IRB POLICY II
Verification of Training on the Protection of Human Participants

In October 2000, the National Institutes of Health (NIH) established a policy requiring education in the protection of human research participants for all investigators and key personnel submitting NIH applications for grants, proposals for contracts, or receiving new or non-competing awards for research involving human participants. As part of its commitment to the protection of human participants, The Pennsylvania State University has developed a training program. Penn State's Institutional Review Boards (IRBs) have determined that all human participants research, conducted under the auspices of Penn State and regardless of funding, will have a training requirement. Investigators will not be able to obtain awards until the training requirement has been met.

Personnel involved in the activities, as defined below, will be required to complete a web-based training on the protection of human participants before final approval will be granted for the application.

Training is required if you:

• are responsible for the design or conduct of a human participant study, OR
• have access to the human participants, OR
• have access to identifying (including but not limited to name, e-mail address, social security number, and videotaping) and confidential data or biological specimens, OR
• are a faculty advisor for student research involving human participants.

Training is not required if you:

• are conducting research using human specimens, tissues, or data that are not identifiable. Investigators or student advisors involved in research under exemption #4* (please see below) are not required to complete this education. (PLEASE NOTE: This type of research still requires a submission of a secondary data application to the Office for Research Protections for status determination and subsequent review and approval.)

*Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. 45 CFR 46.101(b)(1)-(6)

The Office for Research Protections (ORP) is automatically notified when the online training has been completed. A certificate of completion will be sent via email and it is the individual's responsibility to retain a copy for future use.

For those who are currently affiliated or employed with Penn State University: PSU faculty, staff, and students proposing to conduct human participants research, as defined above, are required to successfully complete the on-line training on the protection of human participants, unless:

• the individual in question is a member of the College of Medicine/Hershey Medical Center. In this case, verification of training from the IRB at Hershey will be accepted (check their website at: http://www.hmc.psu.edu/irb/).
• the individual in question has transferred from one of the other CIC (Committee on Institutional Cooperation) Universities to Penn State. In this case, verification of training from the other CIC University will be accepted and PSU training will not be required.
  CIC Universities:
  
  • University of Michigan
  • Michigan State University
  • University of Chicago
  • Northwestern University
  • Ohio State University
  • Purdue University
  • University of Illinois
  • Indiana University
  • University of Iowa
  • University of Wisconsin
  • University of Minnesota
  • Penn State University
• An individual who has transferred from an institution other than a CIC University or Hershey Medical Center will be required to take Penn State's training.

For those who are not currently affiliated or employed with Penn State University:

• The individual in question must provide verification that he/she has completed training on the protection of human participants at the institution where he/she is currently employed or from the National Institutes of Health (NIH).
• If the individual has not completed training, is unable to complete training at his/her institution or does not have training available at his/her institution, then he/she must successfully complete PSU's training or training offered by NIH. NIH's training can be located at http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp.

Penn State's training is available at http://www.research.psu.edu/orp/education/modules/

Original Approval Date: 09/20/01
Last Revised and Approved: 04/15/04