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.

 
HRPP Policies HRPP SOPs HRPP Checklists, Worksheets, and Forms

HRP-210 - Regulatory Review

HRP-300 - OCR - Waiver of Consent HHS

HRP-300 - RCR - Waiver of Consent HHS

HRP-301 - Waiver of Consent Emergency Research

HRP-302 - Waiver of Consent Leftover Specimens

HRP-303 - OCR - Waiver of Documentation of Consent

HRP-303 - RCR - Waiver of Documentation of Consent

HRP-305 - Pregnant Women

HRP-306 - Neonates of Uncertain Viability

HRP-307 - Nonviable Neonates

HRP-308 - OCR - Prisoners

HRP-308 - RCR - Prisoners

HRP-309 - OCR - Unexpected Incarceration

HRP-310 - Children

HRP-311 - Wards

HRP-313 - Non-Significant Risk Device

HRP-320 - VA Criteria for Approval

HRP-400 - OCR - Criteria for Approval

HRP-400 - RCR - Criteria for Approval

HRP-401 - Scientific and Scholarly Review

HRP-402 - Advertisements

HRP-403 - Payments

HRP-404 - OCR - Short Form

HRP-404 - RCR - Short Form

HRP-405 - Additional Criteria DOD

HRP-406 - Additional Criteria DOJ 

HRP-407 - Additional Criteria ED

HRP-408 - Additional Criteria EPA

HRP-409 - Additional Criteria DOE

HRP-410 - Additional Criteria International

HRP-411 - New Information

HRP- 413 - Closure Criteria

HRP-414 - Adults Lacking Capacity

HRP-420 - Regulatory Review

HRP-421 - Human Research

HRP-422 - Engagement

HRP-423 - OCR - Exemptions

HRP-423 - RCR - Exemptions

HRP-424 - Expedited Review

HRP-425 - Drugs

HRP-426 - Devices

HRP-427 - HIPAA Authorization

HRP-428 - HIPAA Waiver of Authorization

HRP-430 - IRB Composition

HRP-431 - Quorum

HRP-450 - Criteria for Approval HUD

HRP-451 - Emergency Use Drugs and Biologics   

HRP-452 - Emergency Use Devices

HRP-453 - Compassionate Use Devices

HRP-454 - Single Patient Expanded Access

HRP-461 - Oregon Genetic Research Anon-Coded

HRP-470 - External IRB Screening

HRP-480 - FERPA

HRP-481 - PPRA