This IRB is not currently approved to review research funded by federal agencies. The GGC IRB is currently in the process of registering with the Office of Human Research Protections (OHRP) at the US Department of Health and Human Services (HHS). This is a necessary first step toward gaining a FederalWise Assurance (FWA), which would authorize the IRB to review federally funded research.
IRB meetings will be scheduled monthly. As per federal regulations, attendance by a majority of the committee including at least one non-scientist is necessary for a quorum; decisions are rendered by a majority vote of those members attending the meeting.
Upon receipt of an application, there will be a verification that all required items have been submitted in full and confirmation of receipt will be sent to the Principal Investigator submitting the application. In the event that the application is not complete, the Principal Investigator will be notified. It is then the duty of the Principal Investigator to submit the complete applications to the IRB submission portal for examination and assignment.
Applications must be fully complete at least one week prior to the regularly scheduled meeting for the academic term.
The chairperson will assign each proposal to two reviewers, one of whom will be assigned as principal reviewer (PR), who will verify the submission is complete and will determine the type of review needed (expedited review, full committee review). Copies of the full application will be made available to all committee members.
Each application will go through an initial review by two members of the IRB. The IRB reviewers will determine if the study poses no more than minimal risk for participants and the application will be exempt from further review. Per federal guidelines, if the reviewers determine that the study poses more than minimal risks to the participants, the application will be sent to the IRB committee for Full Review.
Researchers who plan to conduct human subjects research that they believe to be exempt from IRB review must submit an initial full application to the IRB. Two IRB members will review each application and determine whether or not it meets the criteria for exempt review.
Exempt from further review are projects that involve no deception or coercion of the participants, involve risks no greater than those ordinarily encountered in daily life and that fall into one of the following categories:
- The activity is conducted in an established educational setting and involves normal education practices in order to evaluate or compare educational instructional practices, curricula or methods.
- The research involves the use of standard educational tests (cognitive, diagnostic, aptitude or achievement) and information taken from those tests will be recorded so that participants cannot be identified directly.
- The research involves surveys, interviews or observations of public behavior and the responses will be recorded so that either: (a) participants cannot be identified directly or indirectly by their answers, or (b) the responses could not damage, or harm a subject’s interest, including financial interests, employability or reputation.
- The research is limited to using existing data to which the investigator has access and the information will be recorded so that individuals cannot be identified directly or indirectly.
Full reviews will be conducted on all applications for research that do not qualify as exempt from further review. Full reviews will be conducted completely in accordance with the guidelines provided by OHRP for the protection of human subjects (45 CFR §46.109). At each meeting, the principal reviewer (PR) for each application under review will present a summary of the proposal and any issues the PR has identified. He/she will lead the discussion of that proposal during the IRB meeting(s) at which it is considered. Following a decision by the IRB, the PR will complete a full review form that reports the decision and advises the principal investigator of any changes or modification required to the protocol or the consent forms submitted. All annual and ongoing reviews of the research will be led by the same PR.
In its review of a submitted application, the IRB will primarily focus on the degree of risk presented to human subjects by their participation in the research proposed.
Risk refers to more then the potential for physical harm; it also refers to the potential for emotional harm or discomfort and to the potential for violations of an individual’s privacy and dignity. The IRB will seek to determine that a proposed research protocol meets, at a minimum, the following criteria:
- There are no unnecessary risks to subjects;
- Possible risks to subjects are minimized by the use of sound research design;
- The risks that are present are reasonable in relation to the anticipated benefits of the research;
- The selection of subjects for participation is equitable;
- Informed consent will be sought using appropriately worded communication and consent will be appropriately documented;
- The research plan makes adequate and appropriate arrangements for monitoring data collection to ensure the safety of subjects;
- The research plan makes adequate and appropriate arrangements for protecting the privacy and dignity of subjects;
- The research plan makes adequate and appropriate arrangements for protecting the rights and welfare of subjects who may be vulnerable to coercion or undue influence (such as minors or persons who are educationally or economically disadvantaged).
- The research will be conducted in a manner sensitive to the setting in which it takes place.
Following review by the IRB for an initial or continuing approval, the principal reviewer will notify the principal investigator(s), the IRB members and the senior vice president for Academic and Student Affairs/provost, in writing, of the committee’s decision and/or comments concerning the proposal. When a proposal is not approved, the notification will clearly state the reasons for the decision and provide guidance to the principal investigator(s) regarding proposal modifications that would increase the likelihood of the proposal being approved on resubmission. The principal investigator will be given an opportunity to respond to the IRB comments and decision on the proposal as initially written or may revise the proposal and resubmit. However, the IRB is in no way obligated to approve any proposal considered to present unnecessary risk to human subjects regardless of the proposed benefits anticipated by the principal investigator(s).
IRB approval of a proposed study is limited to the specific research protocol submitted. Investigators are required to conduct their study as described. Approval, except for exempt research, is limited to a 12-month period. Projects that pose a high level of risk or that have had problems complying with IRB requirements in the past may be approved for a period of time shorter than 12 months or may require verification of research activities by someone other than the Principal Investigator. Any project that continues beyond the 12-month period must be re-reviewed according to the procedures in the next section of this document.
Any changes to the research protocol, instruments, informed consent forms, or procedures that occur during the 12-month approval period must be reported to and approved by the IRB prior to implementation, except when such a change is necessary to eliminate an immediate hazard to the subjects. When an immediate change is required for safety reasons, the change and the reason for it must be immediately reported to the IRB and approval of the change must be sought.
Any incident in which a human subject is injured or harmed during an investigation must be immediately reported to the IRB.
All research continuing beyond the period for which it is initially approved will be subject to continuing review. The purpose of the continuing review is to verify and insure that the protocol has been implemented as described and that the level of risk subjects are exposed to remains minimal. At least two months prior to the expiration of an IRB approval, the principal investigator must submit a renewal application. This application must specify the following:
- The number of subjects who have participated during the life of the research project;
- The number of subjects anticipated to participate during the next approval period;
- The number and storage location of consent forms obtained;
- Any adverse reactions or events that have taken place during the approval period and corrective actions taken; and
- Any changes or modifications to the research protocol along with explanations for each change.
Either a full or expedited review will be conducted, and the principal investigator will be notified in accordance with the procedures in place for the initial review.
All proposals, IRB meeting notes, and communications will be stored in the office of the dean of Liberal Arts for a period of not less than three years after the completion of all research activity associated with the proposal. The IRB files and records will be available for inspection by regulatory agencies during regular business hours in accordance with the guidelines in the Protection of Human Subjects, 45 CFR §46.115.
Georgia Gwinnett College will not tolerate unauthorized or non-compliant research at, by members or, or on behalf of the College. This applies equally to research which was never submitted for IRB review, research begun while review was pending, and research for which the IRB has denied, suspended, or revoked authority. In the event the IRB the senior vice president for Academic and Student Affairs/provost discovers an unauthorized research project in process or learns that an authorized project is being conducted in a manner that is not in compliance with the protocol submitted, the committee will, at its discretion, take one or more of the following actions:
- Notify the investigator(s) in writing of their status, instructing them to cease research activity and providing instructions for attaining approval for the research activity;
- Ban said individual(s) from conducting any further research at the College for a term determined by the IRB;
- Notify the researcher’s direct supervisor;
- Notify the appropriate institutional officer at the researcher’s home institution;
- Notify OHRP; and/or
- Notify the appropriate funding agency, if such can be determined.
In addition, GGC faculty or students found to be conducting unauthorized or non-compliant research will be reported to the appropriate administrative official for disciplinary action.
For additional information regarding submissions to the IRB, contact the chair of the IRB.
To report noncompliance with IRB regulations or with the protocol of a study, contact the Office of the Senior Vice President for Academic and Student Affairs/Provost.