IRB Written Policy & Procedure Summary of Recent Updates, July 2014
| WPP IX-3: Personnel Qualifications | The responsibilities of the PI for ensuring qualifications of study personnel have been updated: The PI or Medically Responsible Investigator is responsible for ensuring that all personnel engaged in conducting human research are adequately qualified and are provided with appropriate oversight to perform study responsibilities. When personnel will conduct clinical procedures, the PI or Medically Responsible Investigator is responsible for ensuring personnel hold appropriate, current credentials. It is advised that the VCUHS credentialing system be utilized to verify credentials and privileges for VCU/VCUHS employees. For non0VCU employees performing clinical procedures outside of VCU/VCUHS facilities, verification can include but is not limited to checking current license, certifications, or credentialing through other organizations. For FDA regulated research, all personnel engaged in the research should have active (non-disbarred) status with the FDA.
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| WPP IX-3: Personnel Qualifications | The responsibilities of Department/Division Chairperson or Deans to sign off on IRB studies have been updated: The Principal Investigator’s Department Chairperson, Division Chairperson or Dean or their respective designee must sign off on each new expedited or full board study submission to the VCU IRB to verify: 1) the PI is appropriately eligible and qualified to serve as a principal investigator; 2) adequate personnel including a Medically Responsible Investigator if required are included in the study 3) adequate resources are available for the conduct of the study; and 4) the proposed research has scholarly or scientific merit, ensuring appropriate study design, statistical power and sample size (if applicable), currency of literature review and relevance of research questions, goals, or hypotheses.
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| WPP IX-1: PI Eligibility | Department Chair/Division Chief Responsibilities have been updated: The Department/Division Chairperson or other appropriate supervising administrator is responsible for ensuring compliance with IRB requirements should the PI depart VCU and is required to maintain all research-related documents upon departure of the PI, if departure is less than six years since the completion of the research project or longer if applicable.
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| WPP XII-3: HIPAA and Research | HIPAA Policy updated: The policy now indicates that all identifiable health information collected, used, or maintained with a covered component of the VCU Affiliated Covered Entity, including all of the Schools of Allied Health, is protected health information and must be protected accordingly. The designation of Research-Related Health Information (RRHI) no longer exists. Identifiable health information that once may have been classified as RRHI must now be protected according to HIPAA rules for PHI. The policy also now includes a detailed description of each possible HIPAA pathway that may be applicable for obtaining, using, or disclosing PHI for research purposes.
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| WPP XII-1: Research Record Retention | Record Retention Requirements updated: The policy now references the VCU Policy on Data Ownership, Retention, and Access which requires that data referenced in publication be maintained for a minimum of 5 years post publication or longer depending on sponsor requirements.
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| WPP X-4: Study Closure | Closure of Study with IRB Requirements Relaxed: VCU IRB oversight may end (following a request for study closure) when ALL of the following conditions are met:
Note: For multi-center studies: Continuing review of the research by the VCU IRB is no longer required once the above conditions are met (following a request for closure), even if (i) interactions or interventions with subjects may be occurring at study sites other than those under the VCU IRB approval; or (ii) data analysis of identifiable private information is ongoing at another central site (site other than those under the VCU IRB approval) that collects and analyzes data from all study sites. For studies closed with the VCU IRB under these conditions, investigators may still respond to queries from the statistical center at the other institution regarding previously collected data about subjects who were enrolled under the VCU IRB approval.
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| WPP X-4: Study Closure | Study Expiration/Lapse in Continuing Review repercussions updated: Principal investigators who have any study in an Expired state due to a lapse in continuing review approval will NOT be permitted to submit a new research study for initial IRB review until the expired study has been addressed by submission of a continuing review or study closure request, as appropriate.
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| WPP VIII-9: Noncompliance | Processes for Handling General Noncompliance updated: Noncompliance is defined as failure on the part of the PI or any member of the research team to (a) adhere to the terms of the IRB approval and/or (b) abide by applicable laws, regulations, or VCU policies. All actual or suspected noncompliance must be reported to the IRB using the reporting function in RAMS-IRB, if identified by the study team, or via other means such as telephone or email alert. General noncompliance will generally be managed within the ORSP office, unless the event is also an Unanticipated Problem, in which case, the noncompliance will be handled by the convened IRB. All potential serious and/or continuing noncompliance will be reviewed and managed by the convened IRB.
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| WPP VII-4: Reporting to Regulatory Agencies | Process for Reporting to Federal Regulatory Agencies updated: Findings of Unanticipated Problems involving Risk to Subjects or Others, serious and/or continuing Noncompliance, and study suspensions will be reported to federal regulatory agencies when a study is federally funded. Previously, VCU would report all such events regardless of funding source.
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| WPP XVI-2: Humanitarian Use Devices (HUD) | New Description of Types of Uses for HUDs and How Each will be Reviewed: The WPP has been re-written to provide clarification regarding the different types of HUDS and how each will be reviewed by the IRB. The WP differentiates between 1) HUDs used according to approved labeling and indications for treatment or diagnosis, 2) HUDS used for treatment or diagnosis according to off-label use, and 3) HUDs used in clinical investigations.
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| WPP XVII-12: Department of Defense | Expanded Requirements for Research Supported by the Department of Defense, including the Department of Navy: All non-exempt research supported by the Department of Defense must comply with the additional requirements outlined in this WPP. The IRB will ensure that all of the relevant requirements are met before approving a Department of Defense supported study. Investigators should be aware of all of the requirements and ensure all are addressed in the research protocol submitted to the VCU IRB.
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| WPP XVII-17: Department of Education | Description of Requirements for Research Supported by the Department of Education or the National Institute on Disability and Rehabilitation Research: The WPP describes special requirements that apply when conducting research in schools subject to FERPA (Family Educational Rights and Privacy Act) and PPRA (Protection of Pupil Rights Amendment), including parental consent requirements when surveying students about certain “sensitive” topics. The IRB will determine that proposed research does not conflict with these requirements.
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| WPP XVII-18: Department of Justice | Description of Requirements for Research Supported by the Department of Justice and National Institute of Justice: The WPP describes special requirements that apply to all non-exempt research that is funded by the Department of Justice or the National Institute of Justice. Some specific requirements include the need for a Privacy Certificate to be approved by the DOJ and verified by the IRB, specific requirements for information to be included in the informed consent form, and archiving of data. The IRB will determine that supported research fulfills these requirements.
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| WPP XVII-19: Bureau of Prisons | Research Conducted in a Federal Bureau of Prisons Facility is Subject to Additional Requirements: All research conducted within a Bureau of Prison facility must meet additional regulatory criteria in order to be approved by the VCU IRB and the Bureau of Prisons IRB. Some of these requirements refer to the type of research that may be conducted, how incentives may or may not be utilized, issues of data confidentiality, the need to obtain signed informed consent in most situations and information that must be disclosed in the consent, and storage of informed consent documents. The IRB will determine that applicable research fulfills these requirements.
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