Research Exempt from IRB Review
The most common types of research conducted at Vassar that are exempt from IRB review are the following:
1. “Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.” If these conditions are not met but the IRB determines through a process called “limited review” that that there are adequate privacy and confidentiality protections, the research may still qualify as exempt.
2. “Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection” and the conditions given above under #1 are also met.
“Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.”
“If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.”
Note that if a project doesn’t constitute research, then it is also exempt from IRB review. The HHS defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Oral history is excluded as long as it falls under the category of “scholarly and journalistic activities that collect and use information about specific individuals themselves.” On the other hand “studies using methods such as participant observation and ethnographic studies, in which investigators gather information from individuals in order to understand the beliefs, customs, and practices, not only of those individuals, but also of the community or group to which they belong” would represent “generalizable knowledge” and therefore not excluded from IRB review under these new rules.
Important: not all of the above categories of research are exempt if the participants are minors. A full list of the types of research that are exempt from IRB review can be found here (see section d); if children are involved as participants, also see the information located here.
You as the researcher are responsible for checking the Covid-19 guidelines in the jurisdiction where the research will take place. Your exempt determination form should indicate whether the guidelines apply to your project and, if so, how you will address any relevant safety concerns in your methods and procedures.
You must receive approval from the IRB for your research to be considered exempt. Use the form below to make a preliminary determination of whether or not your project is exempt from IRB review and the IRB will normally respond to you within one week:
Research Eligible for Expedited IRB Review
Research that does not fall into one of the exempt categories but only poses minimal risk to participants (meaning that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests”) can receive expedited review. This means that the proposal can be reviewed by one member of the IRB committee rather than undergoing review by the full committee. A full list of the types of research that can receive expedited review from the IRB can be found here.
Research Requiring Full IRB Review
Research that does not fall in the exempt or expedited category must undergo review by the full IRB committee. This includes any research judged to pose more than minimal risk, which is defined as risks no greater than those commonly encountered in daily activities. Research involving active deception and/or certain participant groups (e.g., minors under 18 years of age, pregnant women, prisoners, or undocumented individuals) is more likely to require full review. You can determine if your proposal requires full review by contacting irb@vassar.edu.