Institutional Review Board

Preparing for Research  |  Human Subject Protections Training

A.Online Training Program

Requirement for all Key Personnel (PIs, CO-PIs, and Other Key Personnel) listed in IRB Applications.

1.Educational Resources

On-line training: All IRB members and investigators involved in human subjects research must complete the Collaborative Institutional Training Initiative (CITI) Human Subjects Research Curriculum. Due to the discontinuation of the NIH online Human Subjects Protection Training, all new certifications submitted to NASA must use the CITI Program. NASA is a participating organization of the CITI Program, through the University of Miami, which offers research ethics education at:

https://www.citiprogram.org

CITI certification is valid for a period of three (3) years.

All "key personnel" or team members listed on the IRB application will be required to complete human subjects education before a study is approved by the IRB.

"Key Personnel" are any individuals responsible for the protocol development or design, conduct, or reporting of research. These include but are not limited to: Principal Investigators (PIs), Co-PIs, faculty advisors, study coordinators, recruitment staff, and anyone else performing study procedures or interventions. These individuals should be listed as Team Members in the protocol submission.

Individuals who are not considered "key personnel" includes technical staff such as: coders, statisticians, data entry personnel, IT support, and others. Administrative staff including secretarial support, logistics coordinators, and other types of administrative staff are also not considered "key personnel."

2.National Conferences and Workshops

Public Responsibility in Medicine and Research (PRIM&R) Conferences Office for Human Research Protections (OHRP) Workshops Association for the Accreditation of Human Research Protection Programs Conferences

B.Documentation of Training

CITI training documentation must be attached to protocol submissions.

An NIH biosketch is a professional profile that consists of general personal information in a standardized format. It is required for all grant applications to the NIH and has been adapted for use in many institutions in lieu of a curriculum vita (CV) because of its uniformity and because it can be stored and reused. Use the NIH Biosketch in place of a CV on all research proposals.