The Code of Federal Regulations mandates that all research activities (including data analysis and publication of results) that involve human subjects must be reviewed and approved by an institutional review board (IRB). Research may not begin until approval is obtained. Unless the activity is determined by the IRB to be exempt from IRB oversight, approval must be renewed on a yearly basis, and research must cease if approval expires. For the complete federal guidelines, please click here.
ACTIVITIES REQUIRING IRB OVERSIGHT
Approval by the Queens College (QC) IRB must be obtained for research involving human subjects conducted by any individual affiliated with the college, or that uses subjects affiliated with the college. This includes, but is not limited to:
- Research conducted on QC campuses by QC-affiliated individuals or others. NOTE: All research involving human subjects at QC must be sponsored by a full-time faculty or staff member of QC.
- Research sponsored by QC in whole or in part (i.e., under the direction of QC personnel or funded through the college).
- Research that uses QC-affiliated subjects or information related to QC-affiliated subjects.
- Research conducted by a QC-affiliated individual cooperatively with another institution. NOTE: QC also requires such investigators to obtain proper approval from the cooperating institution.
- In some cases, research conducted by students.
TYPES OF IRB OVERSIGHT
Depending on the category of subjects to be used and the potential level of risk associated with a project, one of three types of review will be appropriate. The same application form is used in all cases; however, the number of copies to be submitted differs among types (see instructions on the application form). While the investigator is asked to specify the type of review, the IRB will is required to make the final determination in all cases.
Full Board Review
The protocol will be reviewed at a convened meeting of the IRB. The Queens College IRB meets monthly during the academic year. Application deadlines for each meeting are strictly adhered to.
The protocol will be reviewed by the IRB chair or first vice president and one designated voting member of the IRB, rather than by the entire IRB. Reviews are completed within three weeks of receipt. Federal regulations permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved protocols. Projects involving children, prisoners, pregnant women, human fetuses, neonates, or individuals with diminished mental capacity require full-committee review unless data are collected anonymously. Studies involving deception of subjects also require full-committee review.
In accord with federal regulations, a project may be exempt from the requirement for IRB oversight; however, a protocol for any project involving human subjects must be submitted to the IRB for a determination of exempt status. Special restrictions apply for projects involving children as subjects. Exempt protocols are reviewed by the IRB chair or first vice president and one designated voting member of the IRB, rather than by the entire IRB. Reviews are completed within three weeks of receipt.