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Geoffrey Barnes is lead author on study published in the American Journal of Medicine finding new anticoagulants are driving increase in atrial fibrillation treatment and reducing warfarin therapy use.

“The data provides a promising outlook about atrial fibrillation which is known for being undertreated,” says lead author Geoffrey Barnes, M.D., MSc.,  cardiologist at the University of Michigan Health System and researcher at the Institute for Healthcare Policy and Innovation.  “When we don’t treat atrial fibrillation, patients are at risk for stroke. By seeking treatment, patients set themselves up for better outcomes.”

More details can be found here.

Attitudes toward Return of Secondary Results in Genomic Sequencing (Sep-16)

Imagine you are at the doctor’s office because you (or your child) have a serious health condition like heart disease or cancer. To help find out whether any treatment options exist, your doctor suggests that you (or your child) have your genome sequenced.

Genome sequencing may provide information about your (or your child’s) current health condition. However, the genome sequencing could reveal additional and unexpected results not related to the current condition. The doctor wants to know what types of these secondary results you would want to be told.

Mon, January 30, 2017

Kayte Spector-Bagdady has a new commentary out in The Conversation about the law and ethics of research with human biospecimens. It focuses on the recently published revisions to the human subjects research regulations, highlights the debate that ensued from a draft version over its proposal to include nonidentified biospecimens in its definition of "human subject," and summarizes where the final rule landed and possible steps going forward.

Research Topics: 

Panel Discussion: Ethical, Legal, and Social Implications of Genetics and Newborn Screening

Mon, September 25, 2017, 6:00pm
Location: 
Vandenberg Room, Michigan League

Join Joselin Linder, author of “The Family Gene”, and Jodyn Platt, assistant professor in the U-M Medical School in a panel discussion about the ethical, legal, and social implications of genetics and newborn screening. The conversation will be moderated by Kayte Spector-Bagdady, assistant professor in the U-M Medical School and chief of the research ethics service in the Center for Bioethics and Social Sciences in Medicine.

Wed, October 11, 2017

In an editorial in Nature Human Behaviour, Brian Zikmund-Fisher discusses the findings of a recent study about the unintended consequences of argument dilution in direct-to-consumer drug advertising. In a series of experiments, study authors, Niro Sivanathan and Hemant Kakker found that long lists of serious and minor side effects found in drug advertisements actually "dilute" consumers' judgments of the overall risk from side effects.

Funded by NIH - Department of Health and Human Services

Funding Years: 2015-2018

The major goals of this project are to identify the degree to which social disparities exist in physicians' communication about important clinical issues with patients with serious and life-limiting illnesses. This project also studies patient communication behaviors that exacerbate or attenuate those disparities. Results from this research will inform interventions for physicians and patients to promote better communication and thereby reduce or eliminate social disparities in care.

PI(s): Jennifer Griggs

Co-I(s): Masahito Jimbo

Wed, October 03, 2018

Only a small percentage of people in their 50s and early 60s have had their DNA tested – either for medical reasons, to learn their ancestry or out of curiosity – but far more have an interest in getting such tests done, according to a new National Poll on Healthy Aging. Scott Roberts, PhD also discusses the risks of direct-to-consumer testing such as learning out about risks for serious disease and the risk of false positives.

Funded by Patient-Centered Outcomes Research Institute (PCORI)

Funding Years: 2013 - 2015.

Every year, more than 100,000 patients start dialysis to treat kidney failure in the United States. Two types of dialysis are available: hemodialysis (HD) and peritoneal dialysis (PD). HD is done with a machine in a dialysis clinic. PD can be done at home, if the patient or family is willing to perform his or her dialysis treatments. In general, patients survive as long on HD as they do on PD. Based on specific clinical parameters and a patient’s needs, one of the two dialysis types is usually going to be a better fit for a given patient. For example, older patients may not want to be responsible for performing their own treatment, and HD may be a better fit for them. On the other hand, PD may be a better choice for patients who want to be able to travel. The challenge for patients with kidney failure is to identify the dialysis type that best fits their lifestyle. However, there is very little information regarding factors that are important to patients starting dialysis, and often patients choose a dialysis type without fully understanding how it will impact their lives. Patients and their families need more information to be able to make better decisions. PD use is much lower in the United States than in other countries, perhaps reflecting the fact that many patients are not given appropriate information regarding this type of dialysis. Given recent financial pressure on kidney doctors to treat more patients with PD, it is even more important that patients receive better information when making a decision regarding dialysis type. The goal of this study is to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. To understand what is most important to them, we will interview more than 130 patients with kidney disease, some before and some after they start dialysis. We will compare factors reported as important across different types of patients; for example, among men and women, or among those who work outside of the house and those who do not. Using the infrastructure of an existing study of more than 6,800 dialysis patients, we will compare factors identified during the interviews between patients treated with HD and PD. Based on these results, we will develop a Web site presenting information on kidney disease and questions on personal preferences, which will help patients understand which dialysis type is better for them. Results from our study will provide practical information regarding the choice of dialysis type to patients with kidney disease and their families. Patients who are better informed will be able to identify and choose the best dialysis type for their lifestyle and needs. Providing scientific evidence to help patients in their decision process is of great importance, especially at such a stressful time in their lives.

PI(s): Angela Fagerlin, Laurie Lachance, Yi Li, Julie Wright

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.

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

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