Chapter 17

Requirements for Human Research Protection Training

WCG IRB requires investigators to verify on the initial review submission form and each Continuing Review Report form that each member of the research team has successfully completed training in human research protection. Your institution may have additional training requirements, please check with your institutional official.Please note that HIPAA training or prior research experience alone does not satisfy this requirement for training in human research protection. Physicians and their teams who request approval of approval of Clinical Use of a Humanitarian Use Device (HUD) or compassionate use of a drug, biologic, or device are not required to complete training on the ethics and regulations of human research protections.

WCG IRB’s expectation is that training include topics such as ethical principles related to human research protections, federal regulations for protection of research participants, and Good Clinical Practice. If your team has not completed training, please be sure an equivalent training has been completed and is listed in the submission. 

When standard therapy is part of the research, WCG IRB only requires human research protection training of staff members who are involved in the consent process, recording of data, submission of unanticipated problem reports or other procedures specific to the research.

WCG IRB accepts training completed in a variety of formats (such as online modules, live seminars, college courses, self-study texts that provide CEU or CME credit) and from a variety of sources (such as government entities, non-profit institutions, professional organizations, and commercial businesses).   

Examples of courses are listed below. You are not limited to these training resources. Additional opportunities are available through other sources. External links are provided for user convenience and do not represent an endorsement by WCG IRB.

Online:

  • Investigators can meet the training requirement through the Collaborative Institutional Training Initiative (CITI) or CITI International. CITI training for U.S. research is available at: https://www.citiprogram.org. CITI International training for non-U.S. or international research is available at:  https://about.citiprogram.org/.
  • ACRP Certified Principal Investigator Training (CPI certification)
  • DIA Clinical Research Certificate Program
  • OCRA Clinical Research Professional (CRP)
  • Canadian researchers and study staff are required to complete Tri-Council Policy Statement (TCPS 2) training before their submission will be approved. The new TCPS 2: CORE-2022 Course on Research Ethics (CORE) is based on the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022). The online tutorial takes about 4 hours to complete and is available in English TCPS 2: CORE-2022 and French EPTC 2 : FER-2022.
  • The NIH Office of Extramural Research provides an online tutorial called “Protecting Human Research Participants” https://phrptraining.com/.