Institute of Medicine s Clinical Effectiveness Research Innovation Collaborative Participant s statement to HHS on research studying standard of care interventions Claudia Grossmann August 9, 2013
Overview Roundtable on Value & Science-Driven Health Care Learning Health Care System Clinical Effectiveness Research Innovation Collaborative (CERIC) Participant s statement on research studying standards of care interventions 2
IOM s Roundtable on Value & Science Health Care 3
The Learning Health System Vision Our vision is for the development of a continuously learning health system in which science, informatics, incentives, and culture are aligned for continuous improvement and innovation with best practices seamlessly embedded in the care process, patients and families active participants in all elements, and new knowledge captured as an integral by-product of the care experience. 4
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Our Innovation Collaboratives are inclusive affinity groups without walls, bringing together stakeholders with interests and abilities to accelerate progress on opportunities of mutual priority including some identified in IOM reports for the evolution of a continuously learning health system. Together they work to: Align field focus on concepts, challenges and activities Initiate collaborative projects to fill gaps Incubate and pilot test novel approaches to problems
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Exploring the Ethical Framework for a Learning Health System Meeting goals: 1. Discuss conceptual, ethical, and practical issues in continuous health care learning and improvement reviewed in the Hastings Center Report learning health system supplement. 2. Highlight examples of continuous improvement efforts that have run into issues due to the current oversight framework. 3. Identify areas in which the field is in need of practical guidance, and suggest approaches to developing that guidance. 14
CERIC participant s statement on research studying standard of care interventions The Department of Health and Human Services (HHS) is announcing a public meeting to seek public input and comment on how certain provisions of the HHS requirements related to the protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context. 15
Context in order to gather knowledge that is critical to all patients, we need to change the view that research to learn what works is a completely separate activity from patient care. In fact, research to inform us about the best course of treatment must be done within the context of clinical practice to be applicable. Use of protected health information Intentional assignment of patients to different strategies 16
Recommendations* to facilitate evaluation of practices in common use Research as a routine component of care Development of new knowledge should be woven into the delivery of healthcare Eliminate the perverse incentives to degrade the quality of knowledge generation or dissemination in order to allow it to qualify for the less stringent oversight * NOT IOM Recommendations 17
Oversight calibrated to risk and patient s expected role Oversight of studies of routine care should be based on the level of risk, either to the patient or to the misuse of their data, and to the patients expected level of engagement in decision making in standard of care activities Assessment of the risk imposed by studies of routine care should be of the additional risk imposed by the study as compared to regular care for that same situation 18
Consent calibrated to patient expectations and risk should not be required in instances where the decision between one intervention and another is one where the patient s input would not typically be sought (both because providers do not expect patients to be involved, and patients similarly do not expect to be involved)...and where no appreciable additional risks are imposed compared to therapy in the absence of the research activity 19
Enable coordination There should be no barrier to coordination between organizations working in concert with one another Encourage dissemination Widespread dissemination of new knowledge arising from any activity is essential to improving health care Empirical research A program of empirical research to gain a better understanding of expectations and to test approaches will help guide development and implementation of revised regulations 20
Actions within the current regulatory regime Better guidance To make the fullest possible use of the existing regulations, OHRP, the Office of Civil Rights, and the FDA should provide more complete and coordinated (to the greatest extent possible) guidance about activities that are permitted under existing regulation. Redefine health care operations Broaden the definition of health care operations as it is used in the context of HIPAA and the application of the Common Rule 21
Risk-based approach to regulating data More consistent application of risk-based standards and principles to guide regulation of research uses of data Regulation based on the full spectrum of risk Full characterization of the risk to patients in the context of care is important. 22
New and reformed regulations A new ethical framework A new ethics framework that includes responsibility to learn and improve as part of health care is needed to ground this new approach to governance of studies of routine care. Rationalized, harmonized regulation regarding consent, collaboration, and dissemination of new knowledge The regulations of all HHS agencies, including the Office of Human Research Protection, the Office of Civil Rights, and the Food and Drug Administration, covering research on therapies in common use should be harmonized to the greatest extent possible. 23