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IRB Policy II - Training Requirements for the Protection of Human Participants

— filed under: IRB

Purpose:

The purpose of this policy is to define the training requirements of individuals engaged in human participant research and listed on an Institutional Review Board (IRB) submission at The Pennsylvania State University (Penn State).

Applicability:

This policy is applicable to all individuals engaged in human participant research and listed as personnel on an IRB submission. This policy is applicable at all University locations (except the Hershey Medical Center/College of Medicine which conducts independent IRB reviews).

Definitions:

Engagement (Engaged): individuals are considered engaged if they are designing and conducting human participant research, or if they are the assigned faculty advisor for a student conducting human participant research.

Generalizable: refers to being “universally or widely accepted,” (i.e. research findings become common knowledge and formulate the scientific community’s general principles or inferences). Data that will be disseminated beyond the institution of Penn State and its immediate university community is considered generalizable.

Human Participant: (1) a living individual about whom an researcher (e.g. professor or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information, or (2) a participant in research, who is either a recipient of a test article or acting as an experimental control.

Human Participant Research: A systematic investigation designed to develop or contribute to generalizable knowledge that involves gathering/obtaining data about living individuals through intervention or interaction with the individual or by obtaining identifiable private information about the living individual.

Interaction: includes communication or interpersonal contact (e.g. by telephone conversation, or through internet use) between a researcher and participant.

Intervention: includes both physical procedures by which data are gathered (e.g. venipuncture), and manipulations of the participant or the participant’s environment that are performed for research purposes.

Non-affiliated researcher: an individual who is engaged in research and is neither a Penn State employee nor student and listed as personnel on an IRB submission (including exempt level research).

Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Researcher: a Penn State employee or student who is engaged in human participant research and listed as personnel on an IRB submission (including exempt level research).

Policy:

It is the policy of Penn State’s IRB for researchers to complete training on the protection of human research participants. Approval to conduct human participant research will not be granted until the training requirements are satisfied. All training is valid for three years from the time it was completed.

The Institutional Official, IRB members and designated Office for Research Protections (ORP) staff are also required to complete the training requirements.

Training Requirements:

Initial Training Requirements

Researchers must complete the Collaborative Institutional Training Initiative (CITI) course (www.citiprogram.org), which is offered in biomedical and social science modules. The applicable training is based on the focus of the research. Additional training requirements may apply depending on the type of research or training required (e.g., Department of Navy [DON] training through CITI for DON funded research, Biosafety, Radiation, etc.).

Researchers are required to complete the CITI training with the exception of researchers who transfer to Penn State from another institution where they previously completed CITI training. In this instance, researchers are required to provide verification of the completion of the CITI training within the last three years.

Non-affiliated researchers are required to provide verification that training on the protection of human research participants was completed within the last three years.

Continuing Training Requirements

Researchers are required to complete the continuing training requirement, which is a refresher module that is different than the initial training. The refresher training must be completed before their initial training expires. Researchers are required to complete CITI refresher training.

Researchers who transferred to Penn State from another institution and provided other verification of completion of CITI training are required to change their affiliation through CITI to “Pennsylvania State University” prior to completing the refresher training.

Non-affiliated researchers are required to provide verification of the completion of continuing training within the last three years.

Additional Guidance:

Penn State's CITI training is accessible at: http://www.research.psu.edu/training/irb-basic-training. Instructions are accessible at: http://www.research.psu.edu/orp/humans/documents/instructions-on-accessing-citi-training.doc. When the initial training has been completed, the ORP is automatically notified and the ORP database is updated. A completion report is available through CITI and should be saved or printed. It is the individual's responsibility to retain a copy for future use or reference. Completion of Penn State’s IRB initial training is valid for three years; as is the refresher training.