Administration of the IRB

Jurisdiction of the UNT IRB

The UNT IRB is an administrative body established to protect the rights and welfare of human research subjects enrolled in research that is: (1) conducted by or under the direction of any UNT employee or student in connection with his or her UNT responsibilities or studies; (2) conducted using any UNT employees or students as subjects or using any UNT property or facilities; or (3) conducted using UNT’s non-public information to identify or contact human research subjects or prospective subjects, regardless of sponsorship. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. Research that has been reviewed and approved by the IRB may be subject to further review, and may be disapproved by UNT officials. However, UNT officials may not approve research that has been disapproved by the IRB. Except for projects which are approved as exempt from further review, all approved research projects are subject to continuing review and approval by the IRB at least annually or more often as specified by the IRB.

IRB Membership

The Common Rule regulations specify that the UNT IRB must have at least five members. The membership must represent a variety of backgrounds in order to promote complete and adequate review of the research activities commonly conducted by the institution. Also, the IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, 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. Therefore, the UNT IRB must include persons knowledgeable in these areas. The IRB must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. It must also include at least one member who is not otherwise affiliated with UNT and who is not part of the immediate family of a person who is affiliated with the institution. The nonaffiliated member(s) should be knowledgeable about the local community and be willing and able to discuss issues and research from that perspective. When selecting the nonaffiliated member(s), consideration should be given to the type of community from which the UNT will draw its research subjects. Initial and continuing reviews of research requiring Full Board approval must be reviewed at a convened meeting of the IRB at which a majority of the voting members are present, including at least one non-scientific member. Every nondiscriminatory effort should be made to ensure that the IRB does not consist entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. The IRB may not consist entirely of members of one profession. The IRB is authorized to invite individuals with expertise in specific areas to assist in the review of issues that require expertise or perspective beyond or in addition to that available on the IRB. Although these individuals may attend meetings and take part in the discussion of research protocols, they may not vote. Prospective IRB members may also be invited to attend one IRB meeting to learn about the IRB review process, but they may not vote at that meeting. An investigator may be invited by the Chair to present additional information to the IRB members about a proposed study, but the investigator may not remain in the meeting for the deliberation and vote. Due to the confidential nature of the IRB proceedings, the IRB members, the IRB staff, an invited investigator, an ad hoc member invited for special expertise, and invited prospective IRB members are the only persons authorized to attend any convened meetings of the UNT IRB. The UNT Vice President for Research and Economic Development appoints IRB members to serve for 3 year terms and appoints one of the members to serve as Chair. Newly appointed IRB members receive training about how to review proposed research projects and their responsibilities as members of the IRB. The IRB Chair should be a highly respected individual fully capable of managing the IRB and the matters brought before it with fairness and impartiality. The task of ensuring that the IRB is a respected part of the UNT community will fall primarily to this individual. The IRB must be fair and impartial and immune from pressure either from UNT’s administration, investigators whose protocols are brought before it, or external sponsors of research.

Conflict of Interest

No IRB member may participate in the review of any project in which the member has a conflicting interest or in which the appearance of a conflict exists, except to provide information as requested by the IRB. In the case of such a conflict, this should be reported to the IRB Chair and noted in the minutes. A conflict of interest is defined as a conflict between the private interests and the official responsibilities of a person. Examples of conflict of interest include serving on a thesis or dissertation committee for a project being reviewed or holding an ownership interest in an entity where the project is being performed. A member who is required to leave an IRB meeting due to a conflict of interest may not be counted for quorum purposes during his or her absence from the meeting.

Record Keeping

The IRB staff prepares and maintains adequate documentation of the IRB's activities. In addition to these written IRB procedures, such documentation includes copies of all IRB applications (including informed consent documents) reviewed, minutes of IRB meetings, records of continuing review activities, protocol changes, copies of all correspondence between the IRB and investigators, progress reports submitted by investigators, statements of significant new findings provided to subjects, and reports of any injuries to subjects. Minutes of the IRB meetings are kept in sufficient detail to record the following information: attendance at each meeting; separate actions taken by the IRB, deliberations, and votes for each protocol undergoing initial or continuing review by the convened IRB; the vote on actions taken (including the number of members voting for, against, and abstaining); the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. When the convened IRB requests substantive modifications or clarifications regarding the protocol or informed consent documents that are directly relevant to the determinations required to be made by the IRB under 45 CFR 46.111, IRB approval of the proposed research project should be deferred, pending subsequent review of responsive material by the convened IRB. Only when the convened IRB stipulates specific revisions requiring simple concurrence may the IRB Chair or another IRB member designated by the Chair subsequently approve the revised protocol on behalf of the IRB under an expedited review procedure. IRB records are retained for at least three years. Records pertaining to research that is conducted must be retained for three years after completion of the research. All records are accessible for inspection and copying by UNT officials and by authorized representatives of the department or agency supporting or conducting the research at reasonable times and in a reasonable manner. Where 45 CFR Part 46 requires specific findings on the part of the IRB, such as waiver of a signed consent form or approving research involving vulnerable populations, the IRB should fully document its findings in the minutes of the IRB meeting, including protocol-specific information justifying each IRB finding. For research reviewed under an expedited review procedure, these findings should be documented by the IRB chair or other designated reviewer.

Institutional Responsibilities

As an institution engaged in research, UNT must have an established IRB to review and approve research involving human subjects performed at its facilities or performed at any location by its faculty, staff, or students. Before any human subjects research can be conducted, UNT must have a written Assurance issued by the Office for Human Research Protections (OHRP) that certifies it will comply with the requirements of 45 CFR 46; and UNT must certify that all research with human subjects will be reviewed for approval by the IRB established in accordance with the requirements of 45 CFR 46. UNT holds a Federalwide Assurance issued by the OHRP. The IRB is covered under this Assurance.

Training

The Director of Research Compliance is available to provide education on a variety of topics related to ethical issues in human subjects research. The IRB Basics course (“Human Subjects Research + the UNT IRB”) is offered two times per year. Also, faculty members may request that the Director of Research Compliance provide educational sessions for faculty, staff, and/or students involved in human subjects research. The UNT IRB requires education on the protection of human research subjects for all investigators submitting IRB applications and all "key personnel" for the study. There are currently 2 options to complete the required training.  The NIH on-line training course, “Protecting Human Research Participants" is available on their website.  The CITI course, "Human Subjects Research (Social & Behavioral Research Investigators)" can be accessed by following these directions.  Ongoing human subjects research training is also provided to members of the IRB.

Investigations Regarding Possible Non-Compliance

The most common lapses in investigator compliance include unreported changes in the IRB approved protocol or consent documents, misuse or non-use of the IRB approved informed consent documents, lapse in approval for continuing review, and failure to obtain IRB approval prior to starting research activities. When unapproved research or procedures is discovered, the IRB and UNT will act promptly to halt the research, assure remedial action regarding compliance with federal, local, and institutional human subject protection requirements, and address the question of the investigator's fitness to conduct human subject research. Any serious or continuing noncompliance with Department of Health and Human Services (DHHS) human subjects regulations or the determinations of the IRB must be promptly reported by the Vice President for Research and Economic Development to the Office for Human Research Protections (OHRP) and the funding department or agency head.

Reporting of Suspensions, Terminations or Non-compliance

As soon as possible, but no later than within 10 days of determination by the convened IRB, suspensions, terminations and/or non-compliance findings will be reported in writing to the Vice President for Research and Economic Development, who, within 20 days of receipt of such a report, must also notify in writing the relevant Department or Agency Head (sponsor), any applicable regulatory body and OHRP of any suspensions, terminations, and/or instances of serious or continuing non-compliance.