October 26

Director of OHRP Dr. Greg Koski resigns

Director of OHRP Dr. Greg Koski resigns

Date: Wed, 16 Oct 2002

Dr. Greg Koski has tendered his resignation as director of the federal Office of Human Research Protections. We agree, in principle, with Dr. Koski’s assessment: “to preserve public trust in research, the scientific community must go beyond a culture of compliance-it must strive for a culture of conscience–one in which we do the right thing not because we are required to, but because it is the right thing to do…”

However, we firmly believe–and the evidence demonstrates–that without the adoption of mandatory ethical standards, appropriate penalties, and their vigorous enforcement, those who currently disregard the rights and welfare of children and vulnerable adults in clinical research will not be deterred. Dr. Koski’s laudable goal of cultivating “a culture of conscience” can come about only when mandatory protections are in place.

Vera Sharav

—–Original Message—–

From: Office for Human Research Protections (OHRP) [mailto:OHRP-L@LIST.NIH.GOV]On Behalf Of Rice, Garey
Sent: Wednesday, October 16, 2002 3:10 PM
Subject: Open Letter to the Research Community

After more than two years at the helm, Dr. Greg Koski, Director, Office for Human Research Protections, has decided that it is time to return to private life. Dr. Koski will return to Harvard University, effective November 30, 2002.

If you have any questions or require additional information, you may contact Ms. Patricia El-Hinnawy at pel-hinnawy@osophs.dhhs.gov or (301) 435-5654. Please do not respond directly to this listserv announcement. A copy of Dr. Koski’s letter to Secretary Thompson of the Department of Health and Human Services follows:

October 9, 2002

The Honorable Tommy Thompson

Secretary, Department of Health and Human Services

Dear Mr. Secretary:

A little more than two years ago, the Department of Health and Human Services launched a series of initiatives to improve our national system for protection of human subjects in research. The Department’s action came after years of growing public and Congressional concern over the effectiveness of a system implemented nearly thirty years ago and little altered since, despite major changes in the research environment. These concerns were clearly stated in the report issued by the Department’s Inspector General in 1998, and again in 2000, and in reports from several advisory committees, both inside and outside the government over the course of two decades. Sadly, only human tragedy compelled the Department to finally take action.

A major first step was the creation of a new Office for Human Research Protections placed within the Office of the Secretary, a position from which it could provide leadership for the Department’s initiatives. At the request of former Secretary Donna Shalala, I accepted the challenge of becoming the first Director of this new office, charged with providing leadership for the Department’s initiatives.

The past two years have been eventful ones, marked by many challenges and changes. Through the collaborative efforts of committed colleagues throughout the Department, particularly from the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control and Prevention and the Office for Human Research Protection, significant progress has been realized. In fact, after hearing testimony at a public Senate subcommittee hearing last April, even Senator Bill Frist declared, “We are not where we were two years ago.”

When the Department began its efforts two years ago, it did not have a road map to follow. We began with the simple premise that ensuring the well being of research subjects is a responsibility shared by everyone who participates in the research process, and their highest priority. We launched a major remodeling effort that has focused on developing a proactive, performance-based system for prevention of harm to human subjects, one that applies the principles of continuous quality improvement to the oversight process. We have sought to improve not only the effectiveness, but also the efficiency of the process. Most important, we have conveyed to all in a clear, strong and consistent voice, a philosophy that to preserve public trust in research, the scientific community must go beyond a culture of compliance-it must strive for a culture of conscience– one in which we do the right thing not because we are required to, but because it is the right thing to do, a refrain now echoed frequently throughout the research community.

On October 3, 2002, the Institute of Medicine released the final report from a study that the Department commissioned two years ago at the outset of these efforts. The report, entitled “Responsible Research: A Systems Approach to Protection of Human Research Participants” makes recommendations based upon a comprehensive assessment of the current status of our system for human subjects protection. The report reaffirms both the conceptual framework and the programmatic approaches that the Department has been taking, and provides independent, external validation that the path upon which we set out two years ago was then, and remains today, a good one. In this, I believe that all of us in the Department and at our companion agencies can rightfully take a measure of pride, for our successes have come through a great team effort, both within government, and within the research community. We have given substance to our motto, “Doing it right, together.”

I believe that we have made significant progress, and we have many important initiatives underway. At the same time, it is immediately evident that much remains to be done. The Institute of Medicine report will provide valuable guideposts for the Department as it continues its efforts to ensure that every participant in human research will be protected by an effective, comprehensive oversight system aimed at preventing harm. In the end, this system may look very different from what we have known, and it will be better, if we continue to work together with imagination and flexibility to fulfill our shared goals and responsibilities. As the Department continues its efforts, one cannot understate the importance of your strong personal leadership and support for these efforts as elements essential to their success.

Apart from its validation of the Department’s initiatives, the new Institute of Medicine report lays out an ambitious agenda for continuing reform. If it were practicable for me to do so, I would choose to continue in my present leadership capacity for another three to five years to see these efforts through to their ultimate completion. I regret that I cannot. The past two years of public service have placed heavy burdens on my family, and I believe that having this report in hand affords an opportune and appropriate time for me to pass the baton to the next director of the Office for Human Research Protections. Accordingly, I wish to notify you of my intention to return to private life effective close of business, November 30, 2002. I will continue to fulfill my duties and responsibilities until then.

Serving as the first director of the Office for Human Research Protections has been an extraordinary challenge, privilege and honor. I want to take this opportunity to thank you and all of my friends and colleagues throughout the research community for the strong support of our efforts over the past 18 months. The senior leadership team of the Office for Human Research Protections and I will work closely with Assistant Secretary Slater and Deputy Assistant Secretary Lawrence over the next several weeks prior to my departure to ensure a smooth transition in leadership, continuing progress in development and implementation of our programs, and fulfillment of our public responsibilities to protect those upon whom human research depends.


Greg Koski, PhD, MD

cc: Dr. Eve Slater, Dr. Arthur Lawrence, OHRP Leadership Team

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