OFFICE OF SCIENTIFIC AFFAIRS AND BIOTECHNOLOGY

INSTITUTIONAL REVIEW BOARD

Investigator Education Program

Recognizing the complexity of the federal, state and campus policies, procedures and regulations created to adequately protect the rights of human subjects in research, the IRB has adopted the mandatory education program outlined below for all IRB members, Principal Investigators and all project staff (e.g., co-investigators, study coordinators, study nurses) having any contact with human subjects, human subject data or human biological specimens. Recertification is required every two (2) years (no later than September 1, 2003 for individuals who have completed the short exam contained in Protecting Study Volunteers in Research). Effective October 15, 2001, the IRB office will not process any application until the Investigator and all appropriate staff have completed the education program:

• receive and become familiar with Downstate's DHHS Federalwide Assurance (FWA) for the Protection of Human Subjects and Terms of the FWA Assurance (available on disk or on-line);
• receive and become familiar with the Belmont Report — read and re-read before you start any phase of any project involving human subjects (available on disk or on-line);
• receive and become familiar with the Institutional Review Board's Principal Investigator's Procedures Manual for the Use of Human Subjects in Research (available on disk or on-line); and
• complete the on-line Collaborative IRB Training Initiative (CITI) computer-based training program for biomedical research, #1-#12, Hot Topics and #14 Downstate IRB quiz — #13 is optional unless your project includes the Brooklyn VAMC as a study site, and, if required by the IRB Office, the social/behavioral research part of CITI.
  1. To obtain IRB certification or re-certification, click here > CITI certification/training program

PHS Certification of Investigator Education in the Protection of Human Research Participants

Before any PHS (NIH, CDC, etc.) agency will make an award of any new, competing renewal, non-competing renewal or supplement award, the campus must certify that the Principal Investigator and all key personnel (including subcontract personnel where appropriate) have completed the IRB's Investigator Education Program in the Protection of Human Research Participants as described above.

Continuing Education

Completion of this Investigator Education Program should not be viewed as the "end of a requirement" but instead as the "beginning of a process." There are many study-specific variables which create unique human subject ethical or process related issues. Each of these may warrant further discussion or review of relevant background material. The IRB Office maintains an extensive collection of reference materials that may be used to resolve these issues.

All materials listed above may be obtained in the IRB Office (BSB 2-71E). If you have any questions, please contact the IRB Office at 270-2680 or by e-mail at irb@downstate.edu.