“…I quote him at length: There are no limitations on the kinds of importance that the IRB must consider, and therefore if there is the possibility the knowledge may be politically or socially important, the IRB is required to consider those possibilities. Furthermore, if the IRB were restricted from considering the risks of socio‐political effects, then the advisory rule would have the effect of putting a metaphorical thumb on the benefit side of the scale, inasmuch as the risk side of the scale would be artificially lightened by removal of a risk factor …”
Section: Support For the Social‐value Solutionmentioning
confidence: 99%
“…How might we think of providing any assessment of the importance of research without considering these factors? The proposal he is critiquing, which puts forward a national advisory group as the appropriate body for such assessments, would weaken the current system of review by removing one of its central responsibilities, and “the beneficiaries of this weakening would be scientists and firms who engage in controversial research.” I would add that they might also be the researchers conducting low‐quality trials.…”
Section: Support For the Social‐value Solutionmentioning
The volume of clinical research is increasing exponentially-far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because "quality" is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in "usual" care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated.
“…I quote him at length: There are no limitations on the kinds of importance that the IRB must consider, and therefore if there is the possibility the knowledge may be politically or socially important, the IRB is required to consider those possibilities. Furthermore, if the IRB were restricted from considering the risks of socio‐political effects, then the advisory rule would have the effect of putting a metaphorical thumb on the benefit side of the scale, inasmuch as the risk side of the scale would be artificially lightened by removal of a risk factor …”
Section: Support For the Social‐value Solutionmentioning
confidence: 99%
“…How might we think of providing any assessment of the importance of research without considering these factors? The proposal he is critiquing, which puts forward a national advisory group as the appropriate body for such assessments, would weaken the current system of review by removing one of its central responsibilities, and “the beneficiaries of this weakening would be scientists and firms who engage in controversial research.” I would add that they might also be the researchers conducting low‐quality trials.…”
Section: Support For the Social‐value Solutionmentioning
The volume of clinical research is increasing exponentially-far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because "quality" is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in "usual" care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated.
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