Tag: biobank

Fall 2018 publications from Center faculty

Continue reading below for a list of recent journal articles from Center faculty, including online first publications. MSU Library or other institutional access may be required to view these articles.

Recently assigned an issue

Stahl D. Patient reflections on the disenchantment of techno-medicine. Theoretical Medicine and Bioethics. December 2018;39(6):499-513. Available online November 1, 2018. View full text via Springer Link.

Cabrera LY, Bittlinger M, Lou H, Müller S, Illes J. Reader comments to media reports on psychiatric neurosurgery: past history casts shadows on the future. Acta Neurochirurgica. December 2018;160(12):2501-2507. Available online October 24, 2018. View full text via Springer Link.

Fleck LM. Healthcare Priority-Setting: Chat-Ting Is Not Enough; Comment on “Swiss-CHAT: Citizens Discuss Priorities for Swiss Health Insurance Coverage”. International Journal of Health Policy and Management. October 2018;7(10):961-963. Available online July 28, 2018. View full text via IJHPM.

Zhuang J, Bresnahan M, Zhu Y, Yan X, Bogdan-Lovis E, Goldbort J, Haider S. The impact of coworker support and stigma on breastfeeding after returning to work. Journal of Applied Communication Research. 2018;46(4):491-508. Available online July 19, 2018. View full text via Taylor & Francis Online.

Online first

Cabrera LY, Brandt M, McKenzie R, Bluhm R. Comparison of philosophical concerns between professionals and the public regarding two psychiatric treatments. AJOB Empirical Bioethics. Available online November 6, 2018. View full text via Taylor & Francis Online.

Bluhm R, Cabrera LY. It’s Not Just Counting that Counts: a Reply to Gilbert, Viaña, and Ineichen. Neuroethics. Available online October 27, 2018. View full text via Springer Link.

De Vries RG, Ryan KA, Gordon L, Krenz CD, Tomlinson T, Jewell S, Kim SYH. Biobanks and the Moral Concerns of Donors: A Democratic Deliberation. Qualitative Health Research. Available online August 10, 2018. View full text via SAGE Journals.

Cabrera LY, Goudreau J, Sidiropoulos C. Critical appraisal of the recent US FDA approval for earlier DBS intervention. Neurology. 2018. Available online June 13, 2018. View full text via Neurology.

Zhuang J, Bresnahan MJ, Yan X, Zhu Y, Goldbort J, Bogdan-Lovis E. Keep Doing the Good Work: Impact of Coworker and Community Support on Continuation of Breastfeeding. Health Communication. Available online May 17, 2018. View full text via Taylor & Francis Online.

Bioethics for Breakfast: Biobanking Tissue: Trash or Treasure?

Bioethics for Breakfast Seminars in Medicine, Law and SocietyJennifer Carter-Johnson, PhD, JD, and Tom Tomlinson, PhD, presented at the Bioethics for Breakfast event on December 6, 2018, offering their perspectives and insight on the topic “Biobanking Tissue: Trash or Treasure?”

“Big data”—repositories of biological, medical and demographic information about large numbers of people—is a critical platform for discovery of the causes of disease and potential new avenues for its treatment.

This data must come from us, the general public. Data about you might end up in a biobank because you’ve generously agreed to provide it, perhaps by agreeing to join the National Institutes of Health’s All of Us project that aims to recruit a broad representative sample of one million Americans.

Or it might already have been provided for use in research without your knowledge or consent. Research using specimens and medical information collected during your clinical care, once de-identified, doesn’t count as research on a “human subject” under the Federal regulations. Thus, your consent is not required. This source probably provides the great majority of information used in big data research, and acquiring and distributing it has become a multimillion dollar business.

This practice raises a host of questions. Doesn’t my specimen and my medical information belong to me, rather than to the hospital or clinic that collects it? Or have I thrown it away like my trash sitting on the curb each week? Although many people may feel comfortable providing this information for research, others might not. So isn’t it a simple act of respect to ask first? Or are researchers simply the medical equivalent of college students dumpster diving for cheap furniture that has been thrown away? Additionally, if we ask, and too many people say “no,” won’t critical research be hampered, to the detriment of all of us?

Dr. Tomlinson asked attendees to consider this question: Should clinically-acquired specimens and other medical information be treated like the trash that you have no control of once it has left your curb?

Dr. Tomlinson referred to a national study that his research team conducted in 2014 regarding willingness to give blanket consent, focusing on the fact that people care about more than risk – they have concern about how their materials may be used, and they worry about how much they should trust the research establishment. Dr. Tomlinson’s overarching argument was that respect for persons, a fundamental bioethics principle, requires informed consent.

Dr. Carter-Johnson also offered a question: whose treasure is it? Biospecimens and related data can be donated by patients and the public, can be clinically collected de-identified materials, and they can be samples given to private companies like 23andMe or Ancestry.com. Dr. Carter-Johnson also discussed a new startup offering to sequence your genome for free, and highlighted the variety of health and fitness apps that we give our data too. “When something is free, you are the product,” she said. A show of hands revealed that a minority of the attendees had gotten their DNA sequenced.

Dr. Carter-Johnson offered a legal perspective on tissue and genetic data in relation to property and privacy rights. She explained that individuals do not own their own tissue, citing the cases Moore v. Regents of California and Greenberg v. Miami Children’s Hospital Research Institute. However, there have been exceptions, and there are legal ways to “sell” your body (think plasma, bone marrow, sperm, or clinical trials).

When discussing privacy, Dr. Carter-Johnson used 23andMe and Ancestry.com’s privacy policies as examples. These policies are contractual, they are updated frequently, and they are often ignored by the consumer. However, push from consumers as well as bioethicists have led to these policies being more available and accessible.

Audience discussion brought up the famous Henrietta Lacks case, the future of biobank donor policies, and newborn screening programs and biobanks.

Jennifer Carter-Johnson, PhD, JD
Jennifer Carter-Johnson is an Associate Professor of Law at the Michigan State University College of Law and holds both a JD and a PhD in Microbiology. Professor Carter-Johnson uses her interdisciplinary training to study the intersection of law and scientific research.

Tom Tomlinson, PhD
Tom Tomlinson was Director of the Center for Ethics and Humanities in the Life Sciences from 2000 to 2018, and is a Professor in the Department of Philosophy. He chairs the Ethics Committee at Sparrow Health System, and has published widely on the ethics of biobank-based research.

About Bioethics for Breakfast:
In 2010, Hall, Render, Killian, Heath & Lyman invited the Center for Ethics to partner on a bioethics seminar series. The Center for Ethics and Hall Render invite guests from the health professions, religious and community organizations, political circles, and the academy to engage in lively discussions of topics spanning the worlds of bioethics, health law, business, and policy. For each event, the Center selects from a wide range of controversial issues and provides two presenters either from our own faculty or invited guests, who offer distinctive, and sometimes clashing, perspectives. Those brief presentations are followed by a moderated open discussion.

Dr. Tomlinson and co-authors published in ‘European Journal of Human Genetics’

Tom Tomlinson photoCenter Director and Professor Dr. Tom Tomlinson is first author of the article “Effect of deliberation on the public’s attitudes toward consent policies for biobank research,” published in the February 2018 issue of the European Journal of Human Genetics. The work of Dr. Tomlinson and co-authors Raymond G. De Vries, H. Myra Kim, Linda Gordon, Kerry A. Ryan, Chris D. Krenz, Scott Jewell, and Scott Y. H. Kim was supported by the NIH-funded project “Public Preferences for Addressing Donors’ Moral Concerns about Biobank Research.”

Abstract: In this study, we evaluate the effect of education and deliberation on the willingness of members of the public to donate tissue to biobank research and on their attitudes regarding various biobank consent policies. Participants were randomly assigned to a democratic deliberation (DD) group, an education group that received only written materials, and a control group. Participants completed a survey before the deliberation and two surveys post-deliberation: one on (or just after) the deliberation day, and one 4 weeks later. Subjects were asked to rate 5 biobank consent policies as acceptable (or not) and to identify the best and worst policies. Analyses compared acceptability of different policy options and changes in attitudes across the three groups. After deliberation, subjects in the DD group were less likely to find broad consent (defined here as consent for the use of donations in an unspecified range of future research studies, subject to content and process restrictions) and study-by-study consent acceptable. The DD group was also significantly less likely to endorse broad consent as the best policy (OR = 0.34), and more likely to prefer alternative consent options. These results raise ethical challenges to the current widespread reliance on broad consent in biobank research, but do not support study-by-study consent.

The full text is available online through Springer Nature (MSU Library or other institutional access may be required to view this article).

Dr. Tomlinson presents at International Society for Biological and Environmental Repositories Annual Meeting

tomlinson-crop-2016Center Director and Professor Dr. Tom Tomlinson presented a talk on the “Effect of Deliberation on Attitudes Toward Biobank Consent Options” at the International Society for Biological and Environmental Repositories (ISBER) Annual Meeting held in Toronto on May 9-12. The talk presented findings from democratic deliberations held in 2015 as part of a larger NIH-funded project investigating the effect that people’s moral, cultural or social concerns (“non-welfare interests” or NWI) about possible future research uses of donated specimens and data might have on their willingness to donate and on their preferences regarding biobank consents.

The presentation focused on what effect the deliberations in themselves had on preferences among biobank consent options, as opposed to any effects attributable to the educational materials provided during the deliberation day. The study design made it possible to separate these, since participants were randomized into the deliberation group, an education-only group that received paper copies of the presentations with notes, and a control group that received no information. A logistic regression analysis revealed that compared to the education and control groups, the deliberators moved away from a blanket consent to any and all future research uses toward consents that in a variety of ways acknowledged or accommodated donors’ NWIs. These findings supported recommendations for increased transparency, stronger donor participation in biobank governance, and greater efforts to identify concerns among biobanks’ donor communities.

Dr. Tomlinson presents at 3rd Annual Great Lakes Biorepository Network Scientific Meeting

tomlinson-crop-2016The 3rd Annual Great Lakes Biorepository Network (GLBRN) Scientific Meeting was held on October 28, 2016 at the University of Michigan in Ann Arbor. Center Director and Professor Dr. Tom Tomlinson spoke on “Preferences for Biobank Consent Policy are Sensitive to Concerns about Future Research Uses.”

The current research ethics framework gauges the level of ethical protections to the degree of risk to the participant. The lower the risk, the less stringent the requirements for informed consent; when the risk is virtually zero, as with the research uses of de-identified biospecimens and related clinical and demographic data, it is no longer research on a human “subject.”

This framework forgets why people donate their specimens and data to biobanks. They are not merely concerned with what later research will do to or for them. They are hoping their donation may do some good; and correlatively, assuming that it will do no wrong, in ways they would find morally concerning:

  • Some research might threaten a donor’s world view –such as research to better understand human evolution and history.
  • Some donors might be concerned by research that might lead to the stigmatization of others –such as research that looks at genes associated with violence.
  • Or some research may be contrary to the moral, cultural, or political values of the donor – such as research related to abortion or research leading to large commercial profits.

To emphasize the contrasts with the conventional framework, Dr. Tomlinson and his colleagues call these people’s non-welfare interests in later research uses of their donations.

In the talk Dr. Tomlinson presented evidence that such concerns affect people’s preferences among various biobank consent policies, drawn from both a national survey that his research team conducted in 2014 and a series of democratic deliberations held in 2015. The evidence shows that the more people are aware of the range of possible research uses of biobank donations that might be of concern to them or others, the more negative their attitudes are toward blanket consent. In this consent, a donor gives permission up front to any future uses that the biobank would allow, without any further consent or information provided. This is the most common form of biobank consent, but their research shows that a bare majority finds it “acceptable,” and a sizeable minority (38%) think it’s the “worst” option among those presented. Interestingly, the team found similar attitudes expressed toward specific, study-by-study consent, the option that gives each donor the most control over later research uses.

For more analysis of the national survey, see: De Vries RG, Tomlinson T, Kim HM, Krenz C, Haggerty D, Ryan KA, Kim SY. Understanding the Public’s Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey. PLoS One. 2016 Jul 14;11(7).

Dr. Tomlinson is an Executive Board Member of the Great Lakes Biorepository Network and Incoming President for 2017.

Understanding the Public’s Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey

PLOS ONE logoA new research article from Dr. Tomlinson and his research team was published on July 14, 2016 in the open-access peer-reviewed journal PLoS ONE. The article, “Understanding the Public’s Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey,” is authored by Raymond Gene De Vries, Tom Tomlinson, Hyungjin Myra Kim, Chris Krenz, Diana Haggerty, Kerry A. Ryan, and Scott Y. H. Kim. The research is part of the NIH-funded project “Public Preferences for Addressing Donors’ Moral Concerns about Biobank Research.”

Abstract: Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket—or broad—consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using “real-time”—or study-by-study—consent, but this policy places a significant burden on biobanks. In order to better understand the public’s preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective) and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research) had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.

“Understanding the Public’s Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey” is available to read in full on the PLoS ONE website.

Would you donate to a biobank?

Tom TomlinsonCenter Director Dr. Tom Tomlinson and Raymond G. De Vries, Co-Director of the Center for Bioethics and Social Sciences in Medicine at University of Michigan, have co-authored the article “Americans want a say in what happens to their donated blood and tissue in biobanks.” The authors discuss biobank donations, precision medicine, genetics, privacy, and consent.

The last time you went to a hospital, you probably had to fill out forms listing the medications you are taking and updating your emergency contacts. You also might have been asked a question about what is to be done with “excess tissues or specimens” that may be removed during diagnosis or treatment. Are you willing to donate these leftover bits of yourself (stripped of your name, of course) for medical research?

If you are inclined to answer, “Sure, why not?” you will join the majority of Americans who would agree to donate, allowing your leftovers, such as blood or unused bits from biopsies or even embryos, to be sent to a “biobank” that collects specimens and related medical information from donors.

But what, exactly, will be done with your donation? Can the biobank guarantee that information about your genetic destiny will not find its way to insurance companies or future employers? Could, for example, a pharmaceutical company use it to develop and patent a new drug that will be sold back to you at an exorbitant price?

These questions may soon become a lot more real for many of us.

Read the full piece at The Conversation.

Related reading: “Understanding the Public’s Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey” published July 14, 2016 in PLoS ONE, an open-access peer-reviewed journal. Authors: Raymond Gene De Vries, Tom Tomlinson, Hyungjin Myra Kim, Chris Krenz, Diana Haggerty, Kerry A. Ryan, Scott Y. H. Kim.

Center faculty presentations from ASBH 2015

asbh logoThe 17th Annual American Society for Bioethics and Humanities Meeting was held October 22-25, 2015, in Houston, TX. Center faculty Tom Tomlinson, Len Fleck, Libby Bogdan-Lovis, Karen Kelly-Blake, and Devan Stahl presented and participated in panel discussions during the conference.

tomlinsonTom Tomlinson, PhD
Director, Center for Ethics and Humanities in the Life Sciences
At ASBH I had the pleasure of making two presentations early Sunday morning. The first was “Is There a Right Not to Know?” In it I argued (with help from Devan Stahl) that despite presumptions to the contrary, patients with advanced terminal illness do not have a right to refuse information about their prognosis. Among other reasons, such a right pales by comparison to the right that is sacrificed: the right to make end of life decisions about their treatment that best preserves their values and goals. The second was “The Moral Concerns of Biobank Donors: The Effect of Non-Welfare Interests on Willingness to Donate.” In this talk I presented the results of a national survey conducted with colleagues at the University of Michigan. We argued that the survey results demonstrate that the ways in which donated, de-identified, biological specimens and data are later used matter to people’s willingness to give a “blanket consent” to any future research done with their donation. We argue that biobanks should take these concerns into account in the design of their consent process, in their public information policies, and in their review of proposed research studies.

Leonard FleckLen Fleck, PhD
Professor, Center for Ethics and Humanities in the Life Sciences
I presented Sunday morning at ASBH. The title of my presentation was “Precision Medicine/ Ethical Ambiguity?” My focus was on precision medicine as it pertained to cancer care. One often hears of cancers being identified by their “genetic signature,” or the genetic features of a cancer that drive the growth of that cancer. The goal of precision medicine is to design “targeted therapies” that match (and defeat) that genetic driver. Unfortunately, it turns out that most cancers have multiple “potential” drivers, some of which become actual drivers after a targeted cancer drug has contained the first driver. I pointed out that a major ethical problem (a matter of health care justice) is that these cancer drugs have costs of $100,000 or more for a course of treatment and generally yield on average extra weeks to extra months of life. I raised three critical questions: How many of these drugs does any one patient have a just claim to, if used in succession to defeat each emerging driver of that cancer? Keep in mind that about 600,000 individuals die of cancer each year in the US. Do all of them have a just claim to several of these targeted therapies at $100,000 each? Alternatively, a small percentage (maybe 5%) of cancer patients are “super responders” who might gain several extra years of life from having access to one or another of these, perhaps at a cost of $100,000 for each year of life gained. Should they alone have a just claim to these drugs because society is gaining so much more for the social investment? Or should access to these drugs be determined entirely on the basis of an individual’s ability to pay for these drugs (thereby sparing society the need to make explicit and painful rationing decisions)? I concluded that addressing these questions will require thoughtful and respectful democratic deliberation, not simple individual choices.

kelly-blake-crop-facbogdanlovis-crop-facKaren Kelly Blake, PhD
Assistant Professor, Center for Ethics and Humanities in the Life Sciences
In concert with research collaborators Libby Bogdan-Lovis (Assistant Director, Center for Ethics and Humanities in the Life Sciences), Nanibaa’ Garrison, (Seattle Children’s Hospital) and Faith Fletcher (University of Illinois Chicago), I presented “Identity Complexities: Unpacking Concordance in the Medical Workforce.” Our team reported preliminary results of a 2000-2015 scoping literature review to examine presumed benefits of matching URM physicians with patients sharing similar race/ethnic identities. Our project is supported by contributions of research assistants Brittany Ajegba (MSU CHM medical student), Nichole Smith (Vanderbilt premedical undergraduate), and Jessica Torres (University of Illinois Chicago MPH student). We found that of 139 abstracts meeting our inclusion criteria, medical workforce diversity is mentioned the most among variables. Patient outcomes are mentioned the least. Blacks are mentioned more frequently across primary variables. American Indian/Alaskan Native/Native American is mentioned least frequently across variables. Our next phase will be the content analysis of the 139 included articles.

stahl-crop-2015Devan Stahl, PhD
Assistant Professor, Center for Ethics and Humanities in the Life Sciences
I was on a panel with Drs. John Kilner and Jeffrey Bishop responding to Dr. Kilner’s book, Dignity and Destiny: Humanity in the Image of God, for the Bioethics and Christian Theology Affinity Group. Dr. Kilner’s book focuses on the how the image of God grants all humans inherent dignity which cannot be damaged or lost as a result of sin. The respondents then discussed the potential implications this theological anthropology has for bioethics. My response highlighted the need for a reimagining of the theological concept of dignity for persons with profound intellectual disabilities. I argued that although the concept of dignity cannot easily solve the complex issued involved in clinical ethics, it can reframe our interactions with persons with profound disabilities, whose humanity is often questioned in both theology and bioethics. By not basing our concept of dignity on any inherent capacity for intellect, righteousness, equality in relationship, etc., we allow room for those who do not have these capacities to maintain their status as bearers of God’s image and, therefore, claim them as persons worthy of respect and care. Ultimately, I argued that we ought to imagine friendship as the ultimate telos or destiny of human life. When friendship is our goal, our ethical priority is not to ‘fix” or cure what we find broken or defective in others, but to befriend persons so that they too can participate in the good life.

Moral Concerns and the Willingness to Donate to a Research Biobank

tomlinsonA new study led by Center Director Dr. Tomlinson was published this week in The Journal of the American Medical Association, surveying concerns people may have about donating to a research biobank. You can hear more about the research from Dr. Tomlinson in a feature that appeared in MSU Today: “What’s Happening With Your Donated Specimen?.”

“Moral Concerns and the Willingness to Donate to a Research Biobank” by Tom Tomlinson, PhD; Raymond De Vries, PhD; Kerry Ryan, MA; Hyungjin Myra Kim, ScD; Nicole Lehpamer, MA; Scott Y. H. Kim, MD, PhD.

Do People Care What’s Done with Their Biobanked Samples?

tomlinsonCenter Director Dr. Tom Tomlinson has a new article in the July-August issue of IRB: Ethics & Human Research. 

Abstract: When donating leftover biological samples to a biobank for use in medical research, people generally are asked to give a broad consent. This allows their samples and associated medical information to be later used without any further consent. Although risks to donors are virtually eliminated by deidentification of their samples, some donors may have concerns about the moral dimensions of research using their biological samples. We used an Internet survey of Michigan residents (N = 683) to determine the effects that information about future possible research uses has on people’s willingness to donate their biological samples under a broad consent. The presentation of research projects that might raise moral concerns for some individuals reduced the number of respondents willing to give a broad consent and reduced confidence in their decision among those still willing to donate. Even so, the great majority (> 85%) remained willing to donate. We discuss the implications of these findings for the consent and information-sharing policies of biobanks.

Read “Do People Care What’s Done with Their Biobanked Samples?” by Tom Tomlinson, Stan A. Kaplowitz, and Meghan Faulkner via thehastingscenter.org.
MSU Library access may be required to view this publication.