OneTRAC (Translational Research Activities Catalyst)

Important items for a successful application

  1. Understanding the terminology used in the VCUHS Privacy Board application  
  2. Understand if you are you required to consult with an Honest Broker prior to submitting a VCUHS Privacy Board Application
  3. Understand if you need a Data Management Plan for your VCUHS Privacy Board Application  
  4. Understand the VCUHS Privacy Board Application process

Understanding the terminology used in the VCUHS Privacy Board application

  1. Preparatory to Research
    1. Example: chart reviews.
    2. For the VCUHS Privacy Board Application process, this type is defined as if your study requires VCUHS to give you access to personal health information (PHI) before your research starts so you can identify, NOT CONTACT, potential subjects since approval to contact requires an IRB waiver. 
  2. Research on Decedents
    1. For the VCUHS Privacy Board Application process, this type is defined as if your research is done solely on individuals who are no longer alive.
  3. Research with HIPAA Authorization
    1. For the VCUHS Privacy Board Application process, this type is defined as if participants are signing permission to allow VCUHS to disclose their PHI for use in your research.
  4. Research with Waiver or Altered Authorization
    1. For the VCUHS Privacy Board Application process, this type is defined as if IRB approval is needed so you can access and use unconsented subject data to advance your research beyond feasibility.
  5. Partial Waiver of Authorization 
    1. For the VCUHS Privacy Board Application process, this type is defined as when you need to get PHI for finding people to join a study.
  6. Full Waiver of Authorization
    1. For the VCUHS Privacy Board Application process, this type is defined as when the study needs PHI for research without getting authorization from subjects.
  7. Alteration of Authorization
    1. For the VCUHS Privacy Board Application process, this type is defined as if you want the VCUHS Privacy Board/IRB to approve a request that changes SOME parts of a PHI Authorization but NOT all.
  8. Honest Broker
    1. An Honest Broker is a Team Member who conducts Data Curation for research purposes in accordance with this policy. An Honest Broker is a neutral third-party who is not part of the team for a particular research study (i.e., is not one of the investigators, study coordinators, statisticians, or data analysts on a research study). An Honest Broker for a study may not be a co-author on any publication for that same study.
  9. Data Management Plan
      1. Is the result of the study’s Principal Investigator completing the DMS process found HERE. 
        1. This process is defined by the system owner as:  

          “This system is designed to provide VCU personnel with guidance on the handling, transmission, and storage of information; including specific requirements related to the handling of various types of information, IT resources and services offered by the University that can assist in the handling of such information, and specific precautions one should take in handling various types of information. Additionally, this system provides a platform for requestor of data and information to interact with designated Data Stewards. The features of this system are designed to help requestors in constructing formal data security plans that can be used as an addendum to project proposals, to help the Data Stewards in communicating expectations, and to provide an understanding for users on how data and information should be properly handled.”

  10. Documents you may need to provide based on your study
    1. Altered HIPAA Authorization(s)
    2. Honest Broker consultation and/or identified data requirements
    3. VCU Data Management Plan

Supporting Policies

Title

Organization

Policy Number

Protected Health Information, Uses & Disclosures for Research Policy

VCU Health System Authority and Affiliates

COMP-014

De-Identification of Protected Health Information Policy

VCU Health System Authority and Affiliates

MR.PH.004

Uses and disclosures of PHI for which an authorization or opportunity to agree or object is not required

Department of Health and Human Services

45 CFR 164.512(i)

Other Requirements Relating to Uses and Disclosures of Protected Health Information

Department of Health and Human Services

45 CFR 164.514(b)

VCU/VCUHS Enterprise Data Warehouse for Research Protocol

VCU

HM20023298

Pathways for Using VCU Health Data in Research

This flowchart outlines the various pathways for utilizing VCU Health System (VCUHS) data in research, as documented in the VCUHS Privacy Board application process. Understanding these categories—ranging from feasibility assessments to retrospective studies and participant recruitment—can help ensure compliance with HIPAA regulations and institutional requirements. Use this guide to determine the appropriate approvals, waivers, and authorizations needed for your research project.

Download a PDF description of process in image below: Pathways for Using VCU Health Data in Research

To view a description of the Pathways in image below:  Pathways for Using VCU Health Data in Research

Data for Research Purposes diagram with Feasibity, Retrospective Data Study, Recruitment of Participants, and StudyEnrollment sections which are detailed on link to a PDF just prior to this image

Email Notification References:

The following can assist you with searching your inbox for important status notices from the Privacy Board that are sent from privacyboard@vcuhealth.org.

Description

Email Recipient(s) 

Email Subject Line

Research Data Application Link

PI Email Address

A-9075 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Approval Without Revision

Research Data Application Link after Meeting

PI Email Address

A-9426 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Approval Without Revision

Research Data Application Link after Amendment Approval #1

PI Email Address

A-9427 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Approval Without Revision

Research Data Application Link after Amendment Approval #2

PI Email Address

A-9428 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Approval Without Revision

Research Data Application Link after Amendment Approval #3

PI Email Address

A-9429 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Approval Without Revision

Notify Study Team on Research Data Application sent to PI

PI Email Address;Research Coordinator

A-9086 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Research Data Agreement Signatures Sent to PI

Notice to PI that Privacy Board services are not needed based on submitted Application 

PI Email Address;Research Coordinator

A-9097 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Privacy Board Services not Needed

Privacy Board Notice of Normal Full Privacy Board Review required

PI Email Address;Research Coordinator

A-9078 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP
RECORD ID} - Privacy Board Normal
Full Privacy Board Review

Notice to PI regarding Privacy Board Chair Approval for Full Board or Expedited review

PI Email Address

A-9077 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Privacy Board Approved and Expedited

Notice to Coordinator regarding Privacy Board Chair Approval for Full Board or Expedited review

Research Coordinator

A-9100 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Privacy Board Approved and Expedited

Privacy Board Chair Disapproved via expedited workflow

PI Email Address;Research Coordinator

A-9087 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Privacy Board Disapproved

Notify PI & Team on Full Board Review Decision of Disapproved 

PI Email Address;Research Coordinator

A-9098 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Privacy Board Disapproved at Full Board Meeting

Notify Coordinator on Full Board Recorded Decision

Research Coordinator

A-9101 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Full Board made Decision

Amendment Process - Notice to PI that services not needed along with option to simple amend

PI Email Address

 

A-9099 Privacy Board Services Not Needed [next-instance]

Amendment Process - Expedited Pending Consecutive Amend with pathway 

PI Email Address

A-9088 Expedited Pathways Amendment [next-instance]

Amendment Process - First or Consec Amend Privacy Board Chair Disapproved and Expedited

PI Email Address

A-9090 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Privacy Board Disapproved

Amendment Process - Expedited First or Consec Amend Privacy Board Chair Approved

PI Email Address

A-9091 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Privacy Board Approved and Expedited

Amendment Process - Consecutive amend Privacy Board Normal Full Privacy Board Review

PI Email Address;Research Coordinator

A-9092 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Privacy Board Normal Full Privacy Board Review for First or Consecutive Amendment

Amendment Process - Notify PI on Full Board Recorded Decision with Simple Amend link

PI Email Address

A-9094 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Full Board made Decision

Amendment Process - FB Consec Notify PI Team on Full Board Recorded Decision with Simple Amend link

PI Email Address

A-9095 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Full Board made Decision

Amendment Process - To Coordinator, First or Consec Amend Privacy Board Chair Expedited

Research Coordinator

A-9102 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Privacy Board Consecutive Amendment Expedited

Amendment Process - To Coordinator, First or Consec Amend Privacy Board Chair FB

Research Coordinator

A-9103 VCU ONETRAC Notifier - PROC Request #{YOUR REDCAP RECORD ID} - Privacy Board Consecutive Amendment Full Board

Understand if you: 

Are you required to consult with an Honest Broker prior to submitting a VCUHS Privacy Board Application

Need a Data Management Plan  for your VCUHS Privacy Board Application

 

Requires an Honest Broker Consult 

Requires a Data Management Plan

Preparatory to Research

YES

NO

Research on Decedents

YES

YES

Research with Waiver or Altered Authorization

YES

YES

Research with HIPAA Authorization

NO (But Recommended)

YES

Questions about Honest Brokers? Email informatics@vcu.edu

Understand the VCUHS Privacy Board Application process.