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
Human Subjects Research Determination Worksheet
Description
- Use this worksheet to determine if your project meets the definition of human subject research and requires submission of a study.
- Submit this worksheet if you need formal documentation that your study does not require further review or if you are uncertain if your project requires further review.
Form/templates
Guidance
Human Subjects Research Determination Worksheet - Genetics
Description
- If your project involves genetic testing or genetic information, state laws may still apply to your project even if it is otherwise not human subjects research. If your project involves genetics but you do not believe your project is human subjects research, use this worksheet to determine if your project is consistent with state laws and also whether it requires a IRB oversight for a study involving human subjects research.
- Submit this worksheet if you need formal documentation that your study involving genetics does not require further review or if you are uncertain if your project requires further review. If your study is definitely human subjects research involving genetics, include Appendix E (below) rather than this form in addition to the materials needed for a complete submission.
Form/templates
Guidance
Exempt Self-Assessment Tool
Description
- For self-assessment and screening for exemption eligibility.
- Verification of exemption from RCS is required. You may not begin human subject research activities until you submit an Exempt Review Application and receive documentation of an exempt determination from RCS.
Form/templates
Guidance
Forms and Applications
Exempt Review Application and Worksheets
Description
- Submit to request an Initial Exempt Determination.
- Submit to request review of proposed changes to a previously determined exempt study.
Form/templates
- Exempt Application
- Exempt Category Worksheets:
Guidance
Initial Review Application
Description
- Submit to request Initial IRB Review (i.e., Expedited or Full review).
Form/templates
Guidance
Modification (Amendment) Review Application
Description
- Submit to request a change in a previously approved Exempt, Expedited, or Full Review study.
- Submit to request a study be assessed for transition to the 2018 revised Common Rule.
Form/templates
Guidance
Reportable New Information (Event Report) Form
Description
- Submit this form to report to RCS and the IRB any unanticipated problems or events (e.g., study deviations, non-compliance, participant complaints, etc.).
Form/templates
Guidance
- Event Reporting Guidance
- Report new information (RNI) (RAP Instructions)
Continuing Review Application
Description
- Submit 45 days in advance of study expiration to request continuation of all previously approved research (Exempt, Expedited, and Full Board).
Form/templates
Guidance
Study Closure Application
Description
- Submit at least 45-days in advance of a study expiration to request a previously approved study be closed as human subject research activities are complete.
Form/templates
Guidance
Approval in Principle Application
Description
- The AIP application and approval allows UO Sponsored Project Services (SPS) to release funds associated with preliminary phases of research that are preparatory to planned human subject research activities. Submit this application to facilitate review for these conditions.
Form/templates
Guidance
Application Attachments
Funding and Sponsorship Form
Description
- Include this form with an initial review or exemption application if your study is funded.
- Include with a modification application when funding has changed or is being added.
Form/templates
Guidance
External Research Personnel Form
Description
- Include for external research team members who have no institutional affiliation and are working under the direct direction and supervision of UO investigators(s) through an Individual Investigator Agreement (IIA).
Form/templates
Guidance
Conflict of Interest (COI) Form
Description
- This attachment must be completed individually by the Principal Investigator (PI), Faculty Advisor, and each person having responsibility for the design, conduct, and/or reporting of the research. The PI must submit this form only for:
- New research personnel who have identified a real, perceived, or potential conflict of interest on their form. Submit the form(s) with either the Initial Review application or a Modification application.
- Existing personnel who have identified a change to a real, perceived, or potential conflict of interest on their form. Submit the form(s) with Modification application.
Form/templates
Guidance
- N/A
Reliance Request Form - UO Relying IRB
Description
- Include when requesting IRB oversight be deferred to a collaborating institution.
Form/templates
Guidance
Reliance Request Form - UO Reviewing IRB
Description
- Include for multi-site, collaborative research when UO is the reviewing IRB.
Form/templates
Guidance
Individual Investigator Agreement (IIA) Form
Description
- Include with initial, exempt determination, and amendment applications when a member of the research team is independent and unaffiliated with an institution.
Form/templates
Guidance
Protocol Materials
Research Plan
Description
- The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every study submitted for IRB review (expedited/full board) and recommended for exempt applications.
Form/templates
Guidance
Appendix A - Drugs and other Substances
Description
- Complete this Research Plan appendix to provide information to the IRB when your study involves the use of drugs and other substances.
- Provide an appendix for each drug or substance in your research.
Form/templates
Guidance
- N/A
Appendix B - Investigational Device
Description
- Complete this Research Plan appendix to provide information to the IRB when requesting a Nonsignificant Risk (NSR) device determination for an Investigational Device (IDE).
- Provide an appendix for each investigational device in your research.
Form/templates
Guidance
- N/A
Appendix C - Ionizing Radiation
Description
- Use this as an appendix to the Research Plan to provide information to the IRB when your research involves the use of ionizing radiation.
Form/templates
Guidance
Appendix D - HIPAA/Use of Protected Health Information (PHI)
Description
- Complete this Research Plan appendix when your research involves use of Protected Health Information under the HIPAA Privacy Law.
Form/templates
Guidance
Appendix E - Research Involving Genetic Information/Tests
Description
- Complete this Research Plan appendix when your research involves genetic information/tests.
Form/templates
Guidance
Informed Consent and Assent
Informed Consent Form
Description
- Use the template and template guidance to develop an adult consent form, adapting where appropriate to meet the needs of the research design or participant population.
- Consult the Informed Consent Guidance and Waiver or Alteration of Informed Consent Guidance for more in depth information.
Form/templates
Guidance
Assent Form/Script
Description
- Use the assent templates and assent template guidance to develop assent forms for participants who are between 7 and 17 years old. Please adapt where appropriate to meet the needs of the research design or participant population.
Form/templates
Guidance
Oral Consent Script
Description
- Under Construction
Form/templates
- Under Construction
Guidance
- N/A
HIPAA Authorization Form
Description
- Use this template form to develop a HIPAA Authorization for use or disclosure of protected health information.
Form/templates
Guidance
Release Form for Translators and Transcribers
Description
- Use this template form for translator/transcriber agreement of confidentiality provisions
Form/templates
Guidance
If you have questions, please contact Research Compliance Services.
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