Forms and Templates

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 The forms below are primary used for eIRB. To view forms for open paper studies, click the View Paper Forms button below.

 

Research Protocols

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 revised template includes the elements required in the upcoming Revised Common Rule.  Note:  they are compliant with both the Pre-2018 regulations and the Revised Common Rule, therefore, you may begin to use them now.

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. This revised template includes the elements required in the upcoming Revised Common Rule.  Note:  they are compliant with both the Pre-2018 regulations and the Revised Common Rule, therefore, you may begin to use them now.

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 Protocol Template.
For use as applicable e.g. with multi-centered, or industry sponsored protocols, etc.
For use as a resource 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 Protocol Template.

 

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

 

 

Additional Consent Related Documents

Consent Sections (Required For Subject, If Applicable To Your Study; Add Before Main Consent Signature Block)

Consent Addendum (Optional For Subject, If Applicable To Your Study; Section To Be Added After Main Consent Signature Block)

Non-English Research Subjects

Surrogate Consent

Consent For CINJ National Cancer Institute (NCI) Studies Only

Other

 

Other Forms

 

Paper Forms

For Use With Open Paper Studies Only.

  • Addendum HIPAA Protected Health Information [ArtSci]
  • HealthSci Paper Appendices
  • Unanticipated Problems / Adverse Events Report Form: [HealthSci] [ArtSci]