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Policies and Guidance

Written Policies and Procedures

Section VII: General Operations
VII-1 Authority of the IRB and Scope of Review 8-6-14
VII-2 Activities of the Full Board 9-24-14
VII-3 Records, Minutes and Communications 9-24-14
VII-4 Reporting to Regulatory Agencies 6-23-15
VII-5 Appeal of IRB Decisions 7-22-14
VII-6 Required Reporting of Unanticipated Problems Involving Risk 5-13-14

Section VIII: Review Types
VIII-1 Initial Review - Exempt 9-24-14
VIII-2 Initial Review - Expedited 9-24-14
VIII-3 Initial Review - Full Board 9-24-14
VIII-4 Continuing Review 9-24-14
VIII-5 Review of Modification to Research 9-24-14
VIII-6 Review of Revisions Prior to Final Approval and Calculation of Approval/Expiration Dates 5-13-14
VIII-7 Review of Grant Applications 5-13-14
VIII-8 Suspensions and Terminations of Previously Approved Research 4-22-14
VIII-9 Investigations of General, Serious or Continuing Noncompliance 6-23-15
VIII-10 Evaluating and Managing Investigator Conflicts of Interest 09-29-16

Section IX: Principal Investigator Requirements
IX-1 Principal Investigator Eligibility and Statement of Responsibilities 9-24-14
IX-2 Principal Investigator Absences 5-14-14
IX-3 Personnel Qualifications 7-30-14

Section X: Monitoring Activities
X-1 Terms of Approval 9-24-14
X-2 Data and Safety Monitoring Plan Requirements 5-14-14
X-3 Post Approval Monitoring and Quality Improvement Program (PAMQuIP) 10-22-13
X-4 Closure of Study from VCU IRB Oversight 4-22-14

Section XI: Informed Consent
XI-1 Consent Process, Elements, Waiver of Element(s), and Modification 5-13-14
XI-2 Informed Consent Documentation, Waiver of Documentation, and Required Signatures 3-28-16
XI-3 Legally Authorized Representative (Inclusion in Consent Process)
See also WPP#XV-2 Assent/Informed Consent Considerations
5-13-14
XI-4 Consideration of Research Involving Third Parties as Human Subjects 05-13-14
XI-5 Enrolling Research Subjects with Limited English Proficiency (LEP) 03-24-15

Section XII: Safeguarding Confidentiality and Records
XII-1 General Safeguards and Investigator Records Retention 5-14-14
XII-2 Certificates of Confidentiality 5-14-14
XII-3 Health Insurance Portability and Accountability Act (HIPAA) Information and the Conduct of Research 9-25-13
XII-4 Identification and Recruitment of Research Participants 5-14-14
Section XIII: Pregnant Women, Fetuses, and Neonates as Research Participants
XIII-1 Pregnant Women, Human Fetuses, and Neonates (Special Protections) 9-24-14

Section XIV: Prisoners as Research Participants
XIV-1 Prisoners As Research Participants (Special Protections) 9-24-14

Section XV: Children as Research Participants
XV-1 Permissible Categories (Children) 9-24-14
XV-2 Assent and Parental/Guardian Permission Considerations 9-24-14
XV-3 Children in Court-Appointed or State Custody and Emancipated Minors 5-22-14

Section XVI: FDA Regulated Products
XVI-1 Review of Devices - IDE Requirements (SR vs. NSR Determination) 8-12-14
XVI-2 Humanitarian Use Devices (HUD) 4-22-14
XVI-3 Emergency Use of a Investigational Drug, Device, or Biologic 8-12-14
XVI-5 Non-Research Uses (Treatment Use, Single Pt. Use, Parallel Track) 6-21-06
XVI-6 Review of Drugs - IND Requirements 2-5-07
XVI-7 Control of Investigational Drugs, Devices, and Biologics 2-28-10

Section XVII: Special Requirements and Guidance for Investigators
XVII-2 Subject Recruitment and Compensation 9-24-14
XVII-3 Research Involving Genomic Data Sharing 8-15-16
XVII-4Research Involving Data Registries and Specimen Banks 9-4-09
XVII-5 Genetic (DNA) Research 4-22-14
XVII-6 Involving Non-VCU Institutions in Human Subjects Research 9-24-14
XVII-7 Evaluating Consent/Persons with Limited Decision-making Capacity 1-30-08
XVII-8 Equitable Subject Selection 6-21-06
XVII-9 Use of the Internet for Recruitment and Research Data Collection 6-21-06
XVII-10 Research Participant Inquiries/Concerns 9-24-14
XVII-11 Involving Foreign Institutions/Sites in VCU Human Research 8-6-14
XVII-12 Additional Department of Defense (DoD) - Department of the Navy (DoN) Requirements for Human Subject Protection 7-30-14
XVII-15 Involving Independent Investigators in Human Research 6-21-06
XVII-16 Planned Emergency Research, Exception from Informed Consent, and Waiver of Applicability of Informed Consent 9-24-14
XVII-17 Additional Department of Education (DoEd) and National Institute on Disability and Rehabilitation Research Requirements (NIDRR) for Human Subject Protection 9-24-14
XVII-18 Additional Requirements for Human Subject Protection in Research Funded by the Department of Justice (DoJ) including the National Institute of Justice 9-24-14
XVII-19 Additional Requirements for Research Conducted Within the Federal Bureau of Prisons 7-29-14

Special Guidance

Overview

Self Evaluation Tools

Communication

Consent Tracking

Data Management

Drug/Device Accountability

Electronic Regulatory Binder

Event Tracking

Recruitment, Screening, Enrollment & Tracking Subjects

Risk Management

Service Request

Study Monitoring

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.