Determination Tools

Title

Use/Description

Form/Templates

Guidance

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- 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. 

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.

Back to the top of the page

Forms and Applications

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

Exempt Category Worksheets:

Initial Review
Application

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

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.

Modifying (Amending) your Study

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

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 Reporting

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.

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.

 Back to the top of the page

Application Attachments

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.

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).

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

n/a

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

Reliance Request Form - UO Reviewing IRB

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

Relying Site Survey

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

Back to the top of the page

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 study submitted for IRB review (expedited/full board) and recommended for exempt applications.

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.

n/a

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.

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

Back to the top of the page

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 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.

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

Translations and Translated Materials

Back to the top of the page