IRB Forms

Education/Training Requirements

CITI is the only recognized training for PVAMU affiliated personnel and students. IRB CITI Training Instructions

For Initial IRB Approval

• How to Submit an IRB Protocol
• Quality Improvement (QI) Form– Updated 6/22/2020
• IRB Protocol Application (right-click and save to your computer, then open with Adobe Reader)- Updated 6/06/2022
• IRB Informed Consent Template– Updated 8/4/2022
• IRB Information Sheet Template – Updated 8/4/2020

To Amend IRB Protocol

All amendments to approved protocols must be submitted and approved prior to implementation. For guidance on submitting an amendment, click HERE.  Amendments may include, but are not limited to: Addition of personnel; Change in participant numbers; and a Change in survey/interview procedures.

Protocol Closure/Continuation (30 days prior to expiration)

Complete the following forms 30 days prior to the expiration of the protocol approval

• IRB Protocol Continuing Review Form – Updated 6/22/2020
• IRB Protocol Closure Form – Updated 7/12/2022

Unanticipated or Adverse Event Reporting

• Reporting Unanticipated or Adverse Events
• IRB Unanticipated Events Form–Updated 6/22/2020

Non-Compliance Reporting

• IRB Non Compliance

For issues regarding confidentiality, or ethics contact researchcompliance@pvamu.edu

IRB Resources

IRB Frequently Asked Questions (FAQs)

1. I’m a PVAMU student interested in conducting my own research project do I need IRB approval before I can begin?

Yes. Students conducting human subjects’ research require IRB approval or registration before they can initiate their project. Please consult with the Office of Research Compliance staff if you are unsure whether your project constitutes human subjects research.

2. Can I be listed as the Lead Researcher on the IRB Application?

Yes. PVAMU doctoral students can be Lead Researchers/Investigators on human subjects’ protocols with Faculty Advisors identified on the protocol. Faculty Sponsorship is required for all research applications from outside investigators that desire access to the university student population.

3. Should I submit a new IRB application, or be added to my Faculty Advisor’s protocol?

When a student’s research project consists of the collection and/or analysis of data that is part of the scope of an existing faculty member’s IRB approved research, the student can be added to the Faculty member’s protocol, rather than submitting as Lead Researcher on a new IRB Application.

4. How should investigators submit amendments to approved protocols?

Please refer to the following document: IRB Protocol Amendments.

5. Is IRB review necessary if my study involves anonymous surveys or interviews?

Yes. An application is required if you plan to conduct anonymous survey or interview research.

6. How do I apply for IRB review?

Please follow the instructions found on page 1 of the IRB Protocol Form for submitting your protocol for review.

7. How long does it take to obtain IRB Approval/Registration?

For studies involving minimal risk, the approval process takes approximately three weeks or less. For studies involving greater than minimal risk, the approval process takes approximately 2-3 months.

8. How will I be notified when my IRB application is approved?

An official IRB approval letter will be sent by e-mail to the Principal Investigator when all requirements are met.

9. How long is my approval good for?

Most Full Committee and Expedited protocols are approved for one year from the date of review or approval (the IRB may grant a shorter approval period). Continuation of an approved Full Board protocol requires submission of the Continuing Review Form.

10. What is an unanticipated or adverse event and when should it be reported?
Please refer to the following document: IRB Unanticipated Events or Adverse Event Reporting

11. On the IRB protocol form, what is meant by “target population” and “maximum anticipated sample size?

The “Number of Participants (target population)” includes the total number of individuals the researcher intends to recruit or invite to participate in the research study.  The “Maximum anticipated sample size” is the number of individuals the researcher expects to enroll in your research study.  For example, if the target population is every student at PVAMU, the target population would be 9,000.  If a researcher expects 10% of the students at PVAMU to enroll in the research study, the maximum anticipated sample size would be 900.

Contact Us

Office of Research Compliance
Wilhelmina Delco Building, Suite 120
researchcompliance@pvamu.edu
(936) 261-1553 || (936) 261-1588 || (936) 261-1589