Upcoming Changes to the Common
Rule
Presentation to the SPARC meeting
UNC General Administration
By
Deb Paxton
North Carolina State University
Changes to the Common Rule
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Common rule is the standard for human subjects protections
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14 federal agencies have signed on to the common rule and therefore follow the
common rule
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All DHHS
NSF
VA
DOD
NIJ
Department of Agriculture
Department of Energy
NASA
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Department of Commerce
Consumer Product Safety Commission
USAID
Department of Housing and Urban
Development
• Department of Education
• Department of Transportation
• Changes recently published with an implementation date of January 19, 2018 (longer for
cooperative studies)
Changes to the Common Rule
Broad changes to:
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Scope
IRB operations
Informed consent
Exemptions
(see handout from PRIM&R)
Changes to scope
• Definition of research
• Definition of human subject
• Definition of clinical trial
– “….one or more human subjects are prospectively assigned
to one or more interventions (which may include placebo or
other control) to evaluate the effects of the interventions on
biomedical or behavioral health-related outcomes.”
• Identifiable data/specimens – definition of “identifiable” to be
regularly revisited and revised if necessary
• Definitions of vulnerable populations
– pregnant women and people with physical disabilities are no
longer listed as vulnerable to coercion or undue influence
• Inclusion of tribal law when appropriate
Changes to IRB operations
• sIRB
• Formalization of reliance agreements
• “Checking the box” is no longer an option
– institutions will need to codify the application of human
subjects protections to non-human subjects research
• Continuing review of research is not required for:
– research that received expedited review
– research that was reviewed under “limited” IRB review
– research that have completed data collection and are
now only analyzing data or accessing follow up clinical
data from regular clinic visits
Changes to informed consent
• New language to clarify PI responsibilities regarding informed
consent
• New elements
– specific language about collection of identifiable
data/specimens
– biospecimens
– genomes
• Broad consent for data/specimen repositories
• Recruitment/screening waivers
• Electronic signatures accepted
• Consent forms for clinical trials posted online
• Legally authorized representatives
Exemptions
• Wording changes
– “readily ascertained”
– clarification of application of exempt criteria to subparts B,
C, and D
• Addition of “benign behavioral interventions”
– exemption of intervention is not allowed if deception is
involved unless prospective agreement to deception has
been obtained
• Limited IRB review
– opens exemption categories to non-anonymous, nonharmless research if it undergoes “limited IRB review”
• Exemption of secondary use of existing, identifiable
data/specimens
• “Broad” consent referenced and reviewed
Limited IRB Review
• In order to approve a project under “limited review,” the IRB
does not need to find the traditional criteria for IRB approval,
but instead must determine:
– Broad consent for storage, maintenance, and secondary
research use of identifiable private information or
identifiable biospecimens is appropriately obtained
• NOTE THERE IS NOT AN OPTION FOR A WAIVER HERE
– Broad consent is appropriately documented or waiver of
documentation is appropriate
– If a change is made for research purposes to the way
identifiable private data/specimens are maintained, there
must be adequate provisions to protect the privacy of
subjects and maintain the confidentiality of data.
• Additional protections for subjects culnerable to coercion or
undue influence remain in place.
Broad Consent
Broad consent is for the storage, maintenance, and secondary research use of identifiable
private information or identifiable biospecimens.
• Information to be included in Broad consent:
• A description of any reasonably foreseeable risks or discomforts to the subject;
• A description of any benefits to the subject or to others that may reasonably be expected
from the research;
• A statement describing the extent, if any, to which confidentiality of records identifying the
subject will be maintained;
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss
of benefits to which the subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to which the subject is otherwise
entitled
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When appropriate
– A statement that the subject's biospecimens (even if identifiers are removed) may be
used for commercial profit and whether the subject will or will not share in this
commercial profit;
– For research involving biospecimens, whether the research will (if known) or might
include whole genome sequencing (i.e., sequencing of a human germline or somatic
specimen with the intent to generate the genome or exome sequence of that specimen).
Broad Consent, Continued
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A general description of the types of research that may be conducted with the identifiable
private information or identifiable biospecimens.
A description of the identifiable private information or identifiable biospecimens that might
be used in research, whether sharing of identifiable private information or identifiable
biospecimens might occur, and the types of institutions or researchers that might conduct
research with the identifiable private information or identifiable biospecimens;
A description of the period of time that the identifiable private information or identifiable
biospecimens may be stored and maintained, and for which they may be used for research
– “indefinitely” is an option
Unless details about specific research studies are provided, a statement that they will not
be informed of the details of any specific research studies that might be conducted using
the subject's identifiable private information or identifiable biospecimens, including the
purposes of the research, and that they might have chosen not to consent to some of those
specific research studies;
Unless it is known that clinically relevant research results, including individual research
results, will be disclosed to the subject in all circumstances, a statement that such results
may not be disclosed to the subject
An explanation of whom to contact for answers to questions about the subject's rights and
about storage and use of the subject's identifiable private information or identifiable
biospecimens, and whom to contact in the event of a research-related harm.