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still be reviewed by IRB staff, who will then provide documentation indicating that
the study is, in fact, exempt.
Although the paperwork required by some IRBs may feel like a nuisance, you
should consider your IRB as an ally. By insisting upon procedures, IRBs protect
researchers and institutions from problems associated with research that goes wrong.
IRBs can also provide helpful feedback in situations that may raise questions. Some
projects may blur the lines between participating in the research and acting as a col-
laborative partner. For example, projects involving participatory design may involve
ethnographic observation of users in the workplace. Is informed consent necessary in
this case? Although the conservative approach of requiring informed consent is un-
likely to be inappropriate, discussing this question with a member of your IRB might
provide insight into your institution's policies regarding such research. Many IRBs
require researchers to take training courses before conducting any studies involving
human subjects research. These courses may not seem exciting, but they can provide
valuable information that might prove helpful when you are preparing informed con-
sent materials.
Organizations that infrequently engage in human subjects research may not have
an established IRB. This may be particularly true for small companies that run oc-
casional user studies. If you find yourself in such a situation, it may be helpful to
discuss matters with appropriate professionals in your organization, including com-
munity relations staff and legal counsel. IRBs from nearby research institutions
may be willing to provide feedback as well. The use of informed consent forms and
proper procedures is always appropriate, even in the absence of a formal review from
an IRB.
Researchers and regulators share a common interest in optimizing IRB review
requirements and procedures. In the US, a 2011 Advanced Notice of Proposed Rule-
Making (ANPRM) suggested significant changes to IRB procedures, including the
creation of an “IRB of record” provision that would allow one review for all partici-
pants in a multi-institution study, as opposed to separate review for all institutions,
as is the current process. Other changes proposed in this ANPRM include changes to
methods for determining risk, new categories of studies designed to minimize review
requirements for low-risk studies, and revised rules for determining when informed
consent is not required, among others (Cohen and Lynch, 2014). Further discus-
sion of these issues included a “request for information” regarding the use of single
IRB review for multi-institution studies funded by the National Institutes of Health
(National Institutes of Health, 2014). A Sep. 2015 notice in the US Federal Register
revived the federal review proposals with a Notice of Proposed Rule-Making (NPRM)
in response to the 2011 ANPRM. The proposed rules retain many of the changes that
might facilitate HCI research, including the single IRB proposal and the possibility of
defining “certain types of social and behavioral research conducted with competent
adults” as exempt from IRB review (Federal Register, 2015). There is widespread
agreement that some reform of these rules is needed. However, the complexity of
the regulations and the 4-year gap between the ANPRM and the NPRM suggest that
acceptance of these proposals and implementation of any changes may be a gradual