As was previously announced on February 20, 2012, all individuals who may interact with children as part of an IRB-approved protocol are required to have the Protection of Children from Abuse clearances listed below. It is the responsibility of the principal investigator to ensure that all research staff, including faculty, have these clearances prior to any interaction with children. These three clearances are required by Pennsylvania law and/or UPMC and University policies:
- Pennsylvania Department of Public Welfare Child Abuse Clearance History
- Pennsylvania State Police Criminal Record Check
- FBI Criminal Background Check
Note that ‘interact’ refers not only to face-to-face meetings, but includes communication via phone (including text messaging) or internet. Conversely, a participating investigator or support staff member who does not have personal contact with children does not need to obtain clearances (e.g. statistician, non-clinical laboratory personnel, etc.).
After February 1, 2013, no new protocols will be approved by the IRB unless the Principal Investigator attests in OSIRIS that the required clearances have been obtained – see OSIRIS question 220.127.116.11; ‘Have you obtained the following clearances from all research staff who may interact with children?’ This same assurance must be made by principal investigators for all previously approved, active IRB protocols. If needed, the response to OSIRIS Question 18.104.22.168 should be modified to reflect that status by February 1, 2013.
At the time of an audit or any other monitoring visit, the PI will be expected to possess a listing of all research team members who may interact with children and a statement that their clearances have been verified.
Failure to comply with these requirements could result in a finding of serious non-compliance and may require reporting to state and/or federal agencies.
NOTE: Additional information on obtaining these clearances is available on the ‘forms’ page of the University’s Office of Human Resources (OHR) website. OHR is a designated fingerprinting location for the FBI clearance, but other local sites are also available. You must have registered at the Cogent PA website before OHR can take your fingerprints. For more information, call 412.624.8150.
The current question in OSIRIS (22.214.171.124) that asks if the required child clearances have been obtained is being revised to include a “Not Applicable” choice because many studies involving children do not require a personal interaction (e.g., medical record reviews). Research teams who choose this option will be asked to provide an explanation as to why the clearances are not required.