On May 23, 2000, Department of Health and Human Services Secretary Donna E. Shalala announced new federal initiatives to strengthen protections of human research subjects. As had been generally expected, institutions receiving federal funds for research will now be required to provide training in research bioethics training and human subjects protection for all clinical investigators, research administrators, IRB members and IRB staff, and will also be required to carry out audits of approved research to insure that subjects' rights are being protected. Two aspects of the new initiative which had not been anticipated are new steps to enforce conflict of interest rules which will extend to revealing to subjects any financial stake an investigator has in the research -- and the intent to enact civil penalties against individual researchers and institutions who fail to protect research participants.

This is the description of the new actions, taken from Secretary Shalala's press release:

Education and Training. HHS will undertake an aggressive effort to improve the education and training of clinical investigators, IRB members, and associated IRB and institutional staff. NIH, FDA and the Office for Protection from Research Risks (OPRR) will work closely together to ensure that all clinical investigators, research administrators, IRB members and IRB staff receive appropriate research bioethics training and human subjects research training. Such training will be a requirement of all clinical investigators receiving NIH funds and will be a condition of the NIH grant award process and of the OPRR assurance process.

Informed Consent. NIH and FDA will issue specific guidance on informed consent, clarifying that research institutions and sponsors are expected to audit records for evidence of compliance with informed consent requirements. For particularly risky or complex clinical trials, IRBs will be expected to take additional measures, which, for example, could include third-party observation of the informed consent process. The guidance will also reassert the obligation of investigators to reconfirm informed consent of participants upon the occurrence of any significant trial-related event that may affect a subject's willingness to participate in the trial.

Improved Monitoring. NIH will now require investigators conducting smaller-scale early clinical trials (Phase I and Phase II) to submit clinical trial monitoring plans to the NIH at the time of grant application, and will expect investigators to share these plans with IRBs. The NIH already requires investigators to have such plans and they also require large scale (Phase III) trials to have Data and Safety Monitoring Boards (DSMBs). For research on medical products intended to be marketed, FDA will also issue guidelines for DSMBs that will delineate the relationship between DSMBs and IRBs, and define when DSMBs should be required, when they should be independent, their responsibilities, confidentiality issues, operational issues and qualified membership.

Conflict of Interest. NIH will issue additional guidance to clarify its regulations regarding conflict of interest, which will apply to all NIH-funded research. HHS will also hold public discussions this summer to find new ways to manage conflicts of interest so that research subjects are appropriately informed, and to further ensure that research results are analyzed and presented objectively. In addition, these public discussions also will focus on clarifying and enhancing the informed consent process. Based on these public forums, NIH and FDA will work together to develop new policies for the broader biomedical research community, which will require, for example, that any researchers' financial interest in a clinical trial be disclosed to potential participants.

Civil Monetary Penalties. HHS will pursue legislation to enable FDA to levy civil monetary penalties for violations of informed consent and other important research practices-up to $250,000 per clinical investigator and up to $1 million per research institution. While FDA can currently issue warning letters or impose regulatory sanctions that halt research until problems are rectified, financial penalties will give the agency additional tools to sanction research institutions, sponsors and researchers who do not follow federal guidelines. As an interim step, NIH, OPRR and FDA will work more closely together to enforce and target existing penalties.

As reported in the May 24 New York Times, the move to assess fines against researchers requires Congressional action, and there is expected to be resistance to this idea from some members of Congress, as well as from universities, medical centers and others with a stake in research. The idea of monetary penalties is intended to be an intermediate step that pinpoints particular culprits, somewhere between ineffective slaps on the wrist and the wholesale closure of research programs, such as have been seen across the country in the past two years.

How Will This Affect County Researchers?

With the exception of the new civil penalties, all these changes take effect immediately. One of the new requirements, that the consent process be closely monitored, is already in force in the County system, with the initiation last summer of the our Research Quality Assurance Program. Other requirements, such as disclosure of financial interests to research subjects, will be the subject of policies not yet published. The most immediate way in which researchers will be affected is in the requirement for explicit training in research bioethics. Indications from federal regulators are that it will not be enough to ask researchers to read a set of guidelines, as we do now; there will also have to be some formal way to verify that individual researchers are knowledgeable about their responsibilities for protecting human subjects. Other institutions have adopted mandatory training sessions, web-based tutorials, or qualifying exams to accomplish this end. These and other options will be explored in the near future, with the goal of having a program to meet this new requirement before the end of summer. If you have any suggestions, or if you would like to work on the group that will design the program, please call Karen Smith at 312-633-4940 or email at kmsmith@wwa.com.

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