IRB Policies and Forms
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General Researcher ResourcesThis 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.
- Investigator Manual
- Roles and Responsibilities in Research
- HRP-800 –Investigator Obligations
- HRP-801- Prompt Reporting Requirements
- HRP-802 –Informed Consent
- HRP-803 –Documentation of Informed Consent
- HRP-810 –Additional DoD Obligations
- HRP-811 –Additional DoE Obligations
- HRP-812 –Additional DoJ Obligations
- HRP-813 –Additional ED Obligations
- HRP-814 –Additional EPA Obligations
- HRP-815 –Additional FDA Obligations
- HRP-816 –Additional ICH-GCP Obligations
- HRP-820- Students as Research Subjects
- State Laws and Regulations (Help Sheet)
- HIPAA - Authorization for Obtaining Existing Records Outside of OHSU
- HIPAA - Business Associate Agreement
- HIPAA - Data Use Agreement
- HIPAA - Decedents Representation Form
- HIPAA - Prep to Research Form
- HIPAA - Waiver or Alteration of HIPAA Authorization
- Protocol Checklist - Security and Confidentiality
- Local Protocol Conduct Supplement
- Data Security Supplement for Waived Studies
- HIPAA - Accounting of Disclosures (Help Sheet)
- Assent Form - Shriners
- Assent Form - Standard
- Consent - Information Sheet (1.17.2018)
- Consent and Authorization Forms - Clinical (12.13.2018)
- Consent and Authorization Forms - Knight Cancer Institute (12.13.2018)
- Consent and Authorization Forms - Non-Clinical (9.18.2018)
- Consent and Authorization Forms - Repository Only (1.19.2018)
- Consent and Authorization Forms - Shriners (8.12.2014)
- Consent Form - Treatment Use of Drug or Device (3.26.2015)
- HIV Test Information Sheet
Waiving OversightThis 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 OversightThis 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.
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.
HRP-303 - RCR - Waiver of Documentation of Consent
HRP-400 - OCR - Criteria for Approval HRP-403 - PaymentsHRP-404 - RCR - Short Form HRP-410 - Additional Criteria International HRP-420 - Regulatory Review HRP-423 - RCR - Exemptions HRP-425 - Drugs HRP-428 - HIPAA Waiver of Authorization HRP-454 - Single Patient Expanded Access