February 14, 2001
Harold Shapiro, M.D.
Chairman
National Bioethics Advisory Commission
6705 Rockledge Drive
Bethesda, MD 20892-7979
Dear Dr. Shapiro:
The American Political Science Association (APSA), established in 1903, is the major professional society of individuals engaged in the study of politics and government. APSA publishes the leading journal of political science research, the American Political Science Review and through its other programs and projects advances scholarship, nationally and abroad.
Among the APSA's 13,000 individual members are political scientists engaged in research involving human participants. Their research protocols include interviews, extensive surveys, and some laboratory experiments. Political scientists are obligated by the Association's code of ethics to protect the confidentiality, welfare, and safety of research participants. Additionally, political science research is subject to the standards set and the oversight mechanism provided by the Common Rule.
APSA welcomes the opportunity to comment on the draft report, Ethical and Policy Issues in Research Involving Human Participants (December 19, 2000). The Association concurs with the draft report's finding that the current system of human protection is flawed. The principles of the Common Rule are unfortunately inconsistently interpreted by Institutional Review Boards. A significant portion of the confusion is attributable to IRBs that treat social science research as if it involved the same methods, presented the same degree of participant and investigator interaction, and posed the same degree of potential harm to human participants as biomedical research. The Association supports the draft report's conclusion that "review criteria and mechanisms must be appropriate for the particular type of research."
The Association is disappointed, however, that taken as a whole the report remains preoccupied by biomedical clinical and experimental research. Examples used to illustrate problems associated with the Common Rule involve biomedical research almost exclusively. The fact that social scientists often experience too much rather than too little oversight, or oversight out of proportion to the risks posed by their research protocols is ignored. The Association believes the recommendations of the report still rest on the assumption that biomedical research is the modal research activity.
The Association does not support the elimination of exempted research. There are categories of research activity that pose no threat to research participants and to insist that such research should be subject to even administrative review unnecessarily burdens both investigators and the review process. The draft report erroneously concludes that research exempted from IRB review is spared from meeting ethical standards. There is no evidence that social science research currently exempted under the Common Rule has spawned research that has endangered human participants.
Although the draft report acknowledges that social scientists have disciplinary codes of ethics, it discounts the fact that political scientists and their peers in the other social sciences abide by their disciplinary codes, the fundamental principal of which is to do no harm to the research participant.
The availability of "administrative review" is not a panacea. Social scientists have found the expedited reviews available under the current system to be expeditious in name only. In practice, IRBs are often either unwilling or unable to discriminate regarding the potential for harm and the reasonableness of reporting requirements. For example, two investigators from major west coast research universities were subjected to a nine month review of their project despite the fact that nature of the participant/investigator interaction involved asking paid volunteers to call the toss of a coin.
The Association does not support the draft report's contention the judgments of risk and benefits are best made when half of IRB members are non-scientists. It has proven to be difficult enough for scientists to assess risk and determine benefit when dealing with research activities outside their discipline.
Similarly, members with only a passing knowledge of other disciplines' methods are inadequate to the tasks envisioned for them. The "educational" programs proposed by the draft report can not compensate for the lack of training. The Association urges that IRB membership adequately represent the disciplines of the research reviewed. If all research is to be reviewed under the draft report's plan, the rules should clearly provide that social scientists, behavioral scientists, and scholars from the humanities should each be represented in sufficient numbers among IRB members.
The richness of scientific inquiry involving human participants should be recognized and accommodated even as human protections are strengthened. This cannot be accomplished without social scientists becoming directly involved in the reassessment process. APSA respectfully urges the Commission to incorporate an adequate number of social scientists in a fundamental redrafting of the human protections standards and procedures. APSA and its peer scholarly societies among the social sciences and humanities are ready to assist in this effort.
Sincerely,
Catherine E. Rudder
Executive Director, APSA
cc. Robert Jervis, Robert Putnam