Integrating Research and Practice Health System Leaders Working Toward High-Value Care: Workshop Summary (2015) / Chapter Skim
Currently Skimming:
6 Addressing Issues of Regulatory Oversight
6 Addressing Issues of Regulatory Oversight
Pages 71-84
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 71... ...
Quality-improvement researchers, she added, need to "stop being afraid of randomization" be cause they fear that a randomization trial design inevitably leads to the need for a protracted institutional review board approval process. • Well-designed studies can be turned into rigorous academic publications quickly, said Rainu Kaushal, and researchers can translate their findings into actionable information for policy makers and health care stakeholders without jeopardizing publications.
|
From page 72... ...
This definition, she said, means that quality improvement projects conducted internally still fall under the provisions of the Common Rule if the intention is to publish the results and make them generalizable. AN ETHICAL FRAMEWORK FOR LEARNING HEALTH SYSTEMS Nancy Kass proposed a new way of thinking about ethics and human research, one that moves away from the current "distinctions paradigm," which is based on the premise that ethics and oversight should be based on whether an activity meets the regulatory definition of research.
|
From page 73... ...
. Two of these criteria are defined by regulations, and the other three reflect common themes found in the scientific literature concerning morally relevant criteria that distinguished research from clinical care.
|
From page 74... ...
There is, however, a tension that exists between honoring this obligation and taking into account the evidence that clinicians' judgments can be biased, conflicted, or less than fully informed, Kass said. The obligation to provide patients with optimal clinical care, Kass said, raises the question of how a learning activity will affect the net clinical benefit to patients when compared to the benefit of the "ordinary care"
|
From page 75... ...
The questions to ask, she explained, are whether a learning activity will exacerbate or reduce unjust inequalities and if an activity can be structured to advance the goal of reducing unjust inequalities in health care. The sixth obligation says that health care professionals, health care institutions, and payers all have an ethical responsibility to conduct and contribute to learning activities that advance the quality, fairness, and economic viability of the health care system.
|
From page 76... ...
This trial benefited greatly, Huang said, from the fact that the chair of the Harvard Pilgrim Healthcare IRB, which served as the lead IRB for all sites enrolled in the trial, had years of experience in health care quality improvement. The IRB chair knew that in the context of this trial, the protocols met the national criteria for minimal risk and a waiver of informed consent set by OHRP, she explained.
|
From page 77... ...
Thus, a variation in IRB rulings regarding patient consent within a randomized clinical trial can have a significant bearing on the success and standardization of a trial, including cluster randomized trials where the intent is to apply the intervention throughout the cluster in a uniform and representative way. The third example was of a cluster randomized trial of the same antiseptic soap used in the REDUCE trial in 10 pediatric ICUs.
|
From page 78... ...
Furthermore, she said, quality-improvement researchers need to "stop being afraid of randomization" because they fear that a randomization trial design inevitably leads to a protracted IRB approval process. Improving this process and increasing the standardization of rulings across IRB committees, especially in the case of minimal risk studies, will be necessary to take advantage of one of the greatest strengths in study design.
|
From page 79... ...
He said that rather than have the process be one of informed consent, it should be one of informed choice, with the patient actively involved in the decision-making process. In his final remarks, Weinstein discussed the High Value Healthcare Collaborative, previously discussed in Chapter 4, which he started with colleagues at the Mayo Clinic and Intermountain Healthcare and which has grown to include safety net systems such as Denver Health and Sinai Health in Chicago.
|
From page 80... ...
For example, he said, physicians and care teams have little appreciation for how much data sharing takes place under HIPPA authorization. He noted that the IRB process is time consuming, taking an average of 22 hours and 82 e-mail transmissions per care center to work through the IRB and legal approval process.
|
From page 81... ...
"The traditional research community needs to be less afraid of statistical process control and interrupted time series with upper and lower control limits," he said. Brilli added that statistical process control is just as valid a way to show improvement over time as are the more traditional randomization methodologies.
|
From page 82... ...
John Steiner of Kaiser Permanente Colorado asked the panelists to comment on the role of empirically measuring items such as time to IRB completion in order to further the process of reform. As an example, he said that Kaiser has seven research departments and seven IRBs and that looking at the natural history of the studies that pass through each of the IRBs provides information on pain points and barriers and helps identify potential solutions to improve the process.
|
From page 83... ...
ADDRESSING ISSUES OF REGULATORY OVERSIGHT 83 for cancer, but for everyday medical care, I think people are shocked," she said. She and her colleagues have a PCORI pilot grant to conduct engagement sessions with patients, educate them about the learning health care system, and find out what kinds of protections they would like to have in place.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.