When a submission comes to the HSRO it is evaluated to determine the appropriate category of review. There are four categories of submissions:
It is important for Investigators to understand that the Federal office that oversees research with human subjects (Office of Human Research Protections - OHRP) has consistently stated that the federal regulations are a floor and not a ceiling in terms of human subjects protections. The RIT HSRO may require additional protections or modifications where applicable.
The first step in identifying the appropriate category of review is determining if the proposed activity meets the Federal definition of research with human subjects. All submissions are evaluated and those that don’t meet the definition are considered to be Excluded. This means the proposed activity doesn’t fall under the scope of the HSRO and researchers aren’t required to adhere to the Code of Federal Regulations relating to the protection of human subjects.
This most often happens when a proposed activity is a quality improvement activity, or “practice” instead of research. These non-research activities are usually intended to identify and control specific problems or improve programs or services, for example, a survey about handheld devices from ITS or focus groups about what kinds of activities should be offered through the health center. Practice includes interventions that are expected to enhance the well-being of a person through diagnosis or treatment and are not intended to provide generalizable results.
Exempt research activities are those in which the only involvement of human subjects fall into specific categories defined in the Federal Regulations (45CFR46). These activities are considered research and need to be submitted to the HSRO for review to determine which exemption category they fall under. These activities must present no more than minimal risk* and there are some restrictions.
The following subject populations are not eligible for an Exemption:
Children as Subjects
The following types of research activities are not eligible for an Exemption if the subject population includes children:
Research activities that (1) present no more than minimal risk* to human subjects and (2) involve only procedures listed in one or more of the categories below may be reviewed by the IRB through the expedited review procedure.
NOTE: Expedited refers to the type of review – it is performed by the Chair of the Board or an appointed Member instead of the entire Board at a meeting. In spite of the name, it does NOT mean you can request this to make the IRB process go more quickly. There are very specific conditions under which a submission can be reviewed in this manner, it is not a type of review that an Investigator can request.
* Minimal risk means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests