irb-human-subjects/Forms/Submissions/FRM-IRB-001-Protocol-Submission-Form.md

# IRB Protocol Submission Form

| Form ID | FRM-IRB-001 | Revision | 1.0 |
|---------|-------------|----------|-----|

---

## Section 1: General Information

### 1.1 Submission Type

☐ New Protocol
☐ Modification/Amendment to Protocol #: _____________
☐ Continuing Review for Protocol #: _____________

### 1.2 Study Identification

| Field | Entry |
|-------|-------|
| Protocol Title | |
| Short Title (≤50 characters) | |
| Proposed Start Date | |
| Expected Duration | months |

### 1.3 Review Category Requested

☐ Exempt (specify category): _____________
☐ Expedited (specify category): _____________
☐ Full Board Review

---

## Section 2: Principal Investigator Information

| Field | Entry |
|-------|-------|
| Name | |
| Title/Position | |
| Department | |
| Institution | |
| Mailing Address | |
| Phone | |
| Email | |
| Faculty Sponsor (if PI is student) | |

**Training Certification:**
| Certification | Expiration Date |
|---------------|-----------------|
| CITI Human Subjects | |
| GCP (if applicable) | |
| Other: | |

---

## Section 3: Research Team

| Name | Role | Department | Training Current? |
|------|------|------------|-------------------|
| | PI | | ☐ Yes |
| | | | ☐ Yes |
| | | | ☐ Yes |
| | | | ☐ Yes |
| | | | ☐ Yes |

---

## Section 4: Funding Information

### 4.1 Funding Source

☐ Internally Funded (Department/Institution)
☐ Federal Grant (Agency: _____________)
☐ Industry Sponsored (Sponsor: _____________)
☐ Foundation/Non-Profit (Name: _____________)
☐ Not Funded

### 4.2 Grant Information (if applicable)

| Field | Entry |
|-------|-------|
| Grant/Contract Number | |
| Funding Period | |
| Grant Title | |

---

## Section 5: Study Overview

### 5.1 Purpose and Objectives

*Briefly describe the purpose of this research and specific aims (250 words max):*

### 5.2 Background and Rationale

*Provide scientific background and justification (500 words max):*

### 5.3 Research Design

☐ Observational/Non-interventional
☐ Interventional
☐ Clinical Trial
☐ Survey/Questionnaire
☐ Interview/Focus Group
☐ Secondary Data Analysis
☐ Other: _____________

---

## Section 6: Subject Population

### 6.1 Target Population

| Field | Entry |
|-------|-------|
| Minimum Age | |
| Maximum Age | |
| Target Enrollment (this site) | |
| Target Enrollment (total, all sites) | |

### 6.2 Inclusion Criteria

*List specific inclusion criteria:*

1.
2.
3.
4.
5.

### 6.3 Exclusion Criteria

*List specific exclusion criteria:*

1.
2.
3.
4.
5.

### 6.4 Vulnerable Populations

*Check all that may be included:*

☐ None
☐ Children/Minors
☐ Prisoners
☐ Pregnant Women
☐ Cognitively Impaired
☐ Economically Disadvantaged
☐ Educationally Disadvantaged
☐ Students of PI
☐ Employees of PI
☐ Decisionally Impaired
☐ Other: _____________

*If vulnerable populations included, describe additional protections:*

---

## Section 7: Recruitment

### 7.1 Recruitment Methods

*Check all that apply:*

☐ Medical records review
☐ Advertising (print, radio, TV)
☐ Internet/Social media
☐ Flyers/Posters
☐ Direct approach in clinic
☐ Telephone
☐ Email
☐ Referral from provider
☐ Community outreach
☐ Other: _____________

### 7.2 Recruitment Materials

*List all recruitment materials attached:*

| Document Name | Version/Date |
|---------------|--------------|
| | |
| | |
| | |

---

## Section 8: Research Procedures

### 8.1 Study Procedures

*Describe all procedures subjects will undergo (include timeline):*

### 8.2 Duration of Participation

| Field | Entry |
|-------|-------|
| Number of visits | |
| Duration of each visit | |
| Total participation time | |
| Follow-up duration | |

### 8.3 Study Location(s)

| Location | Address |
|----------|---------|
| | |
| | |

---

## Section 9: Drugs, Devices, and Biologics

### 9.1 Does this study involve drugs, devices, or biologics?

☐ No → Skip to Section 10
☐ Yes → Complete below

### 9.2 Drug Information

| Field | Entry |
|-------|-------|
| Drug Name | |
| IND Number (or Exemption) | |
| FDA Approval Status | ☐ Approved ☐ Investigational |
| IND Sponsor | |

### 9.3 Device Information

| Field | Entry |
|-------|-------|
| Device Name | |
| IDE Number (or Exemption) | |
| FDA Approval Status | ☐ Approved ☐ Investigational ☐ Exempt |
| Device Risk | ☐ Significant Risk ☐ Non-Significant Risk |

---

## Section 10: Risks and Benefits

### 10.1 Risks

*Describe all foreseeable risks (physical, psychological, social, economic, legal):*

| Risk | Likelihood | Severity | Mitigation |
|------|------------|----------|------------|
| | ☐ Low ☐ Med ☐ High | ☐ Low ☐ Med ☐ High | |
| | ☐ Low ☐ Med ☐ High | ☐ Low ☐ Med ☐ High | |
| | ☐ Low ☐ Med ☐ High | ☐ Low ☐ Med ☐ High | |

### 10.2 Benefits

*Describe potential benefits:*

**To subjects:**

**To others/society:**

### 10.3 Risk/Benefit Assessment

*Justify why risks are reasonable in relation to anticipated benefits:*

---

## Section 11: Privacy and Confidentiality

### 11.1 Identifiable Information Collected

*Check all that apply:*

☐ Name
☐ Date of birth
☐ Social Security Number
☐ Medical Record Number
☐ Address
☐ Phone number
☐ Email
☐ Photographs/Video
☐ Audio recordings
☐ IP address
☐ Genetic information
☐ Other: _____________

### 11.2 Data Storage and Security

| Field | Entry |
|-------|-------|
| Storage location | ☐ Paper ☐ Electronic ☐ Both |
| Physical security measures | |
| Electronic security measures | |
| Who will have access to data? | |
| Data retention period | |
| Disposition after study | ☐ Destroy ☐ Archive |

### 11.3 Data Sharing

Will data be shared with others outside the research team?
☐ No ☐ Yes (describe): _____________

---

## Section 12: Informed Consent

### 12.1 Consent Process

*Describe how consent will be obtained:*

☐ Written consent from subject
☐ Written consent from LAR
☐ Oral consent with documentation
☐ Waiver of documentation of consent
☐ Waiver of consent

### 12.2 Consent Documents

| Document | Language | Version/Date |
|----------|----------|--------------|
| Consent Form | | |
| Consent Form | | |
| Assent Form | | |
| HIPAA Authorization | | |

### 12.3 Waivers Requested

**Waiver of Consent (45 CFR 46.116(f)):**
☐ Not requested
☐ Requested - Justify below:

**Waiver of Documentation of Consent (45 CFR 46.117(c)):**
☐ Not requested
☐ Requested - Justify below:

**Waiver of HIPAA Authorization (45 CFR 164.512(i)):**
☐ Not requested
☐ Requested - Justify below:

---

## Section 13: Compensation

### 13.1 Subject Compensation

☐ No compensation
☐ Yes → Complete below

| Visit/Activity | Compensation Amount |
|----------------|---------------------|
| | $ |
| | $ |
| Total possible | $ |

### 13.2 Payment Method

☐ Cash ☐ Check ☐ Gift card ☐ Other: _____________

---

## Section 14: Conflict of Interest

### 14.1 Financial Interests

Does any member of the research team have a financial interest in the study sponsor, product, or outcome?

☐ No
☐ Yes (disclosure attached)

---

## Section 15: Required Attachments Checklist

| Document | Attached? |
|----------|-----------|
| Research Protocol | ☐ |
| Informed Consent Form(s) | ☐ |
| Assent Form(s) | ☐ or N/A |
| HIPAA Authorization | ☐ or N/A |
| Recruitment Materials | ☐ or N/A |
| Surveys/Questionnaires | ☐ or N/A |
| Training Certificates | ☐ |
| COI Disclosures | ☐ |
| Grant/Funding Documents | ☐ or N/A |
| Investigator Brochure | ☐ or N/A |
| Site Authorization Letters | ☐ or N/A |
| Data Use Agreement | ☐ or N/A |
| Other: _____________ | ☐ |

---

## Section 16: PI Assurance

By signing below, I certify that:

- I have read and will comply with all institutional policies and federal regulations
- All information in this application is accurate and complete
- I will obtain IRB approval before initiating any changes
- I will report adverse events and unanticipated problems promptly
- I will ensure all study personnel are appropriately trained
- I take responsibility for the conduct of this research

| Field | Entry |
|-------|-------|
| PI Signature | |
| Date | |

---

## Section 17: Department Approval (if required)

| Field | Entry |
|-------|-------|
| Department Chair/Designee | |
| Signature | |
| Date | |

---

## For IRB Use Only

| Field | Entry |
|-------|-------|
| Date Received | |
| IRB Protocol Number | |
| Review Category Assigned | ☐ Exempt ☐ Expedited ☐ Full Board |
| Primary Reviewer | |
| Secondary Reviewer | |
| Meeting Date (if Full Board) | |
| Action | |
| Approval Date | |
| Expiration Date | |

---

*Form FRM-IRB-001 Rev 1.0 - IRB Protocol Submission Form*