Forms and Templates

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 ***The forms below are primarily used for eIRB. To view forms for open paper studies, click the View Paper Forms button above.
NOTE: ‘(rCR) indicates that the form or template below has been revised to be compatible with the Revised Common Rule. If a proposed study is submitted using a form that does not reflect the Revised Rule, the IRB will provide guidance concerning what additional information is required to comply with it


Research Protocols

(rCR) = Compliant with the Revised Common Rule (Learn More) and Pre-2018 Regulations

This template should be used by biomedical and social-behavioral researchers conducting research in which subjects are assigned to receive one or more interventions so that the researchers can evaluate their effects (e.g. clinical trials, CBT, Behavioral Modification studies, or randomized outcome studies). 

This template should be used by social-behavioral and biomedical researchers to prepare a protocol document for any research involving various types of interactional or observational methodologies: observations, interviews, focus groups, surveys, program evaluations, quality of life or interactional research.  

To be used by biomedical and social behavioral investigators proposing 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. This template replaced the Retrospective Chart/Record Review Protocol. 

The National Institutes of Health (NIH) and Food and Drug Administration (FDA) developed a clinical trial protocol template with instructional and example text for NIH-funded investigators to use when writing protocols for phase 2 and 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications. This NIH Template may be submitted to the IRB instead of the applicable Rutgers IRB Research Protocol Template. 

The National Institutes of Health (NIH) offers this protocol template as a suggested general format for clinical trial protocols that are testing a behavioral or social intervention. The NIH advises that use of the template is optional. Investigators may consider using the Rutgers protocol template instead as appropriate to the study's design.

A Local Context Supplement (LCS) must be completed and submitted to the IRB when a Rutgers Investigator proposes to collaborate with one or more other institutions and Rutgers is not the lead site. In such cases, the Rutgers Investigator must disclose in the LCS what specific research tasks s/he will perform, where the tasks will be performed and what and how data will be held by Rutgers and/or transferred between collaborating institutions. [Other information may be requested by an IRB to learn more about local context.] 

For investigators who wish to develop standard operating procedures in order to establish a research [tissue or data] bank, otherwise known as a repository. This SOP Template may be submitted to the IRB instead of the applicable Rutgers IRB Research Protocol Template.

This template should be used by clinicians planning to provide patients access to a Humanitarian Use Device (HUD) in the clinical context. If the HUD is being used in a clinical investigation to evaluate its safety and effectiveness, either for the HDE-approved indication(s) or for a different indication, use instead the Interventional Protocol Template (HRP-503a).


Paper Forms

For Use With Open Paper Studies Only.