Note: Subject recruitment, enrollment, and data collection can only take place under the IRB submission with the fully developed study protocol and materials, not the concept study.
Concept Studies
A concept study is an idea (concept) for a research study, which is submitted for IRB review prior to the development of a complete protocol.
A concept study application allows for Institutional Review Board (IRB) review and approval of a study that is still in the concept stage of development; it is a mechanism to review funded proposals which provide a period of time (and sometimes funding) for the full development of the study protocol, measures, consent forms, recruitment materials, etc.
These types of submissions are typically only necessary when a funding agency/organization requires documentation of IRB review prior to the development of full study protocol. For example, the National Science Foundation (NSF) requires certification or its equivalent from the IRB in order to recommend funding involving human subject proposals; a concept study submission is the mechanism by which the Research Subjects Review Board (RSRB) provides this review.
Once the full study protocol and all supporting materials have been developed, they need be submitted to the IRB for review and approval as a new submission; the concept submission can then be closed.
How to submit a concept study in Click IRB
As with all other submissions, Research Subjects Review Board (RSRB) review of concept studies is facilitated through the Click IRB module within the Integrated Online Research Administration (IORA) system. Step-by-step instructions for navigating the Click IRB system and submitting proposals for RSRB review are available in the Click IRB: Study Staff Guide.
In supplement to these instructions, when submitting a concept study:
- From the dashboard (landing page following log in), select the blue ‘Create’ option and then ‘Create New Study’ under the IRB heading.
- On the ‘Basic Study Information’ page, complete all required fields. For the purpose of this type of submission:
- Identify the submission as a concept review in Question 3 (‘brief description’).
- Answer no to Question 5 (‘will an external IRB act as the IRB of record for this study?’), even if an external IRB might be used to review the research once it is fully developed.
- In lieu of a fully developed study protocol, in Question 8 (‘attach the protocol’), upload a copy of the grant submission.
- On the ‘Study Funding Sources’ page, identify the funding source and the sponsor’s award ID number (e.g., R01 AG00000).
- On the remaining pages, since no human subject research will be conducted under the concept study submission:
- Skip the ‘Local Study Team Members’, ‘Local Research Locations’, and ‘Local Site Documents’ pages; potential study team members do not need to be identified, nor do potential research locations.
- Exception: Team members (e.g., study coordinators) that will assist in managing the IRB submission should be added on the ‘Local Study Team Members’ page.
- Answer ‘No’ to all questions on the ‘Study Scope’ and ‘Ancillary Committee Review’ page.
- Skip the ‘Local Study Team Members’, ‘Local Research Locations’, and ‘Local Site Documents’ pages; potential study team members do not need to be identified, nor do potential research locations.