Training

Training in the protection of human subjects of research is strongly encouraged by the U.S. Office for Human Research Protections (OHRP).  Training is required by the University of Richmond IRB.

Chapter 5 of the UR IRB Policy Guide is devoted to training and states that “Since the September 9, 2008 meeting of the University of Richmond IRB, investigators involved in human subject research at the University of Richmond have been required to present certification to the IRB that they have completed training in human subjects’ protection.  Certification will be required prior to the IRB providing final approval for non-exempt research.”  Training requirements for UR faculty, staff, and students are detailed in Chapter 5 of the UR IRB Policy Guide.  These policies are consistent with those of other responsible institutions conducting research with human subjects.

“While OHRP does not require training, the office is very clear that training in the protection of human subjects of research is a necessary practice.  As stated in an OHRP FAQ:

“The HHS regulations for the protection of human subjects (45 CFR part 46) do not require investigators to obtain training in the protection of human subjects in research. However, an institution holding an OHRP-approved Federalwide Assurance (FWA) is responsible for ensuring that its investigators conducting HHS-conducted or -supported human subjects research understand and act in accordance with the requirements of the HHS regulations for the protection of human subjects. Therefore, as stated in the Terms of the FWA, OHRP strongly recommends that institutions and their designated IRBs establish training and oversight mechanisms (appropriate to the nature and volume of their research) to ensure that investigators maintain continuing knowledge of, and comply with, the following:

  • relevant ethical principles;
  • relevant federal regulations;
  • written IRB procedures;
  • OHRP guidance;
  • other applicable guidance;
  • state and local laws; and
  • institutional policies for the protection of human subjects.

Furthermore, OHRP recommends that investigators complete appropriate institutional educational training before conducting human subjects research.

In some cases, other federal requirements regarding training for investigators must be met, such as the National Institute of Health’s (NIH) requirement for the training of key personnel in NIH-sponsored or -conducted human subjects research.”