Institutional Review Board & Human Subjects' Protections

To ensure that institutional research resources and procedures align for access to Sentara TriNetX the Office of Research is announcing the following requirements to obtain access.  All the steps below must be completed to receive access to TriNetX and to subsequently use data for research purposes.

How to Request Access to Sentara TriNetX:

a. For projects involving medical students:

• The project must first be cleared through Medical Student Research.
• Projects involving trainees, must have a VHS faculty mentor as the PI.
• Contact MSR for assistance.

b. Complete an IRB notification xForm in IRBManager prior to requesting use of TriNetX.

• Save the IRB determination letter so you can upload where requested in the steps below.  The IRB determination is only for activities that are Not Human Subject Research.  An IRB approval is required for all Human Subject Research.

c. Complete a  SENTARA Data Use Attestation. Save to upload in the next step.

d. Request an account through SENTARA Research Data Request Portal.

• Upload the  SENTARA Data Use Attestation where indicated.

Additional Helpful Information

• If you need RISE assistance with refining your project and queries and assisting with projects involving identified data please see the RISE Service Request Form.
• To request downloaded TriNetX data and or EPIC data, update your IRB approval and then share the project with a member of the Sentara data extraction team from the built-in sharing feature in TriNetX.
• Each project/request must go through a separate review.  For example, an IRB determination is only for a specific TriNetX project and cannot be used to access additional or new data.
• This process cannot be used to obtain a dataset when collaborating with TriNetX staff or purchasing a TriNetX dataset.  Those activities must request IRB approval.

An Institutional Review Board (IRB) is an independent regulatory body established to protect the rights and welfare of human research subjects recruited to participate in research activities. The Macon & Joan Brock Virginia Health Sciences at Old Dominion University IRB reviews research involving the use of human subjects at our school and at other designated institutions and private practices. In addition to the school's sites, services are available for sites such as Sentara, CHKD, Bon Secours, other medical facilities and private practices.

The IRB is charged with the responsibility of reviewing all research that involves human subjects. An IRB has the responsibility of protecting the welfare, rights, and privacy of human subjects.  Under federal regulations, an IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

The medical school currently has two internal Institutional Review Boards that oversee biomedical/clinical research. Meetings take place on the 1st Thursday and 3rd Tuesday of each month.  Protocols requiring Board review are assigned to meetings on a first come, first served basis after the submission is verified as complete by the Research Subjects’ Protections office. In addition, a sub-committee of each IRB holds meetings on the same dates to review certain exempt and expedited studies. Requests for Not Research and Not Human Subject Research determinations are made by the IRB staff who may consult with IRB members as needed.

Social Behavioral studies are reviewed by the Main Campus IRB.

The Human Subjects' Protections Program oversees all aspects of human subject protection at Macon & Joan Brock Virginia Health Sciences at Old Dominion University, including administrative support of the Institutional Review Boards.

Many of the school's Human Subjects' Protections Program staff are Certified IRB Professionals. Certification is overseen by a national leader in research ethics, Public Responsibility in Medicine and Research.  Staff members also have varying backgrounds, including pharmaceutical regulatory management, post-graduate degree in science, graduate degree in public health, administration of a research unit in clinical practice, experience serving at a commercial IRB, and together have well over 40 years of direct IRB experience.

The Human Subjects' Protections Program offers presentations on many topics to help investigators and research team members understand the IRB process and requirements. If you are interested in having a presentation made to your department or group please contact the IRB office at 757-446-8423.

We requires basic CITI training by investigators and research team members prior to starting any human subject research project. If a course has been completed through an institution other than Macon & Joan Brock Virginia Health Sciences at Old Dominion University please send the detailed completion report(s) to the IRB email for consideration.

Review the Division of Social//Behavioral and Biomedical/Clinical IRB Reviews.