Rensselaer is committed to protecting the rights and welfare of all human subjects and ensuring sound, ethical research practices by all Renssealer investigators.
Rensselaer embraces the ethical principles for research with human subjects articulated in The Belmont Report: Respect for Persons, Beneficence, and Justice. The rights and welfare of human subjects are also protected by federal law under Title 45 Code of Federal Regulations Part 46, Protection of Human Subjects (45 CFR 46). The Rensselaer Institutional Review Board (IRB) is a federally mandated, independent committee that reviews, approves and monitors all Human Subject Research, as defined in 45 CFR 46, when it involves Rensselaer-affiliated faculty, staff, students or visiting researchers.
The Rensselaer Institutional Review Board (IRB)
The IRB's federally mandated mission is to review all institutional activities that fit the two-part definition of Human Subject Research found in 45 CFR 46:
- Human Subject is “a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual OR identifiable private information.”
- Research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
If an activity conducted by a Rensselaer-affiliated investigator meets the definition of Human Subject Research, then the investigator must submit a Research Protcol for review by the Rensselaer IRB. The IRB will apply the appropriate level of review: Exempt Review, Expedited Review, or Full Review. Note that Exempt Review is the regulatory term for the lowest level of IRB Review. Once the IRB grants an Exempt Approval, the Protocol requires no further oversight from the IRB unless it is materially changed. In such cases, the investigator should discuss the proposed changes with the IRB prior to implementation.
Please also note that certain types of Private Information - which includes some health and medical information - meet the regulatory definition of a Human Subject. It is the current policy of the Rensselaer IRB to advise researchers using Private Information, even when that information is de-identified, whether the activity falls outside the regulatory mission of the IRB or should be submitted for Exempt Review. Whenever an investigator is unsure about how to handle private information, or whether any activity constitutes Human Subject Research, the safest course of action is to consult the IRB.
Submitting a Protocol for IRB Review
Before submitting a Research Protocol for IRB Review, all faculty, staff and students involved in Research activities must complete a training course in Human Subject Research. Rensselaer-affiliated researchers take the course online, at no charge, through the CITI Training Program. Please see the CITI registration and course instructions in the document list in the right sidebar. The next step is to submit a formal Protocol for IRB review. The Institutional Review Board uses an online protocol management system called Mentor IRB to manage the protocol review process. To get started, please download the IRB Protocol Description Template and follow the instructions in "Getting Started with Mentor IRB." Links to both documents are in the right sidebar.
Requesting a "Preliminary Approval" at the Proposal Stage
At the proposal stage, a federal sponsor may request documentation that a study with Human Subjects will be reviewed by the IRB. The IRB provides that documentation in the form of a “Preliminary Approval” once the PI submits the request, with a copy of the proposal, via the Mentor IRB system. A Preliminary Approval does not require an IRB review; the request simply generates an IRB record as a "placeholder" and confirms that no Human Subject Research will commence until the IRB has made a formal determination. Once an award is made, the PI may request an IRB review of the study. Until then, the Preliminary Approval email notification serves as documentation that the PI has an IRB record for the proposal.
The Rensselaer Institutional Review Board
Stanley M. Dunn, PhD, IRB Chair
Robert Hull, Ph.D., Institutional Official (IO)