The rockefeller university

Board of Trustees, and the Hospital Committee of the Board

• The Board of Trustees of the University, acting by and through the Board’s Hospital Committee (the Hospital Committee), is the governing body legally responsible for the operation and support of the Hospital. The purpose of the Hospital is to serve as a clinical facility in which programs of clinical research are safely and effectively carried out and research participants who are healthy or have a disease or condition and who participate in these programs (the “Participants”) receive clinical care according to the highest professional standards.

Institutional Official – Michael Young, PhD, Vice President for Academic Affairs

The Vice President for Academic Affairs serves as the Institutional Official (the “IO”). The IO interfaces with and is responsible to the Board of Trustees on all issues related to the HRPP.

Director of the HRPP – Thomas P. Sakmar, MD

While the Institutional Official is responsible for broad oversight of the HRPP, the Director is responsible for ensuring that the numerous administrative duties of the HRPP are performed and may delegate to others certain duties.

Institutional Review Board

The Rockefeller University IRB reviews studies that involve human subjects as set forth in 45 CFR 46 and 21 CFR 56. The IRB adheres to specific standards, as set forth in its policies and procedures which are available to all members of the Rockefeller scientific community.

Center for Clinical and Translational Services Advisory Committee on Clinical and Translational Science / ACCTS)

The Rockefeller University Hospital (RUH) is supported by an NIH Clinical and Translational Science grant and thus bears the formal designation as The Rockefeller University Center for Clinical and Translational Science (CCTS). The Center is governed by a broadly representative Advisory Committee for Clinical and Translational Science (ACCTS) composed of senior and junior investigators, key RUH staff leaders, and Clinical Scholars. The ACCTS meets at least once a month. In the arena of the HRPP the ACCTS’s functions includes the assessment of all new protocols prior to review by the IRB for:
• • Scientific excellence;
  • Biostatistical validity;
  • Staff training requirements;
  • Appropriateness of data safety and monitoring plans and
  • Compliance with NIH policies, e.g., inclusion of diverse populations of research subjects.

Clinical Research Facilitation Office

The Clinical Research Facilitation Office provides assistance to investigators in developing study protocols that fully meet scientific validity, regulatory requirements, equity in recruitment and human subject protection and ascertains that RUH staffing and resources are available. This is accomplished by one-on-one interaction with experienced clinical coordinators and/or by scheduling “Navigation Meetings” with representation of services such as nursing, pharmacy, bionutrition and RUH administrative staff as appropriate. The aims and deliverables of the navigation process are:
• • Develop hypothesis, aims, and study design
  • Provide for biostatistical support
  • Define primary outcome/s and sample size
  • Strengthen scientific rigor
  • Develop a realistic recruitment and compensation plan
  • Provide a rigorous feasibility analyses by the clinical services
  • Incorporate Human Subject Protection Guidance
  • Assure GCP and translational science training
  • Identify anticipated regulatory/other barriers

Clinical Research Support Office /CRSO

The Clinical Research Support Office provides support for the regulatory activities required for the successful conduct of translational and clinical research conducted at RU through coordination and integration of staff resources and policies via a centralized office, assisting investigators, teams, and staff in the following areas:
• • Recruitment and equitable compensation plans
  • Maintenance of a Repository of Subjects
  • Data and Safety Monitoring Plan (DSMP) development and implementation
  • Education in Human Subjects Protections Training and Good Clinical Practices
  • Monitoring and Auditing (random and for cause)
  • Centralized management of Investigator-held INDs
  • Research Subject Advocacy available to research participants by listening to their problems and concerns, obtaining additional information and offering recommendations to resolve issues.

Office of General Counsel (OGC)

The OGC reviews all clinical study agreements to assure that they include language required to provide the necessary protections for human subjects. When a contract is involved, it is negotiated by the OGC and research may not be initiated before the contract is executed.  A representative of the OGC serves as a member of the IRB and provides expertise with regard to compliance with federal and New York State laws as well as the laws of any other jurisdiction where research is conducted. The OGC also staffs the RU Faculty Conflict of Interest Committee.

Faculty Conflict of Interest Committee

Issues concerning conflict of interest and commitment are subject to The Rockefeller University Policy on Financial Conflict of Interest and Conflict of Commitment in Research and The Rockefeller University Policy of Financial Conflict of Interest in Human Participant Research. The Committee meets as needed to consider and make determinations on conflict of interest issues for RU Investigators and when appropriate proposes a management plan to address the conflict. The Committee forwards its recommendations to the IRB. In addition, the IRB is charged with making an independent assessment if further actions are required.