IRB Policies and Forms

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General researcher resources

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.

Submission forms and information

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.

Consent forms

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

Waiving oversight

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.

Collaborative studies with OHSU IRB oversight

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.

Vulnerable populations

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

Guidance by topic

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.

Human Research Protection Program (HRPP)

The documents found below are the Policies and procedures the IRB follows during the review process for your study. These are only used by the IRB and are for researcher reference only. Researchers do not need to fill them out or upload them to their studies.

Due to the January 21st, 2019, implementation of the Revised Common Rule, some documents below have changed to comply with the revised regulations. Documents with "OCR" in the name only apply to studies approved under the Original Common Rule, while documents with "RCR" in the name only apply to studies approved under the Revised Common Rule. All other documents that do NOT contain either abbreviation, will apply regardless of which regulations a study is approved under.

Some of the HRPP forms linked below require Adobe Acrobat in order to view. If you get a “Please wait” error when trying to open any of the documents below, please see the PDF Guide for instructions on opening the form.