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Policies and Guidance

Written Policies and Procedures

Click Here for a PDF of all Written Policies and Procedures (WPPs)

NOTE: For assistance accessing information related to our programs, please contact ORSP at ORSP@vcu.edu or 828-0868.

 

Special Guidance

The HIPAA Privacy Rule establishes conditions under which covered entities, including the VCU Affiliated Covered Entity can provide researchers access to and use of Protected Health Information (PHI). The Rule is not intended to impede research. However, it does provide for specific ways that PHI can be accessed and used by researches as well as defines how individuals have control over their health information when they are research participants.

HIPAA Forms and Templates

See the IRB Forms page.

VCU IRB’s Guidance for Researchers

Additional Guidance for Researchers

Determining if an activity is Research and/or Quality Improvement can be challenging. Federal regulations require human subject research to reviewed and approved by the IRB, while strictly QI activities do not require IRB oversight. However, some QI activities may also be research and therefore need IRB approval. Please review the following guidance and use the following REDCap decision tool to determine if your activity likely needs IRB approval PRIOR to beginning the activity.

Once you've used these determination tools, if you have questions about whether your project is human subject research that needs IRB approval, please contact ORSP at orsp@vcu.edu.

NEW! If you need documentation from the IRB that your activity is not research or does not involve human subjects, use RAMS-IRB to submit a request for a determination. Learn how on our blog

Overview

Self Evaluation Tools

Communication

Consent Tracking

Data Management

Drug/Device Accountability

Regulatory Binder

Event Tracking

Recruitment, Screening, Enrollment & Tracking Subjects

Risk Management

Service Request

Study Monitoring

VCU PAMQuIP Forms

Study Setup Templates

Conflict of Interest Requirements

The term “Conflict of Interest” refers to situations where financial or other personal considerations may directly and significantly affect, or have the appearance of directly and significantly affecting, a researcher’s professional judgment in research conduct. Unaddressed conflicts of interest impact research integrity of the investigator and the university.

Initial Reviews

Prior to issuing approval for any initial submission to the IRB, a conflict of interest (COI) review must be completed. The COI review may occur concurrently with IRB review, but IRB approval cannot occur until it is determined that no conflicts exist or any conflicts have been acceptably managed.

Investigators should ensure all of the following are completed to help ensure the COI review does not delay IRB approval.

  1. Designate in the Personnel section in RAMS-IRB any research personnel who fulfill the definition of a COI Investigator.

    *COI Investigator – Any individual, regardless of title, role or position, who is responsible for the design, conduct, or reporting of research. Individuals with such research responsibilities may be, but are not limited to, senior/key personnel, sub/co-investigator or subrecipient investigator, medical investigator, collaborator, consultant, student, trainee, or research coordinator. Exceptions include students or other personnel whose research activities are directly supervised. By considering an individual’s degree of independence relative to the research, the PI on the protocol designates those who meet the definition of "COI Investigator".

    See the COI page for more information about designating COI investigators.

  2. All personnel designated as COI investigators must complete a Financial Interest Report (FIR) in the Activity and Interest Reporting System (AIRS). Click here to access AIRS.

Continuing Reviews

At the time of Continuing Review, the IRB will check to ensure that all COI Investigators have updated their Financial Interest Report (FIR) within the past 12 months. Approval for continuing review will be held until all FIRs are current.

Personnel Amendments

When adding personnel who are designated as COI Investigators, a COI review will be completed for each prior issuing the IRB approval for the personnel addition. All new COI Investigators should complete a Financial Interest Report (FIR) in the Activity and Interest Reporting System (AIRS) prior to submitting the amendment to the IRB.

Initial Reviews

Even though an external IRB will review the study, VCU will still conduct a conflict of interest review (COI) for each initial submission. The COI review must be complete and a final disposition provided before ORSP will authorize submission of the study to the external IRB. Any conflicts that are found will be managed jointly between VCU and the external IRB.

Investigators should ensure all of the following are completed to help ensure the COI review does not delay IRB review.

  1. Designate in the Personnel section in RAMS-IRB any research personnel who fulfill the definition of a COI Investigator.

    *COI Investigator – Any individual, regardless of title, role or position, who is responsible for the design, conduct, or reporting of research. Individuals with such research responsibilities may be, but are not limited to, senior/key personnel, sub/co-investigator or subrecipient investigator, medical investigator, collaborator, consultant, student, trainee, or research coordinator. Exceptions include students or other personnel whose research activities are directly supervised. By considering an individual’s degree of independence relative to the research, the PI on the protocol designates those who meet the definition of "COI Investigator".

    See the COI page for more information about who is a COI investigator.

  2. All personnel designated as COI investigators must complete a Financial Interest Report (FIR) in the Activity and Interest Reporting System (AIRS). Click here to access AIRS. The submission will not be forwarded to the external IRB until all FIRs are complete.

Continuing Reviews

VCU will not conduct ongoing COI reviews for studies sent to external IRBs. However, investigators are responsible for ensuring all COI investigators update FIRs as required by COI policies.