An application for Protocol Development Activities (PDA) may be used to release extramural grant funds for activities in preparation of a human subjects research study (e.g., hiring staff, developing study instruments). The PDA is used to obtain IRB certification that described activities do not meet the definition of “human subjects research”. PDA certification is not IRB approval or an exemption; therefore many sponsors that require IRB approval will not accept a PDA. Please confirm with the sponsor that a PDA will be accepted prior to initiation in ARROW.

PDAs are only used when required by the external sponsor (PDAs are not required for intramural funding). For questions related to award setup for human subjects protocols, see RSP’s Award Acceptance and Setup guidance.

There are two circumstances when a PDA should be requested for release of funding:

• You have received a “just-in-time” (JIT) requesting IRB approval, you do not yet have IRB approval and are unlikely to obtain it prior to the given deadline, and the program officer of the funding agency has indicated that a PDA will suffice.
  
  If the program officer indicates that a PDA is insufficient, inquire whether a letter from the IRB with an expected date for study review will suffice. Contact the IRB Directors for more information.
  
• Your funding proposal does not include conducting human research immediately (e.g., within two months), you need funding to conduct activities to prepare for the human subjects component, the external funder requires institutional documentation of the delay in human subjects research activities, and the funder has indicated that a PDA will suffice.

Outside of the above circumstances, for release of funding from RSP when human subjects activities will not begin immediately:

• If the human subjects activities will start within 6 months or less, you should begin an application in ARROW and, on the Funding page, use the chooser to add the funding source administered through RSP. The IRB application will be linked in RAMP within 24 hours. You must submit the application within 6 months to the IRB to avoid the system automatically moving the submission to a withdrawn state.
  
  You must also complete the Principal Investigator Attestation within RAMP to certify that no human subjects research activities will begin absent an approved protocol and provide an anticipated start date for human subjects research activities.

• If the human subjects activities will not begin for at least 6 months or more, you must complete the Principal Investigator Attestation within RAMP to certify that no human subjects research activities will begin absent an approved protocol and provide an anticipated start date for human subjects research activities.