The following data collection activities are not generally considered to be human subjects research and do not need IRB review:
- Data that are being collected for the purpose of internal college programs, such as surveys to help plan or assess programs, feedback gathered to improve college services, etc.
- Quality improvement projects within the institution.
- Course-related activities in which you are gathering data solely for its use within your course.
- Biographical research about an individual's life, including oral histories.
- Projects involving publicly available data, such as census records.
There are some cases in which the data gathered could cross over the line into human subjects research; this happens when the researcher begins to move into generalizable knowledge based on the findings. It is not necessary for you to submit paperwork regarding these activities; however, if you are unsure about whether the data you are gathering counts as human subjects research, you are encouraged to email the committee for clarification. You should always plan to use best practices for data collection relevant to the area of study you are working under.
The HHS Office for Human Research Protections recognizes research as exempt if it poses less than minimal risk to subjects. Projects must fit at least one of the eight categories described at the HHS Office for Human Research Protections page. A majority of the human subjects research conducted at Wesleyan College, especially student research, falls under this category. The determination of "exempt" does need to be confirmed by the IRB; applications for exempt research are considered as they are submitted and only need the approval of the IRB chair (or an alternate member if the project is proposed or supervised by the chair). Projects submitted as exempt that do not meet the requirements for approval will automatically move on to a more advanced level of review, with the PI being notified of any concerns.
The primary investigator (and faculty sponsor, if the PI is a student) will be responsible for properly understanding guidance on this matter. Projects involving research with prisoners are not eligible for exemption; Wesleyan also requires projects from outside researchers to be reviewed at the Expedited or Full Review level, regardless of their content. Note that projects involving deception may only be approved as exempt if the subject is informed in advance that they may be misled regarding the nature or purposes of the research.
Research can be considered Expedited if it poses no more than minimal risk to subjects. Further guidance on what is considered expedited can be found at the HHS site. Briefly, research in this category tends to involve more identifiable data, such as the collection of sweat, blood samples, ultrasound data, etc. This identifiable data also extends to the video or audio recording of participants if they are being used for generalizable research purposes.
Applications for expedited research are considered as they are submitted and only need the approval of the IRB chair (or and alternate member if the project is proposed or supervised by the chair) and one additional committee member.
Research Needing Full Review
Projects involving more than minimal risk to subjects require full committee review. Projects that involve children, individuals who are imprisoned, and individuals who have impaired decision-making capacity fall under this category. So do projects that ask about things that are highly sensitive, could cause emotional harm, or involve illegal activities. Applications for full review are considered on a monthly basis during a meeting of the full committee.