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Savir Punia, MJLST Lead Notes and Comments Editor
The Minnesota Journal of Law, Science and Technology Symposium article, The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science, by Professor Susan Wolf, discusses the current issues researchers are facing with genetic testing. At present, there is a dramatic rise in genetic-based research and tissue banks seeking to discover the genetic mutations and disorders responsible for some of the worst ailments plaguing humans today. As researchers are able to gather data using increasingly sophisticated tools, researchers are finding things they are not looking for, including information that could make a big difference for a donor. According to the 2012 New York Times Article, Genes Now Tell Doctors Secrets They Can't Utter, we are at an awkward interval where our ability to capture information is exceeding our ability to know what to do with it.
Currently, the federal government's National Institute for Health (NIH) is funding projects, including Professor Wolf's research project on return of results, in order to develop guidelines in this thorny subject area. Until then, researchers are operating with a heightened nervousness about when and how to disclose research results to study participants or their families. According to Professor Wolf's symposium article, researchers are already expressing anxiety "that they must navigate between legal threat on both sides - liability for failure to return findings on one side, and liability for wrongly returning on the other."
Given the current state, researchers are tasked with dealing with challenging situations on their own. For example, researchers studying genes unrelated to breast cancer notice members of one family have a breast cancer gene, does this obligate researchers to disclose this finding or not. Currently, a lot of this depends on the types of consent forms used in the research projects. For example, the New York Times article discusses to similar situations with very different results. In the first research project investigators discover that a family does have a breast cancer gene, but does not disclose it because the consent form stated no results would be returned, essentially tying the hands of the researchers. In another study, researchers discovered a woman who had a strong family history of breast and ovarian cancer did not carry her family's breast cancer gene, and they decided on ethical grounds to breach their consent forms stipulations in order to inform the woman and her family. These types of situations are becoming an ever increasing problem, and with no guidance or base line rule issued by any public health organization, researchers will continue to get caught up in return of research results.
Genetic research has brought about rapid advancement and change in how we approach human health, but it also has brought about some great challenges. As important as genetic research is, the individual submitting to it must not be forgotten. As genetic researchers sequence whole genomes and discover mutations in research participants' sequences, there will be more of an imperative to communicate those results back in order to help that participant seek preventative care. Moreover, genetics are unique in that mutations in one individual may affect that individual's entire family. Research participants' families have a stake in their family members' genetic sequences, because what is discovered there could also affect their own lives. Whether to return results to family members is a much more controversial issue and includes certain traditional healthcare privacy rules. As genetics continue to grow and play an important part in our healthcare, issues such as the ones above will need to be clarified and outlined. Research in this area is occurring at a fast pace, and Professor Wolf and her colleagues will be watched closely as they work toward establishing guidelines to power genetic research into the future.
by Mike Walls, UMN Law Student, MJLST Staff
What does it mean to be human? Where does our conception of life and death come from? Scholars and writers alike have been toiling with these questions for centuries. Our understanding of the term "human" is often embedded in the culture we grew up in. For some, human may simply mean the physical embodiment of our soul. To them, the human form is no more than just a transitory stage in our soul's celestial journey. For others, the term is specifically defined by our genetic makeup, chromosome for chromosome, allele for allele, etc. However, our legal understanding of "human" has been especially difficult to discern. States have taken many different approaches.
In his article, "Defining the Essence of Being Human," Professor Efthimios Parasidis discusses various states' interpretations of human. Parasidis discusses Ohio's interpretation of human life as beginning when one can detect the fetal heartbeat. For Ohio citizens, life begins with the beating heart, but it is unclear what this definition means for heart-related anomalies in adult-life, such as a person whose heart ceases to pump blood temporarily. Nebraska focuses on whether pain can be detected in the fetus, although the Act glosses over individuals who are incapable of experiencing pain, or fetus's with delayed sensory development. Mississippi's unsuccessful amendment attempted to define "person" as "every human being from the moment of fertilization, cloning, or the equivalent thereof," which left the door open to further criticism. Should splicing human genes with animal genes necessarily discount human-like organisms from our understanding of human? Would a "manimal" have been covered under the Mississippi law? It appears that elsewhere around the world introducing animal genes into the human form is forbidden, whereas human genes introduced into animals is sometimes permitted.
Parasidis' discussion of various states' conceptions of human life involving pain, heartbeats, and fertilization, led him to attempt to answer the question: "What distinguishes humans from other species?" His answer fell into two categories, the anthropological record (Homo sapiens, Homo neanderthalensis, etc.) and genetics. He concluded that both explanations are vague (or at least their boundary lines do more to raise serious questions than to console skeptics).
As I ponder Parasidis' article as a grown-up, the kid in me has found it difficult to set aside my childhood curiosity for science-fiction. What wisdom could I take from science-fiction without getting sidetracked? I turned to Dr. Moreau for answers. In 1896, H.G. Wells published The Island of Dr. Moreau, based on a mad-scientist destined to create half-men, half-animals, through vivisection. Wells wrote this piece without knowledge of genes or modern discoveries in anthropology and human origins. Wells' interpretation of human and animal is both poetic and informative, and his philosophy on scientific inquiry plagued by moral dilemmas speaks through Dr. Moreau.
Astonished by the bestial creatures he saw on Dr. Moreau's island, the weary naturalist Prendrick viewed Moreau as a heartless scientist, detached from the ethical world we live in. In my favorite chapter, Dr. Moreau Explains, Moreau lays out his unadorned view on the commonalities between man and animal. After Dr. Moreau inserts a blade into his own thigh, he states the following:
"Then I am a religious man, Prendrick, as every sane man must be. It may be I fancy I have seen more of the ways of this world's Maker than you--for I have sought his laws, in my way, all my life, while you, I understand, have been collecting butterflies. And I tell you, pleasure and pain have nothing to do with heaven and hell. Pleasure and pain--Bah! . . . men and women set on pleasure and pain, Prendrick, is the mark of the beast upon them, the mark of the beast from which they came. Pain! Pain and pleasure--they are for us, only so long as we wriggle in the dust . . . ."
On the one extreme, Dr. Moreau believed that anything fathomed under the laws of science (and thus, to him, created by God), was permissible scientific inquiry. To him, pain is unmistakably detached from religion--rather it is incidental to experimentation. Moreover, Dr. Moreau believed pain is simply whatever we make of the sensation ("The capacity for pain is not needed in the muscle, and only here and there over the thigh is a spot capable of feeling pain. Pain is simply our intrinsic medical adviser to warn us and stimulate us."). Moreau's religion is his scientific inquiry, completely unfettered from ethical obligations. On the other hand, Nebraska takes the opposite view. Pain is the factor between life and death. But for Nebraskan legislators, is the criterion of inflicting "pain" on a fetus any more of a medical description than it is a moral obligation? Dr. Moreau and Professor Parasidis would probably argue that simply detecting pain is a smokescreen for anti-abortionists. The Nebraskan viewpoint that pain is a medical factor that necessarily dictates abortion rights might be fogging the issue. I struggle to understand some of our states' preemptive abortion policies, as does Professor Parasidis, in their inability to separate conceptions of human life (when pain is felt) from their legal obligations owed to the individual (informed by science).
The point of all this is rather simple. No matter how we decide to determine what is human, or when life begins, public policy should influence how exacting our legal definition of human is. Dr. Moreau wouldn't sacrifice scientific inquiry for the ethical norms of others. To him, everyone else must reconcile their moral differences with science. Professor Parasidis argues that when legislators use descriptive characteristics (like pain) in their legal definitions, they should also consider other policy implications. Besides the fetus, who else is affected? By redirecting our focus to science, we may free ourselves from biases currently clouding our reproductive rights jurisprudence, and potentially answer the question, what is the essence of being human?
by Sabrina Ly
On February 25, 2013, an article was published in The Dartmouth describing the implementation of its Committee for the Protection of Human Subjects. The purpose of the committee is to answer ethical questions and review proposals regarding human subjects participating in research at Dartmouth College. The committee is comprised of experts and community members "who analyze the risk posed to participants by Dartmouth-affiliated researchers' studies." The timing of its creation could be coincidental, but may have been in response to legal action taken against Boston College subpoening confidential data provided by research participants in the "Belfast Project" in 2012.
Prior to interviews taking place as part of the Belfast Project, researchers promised interviewees that their identities and information contained in the transcripts would not be released until after their deaths. However, upon discovering the existence of the transcripts, British law enforcement worked with the U.S. Department of Justice to subpoena the transcripts to use in its criminal proceedings. This raised significant ethical issues pitting the needs of law enforcement against the need for participant confidentiality in certain research that benefits the public.
by Jeremy So, UMN Law Student, MJLSTManaging Editor
On October 28, Australian researchers published new information about the genetic basis for endometriosis, a condition where the cells lining the uterus flourish in other areas of the body. The researchers, instead of recruiting their own research subjects, analyzed samples stored in biobanks in Australia, Japan, and Europe. Because of their approach, the researchers were able to identify common markers that appeared across the ethnically-diverse study population. The Australian team's findings highlight the increasing importance of biobanks--repositories for biological research samples--which have become a valuable resource in the fields of genomics and personalized medicine
by Ryan J. Connell, UMN Law Student, Joint Degree Program Fellow, MJLST Staff
As genetic research continues to develop, researchers are more apt to make incidental discoveries in the course of the research on a subjects DNA. Susan Wolf, Founding Chair of the University of Minnesota's s Consortium on Law and Values in Health, Environment & the Life Sciences, points out in her article "The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science," that, with this development, there is a serious question that must be asked, but that the law does not really answer: do researchers have to report these incidental findings to the subject?
by Emily Puchalski, UMN Law Student, MJLST Notes & Comments Editor
As scientific research and technological advancement abound in our modern world, often times the law struggles to keep up. The law's struggle to keep up is evident in debates centering on defining personhood. The question of what it means to be a person/human involves the controversial issues of abortion and evolution, which have divided our nation for decades. Although scientists are helping our understanding of what being human means by studying life at its most basic, controversy abounds regarding not only the results of the studies but also the theoretical underpinnings of even allowing the studies. As our nation becomes more polarized between conservative and liberal thinkers the struggle of defining personhood has come to the forefront in politics.
by Ude Lu, UMN Law Student, MJLST Staff.
GMOs, genetically modified organisms, have long been a part of our daily diet. For example, most of the soybeans and corn on the supermarket shelves are GMOs. Currently, the issue of whether these GMOs should be labeled so that customers can make informed purchases is in a heated debate in California. California Proposition 37, which would require labeling of GMOs, will soon be voted in November this year. Proponents from both sides have poured millions of dollars into the campaign.
by Keli Holzapfel, MJLST Student Editor-in-Chief
Given the importance of results discovered by biorepositories and their implications for an individual's health care choices, I believe that the individual has the right to receive his results despite their lack of verification. However, this right to receive results should be premised upon the individual's explicit consent to receive his results, and upon the understanding that by receiving these results, the burden of their verification shifts from the biorepostory to the individual.
Professor Susan Wolf, Founding Chair of the Consortium on Law and Values in Health, Environment & the Life Sciences (which oversees and manages MJLST) discusses the latest bioethical concerns related to in vitro fertilization (IVF) on Minnesota Public Radio's The Daily Circuit program (click play button below):
In related content, MJLST Issue 10.1 included an article by Debora Spar, author of The Baby Business: How Money, Science and Politics Drive the Commerce of Conception and attorney Anna M. Harrington entitled "Building a Better Baby Business" that offers a road map to ensuring quality and equity in the reproductive technology industry.
For insights into understanding legal responses to technological change, using in vitro fertilization as an example, see Understanding Legal Responses to Technological Change of In Vitro Fertilization, by Lyria Bennett Moses in MJLST Issue 6.2.