The Determination Tools section provides self-assessment tools to assist researchers in determining if a project is human subjects research and whether human subjects research may be exempt.
The Forms and Applications section is organized by submission type. Select the relevant document for your submission. Each application assists with identifying additional materials necessary for a complete submission which are posted in the sections below:
When available, guidance specific to preparing forms and application materials is included in the right-hand column of this page. See our Guidance Library for additional topical guidance.
Submissions to Research Compliance Services must use the current version of the materials which are posted below and be submitted through the RAP.
Determination Tools |
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Title | Use/Description | Form/Templates | Guidance |
Human Subjects |
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Exempt |
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Exempt Self-Assessment Tool |
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Forms and Applications |
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Title | Use/Description | Form/Templates | Guidance |
Exempt Review Application and Worksheets |
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Create a single-site study (RAP Instructions)
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Initial Review |
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Create a single-site study (RAP Instructions)
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Modification (Amendment) Review |
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Modifying (Amending) your Study Modification (Amendment) Checklist Modify previously approved research (RAP Instructions) |
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Reportable New Information (Event Report) Form |
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RNI (Event) Reporting Form |
Report new information (RNI) (RAP Instructions) |
Continuing Review |
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Continuing Review and Progress Reporting Continuing Review/Study Closure (RAP Instructions) |
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Study Closure |
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Continuing Review/Study Closure (RAP Instructions)
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Approval in Principle |
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Application Attachments |
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Use/Description
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Forms/Templates
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Guidance
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Funding and |
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External Research Personnel Form |
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Principal Investigator Eligibility, Faculty Advisors, and Research Personnel Requirements |
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Conflict of Interest (COI) Form |
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Conflict of Interest (COI) Form for Investigators Conducting Human Subjects Research |
n/a |
Reliance Request Form - Relying IRB |
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Create a multi-site study where UO is the relying IRB (RAP Instructions) |
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Reliance Request Form - Reviewing IRB |
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Create a multi-site study where UO is the reviewing IRB (RAP Instructions) |
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Individual Investigator Agreement (IIA) Form |
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Protocol Materials |
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Title
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Use/Description
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Forms/Templates
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Guidance
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Research Plan |
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Research Plan Guidance (pdf) |
Appendix A - Drugs & other Substances |
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n/a |
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Appendix B - Investigational Device |
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n/a |
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Appendix C - Ionizing Radiation |
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Appendix D - HIPAA/ Use of Protected Health Information (PHI) |
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Appendix E - Research Involving Genetic Information/Tests |
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Informed Consent and Assent |
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Title
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Use/Description
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Forms/Templates
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Guidance
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Informed Consent |
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Assent Form/Script |
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Oral Consent Script |
Under Construction |
Under Construction |
n/a |
HIPAA Authorization |
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Release Form for Translators and Transcribers |
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If you have questions, please contact Research Compliance Services.
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