About the IRB
Purpose
Research investigators and their institutions have a fundamental responsibility to safeguard the rights and welfare of people participating in their research activities. All review of research activities involving human subjects is performed by the IRB, a
federally regulated committee whose members are not involved in the conduct of the research. The purpose of the IRB rises above performing a legalistic function in the protection of human subjects, by serving as a forum for the development and understanding of the ethical guidelines governing human subjects research. Ultimately, in this effort, the research investigator’s relationship with the IRB forms the bedrock of the human subjects protection program.
The IRB reviews and has the authority to approve, require modification in, or disapprove all research activities, including previously approved research that is currently undergoing new modifications. The research protocol and the informed consent document are the interface of communication for ethical research practices between the IRB and the researcher.
What is an IRB?
In accordance with the Federal Regulations, an IRB—Institutional Review Board--is a committee of scientists, nonscientists and community members who review proposed research involving human volunteers to protect their rights and welfare.
What is Human Subjects Research ?
Human subjects research involves a living individual about whom an investigator—whether professional or a student—obtains information:
- Through intervention or interaction
- Identifiable private information from existing private records
When is it Research?
- Research is a systematic investigation designed to contribute to a generalizable body of knowledge
- May include testing, evaluating, and research development
Who Should Apply for IRB Review?
- CCNY faculty
- Non-CCNY faculty conducting human subjects research at CCNY or involving CCNY facilities, property, or recruitment of students
- Students doing research with human subjects
- Anyone who plans to use CCNY non-public information to identify or contact subjects
What is My Role as a Principal Investigator?
- To understand the principles of human subjects research
- To comply with all IRB decisions and requirements
- Tosubmit a continuing review before implementing any changes to previously approved research
- To submit a continuing renewal application if any aspect of the research—data analysis or human contact--is extending beyond expiration date
- To report adverse and serious adverse events to the IRB immediately
What is My Role as a Faculty Student Advisor?
- Guide students with protocol preparation so that it is ready for review
- Ensure that students are conducting research according to federal and ethical guidelines
- Monitor students for the duration of the approved research to ensure compliance
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