Hello, I’m Misti Ault Anderson with the HHS Office for Human Research Protections.
I’m going to talk with you today about the basics of knowing when to apply the Common
Rule, based on the revised Common Rule that was published on January 19th, 2017.
The Common Rule is part of the Federal Policy for the Protection of Human Subjects, found
in the code of Federal regulations at 45 CFR 46.
It has five subparts: Subpart A is the Common Rule.
Subparts B, C, and D provide additional protections for certain vulnerable populations.
Subpart E provides requirements about IRB registration.
The Common Rule, or Subpart A, was revised and the revisions were published on January
19th, 2017, with a delayed implementation date.
There currently are no revisions to the other subparts.
The Common Rule applies only to nonexempt human subjects research that is funded or
conducted by one of the Common Rule agencies.
For research that is funded or conducted by the Department of Health and Human Services,
all five subparts apply.
For research that is funded or conducted by another Common Rule agency, the other subparts
may or may not apply.
If you have questions about this, please contact your agency.
So when you need to determine whether the Common Rule applies to a specific activity,
first, verify the funding source, and if it is conducted or supported by HHS, or another
applicable agency, then move on to determining whether the activity is considered to be nonexempt
human subjects research.
To decide this, you should ask the following three questions, in this order: Does the activity
involve research, based on the regulatory definition of research?
Does the research involve human subjects based on the regulatory definition of human subjects?
Is the human subjects research exempt?
Let’s go through these questions one by one, and we’ll have a chance to talk about
each of those regulatory definitions.
So the first question: Is the activity research?
The regulations provide a definition of research.
Research means a systematic investigation including research development, testing, and
evaluation that is designed to develop or contribute to generalizable knowledge.
This definition remains unchanged from the pre-2018 Common Rule in the revised rule.
What is new, however, is that the revised Common Rule specifies four types of activities
that are deemed not to be research, which means they are carved out of the definition
of research.
Those four types of activities include: Scholarly and journalistic activities, public health
surveillance activities, collection and analysis of information, specimens, or records, by
or for a criminal justice agency for criminal justice or investigative purposes.
And authorized operational activities for national security purposes.
We’ll talk briefly about each.
The first category of activities that is deemed not to be research is scholarly and journalistic
activities, and these include the collection and use of information that focuses directly
on specific individuals about whom the information is collected.
The key to understanding this set of activities is what was right in the middle of that description.
It’s about only the specific individuals that are providing the information.
So examples include: oral history, journalism, biography, literary criticism, legal research,
and historical scholarship.
So the activities being done are the things that make the difference.
So let me give you some examples.
Looking at historical scholarship: a historical study about the life of a specific civil rights
leader, and only about that individual, would meet the requirements of this set of activities.
It’s only about one individual, and cannot be generalized to a larger group.
So that would not be research under the regulatory definition.
However, a historical study about the societal impacts of the Civil Rights Movement and how
it was driven by specific leaders in that movement, would qualify as research, under
the regulatory definition.
In another example, looking at oral histories: if a researcher or any professional is collecting
oral histories of specific individuals about their experiences in a traumatic event, for
example, the events on September 11, 2001.
But they are collecting individual stories and simply documenting those stories.
That would not meet the regulatory definition of research, because each one focuses only
on the specific individual.
However, if oral histories from numerous survivors of a traumatic event, such as the events of
September 11th, were collected, and then studied to learn about a relationship between those
experiences, and perhaps the lasting effects of surviving a traumatic event, or the psychological
effects stemming from that experience, that would meet the definition of research.
The second set of activities that are deemed not to be research are public health surveillance
activities.
Now, there are two criteria that must be met in order to meet this carve-out from the definition.
First of all, this only applies to activities that are conducted, supported, ordered, requested,
required, or authorized by the public health authority, and the regulations provide a definition
for who is the public health authority.
This is an authority based upon either, it could be a federal authority, the United States,
one particular state, a territory, a political subdivision of a state or territory, an Indian
tribe, foreign government, or an entity of authority from such an agency, including its
employees or agents.
It has that authority based upon an official mandate to address public health matters.
If the activity is not being conducted by the public health authority, then it would
not meet this carve-out.
So the public health surveillance activities, what does that include?
Well, these activities are limited to those that are conducted by the public health authority,
and are necessary to allow that public health authority to identify, monitor, assess, or
investigate potential public health signals that might give information about the onset
of disease outbreaks, or conditions of public health importance.
The purpose of these kinds of activities are to provide timely situational awareness and
priority setting during the course of the event, or the crisis, and the handling and
response to such an event or crisis that might threaten public health.
Thirdly, the collection and analysis for criminal justice purposes: these are activities that
are authorized by law or a court order, solely for criminal justice, or criminal investigative
purposes.
These kinds of activities are necessary for the operation and implementation of the criminal
justice system.
Importantly, note that this would not include social and behavioral studies about the causes
of criminal behavior.
The fourth category of activities that are deemed not to be research are activities for
national security purposes.
These are authorized operational activities that are determined by each agency, in support
of intelligence gathering, homeland security, defense, or other national security missions.
Typically there’s not a lot of this sort of activity that is funded and conducted by
HHS, however it does apply to other Common Rule agencies.
For investigators that are conducting activities that might fall under this carve-out from
the definition, we recommend that you consult with your relevant agency -- perhaps the FBI,
Homeland Security, et cetera, in order to determine whether these are authorized, operational
activities.
The next question that you should ask if you’ve determined that your activity does meet the
definition of research, under the regulations, is: Does it involve human subjects?
The regulatory definition of human subjects remains substantively unchanged in the revised
Common Rule.
However, there have been clarifications to the wording that make explicit OHRP’s interpretation
of this definition.
So a human subject means that a living individual, about whom an investigator conducting research,
either obtains information or biospecimens through an intervention or interaction with
the individual, and then uses studies, or analyzes that information, or biospecimen,
as part of the research.
Or, the investigator obtains, uses, studies, analyzes, or generates identifiable private
information or identifiable biospecimens through the course of the research.
I’d point out here that “investigator” can pertain both to a professional or to a
student.
It’s about the activity that’s going on.
Let’s look at little more at these important terms to understanding this definition.
Two of the terms that are included in the definition for human subjects, and have been
there all along, the definitions remain unchanged.
So just to review, an intervention can include both physical procedures, by which information
or biospecimens are gathered.
For example, drawing blood, or they can include manipulations of the subject, or the subject’s
environment, for the purposes of the research.
An interaction is some sort of communication or interpersonal contact between the investigator
and the subject.
Two definitions that show up in the revised Common Rule, serve the purpose of clarification.
Identifiable biospecimens, are biospecimens for which the identity of the subject is or
may readily be ascertained by the investigator, or associated with the information.
And identifiable private information means private information for which the identity
of the subject, again, is or may be readily ascertained by the investigator or associated
with the information.
So what is the meaning of “identifiability”?
Well, the definition in the regulations of identifiable, remains unchanged.
It still means that the identity of the subject either is or may readily be ascertained by
the investigator, or associated with the information or biospecimens.
However, what’s new here is a commitment from the federal agencies to collaborate at
least every four years to re-examine the meaning of identifiability and to consider any new
or additionally developed analytic techniques that might be capable of generating identifiable
private information, or identifiable biospecimens, which might not have been identifiable previously.
So if the activity in question has been determined to be human subjects research, based on those
regulatory definitions, the next question that you should consider is: Is it exempt?
In the pre-2018 Common Rule, there were six exemptions that could be used for activities
that met those requirements, and by being exempt, they were considered to be exempt
from the regulations, and therefore, the regulations did not apply.
In the revised Common Rule, there are now eight exemptions.
In general, some of these exemptions have been expanded.
One has been replaced, and it has been removed all together, and replaced with a new exemption.
One of the goals here was to exempt more low-risk social and behavioral research that is able
to be considered exempt and lessen some of the burden on IRBs.
One thing to note is that with some of the expanded exemptions, and the two new exemptions,
number seven and eight, they do require a new process called limited IRB review.
And that limited IRB review is to verify that the conditions for those exemptions have been
met and satisfied.
We’re going to list out for you the eight exemptions in the revised Common Rule, however,
we’re not going to go into any detail about them.
Another webinar in this series will address each of these exemptions.
Exemption 1 in the revised Common Rule is for research that involves normal educational
practices conducted in established or commonly accepted educational settings.
Exemption 2 covers research that only involves educational tests, surveys, interviews or
observations of public behavior.
Exemption 3 involves benign behavioral interventions.
Exemption 4 is for secondary research for which consent is not required.
Exemption 5 is for research and demonstration projects conducted or supported by a Federal
department or agency.
Exemption 6 is for taste and food quality evaluations.
Exemption 7 is for storage or maintenance for secondary research for which broad consent
is required.
And finally, exemption 8 is for secondary research for which broad consent is required.
Again, if you’d like specific information on these exemptions, please see the other
webinars in this series.
In review, for what we’ve talked about today: this flow chart represents the process that
you can use to decide whether the Common Rule applies to any particular activity that you’re
thinking about.
The first question you ask yourself is: Is it research based on the regulatory definition?
If the answer is either “no” or it is one of the activities that is one of the categories
that is deemed not to be research, then no, the regulations do not apply.
If the answer, however, is “yes”, you go on to ask: Does it involve human subjects?
Again, by the regulatory definition.
If it does not, if it does not meet the regulatory definition of human subjects, then the regulations
do not apply.
If however it does, so the research involves human subjects, the answer is “yes”, then
you go to the next question, which is: Is it exempt?
If the answer is “yes” and it meets the qualifications for one of the exemptions,
I caution you to double check and make sure that, the limited IRB review might be required,
for certain exemptions that will be case, and for others, it will not, make that determination.
If it meets all of those necessary requirements for the exemptions, then the regulations will
not apply.
If however, the human subjects research does not meet the criterion for any of the exemptions,
then the answer is, “no” it is nonexempt, then you are now in the realm of nonexempt
human subjects research, and you will need to proceed to the process of IRB review, which
will be also addressed in additional webinars on this topic.
Please refer to the text of the revised Common Rule available on OHRP’s website for a complete
and accurate description of the regulatory requirements.
For this presentation, and the information provided here, please review the regulations
at section 46.102, where all of the regulatory definitions are provided, and at 46.104, where
you can find information on the exemptions.
If you have questions about the revised Common Rule, please submit them to us via email at
OHRP@hhs.gov, and please check out the OHRP website, which you can find at www.HHS.gov/ohrp
for additional resources on the revised Common Rule.
Thank you for your attention.
We invite you to review the other webinars in this series, and additional resources that
we’ve provided on our website, for additional information on the revised Common Rule.