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On the Subjects' Side
The research done by HSPH investigators covers a vast range of disciplines and employs a wide array of means and methods. From census data analysis to DNA manipulation, from air-quality assessment to violence prevention- what all of this research has in common is a goal of improving the public's health.
Who ensures that no one gets hurt along the way? An analysis
of the concentration of toxic particles found in a neighborhood a
hundred miles along the jetstream from a coal plant may provide data
valuable for setting EPA emissions standards, but what does it do to
the value of the homes in that neighborhood? Should the residents
be told of the presence of toxic particles? Most people would
answer "yes," but what if we don't know
if the particles are toxic or not?
Should the residents be told of something which may- or
may not- be dangerous?
Willy Piessens, incoming
chair of the Human Subjects Committee.
These are the kind of questions for which the HSPH Human Subjects Committee exists to answer. "Our mission," said Willy Piessens, longtime committee member and, as of September 1, chair, "is to review all research projects of the school with regard for the protection of the human subjects of the research. We act as an advocate for the study volunteers or subjects."
The modern history of human subjects protection originates from the Nuremberg Code, developed at the end of World War II as a standard by which to judge the human experimentation done by the Nazis. In the US, the National Institutes of Health issued their first policies for human subject protection in 1966; they were raised to regulatory status in 1974.
In 1978, a national commission identified three basic principles underlying the acceptable conduct of research involving human subjects: respect for persons, beneficence, and justice. Respect for persons involves a recognition of the personal dignity and autonomy of individuals, and special protection of those with diminished autonomy. Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. Justice requires that the benefits and burdens of research be distributed fairly.
Ethical problems with the school's research are rare,
according to Piessens. "The most common areas of discussion with research proposals pertain
to the confidentiality of research data, issues of
informed consent, and cultural issues in
international research."
The committee at work under outgoing chair
Troyen Brennan (pictured center).
The committee comprises 12 members, including seven faculty members representing the diverse biological, numerical, and social sciences at the school, a student, a staff member, and three community members not otherwise associated with Harvard.
Angie Foss, associate director for human research and law in the Department of Health Policy and Management, serves as administrator of the committee. She explained who should submit an application for approval to the committee: "Anyone at the school who is using humans in any way, no matter how innocuous the plans for the subjects' involvement may seem. Approval by our committee is a requirement for any projects funded by federal dollars. Some journals won't accept articles based on research that was done without the approval of a human subjects committee. But it really has nothing to do with money or publication. It has to do with the protection of people. HSPH requires committee approval for all research projects involving the use of human subjects."
The application process entails the submission of a standard application form along with a copy of the research protocol. Foss distributes the completed packages to each of the committee members for study prior to their monthly meetings. "Then we get together and try to ferret out any possible concerns," said Foss. "The committee works because it's such a diverse group. With 12 people representing different disciplines and backgrounds examining a research protocol, we're able to see things from a perspective other than that of the researcher."
Foss echoed Piessens's recollection that problems with HSPH research are rare, despite two HIV-related research projects that received some media attention for their human subjects protocols last year. One project was criticized for not using a placebo trial, while the other was reproached for using placebos. Both had received approval by the Human Subjects Committee. "Every project is considered independently. We don't give blanket approval for a protocol- we approve a protocol for a particular context," said Foss. "The concern with placebos is 'does it compromise potential treatment for the subjects?' In the first instance, the government was willing to pay for HIV drugs that seem beneficial. In this case, it would be wrong to deny people the possible benefit of those drugs simply to provide a control group for a study. In the second instance, however, the subjects weren't denied therapy in favor of placebo, so we gave that our approval.
"Extensive reviews of both projects have concluded that both researchers are behaving appropriately given the conditions present in the countries where they're performing the research, so we continue to support them."
Asked about the likely evolution in the issues facing the committee, Piessens predicted that the group would probably "see an increase in the number of studies that link genetic mutations or polymorphisms to disease states, or that attempt to identify genetic factors that increase the risk of environmental hazards causing ill health. The big issues will be those of confidentiality and the availability of genetic counseling."
Forms and instructions for applying for Human Subjects
Committee approval will be available for downloading from the World
Wide Web by the end of the summer. The URL for this site will be
announced in Around the School as soon as it
is available.
