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

If the research has minimal risk to participants and fits into one or more of the exempt categories as defined by federal regulations, it is considered Exempt Research. This 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 Research 

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 CU ��«����Ƶ 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 IRB 

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 CU ��«����Ƶ faculty member (who is eligible to be a PI) must be the PI on the project and students can be listed as Co-Investigators. 

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

Students and Faculty Advisors

All graduate students conducting human subject research at CU ��«����Ƶ must have a Faculty Advisor. 

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, conduct and/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 | All researchers need to submit Disclosure of External Professional Activities (DEPA) Form

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

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
• SAMPLE: Consent Form
• HRP-506: TEMPLATE – Pre-screening Consent Script

Additional Resources for Developing Protocols* 

*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 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 - CU ��«����Ƶ 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)

Gather Required Documents for Protocol Submission

• Completed Protocol document (see Step 5 above)
• Completed Informed Consent document (see Step 5 above)
• Supporting Documents (as applicable)
  • Surveys
  • Interview questions
  • Recruitment materials & scripts
  • Questionnaires
  • Any other additional forms/required documents
• Human Subjects Training completion reports for all personnel named on the study (downloadable via the CITI website)

Take Action

Review the IRB Investigator Manual – Required for the Principal Investigator

The IRB Investigator Manual is designed to guide you through policies and procedures related to the conduct of human research. This manual will answer many common questions and will be a valuable reference throughout the lifetime of your study.

Create an Initial Application in eRA

The IRB process begins by submitting an initial application via eRA. For step-by-step instructions, refer to “Initial Application” in the eRA Submission Guides.

Timelines for review and approval will vary depending on several factors. Plan to submit your protocol well in advance of your project start date to prevent project delays due to a pending IRB approval.

Timeline Factors

• Submissions are reviewed in the order in which they are received
• The first response you receive from the IRB may not be an approval, but rather a request for clarification or additional information
• Quality and completeness of the submission will speed up the timeline by reducing requests for clarification or additional information
• Exempt or expedited reviews will generally receive a response in 10-15 business days
• Non-exempt research requiring a full board review require an administrative pre-review (turnaround in approx. 10-15 business days) prior to scheduling a full board review
• Full board reviews are scheduled for the next available board meeting

Take Action

Check Review Status in eRA

Once you have sent in a submission for review, you may check on the status in at any time. The listed status in eRA is the most recent action performed on the study file. For step-by-step instructions to check the status of any review, refer to "Submission Status" in the eRA Submission Guides. 

The IRB may return protocol submissions to the Principal Investigator (PI) for changes. Requests for changes will be marked with the following statuses: Incomplete, Modifications Required or Deferred.

• Incomplete: It lacks key documents or information that makes it impossible for the IRB to review. Common missing information includes incorrect or incomplete Human Subjects  training, missing protocol documents, and missing consent forms.
• Modifications Required: It requires minor changes before approval can be issued. These modifications may be determined by an individual reviewer via expedited review or by Board members at a convened IRB meeting.
• Deferral: Substantial modification or clarification is required, or the IRB is unable to review the submission adequately due to insufficient information (e.g., the risks and benefits cannot be assessed with the information provided). The Response to Deferral submission must be reviewed at a convened IRB meeting.

Take Action

Create a Response Submission in eRA

Investigators are required to make the necessary revisions and submit the revised materials in . This is called a Response Submission. For step-by-step instructions, refer to “Response Submission” in the eRA Submission Guides.

Once you receive an Exempt Determination (status: Exempt) or Approval Letter (status: Approved) from the IRB (see Step 7 for Checking the Status of a Review), download the “official” approved versions of all study documents. These versions of your study documents have been approved and uploaded into eRA by the IRB and must be used to conduct your research.

Take Action

To download approved versions of study documents, log into the record in and navigate to the “Approved Docs” tab at the top of the page. Click the document name link to open each individual document, then you can then save them.