Rensselaer's Institutional Review Board (IRB) is a federally mandated, independent committee that reviews, approves, and monitors all Human Subject Research, as defined in Protection of Human Subjects (45 CFR 46), when it involves Rensselaer-affiliated faculty, staff, students, or visiting researchers. 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 IRB's mission is to review all institutional activities that fit the definition of Human Subject Research found in 45 CFR 46: A human subject is "a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g. venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g. a medical record). Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
The Office of Extramural Research (OER) at NIH has developed a quick decision tool that should assist you with determining if your research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research. Whenever an investigator is unsure whether any activity constitutes Human Subject Research, the safest course of action is to consult the IRB.
For information about IRB reliance agreements with other institutions please contact Dr. Brandt Burgess to initiate the process.
Stanley M. Dunn, Ph.D., Chair
Robert Hull, Ph.D., Institutional Official (IO)
Brandt Burgess, Ph.D., Compliance Director
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. 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 (click on IRB in the top nav) 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."
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.
PI Instructions for Requesting a Preliminary Approval from the IRB:
- Log in to Mentor IRB and create a new Protocol.
- Enter PI name, proposal title and estimated start date in the required fields.
- In the Review Type dropdown menu, choose Preliminary IRB Review.
- For the Protocol Description, upload a copy of the Proposal (cover sheet and full project description - budget and personnel details may be omitted).
- In the Notes to IRB Chair field, briefly describe the anticipated Human Subject Research and click Submit.
- Save the IRB Preliminary Approval email notification as documentation of the IRB record.
NOTE: Human Subject Research tasks include obtaining Informed Consent, administering interventions, collecting data or interacting with live human subjects for research purposes. Human Subject Research also includes access to identifiable private information for research purposes.
- Consent Form Template
- Getting Started with Mentor IRB
- Exempt Research Categories (2018 requirements)
- Guidelines for Expedited Review
- How to Close Out a Study
- How to Renew a Study
- How Your Proposal Will Be Evaluated
- IRB Policies & Procedures - Including Appendices
- IRB Protocol Description Template
- Stem Cell Guidance
- Subpart D