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 |

---

## 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] |