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Any scientific research being conducted by a University of Massachusetts Amherst affiliate that involves interacting or intervening with human subjects/participants must undergo a review by the IRB. The IRB is tasked with ensuring that research plans are in compliance with all laws and regulations, and that the risks to subjects are properly balanced against potential scientific gains. This is in accordance with federal law, and ALL research with human subjects, regardless of location or category of review, is subject to IRB review. Detailed discussion, as well as IRB contact information.

The only exception to review is minimal-risk undergraduate research. Minimal-risk studies are those that are no more likely to cause harm or discomfort than is a subject’s daily routine. Full details of minimal-risk research are included in this Data and Safety Monitoring Plan Template, under Section IV, Assessment of Level of Risk.

Faculty and graduate student research that is funded and/or classified as high risk must be reviewed by an IRB. There are three different types of review: expedited, exempt, and full board.

Before submitting an IRB application, all researchers must also complete an online Human Subjects research course via CITI. Certification of completion of CITI training must also be attached to the protocol application whether the research is funded or unfunded. CITI courses are free and usually take about two hours to complete. Note that there are different modules to choose from but most commonly, the Human Subject Review course is used for sociological research.

Details about the submission and filing process

The Office of Human Resource Protection (OHRP) educational videos also provide introductory information on research ethics, including topics such as informed consent and managing unexpected problems.

OHRP offers a collection of videos and webinars to help the research community better understand the HHS regulations for the protection of human subjects in research and their responsibilities for protecting human subjects.