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).

The Office of the Vice President for Research is responsible for the administration and oversight of research compliance at VT. It oversees the functioning of the IRB, which is within the Office of Research Compliance (ORC). The ORC is under the direction of Associate Vice President for Research Compliance, David M. Moore, DVM. Contact information for VT IRB personnel is available on the Contact Us webpage.

VT's Federalwide Assurance number is FWA00000572

VT's IRB registration number is IRB00000667

Note: the Vice President for Research holds the FWA signatory authority.

It is the researcher's responsibility to seek and obtain prior VT IRB approval as deemed appropriate using the Activities Requiring Virginia Tech IRB Approval flowchart. Projects requiring VT IRB review according to the flowchart require approval regardless of the location of the research activity (i.e., conducted on or off campus), source of funding (i.e., federally funded, privately funded or non-funded), and whether the research is exempt under the Code of Federal Regulations for Protection of Human Subjects (45 CFR 46).

The VT IRB may cede authority to a collaborating institution's IRB, if both institutions agree to do so. VT does not conduct or provide oversight over human subjects research for which investigational devices or drugs are used. The VT IRB will typically not consider review requests from agencies and organizations outside the University for research that does not involve VT faculty or that is not sponsored by VT.

Review agreements exist between VT and Carilion Medical Center, and VT and Virginia College of Osteopathic Medicine (view details).

VT has one IRB responsible for conducting initial and continuing reviews, and providing oversight for all human subjects research activities involving VT researchers or for which VT is engaged.

Review procedures will be conducted in accordance with Virginia Tech�s Federalwide Assurance Terms.

Any time the IRB or staff determine they do not have the necessary scholarly or scientific expertise for sound review, they may request ad hoc consultants. Consultants are independent of the IRB and are selected according to scholarly and scientific expertise. Consultants may be called upon to judge the scientific soundness of a research protocol, make a fair and accurate determination of the risk-benefit ratio, review the cultural appropriateness of the informed consent process, and offer additional and unique expert advice. However, consultants cannot make any review determinations; they may only provide counsel. Individuals providing consultation to the IRB agree to and sign a confidentiality agreement prior to the receipt and review of submission documents, unless the principal investigator waives his/her right to confidentiality.

Protocol materials provided to the IRB shall be considered privileged information, and are accessible to the IRB, Office of the Vice President for Research (OVPR), University Legal Counsel, VT Internal Audit, the Office for Human Research Protections, and others as deemed appropriate by the IRB.

The IRB may deny requests for copies of protocol materials as deemed appropriate or require the written permission of the protocol�s principal investigator prior to the release of records.

The Office of Research Compliance maintains protocols files in a secure manner. Records required by 45 CFR 46 are retained according to 45 CFR 46.115(b).

Virginia Tech IRB meetings are held at least once monthly, typically 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 typically not be considered or reviewed by the IRB until the next scheduled meeting to be held the following month. Learn more about full review deadlines.

The IRB office typically mails all agenda items for review to IRB members 7-14 days prior to each scheduled meeting date. Supplemental materials may be provided to the IRB members any time prior to or on the day of the meeting, as deemed appropriate by the IRB office, if doing so does not hinder full consideration of a protocol. If a Board member advises he/she has insufficient time to fully review a protocol or supplemental material, the protocol may be (as determined by members in attendance) held for review and/or vote at a subsequent meeting or the member may abstain from voting on the particular protocol.

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.

With the permission of the IRB office or Board, investigators are welcome to attend the IRB meeting, or be available by telephone, to respond to any questions that may be raised during the Board's discussion of the study. Investigators are asked to leave the meeting during all votes.

Minutes of each IRB meeting are recorded in writing in accordance with 45 CFR 46.115(a)(2). The IRB approves the previous month's minutes at the subsequent IRB meeting; however, a quorum is not required for such approval. If the Board requests revisions, changes are made after the meeting. The final version of the approved minutes is signed by the IRB Chair and filed (hardcopy) within the IRB office.

Minutes include:

1. Attendance (designating any advocates for vulnerable populations that are present and visitors)
2. A list of full board studies with the respective information:

• Actions taken and decisions made by the Committee, including disapprovals;
• Vote on these actions (including the number of members voting for, against, and abstaining);
• Basis for requiring modifications to the research proposal or consent documents or for disapproving the research proposals;
• A summary of the discussion of controversial issues and their resolution;
• A summary of discussion of issues pertinent to the protocol;
• Minutes will also document determinations required by HHS regulations and in accordance with VT's FWA to include those for waiver or alteration of consent; waiver of consent documentation; and research involving pregnant women and fetuses, prisoners, and children.

3. A list of all initial and continuing review approvals that were taken administratively (i.e., Exempt and Expedited reviews) during the previous month (separate document from the minutes).

Minutes include separate deliberations, actions, and votes for each protocol undergoing initial, continuing, or amendment review by the convened IRB. The vote on all IRB actions include the number of persons voting for, against, and abstaining, in order to document the continued existence of a quorum. The minutes include the documentation of any potential conflict of interest that an IRB member may have with a particular protocol. The IRB Chair or designated person is responsible for monitoring quorum, vote counts, and recording IRB discussion points for the minutes.

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 typically serve for 3-year terms, which may be renewed 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 VT IRB is comprised in accordance with 45 CFR 46.107. There are no quantified attendance requirements placed on IRB members; however, the Chair may recommend termination of membership for attendance reasons. The membership list is not made publicly available.

In cases in which an IRB member or staff person experiences either direct or indirect undue influence or coercion to make a ruling for a specific research study or investigator, the IRB member or staff person is asked to document the issues related to the case in writing to both the IRB Chair and Vice President for Research in order to open a formal report.

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, 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. The Chair polls all members in attendence for potential conflicts of interest prior to the discussion of each protocol agenda item.
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 principal 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.
10. Unless waived, the IRB will 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 to observe the consent process, or any other part of the research process involving human subjects.
11. The IRB will 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.

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. Develops and maintains education and training programs for the IRB members, departmental reviewers, departmental Human Subjects Committees, and research investigators who use human subjects;
4. 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;
5. Chair, or designated reviewer, determines which applications qualify for "Exemption" and which exemption category applies. Notifies the principal investigator and departmental reviewer;
6. Chair, or designated reviewer, 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;
7. Determines which applications require full IRB review and approval.
8. The Chair may request assistance from any IRB member concerning any application;
9. Nominates IRB members and alternate members for appointment or re-appointment by the Vice President for Research;
10. Selects the time and place for IRB meetings;
11. Informs the IRB of "Exemptions" and "Expedited Approvals" given by the Chair since the last meeting of the Board;
12. Records complete minutes of each IRB meeting including discussion and requests for modifications of each application;
13. Records votes on each action taken by the IRB, including abstentions. The total number of votes must equal the number of members present;
14. Distributes the minutes of the last IRB meeting with the agenda materials for the next meeting;
15. Notifies principal investigators and departmental reviewers in writing of Board actions;
16. The Chair may appoint a member of the IRB as "designated Chair" for a meeting or part of a meeting;
17. Approves requests for Interim approval;
18. Serves as the official University contact for all matters regarding research involving human subjects.

The IRB will report protocol non-compliance, unanticipated problems, suspension, and termination to the appropriate agencies and officials in accordance with the Policy for Noncompliance Involving Subjects Research and OHRP's Guidance on Reporting Incidents to OHRP.

In the event that the VT IRB is found to be noncompliant with its Federalwide Assurance or applicable federal regulations, the noncompliance is related to one or more federally funded, non-exempt research protocols, and the noncompliance is serious or continuing, then the incident will be reported to the OHRP. The report will include a detailed description of the noncompliance, and actions the University is taking or plans to take to address the noncompliance.

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.

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.