The VCU Human Research Protection Program Policy

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.    

Key Elements of the VCU HRPP:
The VCU Human Research Protection Program reflects the university in its comprehensiveness of human subjects research activities, ranging from clinical drug trials through twin studies to attitude and perception surveys.  The HRPP is established under the authority of the VCU Office of the Vice President for Research and is supported through institutional resources, including the administrative support and oversight of the Office of the Vice President for Research, including:

• The Office of Research Subject Protections (ORSP):  The 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 and provides public notices regarding research activities.

• The Office of Education and Compliance Oversight (OECO): The OECO provides educational programs and compliance oversight.  Programs have been established through the OECO, including grass-roots awareness of activities that constitute human research, development of human research guidelines for academic programs, broad and comprehensive educational initiatives including continuing educational requirements, and monitoring programs.

• Five (5) Institutional Review Boards (IRBs): have been established (and registered with the federal Office for Human Research Protections) in ongoing support of the research review element of the VCU HRPP.  Each IRB has the responsibility and full capabilities to review and monitor biomedical and socio-behavioral human research.  Of the five VCU IRBs, four are located on the VCU campuses and meet monthly.  Of these four, one IRB panel concentrates on social-behavioral research.  The one off-campus VCU IRB is a central IRB, Western Institutional Review Board, which meets daily and reviews and monitors all industry-sponsored human subjects research (in collaboration with VCU as detailed in a VCU/WIRB written agreement). 

• The Office of Sponsored Programs (OSP):  The OSP works in conjunction with the ORSP and the VCU Office of Grants and Contracts Accounting to ensure that resources are not made available through awards made to VCU unless all human research activities have received VCU IRB review and approval.  This measure provides an additional ‘check’ within the system.

• The Office of Information Technology:  The OIT provides technical guidance and support to facilitate shared information among the offices which contribute to the foundation of VCU HRPP.  A new information system has been adopted for administrative purposes, an electronic protocol submission and review tool is currently under development, and electronic resources have been integrated into the IRB for the purpose of accessing information.

• Partner Initiatives:  The VCU HRPP includes partnership among organizations at the institution, where critical compliance information is shared and additional ‘checks’ are in place to ensure that human research activities do not take place without appropriate VCU IRB approvals.  Examples include policies established by the Massey Cancer Center and the General Clinical Research Center to require documentation of VCU IRB approval prior to utilizing resources related to human research (or scheduling human research activities).

Institutional Authority:
The Human Research Protection Program serves as the fundamental framework for ensuring that the human research is conducted safely, ethically, and within the regulations and guidelines of all recognized authoritative bodies.  The VCU HRPP also aims to facilitate human research among the faculty, staff, and students from all schools and departments within VCU. The HRPP extends to each member of the VCU community through fundamental (at time of employment/enrollment) educational initiatives, through the ongoing activities of the ORSP, OECO, and IRB, and to the business practices established by and between the VCU Medical Center and VCU.

Virginia Commonwealth University (VCU) operates a program to review all human research in accordance with 45 CFR 46.103 and Chapter I of Title 21 CFR 56.109(a).  The institution abides by the terms of a DHHS-OHRP Federalwide Assurance and has established the VCU Human Research Protection Program (HRPP) in order to carry out these terms.

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, state government, or federal government [45 CFR 46.112]. 

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 (for all research, regardless of source of funding)
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).

Mission and Purpose of the VCU HRPP:
The mission and purpose of the VCU Human Research Protection Program is to assure that the rights and welfare of the human subjects are adequately protected in research.  All activities involving ‘research’ and ‘human subjects’ by or involving VCU faculty, staff, students, or volunteer participants are subject to the VCU Human Research Protection Program (definitions and information regarding determining if an activity is a human subject research activity can be found in WPP II-2).  To achieve the mission of the VCU HRPP, the institution advises investigators to consult these WPPs, participate in human subject protection training, and consult with the VCU IRB regarding the development of research protocols (as necessary).  The VCU HRPP requires that all human research activities involve the lowest potential harm to subjects and are reviewed by the VCU IRB to ensure that the activities meet established criteria for protection of human subjects and are appropriately monitored to ensure the ongoing protection of the subjects.

Principles of the VCU HRPP:
The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.  In 1979 the Commission published its report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, commonly called the Belmont Report. Today's federal regulations for the protection of human subjects are based on the ethical principles of the Belmont Report.  The Belmont Report identifies three basic principles as particularly relevant to the ethics of research involving human subjects. 

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 VCU IRB strives to maintain sensitivity to community attitudes and to take into consideration the racial and cultural backgrounds of research subjects.

• 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.  "To respect autonomy is to give weight to autonomous persons' considered opinions and choices…  To show lack of respect for an autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information ... when there are no compelling reasons to do so."  The Belmont Report further specifies that persons with diminished autonomy (e.g., children, cognitively impaired persons) are entitled to protection.  The principle of respect for persons is embodied in the informed consent process.  Three elements crucial to the informed consent process are information, comprehension, and voluntariness.   

• Beneficence

The principle of beneficence requires that the investigator not only protect individuals from harm, but make efforts to secure their well-being.  "Two general rules have been formulated as complementary expressions of beneficent actions in this sense:  (1) do not harm and (2) maximize possible benefits and minimize possible harms...  The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks."  Risks to subjects may be balanced against the benefits to subjects directly or to society as a whole.  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

• Justice

The principle of justice means that the benefits and burdens of the research are fairly distributed.  "For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients...  In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population."  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.  The principle of justice requires that there be fair procedures and outcomes in the selection of research subjects. 

Evaluation 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 for VCU, in conjunction with representatives of other elements of the HRPP, engages in a comprehensive review on a periodic basis.  Within this review, evidence is sought to demonstrate progress, monitoring activities, and evaluation of the following goals and objectives:

1. Has VCU obtained accreditation by the Association for Accreditation of Human Research Protection Programs (AAHRPP).   If not, are clear steps outlined for attaining this goal on behalf of the institution?
2. Do human research investigators at VCU/VCUMC understand their obligations under the Belmont Principles?  Are they familiar with the elements of the VCU Human Research Protection Program?  Are their responsibilities to ensure the protection of human subjects taken seriously?
3. Are human research investigators submitting research proposals, research protocols, consent materials, and other required materials to the ORSP in a careful manner, consistent with policies established by the IRB and their staff?  Do investigators understand the terms of their approval?
4. Is the IRB documentation and recordkeeping system complete, accurate, and flexible enough to provide the necessary documentation of compliance with federal regulations and to satisfactorily serve the VCU human research community?
5. Is the system sufficiently responsive so that human research investigators can plan, obtain approval, and meet reporting requirements in a timely manner that facilitates the educational, research, and clinical missions of the institution?
6. Are IRB members adequately trained for their responsibilities?  Do they understand their duties as outlined in these WPPs?
7. Do the IRBs allow for time to adequately consider each research protocol or other submission to the IRB (e.g., unanticipated problems involving risks to subjects or others)?  Are the opinions of all IRB members sought and respected?
8. Are IRB Panels functioning in such a way that they are thought to be equally competent?
9. Is the burden of IRB membership equitably shared across the institution?  Are some members frequently absent?  Are experts outside the IRB consulted when appropriate?
10. Are IRB decisions communicated efficiently and effectively?
11. Are reports to federal agencies submitted clearly and monitored for follow-up?
12. Do IRB staff members understand their duties clearly and deem them reasonable given the constraints of time and volume of work?
13.  Is there a backlog of submissions or unanticipated problems, pending review?  If so, how are these managed (e.g., screening unanticipated problems and possibly triaging submissions)?
14. What difficulties are the IRBs facing and how does this impact the VCU HRPP?
15. Are innovations (e.g., creative use of technology and staffing models) being considered?  Is there clear evidence of ongoing quality improvement?

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.
VCU IRB Written Policies and Procedures