II. IRB Administration at UMW
A. Role of the IRB
The IRB at UMW exists to oversee the conduct of research with human participants. Its primary responsibility is to protect the welfare of human participants in research and, to this end, the IRB reviews and monitors all research involving humans conducted at the University. The role of the IRB is to ensure that researchers meets current standards and mandates regarding ethical treatment of research participants and to report any problems to the Office of the Associate Provost.
B. Scope of the IRB
The IRB is responsible for all research conducted at UMW by any University employee, student, or agent either in the course of his or her University responsibilities or when using the University’s name, symbols, property, or services in connection with the research. No research using human participants may be initiated without prospective approval by the IRB. The IRB has the authority to approve, require modifications to, or disapprove of, proposed human subjects research. The IRB also has the authority to halt or suspend research when necessary to protect the welfare of research participants. The University’s IRB has no responsibility for, or authority over, research conducted outside the University by individuals not affiliated with the University of Mary Washington.
1. Covered Research
All research conducted by faculty, staff, and students in conjunction with their official duties at UMW is subject to IRB review. Some research conducted by students that is used to fulfill requirements for their degree programs must be approved by the IRB, with exceptions as noted below. Faculty and staff research must be approved by the IRB, whether or not the research receives funding from external sources.
The IRB has no jurisdiction over research conducted by members of the university community which is not related to their official roles and responsibilities. Faculty, in particular, may undertake research projects on their own as private contractors. Such research will be deemed independent of their official roles and responsibilities and not subject to IRB review if: (1) the research is conducted on their own time and not reimbursed by the university or through university accounts, (2) the research is conducted without the use of university space, materials, and supplies, and secretarial or staff support, and (3) any research publications, reports, or presentations will not list the faculty member’s position and affiliation with the University of Mary Washington.
IRB approval is not required for members of the University who act as consultants on human subjects research that involves participants not affiliated with UMW.
2. Research Conducted at UMW by Investigators from Other Institutions
UMW faculty and staff are sometimes approached by investigators at other institutions for cooperation in the latter’s research. For example, department chairs or deans might be asked to assist in the distribution of surveys to faculty or students. This research does not fall under the jurisdiction of the IRB unless: (1) University facilities, including physical space and resources will be used, (2) University officials are actively engaged in or actively cooperate with or encourage participation in the research, or (3) University faculty, staff, or students intend to use the findings or results of these studies for their own purposes.
Approval by the IRB is not required by University officials who wish to inform members of the University community about research or provide them with information about contacting investigators if the latter wish to participate in such research.
3. Student Projects: Research vs. Pedagogy
Some courses at UMW require students to complete projects as a way of teaching them research methods and skills. Institutional Review Boards at institutions of higher education vary according to whether they require student projects to be reviewed and approved. The University of Mary Washington’s IRB does not require student projects conducted in research methods courses to be reviewed if the purpose of these projects is pedagogical in nature. Activities not intended to provide generalizable knowledge are not subject to IRB review. Although the IRB does not require review of such projects, it assumes that instructors in these courses provide close supervision of students, teach students the ethics of human research, and ensure that students conduct these projects in a manner consistent with the precepts of the Nuremberg Code and the Belmont Report (cf. pp. 1-2 and the Appendices section of this Manual).
Note. – Without IRB approval, students are not permitted to continue projects conducted for a research methods course after the semester has ended.
Students in graduate courses, in particular, sometimes use projects to refine their research interests and provide a foundation for a thesis. In order to use these data for theses, or other research purposes, students must either: (1) demonstrate that participants provided informed consent for the project at the time, through procedures approved by the instructor, or (2) obtain consent from people to use previously collected information according to procedures approved by the IRB (i.e., an application for Exemption, Expedited Review, or Full Board Review).
Student projects in courses are subject to IRB scrutiny if they are designed at least partially to provide data for research purposes. For example, instructors may enlist students to assist in data collection or analysis for their own research or may design seminars in which a goal is for students to collaborate on research that will be submitted for publication. These projects constitute research and must be submitted to the IRB for approval before any actual research activity commences.
4. Grant Applications
The IRB requires an investigator submitting a proposal for externally funded human subjects research to have the proposal evaluated and approved by the IRB prior to such submission. This approval is necessary because external funding agencies often require human subjects research to be approved by the IRB prior to the awarding of a grant.
5. Pilot Studies
Investigators sometimes conduct pilot studies designed to develop or refine research procedures and instruments. Although data collected through pilot studies may not ultimately be used in research reports and publications, pilot studies represent part of the research process that leads to the development of, or contribution to, generalizable knowledge. As such, pilot studies require IRB review and approval before they are conducted.
6. Evaluations
Evaluations are subject to IRB review if they fit the definition of research provided above: i.e., a systematic investigation designed to contribute to generalizable knowledge. Not all evaluations fit this definition. Evaluations conducted exclusively for quality assurance, quality improvement, or accountability purposes are not considered research in the current context and do not require IRB review. In these evaluations, there is no intention to share knowledge and information with external audiences. By way of example, a faculty member conducting a routine course evaluation or a department surveying the satisfaction of graduates to improve program quality would not be required to go through the IRB; however, a faculty member or administrator evaluating a program or teaching strat
egy with a view towards reporting the results professionally would be required to have the evaluation process approved by the IRB.
C. Institutional Oversight of the IRB
The Associate Provost for Institutional Analysis and Effectiveness, who reports to the Provost, is responsible for the oversight of all human subjects research conducted at the University. The UMW IRB reports directly to the Associate Provost. The Associate Provost is the institutional official listed on UMW’s Federal Wide Assurance and is ultimately responsible for overseeing the protection of human subjects in research conducted at UMW. Any serious risks or unanticipated problems encountered by the IRB must be reported to the Associate Provost. The Associate Provost is also responsible for developing and administering necessary educational programs to meet the requirements set forth in this Manual.
D. IRB Membership
1. Requirements
To be in compliance with Federal Regulations (45 CFR 46.107), the following requirements and conditions (D.1 a-h) must be met:
a) The IRB will have at least five members.
b) IRB members will represent varying backgrounds and disciplines.
c) IRB members will be diverse relative to race, gender, and cultural background.
d) IRB members will include persons able to ascertain the acceptability of proposed research in terms of institutional commitments, regulations, applicable law, and standards of professional conduct and practice.
e) The IRB will not consist entirely of members of one profession.
f) The IRB will contain at least one member who possesses expertise in a scientific area.
g) The IRB will have at least one member who possesses expertise in a non-scientific area.
h) The IRB will have at least one member who is not formally affiliated with UMW and is not an immediate family member of someone affiliated with the University of Mary Washington.
2. Appointment of IRB Members, Length of Service, and Duties
IRB members at UMW are appointed by the Provost, serve staggered three year terms, and are eligible for reappointment. Members of the IRB are required to review research proposals and then vote to approve, modify, or not approve such proposals. Members are expected to attend IRB meetings, serve as primary reviewers in their respective areas of expertise, and serve as general reviewers for all research discussed at IRB meetings. Members may also conduct expedited reviews as appropriate when designated to do so by the IRB Chair.
3. Appointment of Chair, Length of Service, and Duties
The Chair of the IRB is appointed by the Provost. Chairs serve 3-year, renewable terms. In addition to serving as a voting member of the IRB, the Chair is responsible for convening and conducting IRB meetings. The Chair works with IRB members, institutional officials, and investigators to make sure that applicable requirements are met. The Chair is responsible for signing off on all official IRB correspondence.
4. Conflict of interest
No IRB member may participate in the review of any proposed research project in which the member has a clear interest or involvement in said project.
5. Use of Consultants
The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond, or in addition to, that possessed by members of the IRB. Consultants provide guidance and advice to the IRB but are not considered members of the Board.
E. Training of IRB Members
Appointed IRB members will receive comprehensive reference materials including educational information from the Office for Human Research Protections and this Manual. At a minimum, members will complete the tutorial available at the Office for Human Research Protections website or attend a workshop designed to train them to review research from an ethical and regulatory standpoint. Such a workshop would be given by a trained staff member from the Office of Provost.
F. Administrative Support
1. Budget
Expenditures in support of IRB activities will be charged against the budget of the Office of the Provost
2. Administrative Responsibilities (Chair of the IRB)
a) Scheduling and conducting IRB meetings.
b) Drafting correspondence to UMW investigators.
3. Administrative Responsibilities (Office of the provost)
a) Copying and distributing meeting materials (including minutes of IRB meetings).
b) Ensuring that new IRB members receive necessary training.
c) Serving as a resource for investigators.
d) Maintaining training and reference materials.
e) Maintaining and updating this Manual.
f) Drafting correspondence to government officials.
g) Filing Federal Wide Assurance documents.
G. Record Keeping and Documentation (Office of the Provost)
1. Official Records Maintained for the IRB
a) Written procedures and policies.
b) Maintaining official roster of IRB membership (including members’ names, earned degree(s) and specialty(-ies), and representative capacity).
c) Training records (of IRB members and researchers).
d) IRB correspondence.
e) Documentation of exemptions and exceptions.
f) Minutes of IRB meetings, which shall include: attendance (names of IRB members, researchers, consultants or guests present), actions taken by the IRB, the basis for requiring changes or disapproving research, a list of research projects approved since the last meeting that involved the Expedited Review option.
g) Reports of any adverse events.
h) IRB research proposal files. The IRB will maintain a file for each research application that it receives for review. Applications will be numbered sequentially by calendar year in the order in which they are received. (e.g., the first application in 2005 will be numbered 2005-001). Files will contain the application, documentation of type of IRB review, consent forms, advertising and recruiting materials, applications for protocol revisions, reports of any adverse consequences connected with the research project, and all IRB correspondence related to the research project.
i) Database including the following: title of research project, name(s) of principal investigator(s), funding source (if any), date of approval and any continuing approvals, date marking the end of approval period, type of review (Expe
dited or Full Board), and current status.
2. Retention of Records
IRB records are kept by the University for a minimum of three years either (a) following the review of a non-approved project or, (b) following the completion of an approved and executed research project.