). In addition, ethical obligations extend to making staff aware of what they must do to protect the confidentiality of respondents. This cases raises a set of issues about what researchers must do at the start of a research project and at the end of a project.