IRB Protocol Review Process

The IRB reviews and approves submitted protocol forms in a standard and systematic way that allows for a quick review of social, behavioral and educational human subjects’ research projects. For more information, please refer to How to Submit an IRB Protocol.

Step 1:

Members of the Office of Research Compliance (ORC) review all incoming IRB protocols for the following documentation.

* Completed Social and Behavioral Researchers online training certificates for each person listed on the protocol.

* Initials and signatures of the Principal Investigator (PI), the Faculty Mentor (if applicable) and any Co-Investigators (if applicable) on the protocol form.

* A copy of the grant submission (if applicable).

* A copy of the graduate students’ thesis or dissertation proposal (if applicable).

* Consent forms for human subjects (if applicable).

* Instruments such as surveys or a list of interview questions (if applicable).

* Letters requesting permission to conduct research in a school district (if applicable). Permission should be requested from both the Superintendent of the school district and the Principal of   the school.

* Written permission to use instruments that did not originate from the Principal Investigator or exist in the public domain for public use (if applicable).

*Data use agreements (if applicable).

Step 2:

Members of the ORC will review the protocol form for completeness.  Enough information must be present in the protocol for the IRB to conduct a review.

Step 3:

Members of the ORC will review the protocol form to determine if the work falls under the Family Educational Rights and Privacy Act (FERPA).

Please Note: If you collect educational records from an educational institution, your study may fall under FERPA regulations.  For more information, contact the ORC at research@pvamu.edu.

Step 4:

Members of the ORC will review the protocol form to determine if the work falls under the Health Insurance Portability and Accountability Act (HIPAA).

Please Note:  If you collect information from health care providers or related businesses, your study may fall under HIPAA regulations.  For more information, contact the ORC at research@pvamu.edu.

Step 5:

Members of the ORC will review the protocol form using the Office of Human Research Protections (OHRP) Decision Charts to determine which category the research falls under.  The protocol may fall under one of five categories.

1.     Not Research

If the protocol is determined not to be research, a member of the ORC will prepare a letter for the PI declaring that the protocol is not research.  Once the complete protocol is received, this process typically takes less than one week.

2.    Not Research with Human Subjects

If the protocol is determined not to be research with human subjects, a member of the ORC will prepare a letter for the PI declaring that the protocol is not research with human subjects.  Once the complete protocol is received, this process typically takes less than one week.

3.     Exempt

 If the protocol is determined to be exempt, a member of the ORC will prepare a letter for the PI declaring that the protocol is exempt.  Revisions may be required to declare the protocol exempt.  Once the complete protocol is received, this process typically takes less than one week.

 4.    Expedited

If the protocol is determined to be expedited, a member of the ORC will send the protocol to the IRB Chair to select a reviewer from among the IRB members.  The IRB reviewer has seven calendar days to review the expedited protocol using the following criteria.

* The IRB Protocol Checklist

* The OHRP Informed Consent Checklist

Any requested revisions will be sent to the Principal Investigator by a member of the ORC.  Once all revisions are completed, a member of the ORC will prepare an approval letter for the Principal Investigator.  This process typically takes two weeks.

5.    Full Board

If the protocol is determined to be full board, a member of the ORC will place the protocol on the agenda for the next IRB meeting.  The Principal Investigator (and Faculty Mentor if applicable) will be invited to attend the meeting to present their protocol and answer any committee questions.  The IRB will review the protocol using the following criteria.

* The IRB Protocol Checklist

* The OHRP Informed Consent Checklist

Any requested revisions will be sent to the Principal Investigator by a member of the ORC.  Once all revisions are completed, a member of the ORC will prepare an approval letter for the Principal Investigator.  This process typically takes one to two months but can vary widely depending on the content of the protocol.

Office of Research Compliance
Wilhelmina Delco Building, Room 120
Email: research@pvamu.edu
Contact Telephone Numbers: (936) 261-1553
(936) 261-1588

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