Human Subjects Research Determination Worksheet

• 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.

Human Subjects Research Determination Worksheet - RAP

Does your project require IRB review?

Human Subjects Research Determination Worksheet - Genetics

• 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. 

Human Subjects Determination Worksheet (Genetics) - RAP

• Does your project require IRB Review?
• Oregon Genetic Privacy Laws
• Genetic Privacy Definitions

Exempt
Self-Assessment
Tool

• 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.

Exempt Self-Assessment Tool 

Exempt
Self-Assessment
Guidance

Exempt Review Application and Worksheets

• Submit to request an Initial Exempt Determination.
• Submit to request review of proposed changes to a previously determined exempt study.

Exempt Application

Exempt Category Worksheets:

• Cat. 1 worksheet
• Cat. 2 worksheet
• Cat. 3 worksheet
• Cat. 4 worksheet
• Cat. 5 worksheet
• Cat. 6 worksheet

• Preparing the
  Initial Submission
• Exempt Submission Checklist
• Exempt Definitions
• RAP Instructions
• Exempt Consent Template and Guidance

Initial Review Application

Submit to request Initial IRB Review (i.e., Expedited or Full review).

Initial Review Application Form

• Preparing the Initial Submission
• Non-Exempt Initial Review Checklist
• RAP Instructions
• HSR definitions

Modification (Amendment) Review Application

• 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.

Modification Application

• Modifying (Amending) your Study
• Modify Study (RAP Instructions)

Reportable New Information (Event Report) Form

Submit this form to report to RCS and the IRB any unanticipated problems or events (e.g., study deviations, non-compliance, participant complaints, etc.). 

Event Report Form (RNI)

• Event Reporting Guidance
• Report new information (RNI) (RAP Instructions)

Continuing Review Application

Submit 45 days in advance of study expiration to request continuation of all previously approved research (Exempt, Expedited, and Full Board).

Continuing Review Application

• Continuing Review Reporting
• Continuing Review/Study Closure (RAP Instructions)

Study Closure Application

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. 

Closure Application

• Continuing Review/Study Closure (RAP Instructions)
• Closing Your Study

Approval in Principle Application

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. 

Approval-In-Principle Application

• Approval-In-Principle Guidance
• Approval in Principle RAP Guidance

Funding and Sponsorship Form

• 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.

Funding and Sponsorship Form

Funded and Sponsored Research

External Research Personnel Form 

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).

External Research Personnel Form

Principal Investigator Eligibility, Faculty Advisors, and Research Personnel Requirements

Conflict of Interest (COI) Form

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.

Conflict of Interest (COI) Form for Investigators Conducting Human Subjects Research

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Reliance Request Form - UO Relying IRB

Include when requesting IRB oversight be deferred to a collaborating institution. 

Reliance Request Form - UO Relying IRB - RAP

• Collaboration in Research
• Create a multi-site study where UO is the relying IRB
• RAP Quick Reference - Continuing Review for External IRB Study Guidance for Researchers.pdf

Reliance Request Form - UO Reviewing IRB

Include for multi-site, collaborative research when UO is the reviewing IRB.

• Reliance Request Form - UO Reviewing IRB - RAP
• Relying Site Survey

• Collaboration in Research
• Create a multi-site study where UO is the reviewing IRB

Individual Investigator Agreement (IIA) Form

Include with initial, exempt determination, and amendment applications when a member of the research team is independent and unaffiliated with an institution.

Individual Investigator Agreement (IIA) Form

Collaboration in Research

Research Plan

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.

Research Plan Template

Research Plan Guidance

Appendix A - Drugs & other Substances 

• 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.

Appendix A - Drugs and Other Substances 

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Appendix B - Investigational Device 

• 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.

Appendix B -
Investigational Device

n/a

Appendix C - Ionizing Radiation

Use this as an appendix to the Research Plan to provide information to the IRB when your research involves the use of ionizing radiation.

Appendix C -
Ionizing Radiation

Ionizing Radiation

Appendix D - HIPAA/Use of Protected Health Information (PHI) 

Complete this Research Plan appendix when your research involves use of Protected Health Information under the HIPAA Privacy Law. 

Appendix D - HIPAA

HIPAA

Appendix E - Research Involving Genetic Information/Tests

Complete this Research Plan appendix when your research involves genetic information/tests. 

Appendix E -
Research involving Genetic Information/Tests

Research Involving DNA

Informed Consent
Form

• 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.

• Informed Consent Template
• Exempt Consent Template and Guidance

• Informed Consent Guidance
• Waiver or Alteration of Informed Consent

Assent Form/Script

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.

• Assent Template Ages 7-11
• Assent Template Ages 12-17

Assent Guidance 

Oral Consent Script 

Under Construction 

Under Construction

n/a

HIPAA Authorization
Form

Use this template form to develop a HIPAA Authorization for use or disclosure of protected health information.

HIPAA Authorization Template

HIPAA and Human Subjects Research 

Release Form for Translators and Transcribers 

Use this template form for translator/transcriber agreement of confidentiality provisions 

Release Form for Translators and Transcribers

Translations and Translated Materials