The PDA application is meant to facilitate the submission of applications to the IRB for review when research activities involving human subjects are planned in future but have not been finalized (e.g., the grant incorporates a planning stage) or when an agency or organization requires IRB approval of the concept as part of the application for funding. Only planning activities that do not involve human subjects can be covered by this administrative approval. In order to obtain approval to perform research activities involving human subjects, a separate Initial Review Application will be required. Note: PDAs can be submitted for studies that will be ceded.

Application Format

The PDA application includes a General Application Information (GAI) section with similar pages to other initial review application types (note that some GAI pages, such as study team roles and scientific review will be hidden, as these are not applicable to PDAs). The Protocol Development Activities section includes three main questions for review:

1. Overall Objectives of the grant/funding application
2. The Preliminary Activities that would be performed under the application
3. Human Subjects Activities for which IRB approval will be sought in future

The information provided under Preliminary Activities will depend on the reason for the submission of the PDA. If the PDA is solely to provide evidence of approval in concept for a funding agency, study teams should indicate this in #2, and note that no activities are planned.

If the PDA is being submitted to release funds for preliminary activities that occur before those that would involve human subjects, study teams should describe the specific activities here. The activities should be described in sufficient detail to allow a lay reviewer to determine that activities involving human subjects will not be performed. If the activities involving human subjects likely qualify for exemption, an application for exemption may be the more appropriate application type to submit and the study team should be informed of this recommendation via a reviewer note in the PDA.

The information provided under Human Subjects Activities should describe the activities that the study team plans to conduct as human subjects research.

Once the IRB Analyst has reviewed the PDA application and all reviewer notes have been adequately addressed, the IRB Analyst should complete the Regulatory Oversight section of HRP-401. The purpose of completing HRP-401 is to identify any regulations that apply to the study (e.g., Common Rule, DHHS, DOD).

Next, the IRB Analyst should complete HRP-402 Non-Committee Review. The Analyst should select “Not Human Research” under Review Level and “Meets Criteria” under Determination.

Once the appropriate checklists have been completed, the IRB Analyst should edit the letter for the study team, selecting the PDA template letter. If the PDA has funding linked in ARROW via WISPR, it will be listed in the PDA letter. If the study team has identified “Other” funding, the IRB Analyst should copy and paste the title of the funding into the PDA letter prior to sending to the study team. Note: If the funding is from the National Science Foundation (NSF), the letter should be updated to include their regulatory citation (45 CFR 690.118) regarding projects lacking definite plans for human subjects research in addition to the Common Rule citations already listed in the letter. If the funding is from the Department of Justice (DOJ), all 45 CFR 46 citations need to be removed from the letter (as the DOJ is not a Common Rule signatory) and the citation 28 CFR 46.118, projects lacking definite plans for human subjects research, needs to be added. Once the letter is sent to the study team, the PDA submission moves to the Certified state in ARROW and the review is complete.

Additional Considerations:

• Human subjects training is not required for PDAs.
• Appropriate PI status is required for PDAs.
• If a COI is listed, no action is needed. The COI will be addressed when the application for human subjects research is submitted.

Return to Review Basics

Return to Staff Manual