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.
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.