Requirements for Human Subject Protection Training

BRANY requires investigators to verify on the initial review submission form that each member of the research team has successfully completed training in human research subject protection. The NIH has mandated and OHRP strongly recommends that all investigators and those identified as “key personnel” in human subject research must provide evidence of education in the protection of human subjects. “Key personnel” are defined as individuals who are responsible for the design and conduct of a study. Therefore, all investigators and key personnel, including all co- investigators, and others participating in the conduct of the research must satisfy this requirement. The IRB will deny the privilege of participation to investigators or key personnel until proof of certification is submitted. The IRB will maintain a record of all those who have been certified. Every new and continuation application that is submitted to the IRB will be assessed to ensure that all individuals who will participate in the conduct of the research have been certified.

The BRANY IRB will accept certification programs from individual institutions. As individual institutions may have their own requirements, in addition to what BRANY accepts, please confirm with your institutional official. Investigators must be in compliance with their institution’s re-certification policies.

In the absence of an Institutional certification program or participation in a BRANY program, the IRB will accept evidence of completion of the online National Institutes of Health (NIH) Office of Extramural Research module entitled “Protecting Human Research Participants” or a certificate evidencing completion of the Dunn and Chadwick examination contained in their book entitled Protecting Study Volunteers in Research, which may be obtained through Centerwatch Publications at http://www.centerwatch.com.

BRANY IRB will also consider other forms of human subject protection education on a case-by-case basis. For example, an independent investigator may have completed comprehensive human subject protection education while previously affiliated with an Institution or other organization; in such cases, prior research education completed at an Institution may be accepted by BRANY IRB. The IRB Director (or designated IRB staff), with consultation from the IRB Chairperson(s) and/or the Institutional Official as needed, will evaluate and make determinations of acceptable forms human subject protections education beyond those defined above based on program content. Examples of acceptable evidence of training include, but are not limited to:

  • Certified Principal Investigator (“CPI” designation offered currently by ACRP)
  • Certified Clinical Research Coordinator (“CCRC” designation offered currently by ACRP)
  • CITI Course Completion: Basic Biomedical Research Module (or equivalent)
  • Other equivalents that include training in the US federal research regulations, informed consent requirements, process, and documentation, The Belmont Report, The Declaration of Helsinki, and The Nuremburg Code.

Additionally the BRANY IRB encourages Investigators and research staff to complete Good Clinical Practice Training and HIPAA (Health Insurance Portability and Accountability Act) training. Certificates evidencing completion of such training programs should be submitted to the BRANY IRB.

Please note that HIPAA training or prior research experience alone do not satisfy this requirement for training in human subject protection.

The BRANY Institute for Research Education offers the following course, which can satisfy BRANY IRB’s human subject protection education requirement: IRB Basics

Contact BRANY IRB If you have any questions about whether your training will fulfill BRANY IRB’s requirements for human subject protection training, please contact BRANY IRB.