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Before preparing a protocol for review, determine whether the research qualifies as Exempt Research.

If the researchÌýhas minimal risk to participants and fits into one or more of the exempt categories as defined by federal regulations, it is considered Exempt Research.ÌýThis research is exempt from most federal regulations pertaining to the protection of human subjects, but it is not exempt from state laws, institutional policies or the requirements for ethical research.

Additional information on Exempt ResearchÌý

Take Action

Use the to decide if your research qualifies for exemption. The results will help you determine which templates to use in preparing your protocol for IRB review.

Note: The results of the Self-Assessment are not an official IRB determination. The ºÚÁÏÉçÇøÍø IRB will make an official determination upon reviewing the submitted protocol.

If your research does not qualify as Exempt Research (see Step 1 above), is federally funded and/or FDA regulated, and you are collaborating with outside institutions, Single IRB Review may be required.

In a Single IRB Review, one institution provides review, approval and oversight for the human research activities of investigators engaged in research at multiple institutions (reviewing IRB) and other institutions (relying IRB) cedes IRB oversight to the reviewing IRB. The relying IRBs are responsible for ensuring their investigators have appropriate human subjects training and any conflicts of interest are managed.

The Single IRB Review streamlines the IRB review process and prevents duplication of effort required if each institution’s investigators were required to submit research separately for review.

Additional information on Single IRBÌý

Take Action

Contact irbadmin@colorado.edu to discuss whether a Single IRB Review is appropriate for your collaborative, non-exempt human subjects research.

Principal Investigators

Undergraduate students cannot be Principal Investigators (PIs) on projects with human subject research. A ºÚÁÏÉçÇøÍø faculty member (who is eligible to be a PI) must be the PI on the project and students can be listed as Co-Investigators.Ìý

Graduate students can be Principal Investigators (PIs) on projects with human subject research, but they must have a ºÚÁÏÉçÇøÍø faculty member as a Faculty Advisor.

Students and Faculty Advisors

All graduate students conducting human subject research at ºÚÁÏÉçÇøÍø must have a Faculty Advisor.Ìý

Take Action

If graduate students are conducting human subject research, follow the instructions in the Faculty Advisor Review Form prior to submitting a protocol for review.

Submit Updated DEPA – Required for all researchers (including students) listed on a protocol

All faculty and any other employee or student involved in the design, conductÌýand/or reporting of research are required to submit a Disclosure of External Professional Activities (DEPA) Form to the Office of Conflicts of Interest & Commitment to meet university and federal conflicts of interest and commitment reporting requirements.

Complete the appropriate human subjects training (via CITI) – Required for all researchers (including students) listed on a protocol

All researchers involved with a protocol must complete the appropriate training course for the research:

• Social Behavioral Research Investigators and Key Personnel (Basic Course) or
• Biomedical Research Investigators and Key Personnel (Basic Course)

Take Action

Submit DEPA |ÌýAll researchers need to submit Disclosure of External Professional Activities (DEPA) Form

Complete Training | All researchers need to complete the appropriate Human Subjects CITI Training CourseÌý

Exempt Research

If you used the Exempt Self-Assessment to determine that your research will most likely be Exempt Research(see Step 1 above), use the appropriate Exempt protocol template and informed consent template to prepare your protocol documents:

• TEMPLATE: Exempt Protocol
• TEMPLATE: Exempt In-Person Consent
• SAMPLE: Exempt In-Person Consent Form
• TEMPLATE: Exempt Remote Consent

Non-Exempt Research

If you used the Exempt Self-Assessment to determine that your research will most likely not qualify for an exemption (non-exempt), use the appropriate non-exempt protocol template and informed consent template to prepare your protocol documents:

• HRP-503a: TEMPLATE – Social Behavioral (SBER) Protocol (Non-Exempt)
• HRP-503b: TEMPLATE – Biomedical Protocol (Non-Exempt)
• HRP-502: TEMPLATE – Consent Document
• HRP-506: TEMPLATE – Pre-screening Consent Script

Additional Resources for Developing Protocols*Ìý

*use if applicable

• Recruitment: Advertising and Components Form
• Recruitment: Advertising and Recruitment Guidelines
• Recruitment: Participant’s Brochure
• NIH Consent: Certificates of Confidentiality
• NIH Guidance: NIH Human Research Resource Sheet
• Waiver of Consent: Waiver of Written Consent (Verbal Consent)
• Waiver of Consent: Waiver of Informed Consent
• DoD Funded Research: Scientific Merit Review Letter
• International Research: Foreign Local Review Letter
• International Research (EU/EEA): General Data Protection Regulation (GDPR)
• FDA Device Regulations: Investigational Device Studies
• Guidance: Human Subject Data Security - ºÚÁÏÉçÇøÍø Policy
• Guidance: Deception and Incomplete Disclosure
• Guidance: Focus Group
• Guidance: Research in K-12 Schools
• Guidance: Students as Research Subjects: How to Avoid Undue Influence and Coercion
• Guidance: Classroom Research Projects
• Guidance: Research Involving Marijuana/Cannabis
• Guidance: Protocol Standards and Language for Studies Involving MRI

Take Action

Use the appropriate template to complete the Protocol document for your study (delete template instructions prior to submission) – Save in MS Word format (.docx)

Use the appropriate template to complete the Informed Consent document for your study (delete template instructions prior to submission) – Save in MS Word format (.docx)