Investigators Q & A

The Institutional Review Board (IRB) was established in 1986 as a standing University committee charged with facilitating ethical research involving human participants. The IRB operates under the Associate Vice President of Academic Affairs in accordance with the ethical guidelines set forth by the US Department of Health and Human Services in the Code of Federal Regulations Title 45 Part 46 and the Belmont Report.

The IRB serves as an advisor to researchers on the federal and university regulations and policies related to human research ethics.

Any study or investigation conducted by CCSU faculty, staff, or students involving humans as participants, as well as research conducted by external investigators at CCSU, must be approved by the University's Institutional Review Board (IRB) if this research meets the federal definition of research with human subjects.

According to the federal regulations, research means “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.. constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes” 45 CFR 46.12(l)

If you are unsure if your project meets the federal definition of human subjects research, please contact the IRB for assistance in making this determination.

The IRB is charged with reviewing research projects that involve human participants both to safeguard participants autonomy and welfare and to ensure compliance with federal regulations. CCSU is required to have an IRB because it receives federal funding for research.

If a study is implicated in an 'adverse event' that results in legal action against the investigator, a study's IRB approval status extends CCSU legal resources to the defense of the investigator and/or research associates. IRB approval status also facilitates study publication.

Failure to obtain approval could lead to inadmissibility of research for publication or degree requirements. The IRB does not review any research retroactively.

However, if the data collected is generalizable beyond CCSU and are to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research and requires IRB approval.

CCSU course projects and activities that serve to instruct students in research methodologies and techniques typically do not meet the federal definition of research with human subjects. Under the federal regulations, research means "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." If you are an instructor who wishes to incorporate research with human participants into your classes, please consult our CCSU Policy on Class Research Assignments and IRB Review.

Note that all research with human subjects that is intended to be shared as a public presentation or publication must receive IRB approval.

Quality improvement and quality assurance activities conducted solely for the intent of maintaining or improving quality of services provided at CCSU are not considered research activities. These projects often involve collection and analysis of existing data and for this reason may require approval by the Office of Institutional Research and Assessment. These studies would not need to be reviewed by the IRB.

However, if the data collected is generalizable beyond CCSU and are to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research and requires IRB approval.

The IRB recommends investigators to submit their protocol at least two to four weeks before study activities are scheduled to begin. The IRB strives to be flexible and respectful of academic freedom and reviews each project as a separate case rather than imposing rigid requirements. Therefore, the time required for review depends on the nature of the research. All things being equal, the more comprehensive the submission, the more quickly goes the process.

To foster a smooth review, the IRB encourages students, faculty advisors, and faculty/staff investigators to email or call the office with questions, visit the IRB office, and/or schedule in-class discussion. The IRB is available at all stages of the research process to help investigators design projects to avoid unforeseen ethical barriers to approval.

On average, only 15% of protocols require review by the full Institutional Review Board so you may not need to attend an IRB meeting. If your research is deemed appropriate for a full review at a convened meeting, you will be invited and are strongly advised to attend the IRB meeting during which your protocol will be reviewed. Faculty advisors are encouraged to attend with their advisees.

The full review is an efficient and collegial process in which investigators provide clarification to questions the committee members may have and discuss options for optimizing participant protections and data integrity. Meetings are held once or twice per month to minimize scheduling conflicts. The current IRB meeting schedule is available here.

The IRB is solely responsible for determining whether or not a protocol falls into one of the federally established exemption categories. All protocols submitted to the IRB will be reviewed to determine if the proposed research conforms to one of the exemption categories. There is not a separate process for submitting exempt research at CCSU, and, like all other research conducted with human participants, exempt research must be submitted to and reviewed by the IRB before any data collection begins.

Under the federal regulations, if research is being conducted by researchers from multiple institutions with Institutional Review Boards or at multiple locations, one IRB can take primary responsibility for the review of the joint research project. To use a primary IRB system of review, the IRBs at the other institutions must formally cede their IRB review responsibilities to the designated primary IRB through an Institutional IRB Authorization Agreement (IAA).

Please contact the IRB staff at irb@ccsu.edu if you would like to discuss entering into an IAA agreement for your research. CCSU is available to serve as a primary IRB or, in most instances, can cede the review to another IRB with a Federal Wide Assurance (FWA).

Graduate students who are conducting research for theses or dissertation projects must use CCSU as their primary IRB.

If you are not affiliated with CCSU and would like to recruit from our campus population, please send an email to irb@ccsu.edu stating your interest in recruiting at CCSU. Please attach your official IRB approval notification and your approved IRB protocol, inclusive of all proposed research measures, to your email. Once we receive your email, we will reach out to you about your study.

Any changes to an approved protocol need to be approved by the IRB prior to implementation, except in cases where changes are necessary to eliminate apparent, immediate hazards.

For email submissions:

To submit a modification to your approved protocol via email, download the Protocol Modification Submission Form, and follow the instructions on that form.

For Kuali submissions:

If the initial approved protocol was submitted via Kuali, open the proper protocol, click on “Amend,” and check the sections you would like to modify. Make sure to “Replace” attachments and not delete them. Then click “Submit” or “Notify PI to Submit” depending on your role.

Once submitted, the selected sections will be locked from further editing until the amendments are reviewed. Step by step directions.