Do I need to submit an IRB?
Research or clinical investigations involving humans as your subject must be reviewed by the College’s Institutional Review Board.
Is my project considered research?
Federal law defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(d)].
A systematic investigation would include the methodical collection of data by way of interviews, surveys, tests, observation, (or other research methods) and subsequent data analysis to answer a question. If the descriptors above accurately characterize the work that you’re doing—it is considered research.
What does the term ‘human subject’ mean?
With respect to research, a human subject means a living individual about whom the investigator conducting the research obtains identifiable private information or obtains data through an interaction or intervention with an individual [45 CFR 46.102 (f)]. Again, all proposed research involving human subjects must be reviewed by the IRB before proceeding with the investigation.
How does the IRB review and approval research protocols?
When reviewing IRB applications, committee members aim to answer the following questions:
- Does the research pose greater than normal risk to participants? [45 CFR 46.102 (i)]
- Are participants able to give informed consent?
- Are there any conflicts of interest?
- Does the research involve participants from vulnerable populations?
- By what means does the researcher collect and secure data?
- Is the researcher properly trained to conduct research with human subjects?
What type of training is required to work with human subjects?
In order to conduct research involving human subjects, the principal investigator (PI) and research assistants must complete an online training program through either:
How do I submit my research protocol to the IRB?
Please complete an exempt or full IRB review application and submit to the head of Pomona College Human Subjects Protections Committee.
Six Categories of Exempt Research (IRB Exemption)