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new rules that have the potential to affect the
ability of universities to meet the demands
of the predicted increase in research protocols. Some of these changes (most effective
January 19, 2018) are:
· Informed consent forms must be characterized by greater clarity and focus, and
promote the research subjects’ understanding of the project.
· Some clinical trials must post the informed
consent form online.
· Researchers have the option of using broad
consent for secondary research that uses
identifiable private information and identifiable biospecimens.
· New exempt categories of research projects
that are low risk have been established.
· Institutions are required to have a single
IRB for evaluating multi-site research, or
documentation when the single IRB is not
appropriate (effective January 20, 2020).
· The need for a continuing review has been
eliminated under certain circumstances.
· Documentation is required for reliance
arrangements with non-institutional IRBs.
The research community has had ample
notification of the changes as published in the
January 19, 2017 NPRM. The Advance Notice of
Proposed Rulemaking of 2011 and the NPRM
of 2015 provided fair warning of these changes. 3 The research community thought many of
the proposed changes were rules whose time
had come. Kaiser reiterated the great relief
among certain critics that written consent for
using specimens leftover from clinical care or
specific studies would not be required under
the new rules. 4 The new ruling also helped
prevent privacy issues where specimens
could be linked to individual subjects. Mann
stated that “Under the final rule, informed
consent forms for research participants must
be written more clearly and include a summary of the most important information at the
beginning.” 5 Many would agree.
Unnecessary jargon and rule revelations
clouded the consent process. Most IRB and
ORI staff members would also agree that plac-
ing greater emphasis on reviewing higher-risk
projects reduced the burden on IRBs. Jaschik
stated that:
Early reactions from social science groups
to the changes in the common rule were
positive. Various provisions suggest that
institutional review boards, which must
review proposals to study humans, work
to understand the needs of different kinds
of researchers, and that there are differ-
ent levels of risk associated with taking an
experimental drug and answering confi-
dential survey questions. 6
Broadening the definition of what is
actually exempt research would allow
greater flexibility in IRB reviews and might
reduce workloads.
Klitzman’s landmark survey of 60 IRBs
found that many felt centralized IRBs and
local IRBs offered both advantages and disadvantages. Local IRBs were thought to provide
more “local knowledge” of the research subjects while also providing greater participation
in better “curbside consults” with principle
investigators, facilitating mutual trust. These
qualities were thought to be absent in centralized IRBs. On the other hand, the use of local
IRBs of multi-site research projects might
result in duplication and redundancy in the
review process. 7
Pyle confirmed this opinion when stating
that local IRB reviews might cause significant approval delays. According to Pyle, one
example of these delays would be where local
IRBs might require protocol-level changes
in the informed consent documents to meet
individual policies, further delaying the
approval process. Pyle believed that increased
delays would occur in conjunction with
increased costs, thus making the central IRB
