Human Research Protection Program

The purpose of this SOP is to set forth the training requirements for those involved in or associated with human subjects research being conducted under the auspices of Brandeis University.

This SOP applies to all research personnel listed on an IRB protocol and conducting research under the auspices of Brandeis University, as well as Brandeis University IRB members, HRPP staff, and Institutional Official.

It is the standard operating procedure of Brandeis University that all named research personnel conducting human subjects research under its auspices, as well as all Brandeis University IRB members, HRPP staff, and Institutional Official, are required to complete appropriate training in human subjects research.

Investigators

Brandeis University requires all named research personnel conducting human subjects research to complete the customized online training program through the University of Miami’s Collaborative Institutional Training Initiative (CITI) prior to submission of an IRB Protocol. No IRB protocol will be reviewed without confirmation of completion of CITI training.

All research personnel must choose one of three Training in Human Research Basic Courses (Social & Behavioral Research, Data or Specimens Only Research, or Biomedical Research), as well as all applicable Special Topics courses. Investigators embarking on a new research project must ensure they have completed the required courses associated with the additional research, including both the Basic and Special topics Courses.

CITI training will cover a period of three years from the date of completion. Investigators continuing to keep their protocols open after this period must complete the applicable Training in Human Research Refresher Course, also offered through the CITI program, every three years.

IRB Members

Brandeis University requires all IRB committee members to complete the Collaborative Institutional Training Initiative (CITI) IRB Member basic course prior to participating in the review of research, participate in ongoing training conducted during the monthly IRB meetings, and, prior to the review of applications on special topics, any applicable Special Topics modules.

HRPP Staff

Brandeis University requires all HRPP staff to complete the following Collaborative Institutional Training Initiative (CITI) courses within one week of the commencement of duties: 1) the Social & Behavioral Research Investigators basic course, 2) the Data or Specimens Only Research basic course, 3) the Biomedical Research Investigators basic course, and 4) the IRB Members basic course. In addition, prior to review of applications on special topics, HRPP staff will complete the applicable CITI Special Topics modules.

Institutional Official

Brandeis University requires the institutional official to complete the Collaborative Institutional Training Initiative (CITI) Institutional Official basic course prior to beginning his/her tenure, in addition to the IRB Members basic course.