RCHSPB's mission is to facilitate the clinical research enterprise by providing protocol development and regulatory, clinical trials management and safety oversight for the NIAID intramural and Division of Clinical Research (DCR) programs.
RCHSPB originated in June 2001. branch staff consists of a branch chief, clinical research oversight managers, and administrative support personnel. A contract with Leidos Biomedical Research, provides staffing for key areas of the support that the branch provides. Each oversight manager is responsible for an area of research support and oversees the contract staff’s work.
Clinical Safety Office
Clinical Trials Management (CTM) Group
NIAID IRB Office
The role of the NIAID Institutional Review Board (IRB) is to ensure the safety and welfare of human subjects who participate in research. The IRB office does this by providing advice and administrative support to investigators and IRB members. The office is staffed by a Clinical Research Oversight Manager, a Nurse Specialist, and two IRB Administrators.
NIAID Regulatory Review for Intramural Protocol and Informed Consent or Assent Documents
As outlined in the NIAID standard operating procedure on informed consent/assent documents, before an investigator submits an initial intramural protocol (IND and non-IND studies) and informed consent/assent documents to the NIAID IRB, he or she must submit the protocol documents to the RCHSPB staff for a regulatory review. In addition, amendments to IND protocols must be submitted for regulatory review before they are submitted to the NIAID IRB office.
In support of IND applications, the Regulatory Group
The mission of the RCHSPB Training Program is to provide training support and promote professional development for individuals involved in conducting or overseeing research under the auspices of the NIAID intramural community and those sponsored by the NIAID intramural programs.
Last Updated August 13, 2014