Human Subjects Training Requirements

Summary

All FHCRC investigators and staff involved in the design OR conduct OR reporting of research must take human subjects training every 3 years.

Who needs training?

Training is required for FHCRC investigators and staff involved in one or more of these activities:

• Design: developing the research concept, scientific method, and objectives that involve intervention with a human subject or the use of data or tissue derived from a human subject.
• Conduct: implementation and management of research involving human subjects. Staff conducting research include principal investigators, research staff working on a research study, and others engaged in research activity supporting the research study (e.g., conducting interviews, surveys, data collection).
• Reporting: analyzing, summarizing, or preparing manuscripts involving data derived from a research study involving human subjects.

As of February 1, 2007, training is mandatory for all personnel involved in design OR conduct OR reporting of research. In practice, this will include not only investigators, but also nurses, data managers, lab technicians, and others. (Previously, mandatory training was limited to key personnel involved in the design AND conduct of research.)

How often do I need training?

You need a basic course, if you haven't had one before.

You need refresher training every 3 years.

New FHCRC investigators and staff must receive initial training by the end of the third month after beginning employment.

What training courses will meet the requirements?

Please see the full list of accepted human subjects training courses.

What if I don't comply?

Individuals who fail to meet the training requirements may no longer be involved in human research. The IRO will notify the employee, their supervisor, and the Division Director. The employee would need to respond to the email confirming they would not be involved in research; they can be reinstated when they complete their training.

If the lead investigator of a study fails to meet the training requirements, the IRB will close the study. It can be reopened when the lead investigator completes the training.

Will you send reminders?

Yes. The IRO will send you an email reminding you that your training certification will expire.

How can I find out when I last took training?

Documentation of training is maintained in the Institutional Review Office. Check to see if your name is listed on the IRO's list of people who have taken human subjects training.

If my primary affiliation is with another institution, do I need to meet the FHCRC training requirements?

It depends on your role. If you are the principal investigator on a study submitted to the FHCRC IRB, you need to meet the FHCRC's requirements. (If you have already met requirements that overlap with ours, you do not need to repeat them just for us.)

Other non-FHCRC investigators and study staff should meet the requirements of their own institution; the PI should append a letter to the FHCRC IRB certifying that study staff have met the relevant institutional requirements.

Will FHCRC's training be accepted at my institution?

Please ask your institution.

Have other questions? Email James Riddle, IRO Assistant Director or call him at 667-6501.