Emory IRB Guidance
Version Date 1/28/2019
Revised Common Rule at Emory University
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Definitions
Rule change
Research
The new rule explicitly removes four categories of activities from the
Common Rule’s jurisdiction:
• Scholarly or journalistic activities, including oral history, journalism,
biography, literary criticism, legal research, and historical scholarship
• National security missions
• Public health surveillance
• Criminal justice activities
Emory Impact: The Emory IRB already recognized that these activities were
not within
the IRB’s scope, and did not review them. Thus there will be no change locally as a
result of this clarification in the rule.
Clinical Trial
Definition
The pre-2018 Rule provided no definition of a clinical trial. The 2018 Rule defines a
clinical trial as: “a research study in which 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 t
he interventions on biomedical or behavioral
health-related outcomes.” This aligns with the NIH definition.
Emory Impact: The Emory IRB has been using this definition for NIH-regulated trials
already. The definition in the 2018 Rule relates to the new requirement to publicly
post a copy of the informed consent form after enrollment is closed. Study teams
must remember to comply with this requirement.
Benign
Behavioral
Intervention
The pre-2018 Rule provided no definition of “benign behavioral interventions.” The
2018 Rule uses this term in one of the Exempt research categories, and defines a
benign behavioral intervention as:
Brief in duration, harmless, painless, not physically invasive, not likely to have a
significant adverse lasting impact on the subjects, and the investigator has no
reason to think the subjects will find the interventions offensive or
embarrassing. Examples include having the subjects play an onlin
e game, having
them solve puzzles under various noise conditions, or having them decide how
to allocate a nominal amount of received cash between themselves and
someone else.
Emory Impact: Studies meeting the definition above will now be exempt instead of
needing IRB oversight and expedited review (unless FDA-
regulated or funded by Dept.
of Justice).
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Adapted from University of Arizona new common rule implementation guide
Version Date 1/28/2019
Exempt studies
Rule change
Exempt project
determination
Exemption categories have been extensively changed.
Emory Impact: Some more studies will now be exempt. Emory will not be
implementing the new categories related to “broad consent” at this time.
Exempt
categories
The exempt categories have been revised as noted below. The (*) signifies the
specific change from the pre-2018 Rule.
REVISED Exempt category 1 – research in educational settings
*Revised to specify that the research must not adversely affect students’ opportunity
to learn required educational content or harm chances for educational advancement,
or adversely affect the assessment of educators who provide instruction.
REVISED Exempt category 2 – research involving educational tests, survey
procedures, interview procedures, or observations of public behavior
*Revised to allow collection of identifiable sensitive data, if the study undergoes
“limited IRB review” for privacy and security of data.
NEW Exempt category 3 – research involving benign behavioral interventions (as
defined in the regulations)
*This research cannot involve deception unless the deception is authorized by the
participant
REVISED Exempt category 4 – secondary research involving identifiable private
information or identifiable biospecimens for which consent is not required
*Revised to remove word ‘existing’ to describe data used
* Ident ifiable private data can now be used if the research data is covered by HIPAA
* Other minor clarifications
REVISED Exempt category 5 – research and demonstration projects conducted or
supported by a federal department or agency
*Revised to allow for easier applicability
UNCHANGED Exempt category 6 – taste and food evaluations
NEW Exempt category 7 and category 8 for storage and maintenance for
secondary research for which broad consent is required- will not be
implemented since Emory is not implementing Broad Consent at this time.
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Exempt research
and vulnerable
populations
Pregnant Women – All exemptions may apply if the condition of the exemption is
met.
Prisoners – None of the exemptions apply, except for research aimed at involving a
broader subject population and only incidentally includes prisoners.
Children – Exemptions (d)(1) and (d)(4-8) may involve children. Exempt (d)(2)
(research on educational tests, surveys, interviews or observations) may include
children, but:
*Exempt (2)(i) and (ii) only apply to educational tests or observation of public
behavior when the investigator(s) do not participate in the activities being
observed; and
*Exempt (2)(iii) is not applicable to research with children. This exemption is
where the investigator can readily ascertain the identity of the child.
Emory Impact: Easier to do certain research involving prisoner data, and research
with pregnant women
Limited IRB review
The pre-2018 Rule did not contain the concept of limited IRB review for exempt
research.
The new rule outlines several exempt categories that require an increased level of
review by the IRB; either for data security and privacy protections, or for
confirmation of broad consent elements and return of research results. We will
detail only the ones required for data security and privacy protections.
The exempt category requiring limited IRB review, and which will be relevant at
Emory, are:
• Exempt (d)(3) research involving benign interventions that are identifiable
(directly or through links) and the responses may be damaging to the
subject’s reputation, financial standing, employability, educational
advancement, criminal or civil liability.
• Exempt category (d)(2) – research involving educational tests, survey
procedures, interview procedures, or observations of public behavior
when the data collected is identifiable and potentially damaging/sensitive
(Exemption category (d)(4)
– secondary use of identifiable private information that is
covered by HIPAA
–
will not be useful at Emory. Secondary research use of such data is
intentionally excluded from Emory’s “covered entity” and thus is not protected by
HIPAA.)
Emory Impact:
Submissions requiring limited IRB review will need to provide
information related to these considerations:
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• The extent to which identifiable private information is or has been de-
identified and the risk that such de-identified information can be re-
identified;
• How the information will be used;
• The extent to which the information will be shared or transferred to a third
party or otherwise disclosed or released;
• The likely retention period of the information;
• The security controls that are in place to protect the confidentiality and
integrity of the information; and
• The potential risk of harm to individuals should the information be lost,
stolen, compromised, or otherwise used in a way contrary to the
contours of the research under the exemption.
Expedited Studies
Rule change
Expedited review
categories
There is no change to the expedited categories under the 2018 Rule, but the new
Rule removes the requirement to determine that a project is “minimal risk” – it can
be expedited as long as it falls within one (or more) of the expedited categories. The
one exception is category F9, that requires continuing review.
The FDA and the Department of Justice have not harmonized with this change (so
category F1 cannot be expedited)
Continuing
review
elimination
Studies approved after January 21, 2019 will no longer be subject to continuing
review, unless th
e IRB finds and documents the need to require a continuing review to
enhance the protections of research subjects.
EXCEPTIONS: FDA-
regulated studies, and studies funded by the Department of Justice,
must still undergo annual continuing review.
The Emory RB may require continuing review for minimal risk research when the
research involves:
• Principal Investigator (PI) or co-PIs who have received a determination of
continuing or serious non-compliance in the past two years;
• As determined by the IRB because of a change in risk, protection or inclusion
of subjects, or other concerns that require increased oversight;
• Projects that involve deception that is not prospectively authorized; or
• A conflict of interest management plan exists
• Studies involving an international site or other non-local sites
Existing projects will be assessed at the next continuing review to determine if they
should transition to the new rule.
Moving a project to the new rule means the entire new rule applies. This may require
revisions to the informed consent, reconsent of subjects, and increased data security
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and privacy standards for these existing studies.
Single IRB (sIRB)
review for multi-
site studies
Effective in 2020, the 2018 Rule requires that all multi-site (meaning more than
one site) conduct sIRB review. The sIRB is determined by the prime awardee and
the federal agency supporting the study. Note that the NIH single IRB policy was
effective as of January 25, 2018.
Informed Consent
Rule change
Informed
Consent
requirements
The informed consent requirements have been highly modified. A brief explanation
of the changes is noted:
• Significant changes to the content, organization, and presentation of
information and process to facilitate a subject’s decision about whether to
participate;
• Changes to the basic and additional elements of consent;
• Creation of the concept of broad consent;
• Changes in the criteria for the waiver or alteration of consent;
• New provisions that allow IRBs to approve research for which investigators
obtain information or biospecimens without consent for the purposes of
screening, recruiting, or determining the eligibility of prospective subjects
provided certain conditions are met; and
• Requirement to post* to a federal website a copy of the IRB approved version
of the consent form after closure of enrollment (but within 60 days of last
patient visit).
*Only one posting is required per multi-site study, which can be done by the sponsor.
This only applies to clinical trials that are conducted or supported by a federal
department or agency.
Informed
consent
elements
NEW required element of informed consent for studies involving collection of
identifiable private information or identifiable biospecimens. One of the following
statements must be in the informed consent:
• A statement that the identifiers might be removed from the information, and
after such removal, the information could be used for future research studies
or distributed to another investigator for future research without additional
informed consent; OR
• A statement that the subject’s information or specimens, even if identifiers
are removed, will not be used or distributed for future research.
NEW additional elements of informed consent will be required of applicable research
studies. These additional elements are:
• 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
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share in this commercial profit;
• A statement regarding whether clinically relevant research results; including
individual research results, will be disclosed to subjects, and if so, under what
conditions; and
• For research involving biospecimens, whether the research (if known) or
might include whole genome sequencing.
• New provisions that allow IRBs to approve research for which investigators
obtain information or biospecimens without consent for the purposes of
screening, recruiting, or determining the eligibility of prospective subjects
provided certain conditions are met; and
Review our new templates for informed consent/HIPAA in our website.
Broad Consent
Currently, broad consent will not be applied at Emory.
Other items of interest
Topic
Rule change
Screening,
recruiting, or
determining
eligibility of
prospective
subjects
The new rule states that an IRB can approve access to identifiable information or
identifiable specimens without the prospective informed consent of
the subject for purposes of screening, recruiting, or determining eligibility if:
• The investigator obtains information through oral or written communication
with the prospective subject; OR
• The investigator obtains identifiable private information or identifiable
biospecimens by accessing records or stored identifiable biospecimens.
A waiver of informed consent will no longer be required to access identifiable
information for determining eligibility. However, a waiver of PHI authorization will
still be required as the HIPAA rule does not allow such access without prior written
authorization or a waiver of authorization.
Reminder: You still need IRB approval of the study before recruiting or screening of
subjects. The IRB may require consent depending on the study.
Other federal
agencies
FDA – Cannot implement part of the rules that conflict with FDA regulations. See FDA
guidance.
Department of Justice (DOJ) – Cannot implement part of the rules that conflict with
DOJ regulations.
Newborn
Screening Act
With the implementation of the new rule, the New Screening Saves Lives
Reauthorization Act of 2014 will no longer be effective. Secondary research with
nonidentified newborn blood spots will be treated in the same way as secondary
research with any other type of nonidentifiable biospecimen.
