New policy outlines processes, possibilities for alternative clinical research spaces

A solution for when standard research locations do not meet an investigator’s needs

Clinical researchers have access to multiple Department of Health and Joint Commission-approved Penn State Health clinical spaces to conduct human participants research. Yet, there are times when it is impractical to use these spaces.

Alternative, pre-approved, dedicated clinical research spaces — such as Penn State Clinical and Translational Science Institute’s Clinical Research Center (CRC)*, College of Medicine NMR Facility, Penn State Clinical and Translational Science Institute’s Exercise Research Center (ERC)*, and other departmental research spaces — are available. For most clinical researchers, these locations should provide adequate space to conduct their research; however, there may be nuances to the protocol or the patient population that would warrant the use of alternative locations.

*Penn State CTSI and Penn State College of Medicine have worked together to remove financial barriers to conducting research in these spaces. During this coming year, all space fees at the CRC and ERC in Hershey have been eliminated to better align with the fee structure at University Park.

Policy CR-107: Clinical Research Locations has been created to list pre-approved clinical research locations on campus and outline the process by which an investigator or study team may request approval for an alternative location(s) to conduct a study.

How to request an alternative location for a specific study

1. Principal Investigator (PI) obtains approval (letter, memo, email, etc.) either from the director that maintains oversight of the proposed alternative location, or the Operations Director of the Department which oversees the requested space.
2. PI submits director’s approval with a “Request for Use of an Alternative Research Location” form to the CTO by email (CTO@pennstatehealth.psu.edu) so that request can be reviewed by the appropriate parties.
3. Research Quality Assurance (RQA), CTO, and Facilities Management review the request. RQA will review the request to address biosafety matters if the study involves the collection, procession, and/or shipping of biospecimens. CTO will review the request to address billing compliance and clinical operation matters. Facilities Management will confirm that the proposed alternative location meets applicable regulations, including accessibility, privacy and space assignment.

The Clinical Trials Office (CTO) will maintain a comprehensive list of all approved research locations on its website. The list of approved locations in CR-107 will be updated biennially when this policy is reviewed to include any additional locations that are approved through the process outlined in this policy.

Note: CR-107 only relates to Penn State University and Penn State Health spaces. Approval for use of other spaces (e.g., parks, schools, restaurants, public spaces, etc.) are at the discretion of the IRB and the party/ies who have ownership/oversight of said spaces.

Download the Request for Use of an Alternative Research Location form

View CR-107 for full details on the alternative location request/approval process and other standard operation procedures and policies

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