IV Choose Appropriate IRB Research Protocol Application

Depending on the type of research conducted, the PI completes one of the following Research Protocol templates

Interventional Research Protocol – used by biomedical and social-behavioral researchers conducting research in which subjects are assigned to receive one or more interventions to evaluate their effects (e.g. clinical trials, CBT, Behavioral Modification studies, or randomized outcome studies).

Non-Interventional Research Protocol – used by social-behavioral and biomedical researchers for any research involving various types of interactional or observational methodologies: observations, interviews, focus groups, surveys, program evaluations, quality of life or interactional research.

Secondary Research with Data or Biospecimens Protocol – studies involving use of retrospective or archival data (including materials or specimens). Secondary research with data—which may include written text, images or audio-/visual-recordings—or biospecimens that were or will be collected for other purposes.  

Local Context Supplement – for use when collaborating with another institution(s) leading the research project.

Data/Tissue Repository SOP – for use in establishing a tissue or data bank (repository).

NIH Clinical Trial Protocol and NIH Behavioral and Social Research Protocol templates are also available on this IRB site.

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