DHHS Office of Human Research Protections

Subject: Information on new Office for Human Research Protections

From Olivia Carter-Pokras:

Yesterday, one of the participants asked a question regarding review of translated documents. I responded that I was hoping that this new office would review the use of translation in the informed consent process. Here is more information about the new office.

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Subject: HHS PRESS RELEASE--OFFICE FOR HUMAN RESEARCH PROTECTIONS

Author: mhennegh@OS.DHHS.GOV

Date: 6/6/2000 2:05 PM

Date: June 6, 2000

For Release: Immediately

Contact: OPHS Press Office (202) 205-1842

Headline: New Office for Human Research Protections Created, Dr. Greg Koski Named Director

Edward Greg Koski, Ph.D., M.D., will serve as the first director of the Office for Human Research Protections (OHRP), a new office at the Department of Health and Human Services to lead efforts for protecting human subjects in biomedical and behavioral research, HHS announced today. As recommended last year by the Advisory Committee to the Director of NIH, the new office will be located at the HHS department level, in the office of the Assistant Secretary for Health. It replaces the Office for Protection from Research Risks (OPRR), which was part of the National Institutes of Health (NIH) and had authority over NIH-funded research.

Koski, 50, is currently director of human research affairs at Partners HealthCare System, Inc., in Boston, and Associate Professor of Anesthesia at Harvard Medical School. At Partners HealthCare, he oversees patient protection for research conducted at a consortium of institutions including Massachusetts General Hospital, Brigham and Women's Hospital, and their joint venture with the Dana Farber Cancer Institute, as well as several Partners-affiliated community hospitals and physician practices. "Dr. Koski is a national leader in today's renewed efforts to assure that patients taking part in research are better protected and fully informed," said HHS Assistant Secretary for Health and Surgeon General David Satcher in announcing the appointment. "The new office will have increased resources and broader responsibility, and we will look to it for leadership in articulating our goals for protecting individuals who volunteer to participate in research." "Greg Koski is the right person with the right experience at the right time to take on this challenge," said HHS Secretary Donna E. Shalala. "He understands that everyone in the research community must share the responsibility for protecting research subjects, and he knows how to make institutions and investigators sit up and respond fully to the needs of patients in research. "Medical research today is exploding with opportunity," she said. "But to achieve the benefits of that research, we need a solid foundation of thoughtfully-designed and thoroughly-executed research patient protections. The new OHRP will work with HHS agencies and with research institutions and sponsors to ensure that this foundation is in place and working productively."

The new office will also provide leadership for all 17 federal agencies which carry out research involving human subjects under a regulation known as the Common Rule. The OHRP will officially come into existence this month. At the same time, HHS will also charter a new National Human Research Protections Advisory Committee, to provide broad-based counsel on patient protection and research needs. A Federal Register notice will solicit nominations for the new 12-member committee, which was also a recommendation made last year by the Advisory Committee to the Director of NIH. The new OHRP will focus entirely on protection for human subjects, while treatment for animal subjects will be overseen separately by a new Office of Laboratory Animal Welfare at NIH. The OPRR had been responsible for both human and animal subjects. Taking over from OPRR, the new OHRP will monitor programs for the protections of human subjects at more than 4,000 HHS-funded universities, hospitals and other medical and behavioral research institutions in the United States and abroad. These programs must meet the requirements of HHS regulations for the protection of human research subjects and comply with the assurances that the institutions must have approved by HHS as a prerequisite for funding.

The OHRP will also work with NIH and the Food and Drug Administration (FDA) to carry out new patient protection initiatives announced by Secretary Shalala last month. These include:

new efforts to educate and train clinical investigators and members and staff of the Institutional Review Boards (IRB) that carry out patient protection at research institutions;
new guidance and procedures on informed consent for patients and volunteers in research;
improved monitoring by researchers, sponsors and the FDA to ensure safety and quickly detect any problems; and
clarification of existing policies on potential conflicts of interest affecting researchers, and development of updated policies.

As an immediate action, NIH today released two new guidelines and a set of issues for investigators and IRBs to consider on financial conflict of interest and research objectivity. One of the new guidelines requires that clinical researchers seeking NIH funding certify that they have taken special training in the ethical conduct of clinical research, and the other requires researchers applying for grants to conduct Phase I and Phase II clinical trials to send their clinical trials monitoring plans to the NIH. Each of the documents is available at the NIH website (http://grants.nih.gov/grants/oer.htm).

In the longer term, Dr. Satcher said, HHS will look to the new OHRP to develop new, stronger and clearer patient protection policies, with an expanded focus on performance and prevention as well as enforcement. The overall policies will apply to research funded or regulated by all HHS agencies, and will provide a model for other federally- and privately-sponsored research. Under the new OHRP structure, FDA retains its enforcement authority to ensure that researchers carrying out FDA-authorized drug and medical device clinical trials are complying with HHS patient protection and consent requirements. The new organizational structure will enable more effective coordination of HHS-wide policies and actions, Dr. Satcher said. "With strong leadership and coherent policy guidance for all HHS agencies, researchers will get a single set of messages, they will understand their responsibilities better, and they will understand they are being held more closely accountable," he said.

In addition, Secretary Shalala announced last week that she will seek new authority for FDA to levy civil monetary penalties of up to $250,000 per clinical investigator and up to $1 million per research institution in the event of violations of patient protection agreements. No money penalties are currently available to FDA for such violations, although the agency can issue warning letters and take action to halt research until problems are rectified.

Dr. Koski comes to the new position with a background not only in research management and patient protection, but also in basic and clinical research. His research experience includes clinical investigation over a range of disciplines, including human and animal physiology, biochemical pharmacology, neurosciences and regulatory biology.

In 1991 he was appointed to serve on the Subcommittee on Human Studies, the IRB for Massachusetts General Hospital, which was one of the first such committees in the country created to protect human subjects in research. In 1993 he became chair of the Subcommittee. In 1995, as director of Clinical Research and Development for Massachusetts General Hospital, he helped lead an effort to integrate and improve the IRB processes of that hospital and the Brigham and Women's Hospital when they joined to form the Partners HealthCare System. Dr. Koski lives in Holliston, Mass., with his wife Linda and their three children, Jessica, Hannah and Jared. He will begin work and planning with the new office immediately as a consultant, and take over as director in September.

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6/14/2000, Minority_Health@unc.edu