reducing risk and promoting patient safety for nih intramural clinical research, draft report

What has NIH done to improve patient safety and research support?

Through the hard work of clinical leadership and staff at the NIH Clinical Center and NIH Institutes and Centers, we have made significant advancements to foster and support the highest quality of patient safety and research support. While not a comprehensive list, the following provides key improvements made in recent years.

What are the NIH guidelines for clinical research?

The NIH Guidelines cover aspects appropriate to Basic as well as Clinical Research. Guide for Sharing Research Resources Guide for Standards for Clinical Research within the IRP Guide for Human Biospecimen Storage and Tracking

Are nurses prepared to manage clinical risk effectively?

Accordingly, nurses need to be prepared educationally to manage clinical risk effectively when delivering patient care. Just what form the CRM and safety education of nurses should take, however, remains an open question.

What's new at the NIH Clinical Center?

These improvements bolster the NIH Clinical Center's extensive activities in patient safety and clinical quality. Established a new hospital board with Dr. Laura Forese, Executive Vice President and Chief Operating Officer of New York-Presbyterian, as Chair

Leadership

Established a new hospital board with Dr. Laura Forese, Executive Vice President and Chief Operating Officer of New York-Presbyterian, as Chair

Patient Safety and Quality of Care Improvements

Launched new patient safety event reporting system = Safety Tracking and Reporting System (STARS)

Staff Engagement

Established the Clinical Center Engagement Working Group, and held several town hall-style meetings and ~70 focus group sessions with ~620 staff

Compliance

Created the Office of Research Support and Compliance to ensure that research conducted across all NIH Institutes and Centers, whether in or outside of the Clinical Center, adheres to the highest regulatory, professional, and ethical standards

Facilities

Constructed an interim intravenous admixture unit (I-IVAU), which opened in April 2017 and meets strict USP 797 industry standards

What is the role of participants in clinical research?

A key responsibility of the Clinical Center and the investigator is to assure participants are educated about the protocols in which they are enrolled as well as about the clinical research process. Likewise, providing participants with opportunities to ask questions and voice concerns to the Investigator and the Clinical Center throughout the course of the research protocol is an essential aspect of a human subjects protection program.

What are the requirements for a clinical trial?

Training and education are first-order requirements to ensure that the Principal Investigators (PIs) and Associate Investigators (AIs) on clinical trials have a consistent and complete understanding of their responsibilities. Clinical protocol design requires a working knowledge of clinical trials methodology, biostatistics, and regulatory medicine. Similarly, monitoring the trial during its execu­tion involves many distinct responsibilities—including reviewing each study subject’s record to confirm his or her protocol eligibility, reviewing each study subject’s record to determine compliance with the protocol, reporting adverse events to the IRB, determining neces­sary changes in the protocol and the informed-consent documents and submitting them as protocol amendments to the IRB, monitoring accrual to the study, and stop­ping the study when the requirements of the study design have been fulfilled or when it is clear that the rate of accrual fails to meet expectations.

What is the role of a research sponsor?

The sponsor is defined as the organization that “takes responsibility for the initiation, management and financ­ing of a clinical trial.”3 In the context of the intramural program, the research sponsor is each institute conduct­ing intramural clinical research.

What is the scientific review committee?

All protocols involving human subjects must undergo review of scientific content by an institute scientific review committee. These protocol review committees assess scientific quality, the importance to clinical practice, and the appropriateness of the study to the sponsoring insti­tute. Following the scientific review, all protocols must be reviewed by an institutional review board (IRB) or the Office of Human Subjects Research (OHSR) as required to establish and ensure patient safety and good ethical conduct of the study, including avoidance of conflicts of interest.