Human Research Protection Program

HITECH Act

Training Requirements

ANNOUNCEMENTS

Human Research Protection Training Change

As of July 1, 2010, continuing human research education is required at least every 3 years for individuals involved in the design and conduct of non-exempt human research.

If you have not taken human subjects protection training since 2008, the continuing education requirement may be fulfilled by completing one of the HRPP Modules or completing any one of the CITI continuing education modules available at the Yale Training and Certification. If you have completed human research protection training through CITI for the VA, this will also fulfill the requirement. Email a copy of your CITI certificate to Jean Larson.

Investigators and study personnel involved in human subject research must complete the requisite training sessions prior to submitting a protocol for approval or re-approval to the IRB. This may also include HIPAA Privacy Training (specific to Research.) Complete the Yale Online Assessment to identify your course requirements and to determine whether you have complied with current regulatory and institutional requirements. Please refer to the Yale Training and Certification website.

How can this training requirement be met?

The initial training requirement can be met by completing one of the following options:

  1. Complete the Yale web-based training program or the CITI basic training, available through the Yale training and certification website.
  2. Complete the NIH Protecting Human Research Participants training program.
  3. Provide documentation and certification of completion from some other training provider, i.e., another University's training program, DHHS or the FDA.

The continuing education requirement can be met by attending any Human Research Protection Program educational session, or by completing any one of the Yale human research modules, or any one of the CITI continuing education modules available through the training and certification website, http://www.yale.edu/training/. Training in the use of the Coeus electronic submission system does not meet the continuing education requirement.

Who has to obtain training?

All people identified as study personnel in the application who are involved in the design and/or conduct of research involving human subjects. The definition includes all investigators involved in the design, performance, data acquisition or analysis of the study. The definition also includes any person who may have significant contact with a human subject or identifiable information or data about the subject during the course of the study. These personnel may include student assistants, nurses, technicians, study coordinators and general assistants.

The requirement extends to all funding mechanisms: grants, contracts, fellowships, training grants, investigator financed, etc., as well as to subcontractors on any such awards.

What effect does training have on the protocol?

Participation of individuals on protocols will not be authorized by the IRB until completion of the required training has been verified.

How often is training required?

Completion of the initial human research protections training is required prior to any work on a human research protocol. 

Continuing education is required once every three years for all personnel engaged in Yale human research.

What documentation is required and when is it to be submitted?

Proof of training completion must be submitted to the IRB office on or before the request for protocol approval, re-approval or submission of an amendment for approval. The proof of completion is entered into a Human Subjects Protection Training database and is accessed and reviewed by the IRB and Grants and Contracts offices. Therefore, study personnel need only provide this information initially. Once the data has been entered, it will be reviewed for future protocol and grant activity as well.

Study personnel who opt to take Yale's on-line IRB tutorial, or who complete the CITI training through the Yale training and certification website will automatically have their name and completion date populated into the Human Subjects Protection Training database.  CITI continuing education sessions and continuing education sessions offered by the HRPP will also automatically have their name and completion date populated into the Human Subjects Protection Training database, generally within 48 hours.

How Do I print off a copy of my training profile or certificate of completion for a course?

The Yale training and certification website offers each individual the opportunity to view the courses they have taken, and to print out either a certificate of completion for an individual course, or to print out a training profile, listing all courses completed.  The profile is accessed through the training site/my training information/transcript.  Each course listing has a printer icon at the end, which, when clicked on, produces a training certificate that can be printed.

Study personnel who opt to take another on-line tutorial or who have received training from another institution are required to provide a copy of the completion certificate to the IRB Office. This documentation can be submitted with the application for protocol approval or re-approval or faxed to 785-2847 for biomedical protocols, social behavioral, educational protocols.  IRB office personnel will enter their data into the Human Subjects Protection Training database.