Tag: biospecimen

Tomlinson and De Vries: “Human Biospecimens Come from People”

Tom Tomlinson photoCenter Professor Dr. Tom Tominson and co-author Raymond De Vries have an article in the March-April 2019 issue of Ethics & Human Research, “Human Biospecimens Come from People.” The issue’s theme is “The Scientific Value and Validity of Research.”

Abstract: Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collected during medical care. Individuals differ in the kinds of risk they find concerning and in their willingness to permit use of their biospecimens for future research. For this reason, asking their permission for unspecified research uses is a fundamental expression of respect for them as persons and should be done absent some compelling moral consideration to the contrary. We examine three moral considerations and argue that each of them fails: that there is a duty of easy rescue binding on all, that seeking consent creates a selection bias that undermines the validity of biospecimen research, and that seeking and documenting consent will be prohibitively expensive.

The full text is available online via Wiley Online Library (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.

NIH research grant awarded for project led by Tom Tomlinson and Raymond De Vries

tomlinsonTom Tomlinson, PhD, recently received a research grant from the National Human Genome Research Institute, NIH. Titled “Public Preferences for Addressing Donors’ Moral Concerns about Biobank Research,” the project is being led by Tomlinson and co-PI Raymond De Vries, PhD, of the University of Michigan.

To date, the dominant research ethics framework has focused on protecting research participants against the risks to their welfare that might be created by their participation in health research. This 3-year project is concerned with a different kind of “risk”—the risk that donated, de-identified biospecimens and health information might be used in research that is contrary to the donors’ moral, social or religious beliefs or values. How much do such concerns matter to people’s decisions whether to contribute specimens to research biobanks using a “blanket consent,” that gives one-time permission to use the contribution in any way the biobank deems acceptable? How should information about biobank-supported research projects be provided to potential donors? These and other questions will be answered using a nationally representative survey, coupled with a series of democratic deliberations that ask members of the public to develop recommendations for biobank policies regarding these issues. For more information, click here.

This project continues a line of research that Dr. Tomlinson began in 2010.