23
May2017

PRIM&R has long prided itself on its role as a convener of divergent opinions and viewpoints. One of the ways we fulfill this role is through the development and nurturing of a diverse membership community, hailing from all parts of the research enterprise, from institutions large and small, public and private, from across the country and around the world.

This community sits at the foundation of PRIM&R’s mission; to advance the highest ethics standards in the conduct of research, we must reach those doing the important daily work of research oversight and administration. And in reaching them, we must provide them with the language, skills, and tools that will support them in meeting their obligations to the research enterprise and to the human beings and animals who contribute to research success.

This community of individuals has a role larger than underpinning PRIM&R’s mission, however. They are at the front lines of ensuring the safety and well-being of research subjects and serve as stewards of sound research practices.

This role is critical, but one fraught with the potential for conflict. As institutions face mounting financial pressure and reap larger research rewards, and as both regulations and research become more complex, ethics oversight committees are sometimes viewed as obstructionist or as an impediment to the advancement of science. There is no doubt that our research oversight and administration system can be improved—and we now have an opportunity to see if a revised Common Rule will lead to such improvements in human subjects research in particular.

Whether the revised rule helps (or even remains in force), we know that ethics oversight committees and the dedicated individuals who constitute and support them are better seen—and indeed see themselves—as partners and collaborators in the research endeavor. This distinction is so important that PRIM&R considers it a measure of success in its Strategic Vision for 2026: institutional cultures have evolved such that ethics oversight committees are embraced as helpful collaborators in the research endeavor. (We welcome your insights into how we might assist all aspects of the research enterprise in moving toward this reality.) As we celebrate and recognize our members during Membership Appreciation Month, I find myself reflecting on the work and tenacity of an individual whose conscience and ethical concerns did lead to a better, more successful research enterprise—Dr. Frances Oldham Kelsey, who passed away in 2015, at the age of 101.

In 1960, Dr. Kelsey, a physician and pharmacologist, was a new medical officer at the Food and Drug Administration when an application for FDA approval of the sedative Kevadon, with the trade name of thalidomide, came across her desk.

Thalidomide had already been sold to pregnant women in Europe, Canada, and elsewhere as an anti-nausea drug to treat morning sickness, and the drug manufacturer, William S. Merrell Company of Cincinnati, wanted a license to do the same in the United States. Not satisfied by the evidence presented about the drug’s safety, Dr. Kelsey rejected Merrill’s application, asking for more information. The drug company put pressure on the agency to approve the drug, complaining to Dr. Kelsey’s supervisors and mounting personal attacks against her. Each time they tried to push the application through, Dr. Kelsey stood her ground. This tug of war lasted 19 months.

By late 1961, it was clear that Dr. Kelsey’s vigilance and refusal to bow to company pressure had helped avert a medical disaster in the US. While she was pushing Merrell to provide more safety data, thalidomide had caused thousands of babies to die in utero, and at least 10,000 others in 46 countries to be born with missing limbs and other severe physical deformities. In many other instances, eyes, ears and other organs and tissues failed to develop properly. Only 17 births of babies with thalidomide-related deformities were reported to the FDA in the United States.

Dr. Kelsey’s experience led directly to a series of major reforms to the FDA’s drug approval system in the early 1960s, including requirements that drug companies conduct extensive safety and effectiveness testing before they apply for FDA approval. Over a distinguished 45-year career at FDA, Dr. Kelsey played a key role in strengthening the medical testing regulations, putting in place the modern clinical trial system, and setting up structures, including IRBs, designed to protect human subjects. 

Dr. Kelsey was an example not just of the need for effective regulators and regulations, but an example of the difference principled, committed, and conscientious individuals can make to the cause of advancing good, ethical research. PRIM&R’s membership community, too, are such individuals, whether they advocate for the protection of human subjects, like Dr. Kelsey, or for the welfare and care of animals used in research.

In honor of our Membership Appreciation Month, I want to thank and honor PRIM&R’s members for the work they do every day to protect human subjects and animals, and promote good science. PRIM&R couldn’t do what we do without you.

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