On January 21, 2019 the Final Rule to update the current regulations at 45 CFR 46, Subpart A - "Federal Policy for the Protection of Human Subjects" (the Common Rule) will be effective.
Substantive revisions were made to the regulations to “modernize, strengthen, and make more effective” (HHS 2017) the current system of oversight that has been the federal Common Rule since 1991. The revisions are intended to:
- Better protect human subjects involved in research
- Facilitate research
- Remove ambiguity
- Reduce regulatory burden
Information about the modifications can be found on the OHRP website. CITI Program also has a module on the Revised Common Rule .
Impact on Researchers
- Increased number of research categories approved under Exempt review
- Continuing review no longer necessary for most non-exempt research activities
- New Consent Process requirements
The RIT review process will continue as it is currently with some modifications to existing forms and some researchers may be required to submit additional information. The updated HSRO website will be online January 21, 2019 and the HSRO will assist researchers with the transition during the next few months.
When a submission comes to the HSRO it is evaluated to determine the appropriate category of review. There are four categories of submissions:
- Full Board
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 used on campus 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 human subjects research is a sub-set of research in which the only involvement of human subjects fall into one or more specific exemption categories as 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.
- Exempt projects are not subject to continuing review
- Amendments are only required if changes to the project could alter the exempt determination
- Exempt determination doe not lessen the investigator's ethical obligations including human subjects protections training and providing prospective subjects with information about the research
The following research activities cannot be reviewed under an Exempt category:
- Research involving prisoners as subjects except for research aimed at involving a broader subject population that only incidentally includes prisoners
- Benign behavioral inventions with adult subjects where deception is involved and the subject is not informed regarding the nature or purposes of the research
- Survey or interview procedures when the subjects are children
- Observation of public behavior of children when the researchers interact in the activities being observed
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 HSRO and may be reviewed by another experienced reviewer 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