8.6 KiB
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 | |
| 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:
6.3 Exclusion Criteria
List specific exclusion criteria:
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