The Nanny State Meets the Inner Lawyer: Overregulating While Underprotecting Human Participants in Research

Abstract

Without any systematic data or evidence of a problem, or even a thoughtful analysis of costs and benefits, the application of the human participant review system within universities is overreaching at the same time that some risky experimentation on humans outside of universities is unregulated. This article questions the purpose, feasibility, and effectiveness of current IRB approaches to most "2 people talking" situations and proposes scaling back the regulatory system to increase respect accorded it by researchers and its ability to protect human participants of research from real versus imagined harms. In too many cases, the focus is on form over ethical substance: counting what can be counted, rather than focusing instead on what counts. Some disciplines--oral history and journalism, for example--simply do not belong within the scope of institutional review board jurisdiction. Others, such as survey research, informational interviews, and informal interactions, call for a shift from centralized review to more departmentally based (i.e., rooted in disciplinary ethics) oversight, and clearer guidelines on what requires advance review as opposed to provision of post hoc complaint systems.

La recherche herméneutique en management face à la juridictionnalisation de l’activité scientifique : analyse du problème et exploration de réponses

“…C'est ainsi qu'on observe, à son encontre, une vive montée en puissance des critiques (e.g., Atkinson, 2009;Boden et al, 2009;Dingwall, 2006Dingwall, , 2008Elwood, 2007;Gunsalus, 2004;Israel & Hay, 2006;. De plus en plus de chercheurs s'inquiètent de la dynamique de réglementation en cours -formalisant l'éthique en édictant des référentiels normatifs, standardisés, et définissant un protocole, bureaucratique, de contrôle des projets de recherche.…”

“…Or, sur ce point, les critiques du modèle de régulation actuel considèrent que celui-ci répond à des problématiques singulières, ancrées dans le champ des recherches biomédicales, étrangères à celles connues en sciences sociales. Ainsi, notamment, en raison du fait qu'en ce dernier champ, les sujets sont estimés toujours en situation de contrôler l'interaction avec les chercheurs (Gunsalus, 2004). Ainsi, encore, en raison du fait que les risques encourus par les sujets participants sont, entre les deux champs, sans rapport (Martin, 2007), alors même que le niveau de régulation éthique doit être en relation avec le niveau des risques encourus (Witherspoon, 2009).…”

Education Research and Human Subject Protection: Crossing the IRB Quagmire

“…'' 5 IRBs' Effects on Research A significant problem for both clinical research and education research has been what experts term ''mission creep'' or ''ethics drift,'' 1,2 in which IRBs are unable to clearly delineate and employ the exempt or expedited categories for work that is extremely low risk to human subjects. Even more concerning are reports that university IRBs have required proposal review and approval for routine academic activities, such as interviews performed by students for a class on investigative journalism, 2 and a national organization requiring IRB review for kindergarten science fair participants. 1 Experts question whether the driving force behind the noticeable expansion of IRB review since the late 1990s is due more to fears of losing federal funding than to true concerns regarding human abuses.…”

“…This leads to a pervasive perception of IRB overregulation yet underprotection of human subjects. 2 Although the Office for Human Research Protections (OHRP) reports that 70% of allegations of research misconduct are ultimately not substantiated, 3 the risk of suspension or disruption of research during an investigation, in addition to the possibility of damaging reputations and future funding, creates a national climate of anxiety among researchers and ensures continuation of excessive scrutiny of research processes. In fact, deficiencies detected by OHRP are primarily failures of documentation or failure to follow required procedures, not claims of harm to persons or unethical conduct.…”

Review of procedures for approval of health studies in northern Canada

“…As well, concern has been expressed about the inadequacy of the review process and about the need to consider protection of communities (for example, see [18][19][20][21][22][23].…”