About the Virginia Tech IRB

An Institutional Review Board (IRB) is a committee, or board, of volunteers including scientists, non-scientists, community members, and health care professionals that ensures research protocols involving human subjects are ethical and that the rights of participants are protected.

Specific areas for IRB review include:

1. Evaluation of the nature and purpose of the research;
2. Evaluation of proposed procedures involving human subjects;
3. Evaluation of the risks or harms to the subjects (including physical, psychological, sociological, economic, and legal;
4. Evaluation of the benefits;
5. Evaluation of the risk/benefit relationship;
6. Evaluation of subject population;
7. Evaluation of subject recruitment;
8. Evaluation of the process of obtaining informed consent;
9. Evaluation of research data processing and storage; and
10. Whether there is a need for additional IRB follow-up than on an annual basis.

The application of conscientious judgment by the members who serve on IRBs is pivotal to the entire system of protection of research subjects. Indeed, the system recognizes that there is no simple formula to apply to ethical decisions, and instead it vests the major responsibility of ethical decision making with the IRB. IRB actions are to be based on ethical principles (such as outlined in The Belmont Report). They should fully recognize that ethical decisions involve a balance among such principles (such as respect for persons, beneficence, and justice) along with the importance of the knowledge that may reasonably be expected to result from proposed research (the requirement for which is itself grounded in the principle of beneficence).

Virginia Tech is committed to protecting the rights of and ensuring the safety of human subjects participating in research conducted by faculty, staff and students of the University. This commitment is guided by the ethical principles described in The Belmont Report and in applicable federal regulations. For operational purposes, as required by federal law, this commitment is vested in the Institutional Review Board for Research Involving Human Subjects (the IRB) which operates under a Federalwide Assurance (FWA) on file with the Office for Human Research Protection (OHRP) within the U.S. Department of Health and Human Services (DHHS).

VT's Federalwide Assurance number is FWA 00000572

VT's IRB registration number is IRB00000667

The Board is responsible for reviewing, making decisions about, and overseeing research involving human subjects. The Board typically reviews research of higher risk to research participants, and allows the IRB Chair or designee to approve research of lower risk to research participants.

Virginia Tech IRB meetings are held at least once monthly, occurring on the second Monday of each month, from noon until 1:30 p.m. The deadline for submission of protocols requiring full IRB review and approval at official convened meetings is 10 business days (2 weeks) before the scheduled meeting. Materials submitted for review after that deadline will not be considered or reviewed by the IRB until the next scheduled meeting to be held the following month.

At the discretion of the Chair, and in consideration of the quantity and complexity of protocols to be reviewed by the full IRB, it may be necessary to convene an interim meeting at which those protocols would be discussed.

If no protocols are received prior to the monthly deadline, the Chairperson may cancel the regularly scheduled IRB meeting for that month.

Investigators are welcome to attend the IRB meeting, or to be available by telephone, to respond to any questions that may be raised during the Board's discussion of the study.

All activities involving human subjects in research, regardless of funding source, must be reviewed by the Virginia Tech IRB before recruiting, enrolling, or involving subjects in that research.

Virginia Tech, in following established federal regulations, utilizes three classes of review of human subjects research:

• Exempt review
• Expedited review
• Full Board review

Learn more about the above classes of review.

The IRB Chair may review and approve studies that qualify for exempt and expedited review.

The IRB Chair is appointed by the Vice President for Research. Members of the IRB, and alternate members, are nominated by the Chairperson and appointed by the Vice President for Research. Members of the IRB serve for 3-year terms which can be renewable at the discretion of the Vice President for Research. Upon recommendation of the Chair, the Vice President for Research may terminate the appointment of a member or alternate prior to the expiration of his/her term.

The IRB must have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The following categories must be represented on the Board:

• At least one scientist;
• At least one non-scientist;
• At least one community member who (or his/her immediate family) has no employment or contractual relationships with the institution (Virginia Tech); and
• At least one health care professional.

Federal law requires that the IRB be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB must be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB must therefore include persons knowledgeable in those areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration must be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with those subjects.

1. At the meetings, the IRB will conduct official business only if (a) a quorum [majority including members or alternates, and the Chair or designated chair] is present and (b) a non-scientist member is present. If either condition fails during the meeting (someone must leave, etc.), the IRB may not take any official action from that point until the quorum conditions are restored. Only members or alternates and the Chair or designated chair may vote.
2. If necessary, IRB meetings may be conducted with one or more members or alternates via speaker phone provided that each person on the telephone has received all pertinent materials prior to the meeting, and can actively and equally participate in the discussion of all protocols. The minutes of such meetings will document members or alternates who participated by telephone.
3. The IRB will review, and have authority to approve, require modification in, or disapprove all research activities involving human subjects, including proposed changes in previously approved human subject research. For approved research, the IRB will determine which activities require continuing review more frequently than every 12 months.
4. IRB members will independently review and evaluate applications for approval prior to the IRB meeting, participate in appropriate discussions, and vote to approve, disapprove, require modifications, or table each submission during the IRB meeting. If a member feels that s/he cannot provide an unbiased evaluation of a particular application for any reason, s/he will inform the IRB Chair and not participate in the discussion and voting of that application.
5. The IRB may invite the investigator(s) of a project to meet with the Board during discussion of that project. All visitors will be dismissed before the IRB begins deliberations and takes action.
6. If a member of the IRB has an interest (is an investigator, has a student who is an investigator, etc.) in a request before the Board, that member may be present during the discussion phase to answer questions, etc., but will be excused before the Board begins deliberations and takes action.
7. The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. These individuals may be asked to sign a non-disclosure agreement if they are given a copy of the application, unless the investigator waives his/her right of confidentiality.
8. The IRB will focus primarily on the risks and benefits to the participating human subjects and the measures proposed to reduce or eliminate the risks. However, the IRB may request modifications to the research design or methodology where, in the opinion of the IRB, such modifications will enhance the benefits, reduce the risks, or improve the quality of the research.
9. The IRB will seek to insure that the selection of subjects is equitable, taking into consideration the purposes of the research and the setting in which the research will be conducted. The IRB (or Chair) will review and approve all advertisements for recruiting potential subjects.
10. Unless waived, ensure that legally effective consent documents are obtained and documented from each subject or the subject’s legally authorized representative. The IRB will have authority, or direct the Chair, to observe the consent process, or any other part of the research process involving human subjects.
11. Determine that there are adequate provisions in the research plan to protect the privacy of subjects and to maintain confidentiality of data, where appropriate.
12. Where appropriate, the IRB will determine when additional protections are required for children, pregnant women, prisoners, fetuses, persons with impaired mental abilities, non-English speaking subjects and other vulnerable subjects. For research involving prisoners as subjects, a prisoner or prisoner representative must be added to the IRB when that project is discussed and action taken. OHRP will be notified promptly when IRB membership is modified to satisfy the federal requirements.
13. The Virginia Tech IRB has determined that it will not consider requests from agencies and organizations outside the University that do not involve Virginia Tech faculty or that is not sponsored by Virginia Tech.

1. Serves as a resource person for investigators conducting research involving human subjects and investigators contemplating such research;
2. Keeps abreast of all changes in the regulations governing human subjects research and keeps the IRB and investigators informed;
3. Maintains and keeps current the VT human subjects website;
4. Certifies that investigators have completed the training program and are qualified to conduct human subjects research and maintains a roster of qualified investigators;
5. Develops and maintains education and training programs for the IRB members, departmental reviewers, departmental Human Subjects Committees, and research investigators who use human subjects;
6. Receives all applications for research involving human subjects;
7. Assigns each application a unique number that will serve as the identifier of that project throughout its existence and in the records of the IRB;
8. Determines whether all the required documents are in the applications. If parts are missing or incomplete, returns the application to the principal investigator for revision;
9. Determines which applications qualify for "Exemption" and which exemption category applies. Notifies the principal investigator and departmental reviewer;
10. Determines which applications qualify for "Expedited Review". If all parts of the application are complete and in order, gives "Expedited Approval" and notifies the principal investigator and departmental reviewer;
11. Determines which applications require full IRB review and approval. Makes sufficient copies and distributes in a timely fashion to the full IRB;
12. The Chair may request assistance from any IRB member concerning any application;
13. Nominates IRB members and alternate members for appointment or re-appointment by the Vice President for Research;
14. Schedules the time and place for IRB meetings;
15. Informs the IRB of "Exemptions" and "Expedited Approvals" given by the Chair since the last meeting of the Board;
16. Records complete minutes of each IRB meeting including discussion and requests for modifications of each application;
17. Records votes on each action taken by the IRB, including abstentions. The total number of votes must equal the number of members present;
18. Distributes the minutes of the last IRB meeting with the agenda materials for the next meeting;
19. Notifies principal investigators and departmental reviewers in writing of Board actions;
20. The Chair may appoint a member of the IRB as "designated Chair" for a meeting or part of a meeting;
21. Each approved application, whether "Exempt", "Expedited" or "Full-IRB" approval will have an Approval Date and an Expiration of Approval Date. The principal investigator will be informed of these dates in the approval letter. These dates are typically included in the Consent documents near the signature of the subject;
22. If an approval is connected to a grant/contract proposal, the IRB office will notify the VT Office of Sponsored Programs of IRB action;
23. Prompts investigators approximately two months before the Approval Expiration Date. If the project will continue beyond the Approval Expiration Date, re-approval is required. If the project is complete, requests final report;
24. Receives interim and/or final reports from principal investigators as specified at the time of approval;
25. At the Chair’s discretion, or by direction of the IRB, may perform post-approval visits to observe any phase of an approved research project which involves human subjects;
26. May suspend part or all of an approved research project that is not being conducted in accordance with the approved protocol, IRB requirements or where there has been serious harm to subjects;
27. Maintains all records of the IRB in accordance with University and OHRP requirements;
28. Serves as the official University contact for all matters regarding research involving human subjects.