An R34 Planning Grant provides support for the initial development of a clinical trial or research project, including
- establishment of the research team,
- development of tools for data management
- development of research designs
- finalization of the protocol
- preparation of an operations/procedures manual
- pilot studies or collection of feasibility data for subsequent research projects*
*** When used as a planning grant for clinical trials, this program is not designed for the collection of preliminary data or the conducting of pilot studies to support the rationale for a clinical trial.
Karen Bierman (2013) has suggested that an NIH R34 and an IES Goal 2 proposal have a lot in common. Both require:
- A plausible rationale that the intervention is needed
- reason to believe it has advantages over what’s currently proven and available
- A well-specified intervention model
- basis in theory and prior research
- identified target population
- specification of intended outcomes/effects
- “theory of change” explication of what it does and why it should have the intended effects for the intended population
- Clarity about the relevant counterfactual– what it is supposed to be better than
Examples of NIH R34
Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills (Bierman, Karen)
This project will develop and evaluate a novel intervention designed to improve child social-emotional functioning, which is often impaired in neurodevelopmental disorders. It will evaluate the feasibility, acceptability, and evidence for effectiveness of a play-based intervention designed for preschool children with emerging ADHD, and provide preliminary findings to support a larger-scale efficacy trial.