Institutional Review Board (IRB)
Research Involving Human Subjects
IRB Process in a Nutshell
The terms of our Federal-Wide Assurance (FWA) filed with the Office for Human Research Protections, Department of Health and Human Services, state that the University at Albany assures that all research conducted under its auspices will be conducted ethically following the principles set forth in the Belmont Report and codified in the Code of Federal Regulations .
Federal and state regulations, as well as University policy, require Institutional Review Board (IRB) review prior to conducting research involving human participants. These regulations pertain to any research conducted by anyone affiliated with the university. This includes not only sponsored research, but also theses, dissertations, and class projects. Research involving human subjects conducted by any faculty, staff, or student under the auspices of the University at Albany must be reviewed by the IRB.
It is the responsibility of the Investigator to submit the proposed research to the IRB for approval before the research has begun. You may not start your research until your protocol has been reviewed and approved by the IRB and your informed consent and accompanying recruitment materials have been date stamped.
The IRB requires all individuals listed on an IRB protocol to complete the required Human Subjects Training before approval will be granted.
Review the Investigator’s Handbook: Human Subjects Research/IRB to learn:
- the requirements for key research personnel
- the rights of human participants in research
- the roles of the Institutional Review Board (IRB) and the Office of Research Compliance (ORC) in the research process
- the types of research: exempt, expedited, full board
- the IRB review criteria
- how to preare and submit documents for IRB review
- how to obtain the required training in the protection of human participants in research
Use only Current IRB Forms dated September 2006 or later. Applications submitted on the incorrect forms will be returned without review by the IRB.
Prepare and submit the required number of copies of the completed application to the Office of Research Compliance, MSC 312.
ORC will email the results of the IRB review back to the Investigator generally within 15 business days after submission. The official IRB letter of approval and date stamped informed consent will follow pending clarification by the Investigator of any issues, as requested by the IRB.
Any and all changes to an approved protocol must first be reviewed and approved by the IRB. Use a Modification Request Form - IRB to submit any modifications to the approved protocol.
Approvals are usually valid for 1 year. Before the approval term expires, submit a Continuation Request Form - IRB or Closure Request Form - IRB to the IRB.
Retain IRB records and accompanying documentation for at least 3 years from the date the research was completed.
For more details, see the Investigator’s Handbook: Human Subjects Research/IRB.
Date: 8.22.07
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