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IRB Review

Notice: All IRB Submissions after July 31, 2018 MUST be completed using the IRB-PAC. Training Videos for the IRB-OAC can be found HERE. Check back for updates.

Does my Project Need IRB Review?

Federal, state and university regulations require Institutional Review Board (IRB) review prior to conducting research involving human subjects. These regulations pertain to any research conducted by anyone affiliated with this university regardless of where the activity occurs.

What is research?

"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For Example, some demonstration and service programs may include research activities." [45 CFR 46.102(d)]

If you answer “yes” to the questions below, then your project needs to be reviewed by the IRB.

  • Is the activity a systematic investigation?
  • Is it designed to contribute to generalizable knowledge?
  • Does the research involve obtaining information about living individuals?

1. Department-Level Review

Student research may be reviewed at the Department level if it is done solely as a classroom exercise. This activity meets one or two criteria of the federal definition of research (participants are living, and the project is a systematic investigation), but not the third criterion: it is not designed to contribute to generalizable knowledge.

Each department may designate an IRB representative, who should be CITI Training certified or have read the Belmont Report. The IRB representative will review the proposed classroom exercise according to the checklist below. Records will be kept in the Department, but must be available to be examined by the IRB upon request.

View Checklist

In order to be eligible for department-level review, the classroom activity must satisfy all the following conditions:

  1. Results NOT intended to be generalizable or published. The project is done purely as a pedagogical exercise, to teach students about the research process or discipline. The project is not intended to contribute to the discipline, address a theoretical issue or otherwise contribute to generalizable knowledge. The results of the project will NOT be published or distributed outside of the class (Example: a classroom presentation or a paper written for a class would qualify, whereas research presented a the Learning and Research Fair, a Presidential Scholar's project or a Kilmer project would not).
  2. NO more than minimal risk. Subjects are exposed to no more than minimal risk (i.e., the level of risk that they would typically encounter in their daily lives).
  1. Subjects are NOT asked about sensitive, personal, incriminating or private information or issues, nor is such information collected about them (this includes information about sexual behavior or attitudes, immigration status, drug use, criminal activity, medical history or   conditions, grades, or other information that could stigmatize the subject, etc.).
  2. No information is collected that could harm the subject’s reputation, employability, or financial standing or that could place the subject at risk for criminal or civil liability.
  3. The project will NOT manipulate the behavior of subjects beyond the range of their typical daily life.
  4. The project will NOT involve physically or psychologically invasive contact with subjects.
  5. The project will NOT involve deception of subjects. Subjects are fully informed and given the opportunity to voluntarily consent to participation
  6. NO vulnerable subjects. Subjects are adult (i.e. age 18 or older) members of the general population and NOT members of vulnerable populations (e.g., children, women who are pregnant, persons with cognitive impairments, persons who are socially, economically or educationally disadvantaged, persons with disabilities, prisoners, persons with significant health problems, etc.). Please note that "research" with children is not eligible for Department-level review, even if it is not intended to contribute to generalizable knowledge.
  7. NO cooperating organizations. The activity will be conducted within the SUNY Potsdam community. Data may also be collected from relatives or acquaintances of members of the SUNY Potsdam community, but no other institution can be involved in the classroom exercise.

    If any ONE of the above is NOT true of the project/assignment/activity, then the instructor must submit an application for the use of human subjects in research. The application will be reviewed at the Exempt, Expedited, or Full Board level.

2. Exempt Review

Exempt review does not mean that the project is not reviewed by the IRB. It means that, because it entails no risk or only minimal risk of harm for the human subjects, it is "exempt" from the higher levels of review (Expedited, Full Board). Because there’s an inherent conflict of interest, investigators may not make the determination that their research is exempt. Applications for certifications of exemption are reviewed only by the IRB Chair. The process is much faster than for Expedited and Full Board applications, and it entails much less paperwork.

3. Limited IRB Review

Limited IRB Review Research that involves no risk or no more than minimal risk to participants and is exemptible but requires that a limited IRB review is conducted to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens. Limited IRB Review is conducted by the Chair and/or one or more experienced members of the board.

4. Expedited Review

Projects that entail no more than minimal risk to participants, but are more intrusive than exempt projects, may qualify for Expedited review. Expedited review projects are reviewed by the IRB Chair, and/or by one or more experienced members of the board, depending on the nature of the project.

5. Full Board Review

Research involving more than minimal risk to the participant requires review by the full IRB in a convened meeting.  Full-board review covers all research that does not qualify for expedited review or review for certification of exemption.