Human Subjects Applications, Forms, and Guidance

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.

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RAP Guidance

Determination Tools

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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.

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Guidance

Forms and Applications

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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

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.). 

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Guidance

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).

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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. 

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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. 

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Guidance

Application Attachments

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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.

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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).

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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.

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Guidance

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Reliance Request Form - UO Relying IRB

Description

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

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Guidance


 

Reliance Request Form - UO Reviewing IRB

Description

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

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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.

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Guidance

Protocol Materials

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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.

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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

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Appendix B - Investigational Device 

Description

  • Complete this Research Plan appendix to provide information to the IRB if your research involves using a device on participants and/or their biological specimens AND you are collecting data about the device potentially related to safety or effectiveness (e.g., device accuracy, sensitivity, reliability, how well it works, associated side effects, impact on the body or health outcomes). 
  • Provide an appendix for each investigational device in your research.

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Guidance

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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.

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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. 

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Guidance

Appendix E - Research Involving Genetic Information/Tests

Description

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

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Guidance

Informed Consent and Assent

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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.

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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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