Culture and Meaning in Health Services Research by Elisa J Sobo

Author:Elisa J Sobo [Sobo, Elisa J]
Language: eng
Format: epub
Tags: Social Science, Anthropology, General
ISBN: 9781315430911
Google: s9BmDAAAQBAJ
Publisher: Routledge
Published: 2016-06-16T05:10:16+00:00

THE ROLE OF INSTITUTIONAL REVIEW AND INFORMED CONSENT

The last aspect of the research world that I mention here is the institutional review board or IRB. Institutional review is a complex process that, on the surface, has little to do with methodological discussion. Still, it bears some scrutiny because without it, in many nations, research simply cannot happen. I already have noted that the IRB’s role is to ensure, through proposal review and related inspection-type processes, that any research conducted under their institution’s auspices is ethically designed and implemented. All of my research has been IRB-sanctioned, including that drawn on for examples in this book. So has some of the work that I have undertaken initially for quality improvement (QI).

Although IRB approval is not required for QI efforts, it is definitely desirable when external or generalizable implications are to be explored and findings disseminated (Bellin and Neveloff Dubler 2001). One can go back, after the fact, to request clearance to publish, but it is immensely preferable to work with the IRB from the start; to do otherwise in situations where publication or other forms of extra-mural dissemination are immanent is dishonest and unethical. This is the case even though IRB time-frames can cause the project to be lost.

Many IRBs meet only monthly, and applications to be reviewed may have to be in up to a month prior to that. If an IRB is undergoing internal transitions, such as to board membership, timelines can be lengthened. They also are affected when an IRB notices a point of concern in an application. This can be very helpful, as not all ethical problems will be obvious to researchers; in many cases, the added scrutiny has revealed problems that then can be fixed. Other times, IRB change requests may be a hindrance, as when board members are not familiar with the methods used or, when pressed for time, they read proposals too fast and thereby overlook data and human subjects protection plans. They also can misunderstand the nature of everyday risk and thereby treat minimal risk research, which most anthropologically informed HSR projects will be, as if they are the high risk equivalent to medical experimentation (Dingwall 2008).

Another factor affecting the time review takes is the number of IRBs entailed. The effort involved in securing all necessary IRB approvals for multi-site work or work undertaken by collaborators with diverse affiliations and thus varied IRBs is multiplicative; different IRBs can have different standards and demands in addition to differing board meeting timelines and proposal due dates. When planning a project, it is best to build in extra time to ensure that all the paperwork and approvals will be in order on the day that data collection is scheduled to begin.

Data cannot generally be collected from or about human beings without an approved informed consent process. Engagement in the process of informed consent usually must be documented, for instance, with the potential participant’s signature on an IRB-approved consent form. To be approved, a proposed informed consent process

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