Be certain to read this section before completing an application form. In many cases, no Hillsborough Community College (HCC) forms will be required to receive initial Institutional Review Board (IRB) approval for your research.
If your research does not include human subjects, it does not fall under the purview of the HCC Institutional Review Board. No research involving living animals is conducted at the College.
If you are submitting a grant proposal, your proposal will serve as the initial IRB application. Also see Information for Grant Writers below.
If you are an HCC employee whose research is being conducted as part of degree requirements at another educational institution, the paperwork required for your IRB approval at that institution will most likely suffice for HCC’s IRB. Please contact the chairperson of the HCC IRB for additional guidance.
If you are not affiliated with HCC, you must first find an administrator or full-time faculty member currently employed at HCC who is willing to sponsor your research. Please contact the chairperson of the HCC IRB for additional guidance after identifying an HCC sponsor.
If your research does involve human subjects, it must be reviewed by the HCC IRB prior to any recruitment of subjects or data collection. Conducting human subjects research without IRB approval is a violation of federal regulations and College procedures. The time involved for the IRB to review this research will primarily depend on the level of review required.
Types of IRB Review
The three levels of IRB review defined in federal regulations are exempt, expedited, and full board. Only the IRB is authorized to determine which level of review is appropriate. However, the QuickStart Guide found on the IRB webpage will help you determine what level of review your research will undergo. Additional information about the types of review can be found on the Glossary tab.
In general, research that involves no more than minimal risk to human subjects (except those in specially protected categories discussed below) is likely to be deemed exempt or expedited. Full board review is required for research studies that involve greater than minimal risk or include populations that need additional protection.
Most research at the College involves standard educational practices in commonly accepted educational settings and often includes the use of educational tests, surveys, or interviews. As allowable by federal regulations, the HCC IRB would most likely deem these proposals to be exempt as stipulated in 45 CFR 46.101. However, there are exceptions. If your research includes subjects under the age of 18, the research protocol must be approved by the full IRB.
The Code of Federal Regulations also requires special protection for pregnant women, human fetuses, and neonates as well as prisoners. Individual IRBs have the discretion to add additional protections for other populations of human subjects; for example, persons with diminished mental capacity and persons who are homeless. Research involving any of these populations requires review by the full HCC IRB.
Exempt and expedited review will typically be completed within 7 to 10 business days after all documents have been received by the IRB and any questions have been fully addressed. Research requiring full board approval will be reviewed at the next scheduled meeting of the IRB and must be received at least two weeks prior to the meeting. At present, the full IRB is scheduled to meet biannually but can be convened on an as-needed basis.
Information for Grant Writers
All grant proposals are reviewed when they are submitted to the Grants Office. A determination of the level of IRB involvement is made if sufficient information is available in the proposal. The signature of the chairperson of the IRB is required on the Approval to Submit form, if applicable, prior to the President’s final approval. It is not necessary for the Principal Investigator to submit additional paperwork unless instructed by the IRB chairperson or designee.
Approval for research that has been determined to be exempt will expire in five years from the date of the IRB approval letter. However, any modification to the research protocol may change the level of approval. The HCC IRB must be notified in writing immediately of any changes to the research protocol. If the study is completed prior to five years, the principal investigator must request in writing that the study be closed out by the IRB.
All other approvals are valid for one year, unless there is a modification to the research protocol. It is the responsibility of the PI to request a renewal of all research no less than two weeks before the expiration as noted in the IRB approval letter. If a renewal is not received in a timely manner prior to the expiration date, all research activities with human subjects must be suspended until the study renewal is approved.
Responsibilities for Renewal or Close-out
It is the responsibility of the PI to notify the HCC IRB in writing of any changes to the research protocol, regardless of the approval level. Changes to recruitment materials and informed consent forms are considered part of the research protocol. Copies of the approved form(s) and suggested changes must be forwarded to the IRB prior to their implementation.
IRB Initial Application