Collaboratory Coordinating Center Ethics of Standard of Care Research - - PowerPoint PPT Presentation

Collaboratory Coordinating Center Ethics of Standard of Care Research

Jeremy Sugarman, MD, MPH, MA Kevin Weinfurt, PhD

Overview

• Background
• NIH supplements
• Specific Aims
• Methods
• Drivers for data collection
• Q & A

Background

• Ethics and regulatory issues in the Collaboratory
• Minimal risk
• Consent
• FDA regulated products
• Privacy
• Data monitoring
• Stakeholder Advisory Group
• SUPPORT

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[This letter reflects the removal of an addressee that was not engaged in this human subjects research and replaces the previously issued determination letter (dated February 8, 2013).]

Office of the Secretary DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Assistant Secretary for Health Office for Human Research Protections The Tower Building 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 Telephone: 240-453-8298 FAX: 240-453-6909 E-mail: Lisa.Buchanan@HHS.gov

March 7, 2013 Richard B. Marchase, Ph.D. V.P. for Research & Economic Development University of Alabama at Birmingham AB 720E 701 20th Street South Birmingham, AL 35294-0107 RE: Human Research Protections under Federalwide Assurance (FWA) 5960 Research Project: The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) Principal Investigator:

• Dr. Waldemar A. Carlo

HHS Protocol Number: 2U10HD034216 Dear Dr. Marchase: Thank you for your response to our July 18, 2011 letter and subsequent emails regarding our request that your institutions evaluate allegations of noncompliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46) and our subsequent questions and concerns regarding the above-referenced research. The SUPPORT study was a randomized multi-site study conducted at approximately twenty- two sites and reviewed by at least twenty-three institutional review boards (IRBs). Approximately 1,300 infants were enrolled in this study from 2004 to 2009. The study was designed to 1) learn more about treatment with continuous positive airway pressure (CPAP) which is positive pressure applied with a face mask to help keep the lungs inflated, and 2) to learn the appropriate levels of oxygen saturation in extremely low birth weight infants by comparing a lower versus a higher range of levels of oxygen saturation in such infants. The University of Alabama, Birmingham (UAB) was the lead site for the portion of the study

Regulatory Criticism of SUPPORT

• “…the informed consent document for this trial failed to

adequately inform parents of the reasonably foreseeable risks and discomforts of research participation”

• “excess risks” of being in the low oxygen arm
• “excess risks” of being in the high oxygen arm

http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf Slide courtesy of Steven Joffe, MD, MPH

Slide courtesy of Steven Joffe, MD, MPH

Alternative Bioethical Views

Public Hearing

http://www.hhs.gov/ohrp/newsroom/rfc/Public%20Meeting%20August%2028,%202013/aug28public.html

Major Areas of Controversy

• Consent
• Risks and benefits
• Standard of care

NIH Supplements

• CTSA (Magnus and Wilfond)
• NIH Collaboratory
• ABATE (Huang)
• TiME (Dember)
• Coordinating Center

NIH Ethics Supplements

Coordinating Center

(Duke & Hopkins)

TiME

(University of Pennsylvania)

ABATE

(University of California ‐ Irving)

NIH Collaboratory CTSA

(University of Washington & Stanford)

CTSA Supplement: Research on Medical Practice (RoMP)

• Assess attitudes about CER and consent
• Develop videos, vignettes to educate participants, public
• Focus groups among parents and patients who have been seriously or

chronically ill

• National surveys of representative samples of general public and of

patients or parents of patients who have been hospitalized in past year

• In depth interviews to follow up
• Assess attitudes of IRB members about CER risks, benefits and

consent

• Focus groups
• PRIM&R assisting us in survey of IRB members nationwide
• Follow up Interviews

Adapted from Wilfond & Magnus

ABATE Supplement

• Address the ethical gray space related to the interface of

minimal risk research and quality improvement studies as they would be applied to Learning Health Systems

• Identify if a common ethical framework exists
• Survey IRB chairs, leaders of healthcare quality improvement

programs, and patients

• Common constructs evaluated across all 3 surveys

Adapted from Susan Huang, 11/26/13

TiME Supplement

To answer the question:

“Might pragmatic trials, in the service of learning, curtail individual patients’ and physicians’ autonomy to choose specific treatments?”

The project seeks to understand:

(1) how patients and physicians value treatment autonomy (2) how these valuations differ in the contexts of research vs. care (3) whether limitations on treatment autonomy ought to influence how investigators obtain informed consent / provide notification

Via a mixed‐methods study of dialysis patients and providers

Adapted from Laura Dember, 11/26/13

Collaboratory Coordinating Center Ethics Supplement Team

• PI: Rob Califf
• Project leads: Jeremy Sugarman and Kevin Weinfurt
• Duke
• Laura Beskow
• Kate Brelsford
• Johns Hopkins
• Juli Bollinger
• Matt DeCamp
• Rachel Dvoskin
• Nancy Kass
• Dave Kaufman
• Debra Mathews

Overarching Goal

To improve understanding of when and how different stakeholders believe research testing

• r comparing interventions that are each

considered standard of care are acceptable and when traditional or modified approaches to consent for it should be sought.

Specific Aims

AIM 1: Collect rich qualitative data from multiple stakeholders to identify the broad range of attitudes, beliefs, and preferences concerning the need for research in usual care settings and related consent issues. AIM 2: Systematically identify the factors that influence U.S. adults’ beliefs concerning research and consent in different usual care situations. AIM 3: Convene a summit meeting to share emerging results and findings from related projects. AIM 4: Test different approaches to consent for research in usual care settings within the context of one or more NIH Collaboratory demonstration projects.

Stakeholder Interviews Patient Focus Groups Quantitative Survey/Experiment Randomized Trial of Consent Models IRB Chairs U.S. Regulators Healthcare Admin/Counsel Investigators Nurses Non‐research clinicians 8‐10 focus groups Stratified by disease severity 3 sites (Duke, Hopkins, TBD) Nationally representative sample of US adults Test alternative models of consent/notification Design TBD

2 (Among Many!) Challenges

Feelings and Beliefs about

The Doctor

Ability to select best treatment Ability to manage changing course Awareness of uncertainty in usual care decisions Feelings about uncertainty in usual care decisions Trust (and need to trust)

Creating the Appropriate Context for Eliciting Preferences

Ethos in U.S.: The Informed Consumer

Should want all of the information Should want to make all decisions for themselves

Creating the Appropriate Context for Eliciting Preferences

Broader costs (to institution, science, society) Benefits to society (priority of research question) Current practices for other types of decisions Other?

Drivers for Data Collection

• In the headlines (SUPPORT, etc.)
• Experience in the Collaboratory

Q & A