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January 21, 2013 | Posted By Zubin Master, PhD

Biobanking involves the collection and long-term storage of biological material (e.g., cells, DNA, tissue, blood) and health information (medical history, age, weight, diet, lifestyle). Biobanking permits the examination of genetic and other biological markers on thousands of samples at a time in a given population. Thus, there has been a tremendous amount of interest by scientists, clinicians, and even bioethicists on biobanking. It has been touted as the next frontier expanding on the work done with genomics and proteomics. The value of biobanking research is that although the samples and health information are collected at some point and stored, they can be used for future research when new biomarkers are discovered. Many if not most bioethicists have explained that biobanking risks are pretty low. Risks surrounding privacy can be protected so long as proper measures are in place. As sample collection involves a blood draw or collecting tissue as part of routine care, there is also low risk of physical harm to participants. Because of the scientific and social value of biobanking and its potential minimal harms to participants, many scholars have explained that a broad or blanket informed consent procedure is suitable. According to biobanking advocates, broad consent (consent to certain broad categories of research i.e., cardiovascular or cancer research) or blanket consent (consent to all research or any medical research) is both ethically and legally permissible because re-consenting to each and every future study is resource intensive and burdensome, and there is little harms to participants and privacy risks can be protected. So what’s the problem?

Well there are several issues that need to be better addressed:

1) For starters, informed consent in Western bioethics requires that information of the study such as the objective, methods, risks and benefits be provided to participants in order for individuals to make an informed choice on whether they wish to participate or not. Thus a broad or blanket consent cannot provide all of this information simply because these parameters are likely to change when new future studies are being done. In this sense, is broad or blanket consent a true informed consent?

2) There is risk! Although the physical risks to participants are pretty minimal, there are social risks to both individuals and to society. There are risks of stigmatization and discrimination of certain cultural, racial or illness groups. This can be seen in the well-known Havasupai case. Researchers at Arizona State University (ASU) collected and used samples for diabetes research from the Havasupai tribe who had a higher prevalence of diabetes. As the consent obtained was general, scientists began to perform research for inbreeding, schizophrenia, and traced the evolutionary ancestry of the tribe. This caused the tribe to sue ASU and ASU settled by issuing a formal apology, returning samples, and paying the tribe. Certainly this type of research could be stigmatizing and discriminating. Other research surrounding alcoholism and many mental and psychological disorders known to have some genetic influence can also be stigmatizing.

3) Different publics have different levels of trust in different stakeholders. There are several studies that clearly show that the general public has greater trust for physicians and scientists that work in certain social institutions than others. E.g., scientists working in public institutions like universities or hospitals are more trusted than those working for government or private industry. The differing levels of trust can also be seen in a case on biobanking. In Texas, the Department of Health and Human Services collected blood samples to do newborn screening but retained them without obtaining permission. This resulted in a class action suit against the government resulting in the destruction of more than 5 million samples. What is interesting about this case is that several parents simply did not trust “big brother” to keep samples. And this makes sense. Biobanking samples can also be used for criminal profiling. Many in the public may be unaware of the uses of biobanked samples or simply don’t want them to be kept in institutions they trust less.

4) There are several public perception studies that show that many people desire some form of control over their samples and health information. They don’t want it to be freely shared with other biobanks or to be used for research they don’t approve of. Should we not consider the wishes of those that desire greater control over their samples and health information? Some have applied public health ethics principles to biobanking calling it a public good and it is thus mandatory for its citizens to participate in unless they actively opt out. Although in cases of public health emergencies certain research ethics norms may be bypassed, but is biobanking really a public health concern or is its value undeniable that samples must be banked without re-consent?

5) The last theoretical concern is that perhaps even deidentifying or anonymizing samples will not protect people’s privacy. Given some health and demographic information associated with a sample may be available, and that genetic codes are unique to individuals, could it be possible to identify people who have participated in biobanking projects?

To summarize, the idea of informing participants is important even if risks are low. Moreover, scientific and social value of research does not trump informed consent and people should be given the opportunity to fully exercise their individual autonomy. Bioethics scholars need to figure out ways that can minimize the risks associated with biobanking while allowing the science to move forward.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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