Can patient participants be charged a co-pay to participate in a study intervention? Can this or other sources of revenue, be used towards supporting the PCORI project?

Recipient institution must obtain approval from their Institutional Review Board (IRB) and/or Data and Safety Monitoring Board (DSMB) to include co-pays or other activities that will generate revenue as a result of carrying out the PCORI project. Once IRB and/or DSMB approval is received, the activities, expected funds/revenue generated, must be clearly outlined in the Proposal, Budget, and Budget Justification, and PCORI’s approval sought. 

Any generated revenues must be disclosed and offset against current project expenses thereby reducing the overall budget amount that can be collected from PCORI. Otherwise, the overall award amount would, in effect, increase and appear as program income or revenue-generating activities.

IMPORTANT: PCORI is prohibited by authorizing legislation from generating revenue or program income as a result of its funded research, and cannot accept revenue from any source other than the PCORTF.