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Would you participate if you knew this? (Mar-04)

When you decide to participate in a research study, what do you think the reserachers should inform you about?

Imagine that you have been diagnosed with depression. You see an ad in the local newspaper that a research group is studying a new drug for the treatment of depression and is recruiting people like yourself to participate. The study will investigate how effective the drug is at treating depression and will also look at whether the drug has any negative side effects.

Suppose the new drug is made by a small biotechnology company. The researcher owns a substantial portion of the stocks of the company. The value of the company's stocks can rapidly go up or down by large amounts depending on whether the drug is seen to be safe and effective for treating depression.

How important is it for you to know about the researcher's stock investment in the company before you consent to be in this study?

Do you think that the researcher should be required to tell you about his stock investment in the company before you are asked to participate?

Which option best reflects what you would do, given the researcher's stock investment in the drug company?How important is it for you to know about the researcher's stock investment in the company before you consent to be in this study?

  • Extremely important.
  • Very important
  • Somewhat important
  • Not very important
  • Not at all important

Do you think that the researcher should be required to tell you about his stock investment in the company before you are asked to participate?

  • Yes
  • No

Which option best reflects what you would do, given the researcher's stock investment in the drug company?

  • I would not participate in this study.
  • I'm not sure
  • I would still consider participating in this study

First, a little background:

The scenario you read and the questions you just answered were similar to ones that were asked to participants who have actually been diagnosed with depression. Also, individuals with coronary heart disease and breast cancer were given scenarios in which the researcher was said to be studying drugs that treated these health conditions. In the actual study, participants read seven scenarios, each having to do with a researcher's or university's personal financial investment in the drug being investigated. For instance, other scenarios included the university medical centre owning stocks of the drug company, the researcher receiving a lump sum of money per person enrolled in the study, and the drug company paying for the study.

Why were those questions important to ask?

Much of clinical research depends on patient volunteers to serve as research subjects. Patients must rely on the trustworthiness of the researchers who recruit them to help them decide whether to enroll in the study. This is especially true since benefit from participation can be uncertain. If an investigator or institution does not disclose that they have personal financial connections to the drug being studied, this could potentially undermine the trust of the participants. At the time that this study was submitted, there were no federal requirements on investigators or their institutions to disclose such financial conflicts of interest to potential research participants. This may continue to be the case in the future.

What can we say based on this study?

This study found two important trends: (1) Most potential research participants desired to be informed (and believed this should be required) regarding financial conflicts of interest in research, and yet (2) most still wanted to participate in such research. A clear majority still wanted to participate even in the most controversial scenario, which was the one you read on the previous screen. From these findings, then, it seems that the current practice of non-disclosure of financial conflicts of interest do not conform to the values and wishes of potential patient volunteers. It is not clear, however, whether disclosure, management, or elimination of financial conflicts of interest is the best solution. This study should not be taken to mean that only disclosure is required.

For more information see:

SYH Kim, RW Millard, P Nisbet, C Cox, ED Caine. Potential Research Participant's Views Regarding Researcher and Institutional Financial Conflicts of Interest. Journal of Medical Ethics, 30. 73-79. 2004.

J. Scott Roberts, PhD

Faculty

Scott Roberts, PhD, is Professor of Health Behavior & Health Education at the University of Michigan’s School of Public Health (U-M SPH), where he directs the School’s Public Health Genetics program and teaches a course on public health ethics. A clinical psychologist by training, Dr. Roberts conducts research on the psychosocial implications of genetic testing for adult-onset diseases.

Last Name: 
Roberts

Funded by National Institutes of Health

Funding Years: 2015-2018

Institutional Review Boards (IRBs) provide oversight to clinical research involving human subjects to protect participants and ensure ethical research conduct. Local IRBs review research performed just at their own site, while Central Institutional Review Boards (CIRBs) review research being conducted at many sites. Regardless of whether reviews are performed locally or centrally, they must take into account any local context specific to the site where the research will be performed. CIRBs may provide more effective, equitable, and efficient review of large multicenter clinical trials, but whether CIRBs can effectively consider local context is unknown. Local context review is especially important in a kind of research called exception from informed consent for emergency research. In this kind of research, patients who are comatose or otherwise critically ill and unable to consent for themselves may still participate in trials if thir condition is life-threatening and the experimental therapy is only effective if given right away. To perform this kind of trial, researchers must also consult with the community and publically disclose information about the study. Information about those consultations must then be considered by an IRB as part of local context review. The purpose of this project is to explore, revise, and test measures of local context review of community consultation for this type of research, by local and central IRBs. We will work with key stakeholders to identify goals and processes, use these data to develop measures in domains such as trustworthiness and acceptability, and then use these measures to compare local IRB reviews to those of a simulated CIRB for a real trial. This project will be conducted within the Neurological Emergencies Treatment Trials (NETT) network and the Pediatric Emergency Care Applied Research Network (PECARN). These networks will serve as an "empirical ethics lab" in which best practices are developed.

PI(s): Robert Silbergleit

Co-I(s): Michael Fetters, Michael Geisser, Adrianne Haggins, Alan Sugar, Sacha Montas

Fraukje Mevissen, PhD

Alumni

Fraukje Mevissen is an Assistant Professor in Applied Psychology at Maastricht University, Dept. of Work and Social Psychology. Dr. Mevissen was a Visiting Scholar at CBSSM from January-July 2014. For her PhD, she studied risk communication and risk perception regarding sexually transmitted infections among young adults at the department of Health Education and Promotion. She then continued as a postdoc researcher at the W&SP department, focusing on development and evaluation of behavioral/health interventions.

Last Name: 
Mevissen
Wed, May 28, 2014

A recent study led by Dr. Sarah Hawley has found that most women who get a double mastectomy to prevent breast cancer don’t need to do it, and are often motivated by fear. Her study has been receiving national press and has been featured in NBC News, CBS News, the Chicago Tribune, MSN, and many, many other venues. Reshma Jagsi and several others were co-authors on this study.

Bioethics Grand Rounds -Scott Grant MD, MBE

Wed, May 24, 2017, 12:00pm
Location: 
UH Ford Auditorium

Scott Grant, MD, MBE, University of Chicago: "Dealing with complications and poor outcomes and surgical futility"

Scott Grant, MD, MBE, University of Chicago

Abstract: Surgical complications are ubiquitous and effect all surgeons. This talk will review how surgical ethics is distinct from traditional medical ethics in that surgeons have a greater and more direct responsibility for the outcomes of their patients than medical doctors. It will review how surgery harms before healing and the importance of weighing risks and benefits in decision making. Ways of assessing perioperative risk and preventing complications will be reviewed. Strategies for coping with complications will be described. Human error theory and the "Swiss cheese" model of human error will briefly be discussed. The SPIKES protocol for breaking bad news will be reviewed. Different definitions of futility will be described. Various procedural approaches to futility disputes will be analyzed. The best tool in approaching challenging "futility" situations will be described - open and honest communication between the patient or surrogate and the physician.

Funded by Robert Wood Johnson Foundation

Funding Years: 2013-2014

Patients and the public are being inundated with a flood of health data and being asked to take a greater role in applying this data to make medical decisions regarding their own health. While general guidelines exist for "best practices" in medical risk communication, this work has not always considered the specific communication goals of the risk message or the specific information or practical needs of the patient. The  Communicating Health and Risk Messages (CHARM) project will address the gap in our current knowledge by informing the design of health risk data visualizations  across the full spectrum of risk communication goals.

PI(s): Vic Strecher, PhD, MPH

Co-I(s): Lawrence An, Angela Fagerlin, Kenneth Resnicow, Brian Zikmund-Fisher

James Burke, MD

Faculty

Jim Burke, M.D. is a neurologist who completed residency and a stroke fellowship at the University of Michigan. His undergraduate degree is from the University of Notre Dame and his medical degree from the Loyola University Stritch School of Medicine. He is interested in understanding how physicians use the complex information acquired from modern diagnostic tests and improving decisions to order such tests.

Research Interests: 
Last Name: 
Burke

Dr. Jason Karlawish, Professor of Medicine and Medical Ethics at the University of Pennsylvania, will discuss his forthcoming novel, "Open Wound: The Tragic Obsession of Dr. William Beaumont" on Thursday, October 20, 3-5 pm, at the Biomedical Research Science Building (BSRB), Room 1130.  "Open Wound" is a fictional account of true events along the early 19th century American frontier, tracing the relationship between Dr. William Beaumont and his illiterate French Canadian patient.  The young trapper sustains an injury that never heals, leaving a hole in his stomach that the curious doctor uses as a window both to understand the mysteries of digestion and to advance his career.  A reception will follow the talk, and books will be available for purchase on site from Nicola's Books.  The event is co-sponsored by the Center for Bioethics and Social Sciences in Medicine, the Center for the History of Medicine, and the University of Michigan Press.  Click here for more information about the book. 

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