Health Sciences Report Summer 2003

Opinion
By Jeffrey R. Botkin, M.D., M.P.H. U of U associate vice president for research integrity Professor of pediatrics and adjunct professor of human genetics and internal medicine U of U School of Medicine

Why does a university need a vice president to oversee research integrity?

Roughly 40 years ago, a Harvard anesthesiologist, Henry Beecher, published an analysis of 22 clinical research articles that had appeared in the U.S. medical literature. Beecher made the startling claim that these articles and similar publications demonstrated that unethical research was commonplace.

In some projects, for example, numerous subjects died when treatments of known efficacy were withheld in placebo- controlled trials. It was apparent that, for the occasional scientist, the zeal for discovery clouded ethical judgment. This landmark article became one of the cornerstones of contemporary research ethics and was instrumental in founding our current system of peer review and informed consent for research.

From the 1970s through the early 1990s, a series of professional groups, fueled by broad social dialogue, established a set of standards and regulations by which human subject research is to be conducted. A key element of the new process is the Institutional Review Board, or IRB. This panel, composed of academic peers and lay participants, has the responsibility of reviewing research protocols to address research ethics, including the informed consent of participants. Without IRB approval, a human research protocol cannot be conducted. While this system is cumbersome, it has placed the protection of research subjects at the forefront of an institution's research enterprise.

In the last three years, there has been renewed attention to research ethics. In part, this is due to high-profile tragedies, like the deaths of Jesse Gelsinger in a gene therapy protocol at the University of Pennsylvania and a young woman in an asthma study at Johns Hopkins. Such cases have brought intense scrutiny to institutions to determine whether they were conforming with research standards and regulations. More broadly, Congress and the executive branch of the federal government have exerted their oversight powers to assure that research institutions do conform. This new stringency has resulted in entire research programs being halted at a dozen institutions for failures to comply with federal regulations. These decisions come at enormous cost to the reputations and research efforts of institutions and investigators.

In response to this new climate, universities across the country have redoubled their efforts to make sure research is being conducted with appropriate safeguards. The renewed attention to research ethics nationally has included other important issues, including financial conflicts of interest for investigators and institutions, research misconduct, and safety concerns.

The University of Utah is the flagship research institution in the state and one of the premier research institutions in the country. In 2002, we received in support of research more than $275 million, a number that grows on an annual basis. With the volume and complexity of research at the U, President Machen and Ray Gesteland, vice president for research, developed a new position, associate vice president for research integrity, to oversee the University's activities with respect to the IRB, conflict of interest in research, research misconduct, biosafety, and the Resource for Genetic Epidemiologic Research. The education of faculty and staff on these issues also is an important aspect of the position.

Fortunately research ethics is not a static domain, nor one that is exclusively devoted to compliance with regulations. There are active debates over the ethics of research in a variety of areas including research with stem cells, pregnant women, incompetent individuals, children, and aspects of genetic research, placebo research, and social and behavioral research, to name only a few. The field will continue to evolve, and we can expect that we will be doing things differently, and even better, in the future. No doubt we will continue to struggle with the proper balance between the constraints and assurances of oversight on the one hand, and the creativity and risks of unfettered research on the other. We expect to be at the forefront of these debates at the University of Utah.

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