This section contains documents and resources about various laws and regulations, researcher obligations, and gaining access to research-related OHSU systems. In addition to federal regulations and institutional obligations, there may also be additional obligations for certain federal funding agencies (FDA, DoD, etc.) and state laws applicable to a study. Requirements for study processes, such as for Informed Consent and Reporting new information (adverse events, protocol deviations, noncompliance) are also included.

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This section contains the forms and templates researchers would fill out and upload in their eIRB submission. Guidance documents related to these submission materials and using the eIRB system are also found here.

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This section contains templates, boilerplate language, and guidance researchers would use to create study consent and assent forms.

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This section contains templates, forms, and guidance for studies in which the OHSU IRB is waiving oversight to an External IRB. The reliance agreement templates below, such as the IAA, are specific to OHSU waiving oversight. See Using Central or External IRBs for helpful information.

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This section contains templates, forms, and guidance for studies that involve other sites for which the OHSU IRB is providing oversight. The reliance agreement templates below, such as the IAA, are specific to OHSU providing oversight. See Relying vs. Reviewing for helpful information.

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This section contains forms and guidance specific to vulnerable populations, like children, prisoners, and decisionally impaired adults.

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This section contains guidance documents related to specific types of studies, or by what is occurring in a study. The information covered ranges from EFIC studies, clinical trials, to the use of stem cells.

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Human Research Protection Program (HRPP)

Policies and procedures the IRB follows during the review process for your study are made available in O2.