IRB Protocol Management

The Institutional Review Board (IRB) ensures that research involving human participants meets ethical standards and regulatory requirements. AcaTrove's IRB module provides a structured workflow for creating protocols, submitting them for review, responding to board feedback, and maintaining approved protocols throughout their lifecycle.

Creating an IRB Protocol

1. Navigate to /compliance and click + New Protocol, then select IRB.
2. Complete the protocol sections:

Study Information

• Protocol title and short title.
• Principal investigator and co-investigators.
• Estimated start and end dates.
• Funding source and grant number (if applicable).

Study Design

• Research objectives and hypotheses.
• Study type (interventional, observational, survey, interview, secondary data analysis).
• Participant population description and eligibility criteria.
• Expected number of participants.
• Recruitment methods and materials.

Risk Assessment

• Potential risks to participants (physical, psychological, social, economic, legal).
• Risk level classification (minimal risk, greater than minimal risk).
• Risk mitigation strategies.
• Data safety monitoring plan (for higher-risk studies).

Informed Consent

• Upload or compose the informed consent document.
• Describe the consent process (how, when, and by whom consent will be obtained).
• Indicate whether a waiver of consent is requested and provide justification.
• For studies involving minors, include assent and parental permission forms.

Data Management

• Types of data collected and storage methods.
• Data security measures and encryption.
• De-identification or anonymization procedures.
• Data retention period and destruction plan.

Attachments

• Surveys, questionnaires, interview guides.
• Recruitment materials (flyers, emails, social media posts).
• Supporting documents (grant excerpts, letters of support).

IRB protocol creation form with study information and risk assessment

Submitting for Review

When your protocol is complete, click Submit for Review. AcaTrove routes the protocol to the appropriate review pathway:

• Exempt Review -- For studies that qualify for exemption under federal regulations. Reviewed by a single designated reviewer.
• Expedited Review -- For minimal-risk studies that qualify for expedited processing. Reviewed by the IRB chair or designated reviewer.
• Full Board Review -- For studies involving greater than minimal risk. Reviewed at a convened IRB meeting.

AcaTrove suggests the appropriate review type based on your risk assessment, but the IRB makes the final determination.

Review Workflow

Once submitted, the protocol enters the review workflow:

1. Administrative Review -- The compliance office checks the submission for completeness.
2. Assigned Reviewer(s) -- One or more board members are assigned to review the protocol.
3. Board Action -- The reviewers (or full board) take one of four actions:
   • Approved -- The study may proceed.
   • Approved with Conditions -- Minor changes required; approval is granted once conditions are met.
   • Modifications Required -- Substantive changes needed before approval.
   • Not Approved -- The study cannot proceed as proposed.

IRB review workflow showing submission, review, and approval stages

Responding to Board Feedback

If the board requests modifications:

1. Open the protocol from your compliance dashboard.
2. Review the board's comments, which are attached to specific sections.
3. Make the requested changes.
4. Write a response letter addressing each comment.
5. Click Resubmit. The revised protocol returns to the reviewer(s).

Renewals and Continuing Review

Approved protocols typically require annual renewal. AcaTrove automates the renewal process:

• You receive reminders at 90, 60, and 30 days before expiration.
• Click Renew on the protocol to generate a continuing review form pre-populated with protocol details.
• Report any changes to the study, adverse events, or protocol deviations since the last approval.
• Submit the renewal for review.

Amendments

If you need to change an approved protocol (new procedures, additional participant populations, revised consent forms), file an amendment:

1. Open the approved protocol and click File Amendment.
2. Describe the proposed changes and their rationale.
3. Upload revised documents.
4. Submit the amendment for review.

Tips

• Use AcaTrove's template library to start with a pre-formatted protocol that matches your institution's requirements.
• Keep your informed consent document clear and at an appropriate reading level for your participant population.
• Respond to board comments promptly -- delays in response extend the review timeline.
• Link the IRB protocol to its corresponding project so team members can verify compliance status.