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+# 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
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |