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Human Studies Council

-Institutional Review Board-

 

What is the Human Studies Council?
The Human Studies Council (HSC) was established in 1986 as a standing University committee charged with facilitating ethical research involving human participants. The HSC operates under the Associate VP of Academic Affairs/Dean of Graduate Studies 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 HSC serves as an advisor to researchers on the federal and university regulations and policies related to human research ethics.

 

Who is required to submit research proposals to the HSC?
Any study or investigation involving humans as participants which is conducted by CCSU faculty, staff or students, as well as research conducted by external investigators at CCSU, must be approved by the University’s Institutional Review Board (IRB), referred to at CCSU as the Human Studies Council(HSC). 

The HSC understands that faculty and students are moral agents guided by the code of ethics of their particular worldview and discipline. Nonetheless, it is University policy that anyone (faculty, staff, students) doing research on or off-campus using human participants as subjects must submit a proposal to the HSC. 

Whether for publication or academic credit, all research involving humans must be reviewed and authorized by the HSC prior to any participant recruitment or data collection activities. 

 

Why?
The HSC 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 HSC approval status extends CCSU legal resources to the defense of the investigator and/or research associates.  HSC approval status also facilitates study publication. 

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

 

What is Research?  
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition may be funded or unfunded, or may be conducted as a component of another program not usually considered research.

 

What is Human Participant Research?
Human participant research means any systematic investigation that relies on human interaction or interaction with data or specimens from individuals who are alive.

What about course projects?
CCSU course projects and activities that serve to instruct students in research methodologies and techniques may not contribute to generalizable knowledge.  Advisors should consider the following before determining if their student project should be submitted to the Human Studies Council for review. 

Will the instructor vet the student projects for their appropriateness or would they prefer the HSC to do so An instructor, like the HSC, will consider the how the student will invite participation (recruitment) and what they will ask he participant to do (intervention).  Both aspects of interaction with human participants should respect the individuals and reflect well on CCSU, the instructor and the student. 

Does the student intend to use the project as a basis for a public presentation or publication?  While this may not be the intent of the course project, the student and instructor may decide the project and results merit public display (e.g. Research and Creative Achievement Day) or publication.  Projects presented in these mediums require formal prior approval by the HSC. 

 

What does NOT require HSC review?     
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 HSC.  

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 HSC approval.

 

How long does the HSC review process take?    
The HSC recommends investigators to submit proposals two to four weeks before study activities are scheduled to begin. The HSC 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 HSC encourages students, faculty advisors and faculty investigators to email or call the office with questions, visit the HSC office and/or schedule in-class discussion. The HSC is available at all stages of the research process to help investigators design projects to avoid unforeseen ethical barriers to approval. 

 

Who should attend HSC meetings?    
On average, only 15% of protocols require review by the full Human Studies Council so you may not need to attend an HSC meeting. If your research is deemed appropriate for Full Review, you are strongly advised to attend the HSC meeting during which your proposal 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 HSC meeting schedule is available here.

 

What constitutes a complete HSC submission?
See the Protocol Submission Checklist page of our website; consult the New Protocol Submission Guideor contact the HSC office.

 

QUESTIONS? 

Please call the HSC Chair:
Dr. Bradley Waite (860-832-3115)

or email the HSC Administrator at HSC@ccsu.edu

 

 

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