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
Impact on Researchers
- Increased number of research categories approved under Exempt review
- Comtinuing 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.
There are two main questions that determine whether an activity is reviewed by the HSRO.
- Is it research, and
- Is it research with humans
“a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” (ref. 45CFR46)
The key word in the definition is designed. The HSRO looks at the primary intent of an activity. If the intent is to generate new or generalizable knowledge – information that can be applied in other settings - the activity is considered research.
Human subject means:
“a living individual about whom an investigator (whether professional or student) conducting research obtains:
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.” (ref. 45CFR46)
Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
An activity that meets the above criteria would be considered research and the responsibility of the HSRO. Often people believe that since they don’t plan to publish their results they don’t need review by an HSRO. This is incorrect; intent to publish has no part in determining whether an activity needs review.
General attributes of research
Produces generalizable knowledge
Benefits extend beyond the participants
General attributes of non-research
Intent is to identify and control a specific problem or improve a program or service
Benefits are primarily or exclusively for the participants or their community
Data are used to assess and/or improve the program or service
Knowledge doesn’t extend beyond the scope of the activity