Section II:

VCU Human Research Protection Program

WPP #: II-1

Title 1:

HRPP Overview (Including Institutional Authority, Purpose, and Principles)

Effective Date:

09-24-14

Revision History:

06-20-00; 06-07-04; 12-06-04; 04-30-06; 6-21-06; 11-1-06; 9-1-09; 10-5-10; 1-27-14; 2-17-14; 2-25-14

Policy Statement

VCU supports a Human Research Protection Program (HRPP) to assure that the rights and welfare of the human subjects are adequately protected in research. The HRPP is established under the authority of the VCU Office of the Vice President for Research and is supported through institutional resources including those identified below. All activities involving 'research' and 'human subjects' conducted by VCU faculty, staff, or students, are subject to the VCU Human Research Protection Program. All individuals contributing to the HRPP, including researchers, IRB members, and university administrators and staff, are expected to adhere to the Belmont Principles of ethical conduct and have the responsibility to ensure all research related activities comply with applicable federal and state regulations as well as local policies.

Description

Virginia Commonwealth University (VCU) recognizes its mission to foster scholarly activities that reflect the interdisciplinary nature of its identity as Virginia's major urban university and academic health care institution. Because of its location within the state, VCU is in the unique position of using the urban environment as a laboratory for studying and developing new approaches to problems pertaining to the public and private sectors. VCU’s Human Research Protection Program (HRPP) reflects the university in its comprehensiveness of human subjects research activities, ranging from clinical drug trials through twin studies to attitude and perception surveys.

  1. Components of the HRPP
    1. Institutional Review Boards (IRBs): The Institutional Official has delegated to the VCU IRB the responsibility for ensuring that all research adheres to appropriate regulations. VCU names four internal IRBs and three external IRBs on its Federalwide Assurance in ongoing support of the research review element of the VCU HRPP. Of these IRBs, four are located on the VCU campuses. Of these four, one IRB panel concentrates on social-behavioral research; the other three review primarily biomedical research. VCU also utilizes Western Institutional Review Board for review and ongoing oversight of all industry-sponsored human subjects research (in collaboration with VCU as detailed in a VCU/WIRB written agreement). The National Cancer Institute Central IRB (NCI CIRB) is utilized for approval of applicable cooperative group pediatric and adult oncology research.
    2. IRB Leadership and Enhancement Committee (ILEC): A committee comprised of VCU IRB chairpersons, IRB administrative leadership, unaffiliated IRB members, investigator representatives, and a coordinator representative providing oversight for the VCU Human Research Protection Program.
    3. The Office of Research Subject Protections (ORSP) provides administrative support to the IRB including records management and resources for IRB members and all VCU personnel (investigators and non-investigators who have questions about research protections). This office serves as the public outreach arm of the IRB providing educational opportunities to the research community and overseeing required human subjects training. The office also oversees a post approval monitoring program and compliance activities, including fulfillment of reporting responsibilities to federal authorities.
    4. The Office of Research Integrity and Ethics (ORIE) provides oversight and administrative support to the Conflict of Interest Committee, manages allegations and proceedings involving research misconduct, and serves as an ethics resource to the research community.
    5. The Conflict of Interest in Research Committee is appointed by the Vice President for Research to (1) review those cases in which an Investigator has disclosed financial interests that may be affected by the results of his/her research project and (2) recommend management strategies to the Vice President for Research.
    6. Privacy Boards: The four constituted IRBs operating at VCU carry out the function of a privacy board as defined by 45 CFR 46.164 for the purpose of ensuring privacy protections of health information used or created in the conduct of human subjects research.
    7. The Office of Sponsored Programs (OSP) is VCU's central office for the management and university approval of all externally sponsored projects. Sponsored Programs performs four basic functions: (1) reviewing and approving all Sponsored Programs proposals and awards for external funding; (2) serving as the University's negotiating and executing office for sponsored program agreements and relationships; (3) interpreting the regulatory and contractual administrative requirements/terms of these relationships, and (4) distributing information received concerning external funding availability to appropriate faculty.
    8. The Office of Research Information Systems provides technical guidance and support to facilitate shared information among the offices which contribute to the foundation of VCU HRPP.
    9. Clinical Research Services Unit (CRSU) provides services to assist investigators and research coordinators in maintaining regulatory compliance and conducting high quality clinical research. The CRS provides education, study start-up assistance, budget development services, and reviews some institutional components for industry sponsored trials prior to IRB approval, among other services. The CRS also supports the Clinical Research Services Unit, which is available to all VCU Health System and VCU faculty members who want to conduct clinical research. Studies to be conducted on the CRSU must be reviewed and approved by both the IRB and the CRSU Advisory Committee.
    10. Massey Cancer Center Protocol Review and Monitoring Committee (PRMC) reviews research involving patients with cancer or family members of patients with cancer. PRMC conducts pre-study reviews to ensure adequate study design and conducts data safety monitoring reviews throughout the life of a study. Verification of PRMC review is required prior to IRB approval.
    11. Institutional Biosafety Committee (IBC) is managed by the Chemical and Biosafety Section of the VCU Office of Environmental Health and Safety and is responsible for review of all research involving rDNA, biohazardous agents, carcinogens, acute toxins, and any other proposed procedures involving significant biohazardous risks. All research involving any of these materials or agents must be registered with the IBC before work may begin. When applicable, documentation of IBC approval is required prior to IRB approval.
    12. Radiation Safety Committee (RSC) is managed by the Radiation Safety Section of the VCU Office of Environmental Health and Safety and is mandated by the VCU/VCUMC Nuclear Regulatory Commission license. The charge of the RSC is to oversee use of licensed material and radiation-producing devices. The IRB requires documentation of RSC approval prior to IRB approval if the use of radiation is NOT for the subject’s direct clinical benefit.
    13. VCU Deans / Department Chairpersons assist in ensuring that research is submitted to the IRB as required and that research conduct adheres to the terms of IRB approval and the VCU Written Policies and Procedures.
  2. Regulatory Compliance

    The institution abides by the following regulatory authorities, carried out by the VCU IRB and its administrative departments and offices:

    1. U.S. Department of Health and Human Services Title 45, Part 46, Subparts A, B, C, and D
    2. U.S. Food and Drug Administration Chapter I of Title 21 CFR 50 (for FDA regulated research only)
    3. U.S. Food and Drug Administration Chapter I of Title 21 CFR 56 (for FDA regulated research only)
    4. Commonwealth of Virginia Code of Virginia 32.1 Chapter 5.1 Human Research (for all research).
  3. Institutional Authority

    The Vice President for Research has the authority to review decisions of the IRB, as it operates to implement the VCU HRPP. In the case of an approval decision, should the Vice President for Research conclude that a project does not fully comply with the policies or obligations of VCU, the project may be administratively disapproved, suspended, or terminated on behalf of the institution. In the case of a decision by the IRB to disapprove, suspend or terminate a project, the decision may not be reversed by the Vice President for Research or any other officer/agency of VCU [45 CFR 46.112].

  4. Principles

    The VCU IRB subscribes to the basic ethical principles of the Belmont Report in the review of all research activities, including informed consent, risk/benefit analysis and the selection of subjects for research. The IRB strives to maintain sensitivity to community attitudes and to take into consideration the racial and cultural backgrounds of research subjects.

    1. Respect for Persons

      The principle of respect for persons means respecting an individual's autonomy (his right to make decisions for himself). This means that individuals should participate in research voluntarily and be given enough information to make an informed decision about whether or not to participate. The Belmont Report further specifies that persons with diminished autonomy (e.g., children, cognitively impaired persons) are entitled to protection. This principle is upheld through the informed consent process by ensuring that consent be provided in a manner that is understandable, that subjects have adequate opportunity to consider participation, and that the decision is able to be made free from coercion.

    2. Beneficence

      The principle of beneficence requires that the investigator not only protect individuals from harm, but make efforts to secure their well-being. When the investigator and the IRB perform a systematic risk/benefit assessment, they are applying the principle of beneficence. Risk is evaluated by considering both the chance or probability of harm and the severity or magnitude of the possible harm. Risk may include consideration of psychological, physical, legal, social, and economic harm. Benefit, on the other hand, is the anticipated positive value of the research to either the subject directly or to society in terms of knowledge to be gained

    3. Justice

      The principle of justice means that the benefits and burdens of the research are fairly distributed. The principle of justice requires that there be fair procedures and outcomes in the selection of research subjects. It is a violation of the principle of justice to select a class of subjects (e.g., welfare patients, an ethnic minority, institutionalized persons) simply because of easy availability rather than for reasons directly related to the problem being studied.

References

Title 45, Part 46, Subparts A, B, C, and D
Chapter I of Title 21 CFR 50
Chapter I of Title 21 CFR 56
Code of Virginia 32.1 Chapter 5.1 Human Research
The Belmont Report; Ethical Principles and Guidelines for the Protection of Human Subjects of Research