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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 National Institutes of Health

Funding Years: 2011-2016

This proposal seeks to advance our understanding of the role of psychosocial and environmental health risk factors as well as medical care in understanding the large socioeconomic and racial/ethnic disparities in health and the way health changes with age in our society. It does so by proposing to extend to four waves and 15 years of follow-up an ongoing prospective study (known as Americans' Changing Lives) of a nationally representative sample of 3,617 adults aged 25 and over in the coterminous United States, who were first interviewed in 1986, with reinterviews of about 83 percent of the surviving members of the original sample already completed in 1989 and 1994, along with ongoing mortality ascertainment on the full original 1986 sample. A proposed fourth wave would be collected on about 83 percent of the surviving sample (estimated respondents - 2,300 of about 2,800 survivors) in 2001, primarily by telephone and in person as necessary, with mortality ascertainment continuing indefinitely and the hope and intent of reinterviewing surviving respondents again about 20-22.5 years after the baseline interview. The ongoing ACL study has generated a large body of publications both by staff of the ACL project and users of the public use data sets for the first two waves (with the third wave to be archived for public use by the end of 1999). ACL analyses and publications have illuminated to the role of a broad range of psychosocial factors, ranging from health behaviors through stress and adaptive resources to productive activities, in predicting health, changes in health and mortality, and in mediating or explaining socioeconomic differences in health. It has also played a major role in understanding the nature, causes, and consequences of paid and unpaid productive activities over the lifecourse. The proposed continuation and extension of the ACL project will address a number of aims: (1) continuing and enhancing ongoing analysis by extending prospective follow-up to 15 years, allowing for better analysis of- (a) time- varying covariates, (b) the impact of changes in risk factors on changes in health, and (c) potential reciprocal relationships between and among SES, psychosocial risk factors and health; (2) enhancing and improving the measurement of a number of variables already being considered in ongoing analysis, including SES (e.g., improving assessment of wealth), productive activities, religious beliefs and behaviors, and personality or dispositional factors (e.g., hostility, optimism, hopelessness, and John Henryism); (3) adding new measures to ACL 4 or (via archival data) to all waves of data for both medical care and exposures in physical and social environments; and (4) to undertake more focused analysis of racial/ethnic differences in health and explanations of them.

PI(s): Sarah Burgard

Co-I(s): Wen Ye, Michael Elliott, Philippa Clarke, Kenneth Langa

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

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

Lewis Morgenstern, MD

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

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