From the Deputy Director for Intramural Research

A Red Alert for the NIH

BY MICHAEL GOTTESMAN

The intramural research program (IRP) depends heavily on input from outside experts to evaluate our laboratory and clinical research activities, including reviews by our Board of Scientific Counselors (BSC) and occasionally more global outside advice such as the recent Long-Term Planning Report from a subcommittee of the Advisory Committee to the Director (ACD). Most recently, in response to serious deficiencies discovered in May 2015 in the Clinical Center’s Pharmaceutical Development Section (PDS), NIH Director Francis Collins commissioned a report from an ACD subcommittee called the “Red Team,” chaired by Norman Augustine, formerly chief executive officer of Lockheed Martin, to determine the underlying causes of the PDS problems and to recommend a way forward designed to prevent similar problems from happening in the future.

The Red Team report was released on April 21, 2016. It concluded that deficiencies in practices in the PDS facilities—failure to comply with current good manufacturing practice (cGMP), a tendency to put research priorities ahead of safety concerns, and lack of reporting deficiencies up the chain of command so that corrective actions could be undertaken—were to some extent systemic and not limited to the PDS (http://www.acd.od.nih.gov/presentations/Red_Team_presentation.pdf).

These issues, if not attended to quickly, have the potential to put patients and, in some cases, staff at risk. In fact, some of the other facilities at the NIH that prepare sterile materials for use in clinical research were found to suffer from similar deficiencies incompatible with FDA requirements and have either been closed or are undergoing remediation. It is important to note that none of these problems have resulted in any direct harm to patients. But to maintain the deserved reputation of the Clinical Center as one of the best places in the world to participate in clinical research, we must take the findings of the Red Team very seriously and embrace its 11 wise, thoughtful recommendations. The report and its recommendations were relayed to institute and center directors, scientific directors, clinical directors, and the entire NIH clinical research community in a series of meetings on April 21 and 22, 2016.

The Red Team noted that in some cases it appeared that an emphasis on research was placed ahead of patient safety, and this emphasis must change. Such a change may require some investigators to reset their priorities and all of us to fortify our attention to patient care. The NIH clinical staff is highly dedicated to patient care, but that does not mean that we cannot improve our clinical-care practices and oversight even further. And the requirement “if you see something, say something” puts us all on notice that any concerns about practices that might threaten patient safety need to be reported to supervisors and beyond until appropriate action is taken. An improved system to accomplish this anonymously, if necessary, will be put into place.

There will be organizational changes to oversee and enforce new safety and compliance standards including a new Research Support and Compliance Unit (RSCU) in the Office of Intramural Research; a new Clinical Practice Committee to set standards for all clinical practice at the NIH; and an external hospital board, similar to those that oversee most U.S. hospitals, to ensure compliance with the highest standards of care.

On April 21, Dr. Collins announced that Laura Forese, executive vice president and chief operating officer of the New York–Presbyterian hospital system, will be the first chair of this new board. She is an orthopedic surgeon and has extensive experience in managing a vast hospital system.

Our very own Kathryn Zoon, formerly the scientific director of the National Institute of Allergy and Infectious Diseases and, before that, the director of the FDA’s Center for Biologics Evaluation and Research, will be the interim director of RSCU. She will work with me to help establish the office and oversee the development of a governance system that ensures compliance with regulatory and safety requirements at the NIH. These experienced leaders will make sure that we make all of the needed practice and policy changes that are outlined in the Red Team report.

The last sentence of the report captures the essence of the evaluation: “If the recommendations proposed herein…are implemented, the IRP can provide the essential degree of patient safety while continuing its record of extraordinary scientific accomplishments.” As with the many valuable recommendations that we have received over the years, our prompt and complete attention to this advice will make the NIH an even more effective research institution in which we clearly incorporate compliance with applicable regulations and policies into our scientific culture. (Please see the new “Guidelines and Policies for the Conduct of Research at the NIH” at http://1.usa.gov/1ruB9WK)

To see a videocast of the April 22, 2016, NIH Clinical Center Town Hall meeting at which Red Team report was presented, go to http://videocast.nih.gov/launch.asp?19639 (NIH only).

ACD Long-Term Intramural Research Program (LT-IRP) Planning Working Group

• Presentation: http://acd.od.nih.gov/presentations/2014-12-11_ACD_LT-IRP_Cato.pdf.
• Report: http://acd.od.nih.gov/reports/ACD-IRP-WG-report.pdf.

Michael Gottesman’s essay on the IRP long-term planning report in the July-August 2015 issue of the NIH Catalyst: https://irp.nih.gov/catalyst/v23i4/from-the-deputy-director-for-intramural-research.