Section II:

VCU Human Research Protection Program

WPP #: II-4

Title 4:

HRPP Quality Assurance/Improvement Elements

Effective Date:

2-25-14

Revision History:

12-06-04; 09-30-05; 04-28-06; 06-21-06; 11-01-06; 02-05-07; 9-01-09

Policy Statement

VCU supports a quality assurance/quality improvement program in its operation of the Human Research Protection Program (HRPP).

Description

  1. Institutional Training and Education:

    VCU provides institution-wide educational initiatives for the purpose of ensuring the continued development of awareness about human research protections. These educational initiatives are the heart of the VCU HRPP and promote ongoing compliance by creating an awareness of and appreciation for the ethical standards upheld and valued by the institution. These initiatives include:

    1. The Office of Research Subjects Protection (ORSP) delivers a rotating series of workshop for the research community focusing on working with the IRB, ethical conduct of human participant research, and regulatory compliance.
    2. The Center for Clinical and Translational Research (CCTR) delivers educational workshops designed to assist researchers with regulatory compliance. The CCTR education core also offers clinical and translational science masters and doctoral programs to develop researchers who will have the interdisciplinary insights and skill sets necessary to be major contributors to the translation of basic research to the bedside, or from the bedside into community practice.
    3. VCU offers a graduate level course in the Responsible Conduct of Research (MICR 510 Scientific Integrity). The course covers contemporary issues relating to scientific integrity and responsible conduct.
    4. At a more fundamental level, additional training programs and materials are available at department levels to ensure that all persons have an opportunity to learn about human research and the VCU HRPP (e.g, student handbooks, thesis guides, and flyers). The ORSP frequently conducts ‘in service’ programs at the departmental level to generate awareness of the VCU HRPP and promote and understanding of the ethical principles upon which the regulations are based.
  2. Post-Approval Monitoring:

    The Institution supports several efforts designed to evaluate the conduct of ongoing research. Questions, concerns, and self-reporting by investigators and research staff are also viewed as an avenue to evaluate knowledge and implementation of ethical and compliant research practice. The following evaluative programs help ensure ongoing quality improvement at the study-site level:

    1. Continuing Review by the IRB and Required Reporting: see VCU IRB WPP VIII-4: Continuing Review.
    2. Post Approval Monitoring and Quality Improvement Program: The ORSP conducts post approval monitoring of VCU study sites including random (not-for-cause), requested (for-cause), and educational support visits. See VCU IRB WPP X-3: Post-Approval Monitoring of IRB-Approved Protocols.
    3. Voluntary Study Site Quality Improvement Program: VCU has developed a voluntary study self-evaluation tool to assist investigators and research staff in conducting their own review of compliance documentation, with specific attention to meeting the approval requirements of the VCU IRB throughout term of approval.
    4. Clinical Research Services (CRS) Study Start-Up and Ongoing Oversight Visits: The CRS carries out study start up and post approval monitoring visits of studies that are conducted in the Clinical Research Services Unit and have no other monitoring program in place.
    5. Massey Cancer Center (MCC) Post Approval Monitoring Program: The MCC monitors data and regulatory compliance of investigator-initiated studies conducted under the umbrella of the NCI cancer center.

    These evaluative activities help the ORSP to determine what informational needs exist on the part of those people who are most likely to take part in the planning and conduct of human research and react to those needs through additional programming and/or resources.

  3. Invitation for Comment/Suggestions:

    Any person (investigator, staff, research subject, etc.) may contact the ORSP to make comments and/or recommend changes to the procedures followed by the VCU IRB. It is helpful to get feedback about the usefulness of these WPPs, our websites, and other procedures. Specific suggestions for improvement are always welcome and often result in constructive additions/changes to these WPPs.

    Question or suggestions may be directed to:

    Office of Research Subjects Protection
    827-1735 or ORSP@vcu.edu

  4. Assessment of IRB Function:

    The function and/or performance of the VCU IRB is continually monitored and evaluated by the Director of the Office of Research Subjects Protection(ORSP). The ORSP monitors the conduct of the VCU IRB meetings, as well as provides resources and guidance for full panel meetings, for expedited/exempt reviews, and determinations of non-human subject research. The ORSP Post Approval Monitoring and Quality Improvement Program monitors IRB performance and IRB documentation through the review of IRB files and study documentation pertaining to study visits.

  5. Assessment of ORSP Support of IRB:

    The Assistant Director of the Office for Research Subject Protections (ORSP) provides ongoing oversight of the ORSP to support the VCU IRB and maintain compliance with all federal, state, and local laws.

    The ORSP uses audit procedures and VCU IRB business rules on an ongoing basis to identify and investigate and/or predict problems within the VCU IRB Administrative Database (e.g., delays, incongruence, or backlogs). The Director of Information Technology for the Office of Research and Innovation serves as a resource for improvement of data management systems.

  6. Assessment of the VCU HRPP:

    Post-Approval Monitoring, Investigator and IRB groups and surveys, and informational system monitoring serve as major components of the evaluation efforts which allow the institution to:

    • Monitor and measure the effectiveness of the human research protection program;
    • Plan improvements based on those measures;
    • Implement planned improvement; and,
    • Monitor and measure the effectiveness of those improvements.

    The Institutional Official (IO) has ultimate responsibility for all aspects of the Human Research Protection Program (HRPP) at Virginia Commonwealth University (VCU). First and foremost, the IO is responsible for developing an institution-wide climate of compliance with ethical, legal, and regulatory principles, mandates and policies for the protection of human research subjects. As a means to this end, the IO is responsible for maintaining accreditation of the HRPP. The IO’s oversight responsibilities include, but are not limited to, making certain that the following conditions are met within the HRPP at VCU.

    1. Personnel (including Deans, Department Heads, Principal Investigators (PIs), Co-Investigators, Institutional Review Board (IRB) Chairpersons and IRB members, Research Coordinators, students, trainees, and visiting scholars) receive sufficient education in research ethics to assure that all human research subjects for whom VCU has responsibility are treated with Respect, Beneficence and Justice.
    2. VCU personnel involved in research, or supervising those conducting research, to the degree consistent with their responsibilities, are compliant with federal and state laws, regulations, and policies for the protection of human research participants.
    3. Personnel identified in item l (above) have completed required and appropriate on-line education modules (eg., CITI course) to aid them in meeting their responsibilities to human research subjects.
    4. The VCU Office for Research Subjects Protection (ORSP) operates an efficient system for IRB review of protocols involving human research subjects and oversees compliance with federal, state, and local laws, regulations, and policies pertaining to the protection of human research subjects.
    5. The VCU Office for Research Integrity and Education (ORIE) operates an efficient conflict of interest review program via the Conflict of Interests Committee and ensures researcher conflicts of interest are appropriately addressed by the IRB.
    6. The IRB Leadership and Enhancement Committee, which includes IRB Chairs and Vice-Chairs and HRPP leadership personnel, meets on a regular basis to facilitate consistency and quality improvement of the IRB process. The Committee also considers appeals of IRB determinations that are brought forward by investigators.
    7. IRB panels function in a manner that commands respect. Panels are equally competent to review proposals and protocols assigned to them. IRB panels are to avoid discrimination for or against protocols based on the originating school, department or discipline.
    8. IRB memberships, and other aspects of the HRPP, are equitably shared by Schools and Departments within VCU that conduct research involving human subjects.
    9. IRB members provide thoughtful and timely review of assigned protocols and regularly attend IRB meetings. Failure to do so is dealt with in an appropriate manner.
    10. Experts outside the IRB panels are consulted by IRB Chairpersons or members whenever appropriate. The HRPP collaborates with entities outside the Office of Research and Innovation as needed to ensure ethical conduct of research.
    11. 11. High quality in the HRPP is constantly sought and improvement in the HRPP is carefully considered and prudently adopted whenever appropriate.

References

WPP II-1: Human Research Protection Program Policy

WPP V-1 Investigators and Research Personnel

WPP V-2 IRB Members and Staff

IRB WPP VIII-4: Continuing Review

VCU IRB WPP X-3: Post-Approval Monitoring of IRB-Approved Protocols