irb-human-subjects/SOPs/Protocol-Review/SOP-IRB-001-Protocol-Submission.md

Standard Operating Procedure: IRB Protocol Submission and Review

Document ID	SOP-IRB-001
Title	IRB Protocol Submission and Initial Review Process
Revision	1.0
Effective Date	[DATE]
Author	[AUTHOR]
Approved By	[APPROVER]
Department	Institutional Review Board

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1. Purpose

To establish standardized procedures for the submission, review, and approval of human subjects research protocols in accordance with federal regulations (45 CFR 46, 21 CFR 50/56) and institutional policies.

2. Scope

This procedure applies to all research involving human subjects requiring IRB review, including:

• Biomedical research
• Behavioral research
• Social science research
• Educational research
• FDA-regulated research (drugs, devices, biologics)
• Exempt, expedited, and full board reviews

3. Responsibilities

3.1 Principal Investigator (PI)

• Prepare and submit complete protocol application
• Ensure research team training compliance
• Respond to IRB stipulations
• Maintain protocol compliance

3.2 IRB Coordinator

• Process submissions for completeness
• Assign review pathway
• Coordinate reviewer assignments
• Track submission timelines
• Communicate decisions

3.3 IRB Chair/Vice Chair

• Conduct expedited reviews
• Prepare agenda for full board
• Sign approval letters
• Address urgent matters

3.4 IRB Members

• Review assigned protocols
• Participate in convened meetings
• Vote on protocol actions
• Maintain confidentiality

4. Definitions

Term	Definition
Common Rule	Federal Policy for the Protection of Human Subjects (45 CFR 46)
Exempt	Research meeting criteria that does not require ongoing IRB oversight
Expedited	Minimal risk research eligible for review outside convened meeting
Full Board	Research requiring review at convened IRB meeting
Minimal Risk	Risk no greater than encountered in daily life

5. Procedure

5.1 Pre-Submission Requirements

Before submission, PI must ensure:

• All study personnel have completed required training (CITI, GCP)
• Training certificates uploaded to protocol file
• Conflict of interest disclosures current
• Department/division approval obtained (if required)
• Funding information available
• Study documents prepared (protocol, consent, recruitment materials)

5.2 Protocol Submission

5.2.1 Required Application Components

Document	Required for All	Notes
Protocol application form	☐	Complete all sections
Research protocol/plan	☐	Detailed methods
Informed consent form(s)	☐	Unless waiver requested
Recruitment materials	If applicable	Flyers, scripts, ads
Data collection instruments	☐	Surveys, questionnaires
Investigator brochure	FDA-regulated	Drug/device studies
Grant/funding documents	If externally funded
Training documentation	☐	All personnel
COI disclosures	☐	All personnel
Site authorization letters	Multi-site	External sites
Translations	Non-English	Consent, materials

5.2.2 Submission Process

1. Complete application in electronic system
2. Upload all required documents
3. Obtain department approval routing
4. Submit to IRB

5.3 Administrative Review

IRB staff conducts administrative review within 3 business days:

Check	Action
Application completeness	Return if incomplete
Required documents attached	Request missing items
Training current	Verify certificates
COI disclosures filed	Confirm compliance
Regulatory pathway	Assign review category

5.4 Review Categories

5.4.1 Exempt Determination

Research may qualify for exemption under 45 CFR 46.104 categories:

1. Educational settings research
2. Surveys, interviews, observation (with limitations)
3. Benign behavioral interventions
4. Secondary research with identifiable data
5. Federal program evaluation
6. Taste/food quality studies
7. Storage or maintenance of specimens/data
8. Secondary research for regulatory purposes

Process:

• IRB staff or designated reviewer conducts exemption determination
• Timeline: 5 business days
• Outcome: Exempt letter or escalation to expedited/full review

5.4.2 Expedited Review

Eligible for expedited if:

• Minimal risk, AND
• Falls into expedited categories (45 CFR 46.110)

Expedited Categories include:

1. Clinical studies of approved products
2. Collection of blood samples
3. Prospective collection of specimens (non-invasive)
4. Data collection through non-invasive procedures
5. Research on characteristics/behavior
6. Voice, video, image recording for research
7. Study of existing data/specimens
8. Continuing review (specific conditions)
9. Minor changes to approved research

Process:

• Assigned to IRB Chair/Vice Chair or experienced member
• Timeline: 10 business days
• Outcomes: Approve, require modifications, refer to full board

5.4.3 Full Board Review

Required when:

• Greater than minimal risk, OR
• Not eligible for expedited categories, OR
• Involves vulnerable populations with complex issues

Process:

• Assigned primary reviewer(s)
• Placed on meeting agenda
• Quorum required for deliberation
• Outcomes: Approve, modifications required, table, disapprove

5.5 Review Criteria

IRB must determine that all of the following are satisfied:

Criterion	Requirement
Risks minimized	Through sound design, existing procedures when possible
Risks reasonable	In relation to anticipated benefits
Equitable selection	Of subjects, including vulnerable populations
Informed consent	Sought and documented appropriately
Data safety	Adequate provisions for monitoring
Privacy/confidentiality	Adequate protections in place
Vulnerable populations	Additional safeguards when appropriate

5.6 Informed Consent Evaluation

Required Elements of Consent (45 CFR 46.116)

• Statement that study involves research
• Explanation of purposes
• Expected duration of participation
• Description of procedures
• Description of reasonably foreseeable risks
• Description of benefits
• Alternative procedures or treatments
• Confidentiality protections
• Compensation/treatment for injury (if applicable)
• Contact information
• Statement that participation is voluntary

Additional Elements (as applicable)

• Unforeseeable risks
• Circumstances for termination
• Additional costs to subject
• Consequences of withdrawal
• Significant new findings disclosed
• Number of subjects
• Biospecimen commercial use statement
• Whole genome sequencing statement

5.7 IRB Meeting Procedures

1. Quorum Requirements

   • Majority of members
   • At least one non-scientist
   • Scientific expertise relevant to studies reviewed

2. Meeting Process

   • Primary reviewer presents protocol
   • Discussion by members
   • PI may be invited for questions
   • Deliberation (PI excused)
   • Vote by show of hands

3. Voting Actions

   Action	Definition
   Approved	Ready to proceed
   Approved with modifications	Minor changes required (verified by Chair)
   Tabled	Substantive concerns requiring major revision
   Disapproved	Criteria not met, does not meet regulatory requirements

5.8 Post-Review Communication

1. Approval Letter Includes:

   • Approval date
   • Expiration date (if applicable)
   • Approved documents and versions
   • Approval conditions
   • Continuing review requirements

2. Modifications Required Letter

   • Specific changes requested
   • Timeline for response
   • Process for resubmission

3. Disapproval Letter

   • Reasons for disapproval
   • Right to respond/appeal

5.9 Response to Stipulations

1. PI submits written response addressing each stipulation
2. Revise documents as requested
3. Upload revised materials
4. Chair/reviewer verifies adequacy
5. Final approval issued when complete

6. Timelines

Review Type	Target Timeline
Administrative review	3 business days
Exempt determination	5 business days
Expedited review	10 business days
Full board (to meeting)	Next scheduled meeting
Post-meeting stipulations	10 business days after response

7. Documentation

• FRM-IRB-001 Protocol Submission Form
• FRM-IRB-002 Informed Consent Template
• FRM-IRB-003 Reviewer Checklist
• Meeting minutes
• Approval/action letters
• Correspondence log

8. References

• 45 CFR 46 - Protection of Human Subjects
• 21 CFR 50 - Protection of Human Subjects (FDA)
• 21 CFR 56 - Institutional Review Boards (FDA)
• OHRP Guidance Documents
• ICH E6 Good Clinical Practice

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Revision History

Rev	Date	Description	Author
1.0	[DATE]	Initial release	[AUTHOR]