Ethics

What Does It Mean to Be Human?

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?


Subpeona of Data Provided by Research Participants Under Confidentiality Agreement Raises Concerns

by Sabrina Ly

Thumbnail-Sabrina-Ly.jpg 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.

The problem of subpoenaing confidential human research information is further elaborated in an article recently published in Issue 14.1 of the Minnesota Journal of Law, Science and Technology. In Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice, Wolf, et al., discuss the importance of enforcing a certificate of confidentiality in human research studies. Confidentiality in order to obtain information from human subjects during research is vital to progression and understanding in health, science and many other fields. Often research requiring a promise of confidentiality involves difficult and controversial subjects that would be nearly impossible to study without an assurance of confidentiality.

A certificate of confidentiality encourages individuals to volunteer information they might not otherwise be willing to disclose by protecting their identity and privacy. By breaking the promise of confidentiality, the subpoenaing of the “Belfast Project” threatens academic freedom, and may deter future research participants from providing accurate personal information. Such reluctance to provide information could harm the work of researchers who might otherwise advance understanding and provide valuable insights on difficult issues. One example in which research is difficult without confidentiality is the willingness of individuals to share information about their sexuality, sexual behaviors, or drug-using behaviors. In past studies, researchers have been able to use this information to derive how HIV spread and implement methods to prevent the spread.

The broad benefits to society of upholding academic freedom, the right to privacy, and freedom of information, far outweigh any claim law-enforcement may have to subpoena confidential research data. While an individual prosecution may be important, the damage caused by allowing such a breach of confidentiality could greatly hinder society-benefiting research. The importance of enforcing certificates of confidentiality to prevent the criminalization of human research subjects is significant.

Boston College has filed a petition for a writ of certiorari in the Supreme Court to appeal the First Circuit’s ruling upholding the subpoenas.


To Serve or Not to Serve the Shareholders; That Is the Question

by Maya Suresh, UMN Law Student, MJLST Staff

Thumbnail-Maya-Suresh.jpgHikma Pharmaceutical Company recently received the 2012 Client Leadership Award of the International Finance Corporation (IFC) due to its strong commitment to the community and leadership in the Pharmaceutical Industry. The award is given to companies that display this commitment through a variety factors, including strong corporate governance. As the biggest pharmaceutical manufacturer in the Middle East, Hikma has helped the public by providing affordable and lifesaving medicines to those in need. The CEO of the IFC lauded the corporation for setting the standard for corporate social responsibility within the industry.

The importance of these actions taken by Hikma was the basis for Martin Hirsch’s article, “Side Effects of Corporate Greed: Pharmaceutical Companies Need a Dose of Corporate Social Responsibility,” published in Issue 9.2 in the Minnesota Journal of Law, Science & Technology. The article talks about the tension that exists between the shareholders of pharmaceutical companies and the public the companies strive to serve. The shareholder model of corporate governance focuses on maximizing shareholder profit which often results in the production of lifestyle drugs over drugs that cure life threatening diseases. Lifestyle drugs include medicines for baldness and toe fungus that are in high demand and thus, sold for large profits. However, the lifesaving drugs, that are the most needed, are the ones the pharmaceutical companies refuse to produce. These drugs are mostly in demand by those living in poorer regions of the world. However, they typically cannot afford the high price point the pharmaceutical companies set the drugs at. Thus, the drugs are not bought, even though they are desperately needed, which leads the pharmaceutical companies to stop investing money into developing and producing them.

Hirsch argues that some companies take these actions further by influencing doctors’ diagnoses of patients, in an effort to increase the sales of higher revenue generating drugs. The actions of Hikma could lead consumers to believe that there is hope for the public, and that some companies are beginning to take a stand on this skewed model that has plagued the industry. However, some companies continue the practice of producing lifestyle drugs, versus lifesaving drugs.

WebMD has come under recent criticism for succumbing to that pressure when it should be serving as an objective medical resource for the public. A rigged online test for depression led test takers to believe they may be at risk for depression, when in fact they were not. This served as the perfect example of companies working to serve the BigPharma industry rather than the public. Unfortunately, as Research Associate Rallis asserts in the article, WebMD has no plans to alter its business model and as such, won’t be breaking ties with the industry anytime soon.

There appears to be some hope that the tension within the industry will resolve itself as the actions by Hikma will hopefully rub off on others in the industry. However, it is also clear that there is still work to be done.


Biobanks Revisted

by Jeremy So, UMN Law Student, MJLSTManaging Editor

Thumbnail-Jeremy-So.jpgOn 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

The increasing importance of biobanks was recently highlighted in a symposia sponsored by MJLST. In the accompanying Spring 2012 issue, researchers and lawyers discussed the one of the primary problem facing researchers who use biobanks: whether to return research results and incidental findings to research participants.

While the Australian researchers have decided to track down the original participants in order to share their findings, other researchers have hesitated to use the same approach. Karen J. Maschke highlighted several such reasons in her recent article “Returning Genetic Research Results: Considerations for Existing No-Return and Future Biobanks.” In the article, Maschke focuses on the approaches of American biobanks researchers, who generally do not share their results with individuals whose DNA was analyzed.

For American researchers, Maschke notes that samples stored for biobank research are regularly deidentified, making it difficult to impossible to contact the original donor. Such a system exists in part because of concerns over whether consent would be granted for samples to be used in certain types of research. Combined with conflicting interpretations of government regulations and other difficulties in actually returning sample results, researchers have hesitated to adopt a disclosure-based system for research results.

Although some may remain hesitant, cooperation between researchers and biobank participants has not necessarily led to negative outcomes.

The importance of resolving this conflict is highlighted by the increasing prevalence and importance of biobanks to scientific research. Several countries are working on expanding their biobank networks. Now, before competing standards come to dominate the field, a uniform system for the return of results should be determined and implemented.


Incidental Findings: It’s My DNA, and I Want to Know if Something Is Wrong With It.

by Ryan J. Connell, UMN Law Student, Joint Degree Program Fellow, MJLST Staff

Thumbnail-Ryan-Connell.jpgAs 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?

Is this something that necessarily must be addressed by the law? I think so. Researchers need guidance on this front. Right now if a researcher finds something that may or may not have adverse health consequences for a subject the researcher must balance competing interests. What if they do disclose the risk? Is a pure researcher qualified to evaluate medical risks? The researcher could be very wrong in their analysis; could a subject who was told that they might be at risk for a serious health problem, but was not, hold a researcher liable for emotional stress? On the other hand, if a researcher comes across some potential risks and does not tell the subject, and the subject suffers as a result, should the researcher be liable?

I think the answer to this problem lies in waivers. Before people make themselves subject to research they should sign a waiver to either not hold a researcher liable for any incidental findings reported, or agree to not receive any information about any incidental findings.

This really should be the patient’s decision. Some geneticists think that it is better not to let people know if they have a risk for Huntington’s disease, or Alzheimer’s disease because there are no interventions. Likewise some geneticists feel that they would only report a risk of cancer if it is specifically requested.

From my point of view, if my genes are used for research and the researchers find that I am at risk for something, I want to know. I don’t care if there is nothing that I can do about it; I should know about it. My personal view is not shared however, some feel like they want to contribute to research, and then they don’t want to be bothered again.

This is a complicated issue with no clear solution. How do you feel? Do you want a researcher to tell you if they think you are at risk? Would you hold a researcher liable if they mistakenly told you that you were at risk for a horrible disease? Or would you be more likely to hold a researcher liable for not telling you that you were at risk for a disease? Do you think a waiver, or some other agreement is necessary between a researcher and a subject before any research is conducted?


Unlocking the Abortion & Evolution Debates:Defining the Essence of Being Human

by Emily Puchalski, UMN Law Student, MJLST Notes & Comments Editor

Thumbnail-Emily-Puchalski.jpgAs 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.

In his recent article in the Minnesota Journal of Law, Science & Technology, Defining the Essence of Being Human, Efthimio Parasidis contemplates how science could aid the law in attempting to define a person and looks at modern examples of the personhood debate. One of the examples Parasidis describes are personhood amendments that are often backed by anti-abortion groups seeking to have life defined as beginning at conception. These so called personhood amendments have begun to spring up in various states and in many instances the groups attempt to get them on ballots for the public’s vote. Interestingly, after Parasidis’s publication an attempt in Ohio to define life as starting with fertilization failed to get the requisite number of signatures to get on the ballot.

The failure of Personhood Ohio to get the requisite number of votes could foreshadow a big issue in the upcoming presidential election, because Ohio is a battleground state for the by all accounts close presidential race between Obama and Romney. Whether the failure of the amendment signals trouble for the Romney-Ryan ticket is unknown. Interestingly, Romney’s position on abortion has been he opposes abortion except in cases where it may be required for the mother’s health or the pregnancy was the result of rape or incest. While Ryan seems to have tempered his pro-life views during the election.The Romney-Ryan ticket is in a difficult place trying to win the conservative vote while still trying to win Ohio where enough signatures were not garnered.


Unlocking the Abortion & Evolution Debates:Defining the Essence of Being Human

by Emily Puchalski, UMN Law Student, MJLST Notes & Comments Editor

Thumbnail-Emily-Puchalski.jpgAs 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.

In his recent article in the Minnesota Journal of Law, Science & Technology, Defining the Essence of Being Human, Efthimio Parasidis contemplates how science could aid the law in attempting to define a person and looks at modern examples of the personhood debate. One of the examples Parasidis describes are personhood amendments that are often backed by anti-abortion groups seeking to have life defined as beginning at conception. These so called personhood amendments have begun to spring up in various states and in many instances the groups attempt to get them on ballots for the public’s vote. Interestingly, after Parasidis’s publication an attempt in Ohio to define life as starting with fertilization failed to get the requisite number of signatures to get on the ballot.

The failure of Personhood Ohio to get the requisite number of votes could foreshadow a big issue in the upcoming presidential election, because Ohio is a battleground state for the by all accounts close presidential race between Obama and Romney. Whether the failure of the amendment signals trouble for the Romney-Ryan ticket is unknown. Interestingly, Romney’s position on abortion has been he opposes abortion except in cases where it may be required for the mother’s health or the pregnancy was the result of rape or incest. While Ryan seems to have tempered his pro-life views during the election.The Romney-Ryan ticket is in a difficult place trying to win the conservative vote while still trying to win Ohio where enough signatures were not garnered.


Got GMOs?

by Ude Lu, UMN Law Student, MJLST Staff.

Ude-Lue.jpgGMOs, 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.

GMOs are plants that have been genetically engineered to be enhanced with characteristics that do not occur naturally, so that the harvest can be increased and the cost can be lowered. One example of a prominent GMO is soybean. Monsanto–a Missouri based chemical and agriculture company–introduced its genetically modified soybean, Roundup Ready, in 1996. Roundup Ready is infused with genes that resist weed-killers. In 2010, 93% of soybeans planted in the United States were Roundup Ready soybeans.

Although GMOs are one of the most promising solutions to address the sustainability of food supply in view of the growing global population, there are concerns in the public regarding their safety, and confusion as to which federal agency has responsibility for regulating them.

Amanda Welters in her article “Striking a balance: revising USDA regulations to promote competition without stifling innovation” published in the Minnesota Journal of Law, Science, and Technology explains the current regulatory scheme of GMOs. Three primary agencies regulate GMOs: the Food & Drug Administration (FDA), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA). The FDA regulates GMOs in interstate commerce that are intended to be consumed by animals or humans as foods, the EPA monitors how growing of GMOs impacts the environment, and the USDA assesses the safety of growing GMO plants themselves.

Specifically, the Animal and Plant Health Inspection Service (APHIS) in the USDA is responsible for ensuring crops are free of pests and diseases. APHIS is currently in the process of revising its regulations for GMOs in an attempt to improve transparency, eliminate unnecessary regulations and enhance clarity of regulations. Under the proposed regulations there will be three types of permits for GMOs: interstate movement, importation, and environmental release.

Taking the position that GMOs are generally beneficial and unavoidable, Welters suggests that the USDA should frame a regulatory structure similar to the Hatch-Waxman Act and the Biosimilar Act to promote both innovation and competition. Readers interested in the regulatory issues of GMOs and the balance between the interests of patent innovators and generic follow-ons would find Welters’ article informative and insightful.


An Individual Right to Return of Research Results

by Keli Holzapfel, MJLST Student Editor-in-Chief

Keli-Holzapfel-Thumb-White-Back-II.pngGiven 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.

Biorepositories are collections of biospecimens that are tested and analyzed for scientific purposes. The testing performed on these biospecimens has become the basis for development of various molecular tests, which is becoming critical for the shift toward personalized medicine. Therefore, as technology advances, the quality and management of biorepositories is becoming more important. This is especially critical for the return of accurate patient data resulting from biospecimen analysis. However, managing and conducting a biorepository in the way necessary for return of results can be very complex and expensive. There must be many measures in place to prevent mistakes in identification and to ensure the quality of the biospecimen being tested. Currently, there are many existing biorepositories that do not meet the needed Clinical Laboratory Improvement Amendments (CLIA) standards for return of results. For an in-depth discussion of the current state of biorepositiories and issues surrounding return of results, see the article “Perspective on Biorepository Return of Results and Incidental Findings” written by Steve Jewell. For an example on what biorespositories need to do to improve their management and specimen oversight, see the College of American Pathologists, Accrediation Information.

As alluded to above, some of the important questions that arise from the return of results to an individual are inherently linked to the reliability of the result. For example, what should be the necessary standard for a result to be returned to the individual? Is the current threshold for returning results too high? As mentioned, many biorepositories do not meet the necessary guidelines for CLIA certification, which is required for returning of results. This means that potentially critical information is not shared with the individual involved. Is this ethical? Should biorepositories that discover critical information be required to return results to an individual even though the results are not CLIA certified? But if the results are wrong, is the emotional distress that may ensue from the return of results as unethical as withholding the results?

Due to the current state of biorepositories, and the huge implications that return of results may have, I think the best solution is to allow for consent-based return to an individual, with the understanding that any returned result needs to be independently CLIA certified. Therefore, only individuals who consent to receive results would get them, the individuals would receive the results with the understanding they could be incorrect, and then further testing would be done to validate the results to the necessary high standards. For additional in-depth discussion of issues surrounding CLIA and non-CLIA certified return of results, see “Ethical and Practical Guidelines for Reporting Genetic Research Results To Study Participants: Updated Guidelines from an NHLBI Working Group.”

For other insights and recommendations regarding return of research results, see MLST’s Winter 2012 symposium issue, “Debating Return of Incidental Findings and Research Results in Genomic Biobank Research–Law, Ethics, and Oversight


Bioethic Concerns 34 Years After 1st Test Tube Baby

mjlst-logo-button.pngProfessor 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.