Determination Tools

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 protocol.
• 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.

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.

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Forms and Applications

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

Exempt Application

Initial Review
Application

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

Amendment Review
Application

• Submit to request a change in a previously approved Exempt, Expedited, or Full Review protocol.
• Submit to request a protocol be assessed for transition to the 2018 revised Common Rule.

Amending your protocol

Amendment
Checklist

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

Continuing Review
Application

• Submit 45 days in advance of protocol expiration to request continuation of previously approved protocols that were determined to require continuing review (i.e., Full Review and some Expedited).

Renewing your protocol

Continuing Review
Checklist

Study Closure
Application

• Submit at least 45-days in advance of a protocol expiration to request a previously approved protocol be closed as human subject research activities are complete.

• Submit at least 45-days in advance of a protocol expiration to:
  • Request an extended project period for a protocol determined to be Exempt.
  • Request an extended project period for an Expedited protocol that was determined to not require continuing review.
• NOTE: Expedited protocol that require continuing review must use the Continuing Review Application Form.

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.

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Application Attachments

Funding and
Sponsorship Form

• Include this form with an initial review or exemption application if your study is funded.
• Include with an amendment application when funding has changed or is being added.

Funding and Sponsorship
Form

Funded and Sponsored Research

Research Personnel
Form

• Include with all initial, exempt determination, and continuing review applications.
• Include with amendments when changes to personnel are proposed.

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 the Amendment 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 an Amendment Application.

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

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IRB Authorization Agreement (IAA) Request Form

• Include with initial, exempt determination, and amendment applications when requesting IRB oversight be deferred to either UO or a collaborating institution.

IRB Authorization Agreement (IAA) Request Form

Collaboration in Research

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

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Protocol Materials

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 protocol submitted for IRB review.

Research Plan Template

Research Plan Guidance (pdf)

Appendix A - Drugs & other Substances

• Use this as an appendix to the Research Plan 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

• Use this as an appendix to the Research Plan 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

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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

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

• Use this as an appendix to your Research Plan when your research involves use of Protected Health Information under the HIPAA Privacy Law.

Appendix D -
HIPAA

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Appendix E - Research Involving Genetic Information/Tests

• Use this as an appendix to your Research Plan to provide information to the IRB when your research involves genetic information/tests.

Appendix E -
Research involving Genetic Information/Tests

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Informed Consent and Assent

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

Informed Consent Template Guidance

Informed Consent Guidance

Waiver or Alteration of Informed Consent Guidance

Assent Form/Script

Under Construction!

Under Construction!

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Oral Consent Script

Under Construction!

Under Construction!

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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

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