Legal Issues Relating to Stem Cell Research

By Girish Deepak, National University of Advanced Legal Studies, Kochi

Editor’s Note: Stem cell research is a field of biotechnology which can even cure neuro-degenerative diseases which presently have no cure. Embryonic stem cell research is the most effective in this respect. However, the question of human rights comes in, as the embryo does not survive due to the stem cell research. This paper analyses the legal aspect connected with stem cell research.

Introduction

Human beings have, since time immemorial, found an unnatural appeal towards increasing their life span and improving the quality of living. It is this allure towards the promise of a better life that has lead to the advancement in the field of medicine.

This development from a hesitant use of plants and herbs to alleviate the pain experienced by ancient people which hailed the medicinal properties as magical and the labelling of innocent doctors as witches, carrying out the work of the devil. Since those times, medicine has constantly improved and evolved; from the lowest of points to the use of extremely advanced technologies to cure undreamt of diseases. This gradual evolution has spanned over decades leading to the present medicinal availability. Add to that the innovation in the field of technology, and its application in the biological discipline; many doors are opened to those who would want to ease the pain and suffering of the people on earth.

But like anything else, sometimes this research under the name of science crosses the line of ethical and moral issues. In times like these it is necessary for us to come up with a few basic rights to protect the best interests of humans. Hence Human rights, as they are rightly called, are “commonly understood as inalienable fundamental rights to which a person is inherently entitled simply because she or he is a human being.”  These human rights provide us with the necessary safety net to prevent any violation of what are seen to be inalienable rights, be it any cause or reason, crossing them would be against what the human race stands for in terms of dignity and equality of human beings. It also prevents the immorality of society which would otherwise have been caused.

Stem Cell Research

The advancement in science and technology has been incredible in the past few decades. The breakthroughs in the field of biology alone have been remarkable. Add to that the findings in the medicinal field and the touch of technology; unimagined doors stand open to us, to delve into the spheres of biomedicine and biotechnology, which hasn’t yet been tapped to its full potential.

Stem cell research is one of the latest aspects that have come to light in the field of biotechnology. It has had an enormous impact in the medicinal. With this new development it promises to cure even neuro-degenerative diseases like spinal cord injuries, Parkinson’s and Alzheimer’s.

Under stem cell research there are several different types of research being covered. Some of the research being carried out include embryonic stem cell research, adult stem cell research etc. Human embryonic stem cell research has always been a debatable issue, because of its potential ramifications as a violation of human rights. The issue of whether it is an act of morality, to kill an unfertilised embryo in order to possibly save many is the biggest question.

History of Stem Cell Research

The establishment of this branch of science began with the work of Toronto scientists Drs. James Till, a biophysicist, and Ernest McCulloch, a haematologist, published accidental findings in “Radiation Research” that proved the existence of stem cells, cells that can self-renew repeatedly for various uses. Both of them worked for the Ontario Cancer Institute (OCI) at the time.

This form of research has a very recent history and is a fairly new branch of science having only about 50 years. But it has yet shown tremendous progress and has very large potential.

Stem cells have been successfully used to treat several neuro degenerative diseases such as

  1. Parkinson’s disease
  2. Alzheimer’s
  3. Spinal Cord injuries
  4. Regeneration of damaged organs

Procedural aspects of stem cell research

To fully comprehend the implication of such a question, it is necessary for us to first understand the process of human embryonic stem cell research.

Embryonic stem cells, prima facie, are a valuable resource because of what scientists claim to be a treasure trove of previously unknown cures. They are the basic foundational cells of the body. Moreover, they are also pluripotent, which gives them the ability to differentiate into specialised groups of cells later in their stages of development.

Human embryonic stem cell (HESC) research offers much hope for alleviating the human suffering brought on by the ravages of disease and injury. HESCs are characterized by their capacity for self-renewal and their ability to differentiate into all types of cells of the body. The main goal of HESC research is to identify the mechanisms that govern cell differentiation and to turn HESCs into specific cell types that can be used for treating debilitating and life-threatening diseases and injuries.[i]

Embryonic stem cells are mainly derived from human embryos. These embryos develop into blastocysts, 4 – 5 days after fertilization. During this time, around 50 – 150 cells are present. The human blastocyst is then destroyed and the parts are divided. The different parts of the cell are differentiated into the inner cell mass and the extra-embryonic tissue and are separated. These inner mass cells are then placed in a Petri dish and allowed to grow/multiply until a stem cell line is established. For the differentiation to take place, the line is removed from the supporting cells and then co-cultured or grafted. When the stem cells are removed from the human blastocyst, the blastocyst is left dead without being able to complete its maturation process. HESCs are derived from donated embryos which would otherwise have been discarded. The following image gives a clear idea of how the process takes place.

400px-Stem_cells_diagram

[ii]

Tracing the issues of Stem Cell Research

This branch of research has always been fraught with several debates on issues regarding to funding and the legal and moral aspects of this type of research. In USA in particular Stem cell research has remained a constant issue of controversy since its discovery. This can be traced very astutely as follows:

  • In 1974, the Congress Banned nearly all federally funded fetal tissue research until the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, established by the National Research Act, devised guidelines for it.
  • In 1975 an Ethics Advisory Board was established, whose guidelines were to look into the issues regarding fetal and fetal tissue research that originate from abortions.
  • In 1980, President Reagan Killed the Ethics Advisory Board, leading to a de facto moratorium halting federal funding of human embryo research due to the EAB’s disbanding.
  • In 1988, though, the Federal Panel Approved Funding of Embryo Research after a lengthy debate on its merits and demerits.
  • In 1990, President George H.W. Bush Vetoed the Bill Lifting Moratorium, thus denying funding to stem cell research.
  • Finally in 1993, President Clinton by an Executive Order Lifted the Moratorium but subsequently again reversed it in 1994 due to extensive public outrage and pressure.
  • In 1995, the Dickey-Wicker Amendment, named after its sponsors Jay Dickey  and Roger Wicker, a Congress measure which prohibited the use of federal funding to embryonic research purposes as the use of human embryos was seen as a violation of human rights, was enacted.
  • In 1998, James Thomson Isolated Human Embryonic Stem Cells, This discovery also initiated the ethical debate on human embryonic stem cell research because his team derived the stem cells through a process that destroyed human embryos.
  • In 1999, HHS Legal Opinion certified Research on hESC Lines as according to NIH standards the Dickey-Wicker amendment did not apply to federal funding for research on embryonic stem cells because the cells did not meet the statutory definition of an embryo.
  • In 2001, President Bush Prohibited Federal Funding of Human Embryonic Stem Cell Research, but his policy did not affect research in the private sector or research conducted with state funding.
  • In 2005, National Academies Releases “Guidelines for Human Embryonic Stem Cell Research”, setting guidelines and requirements for stem cell research.
  • In 2007, Yamanaka and Thomson Independently Derived iPS Cells, Shinya Yamanaka of Kyoto University and James Thomson of the University of Wisconsin-Madison both published papers on their separate discoveries of induced pluripotent stem cells. These pluripotent cells were created from skin cells that had four genes inserted into them with viruses. This procedure resulted in the skin cells acquiring properties similar to embryonic stem cells. Researchers then coaxed these so-called iPS cells into becoming beating heart cells and nerve cells.
  • In 2009, President Obama Reversed George W. Bush’s 2001 Executive Order, and thus removed barriers to Responsible Scientific Research involving Human Stem Cells.
  • In 2010, Advanced Cell Technology Won FDA Approval To Test Stem Cell Therapy For Degenerative Eye Disease, Regenerative medicine company Advanced Cell Technology received federal approval from the US FDA to begin a multi-centre clinical trial that tests human embryonic stem cell treatment on patients with Stargardt’s Macular Dystrophy, a disease that causes blindness. The trial ended successfully with no signs of side symptoms and proved the treatment to be safe. Two patients also showed signs of improvement in vision.
  • In 2012, the Court of Appeal upheld federal funding of embryonic stem cell research, a senior US appeals court ruled on August 24, 2012 that the US National Institutes of Health (NIH) is legally able to fund research based on human embryonic stem cells. The decision was made by a three-judge panel of the US Court of Appeals for the District of Columbia Circuit and upheld a 2011 decision by a lower court, which found that the NIH’s funding of the research was legal despite a 1996 law (Dickey-Wicker Amendment), passed by Congress, which previously forbade funding research in which human embryos are destroyed.

This is not only the case in the US, the whole of the European Union has had severe deliberations on this. In a vote for funding future medical developments in terms of research grants the EU’s 54bn euro (£37bn) research budget for 2007-13, is of special encouragement. This will give stem cell research ample funds to continue forward and create breakthroughs.

The EU’s 25 member states take different regulatory positions on human embryonic stem cell research, reflecting the diversity of ethical, philosophical and religious beliefs throughout Europe. These differences are reflected in the laws of each country.

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Ethical Questions Raised

Despite its assurance for the advancement in biomedicine, HESC research has been met with very strong opposition. This takes root in the ethical dilemma that an embryo has to be destroyed in order to further the research; ergo a human life is being destroyed. Many who oppose this research see the destruction of embryos as being unforgivable.

Because these stem cells are a necessary part of the embryos development, isolating the hESC necessitates the destruction of the embryo, which turns what was beautiful into a disgrace”.[iii]

If seen from a completely consequential point of view, the supposed wonders that are to be gleaned from the HESC research almost always outweighs the cons of such a thing being carried out.

But it is morally impermissible to intentionally kill human beings. And many believe the embryo that is being destroyed to be a human being. Hence by logical conclusion of that argument, it is morally impermissible to destroy a human embryo. It is weighed in the same way as abortion of foetuses and seen as murder by many. It is considered a sacrilege by them to “kill” embryos, even though they would otherwise have been discarded as the couples who donated them no longer wanted the said embryos.

Here, on one side the human embryo is seen as the precursor to a human being, the future of human species. It is supposed to be treated with respect and the question of destroying such a human embryo is unthinkable.

On the other hand, the embryo is seen as being too rudimentary to give it the status of a human being. It cannot be believed to have been breathed with life if they are not fully developed. Hence, it is not possible for these embryos to have rights and interests. The opposition, according to them, will just hinder the scientific development which will in fact be helping millions save their lives in the future.

In the view of James Thomson, the first scientist to isolate and culture embryonic stem cells in June 2005,responding to the question of how he feels about the moral implications of using components of human life for future embryonic stem cell research, in an interview with MSNBC’s Alan Boyle:

“The bottom line is that there are 400,000 frozen embryos in the United States, and a large percentage of those are going to be thrown out. Regardless of what you think the moral status of those embryos is, it makes sense to me that it’s a better moral decision to use them to help people than just to throw them out. It’s a very complex issue, but to me it boils down to that one thing.”

Conclusion with possible solution

Another viable option in the development of stem cell research is the use of adult stem cells. With the advent of modern technology, it is now possible to convert adult stem cells into a form which mimics the behaviour of embryonic stem cells. These cells known as induced pluripotent stem cells (iPS) have been seen to be able to have the ability to differentiate into most other cell types, which is typical of embryonic stem cells.

This research has generally been carried out outside India, where the use of a child for research is seen as a taboo. Children are seen as the gift of God, and hence their use for what is essentially seen as “cutting up and being experimented on” is considered blasphemous.

There have been several cases in the US Supreme Court in which this issue has been debated repeatedly. The main problem faced by stem cell research is funding for its activities. The apex authority in the US has on multiple occasions supported the stem cell cause. Stumbling upon for an answer, because of its potential moral and ethical ramifications they have ultimately decided that the benefits of this research far outweigh the discomfort caused.

In the matter of funding the National Institutes of Health (NIH) has played a pivotal role. They have for a long time been advocating the cause of stem cell research. Various US Presidents have had varying responses to this issue. George .W. Bush, in his tenure he decided to allow stem cell funding by the NIH but at the same time removed lines of direct federal funding for the project. This was received very ambiguously by both the sides of the stem cell war. On one hand it did not stop the stem cell project, but at the same time it did not allow the research to progress in full throttle. It was an attempt to appease both sides and ultimately could satisfy neither.

This was followed by the tenure of Barack Obama who, at the outset itself showed staunch support to stem cell research and accordingly made several reforms which gave stem cell research the free reign it so desperately needed. This was done in the general consensus of the American society and was thus seen as an overall positive move.

New challenges will arise as ESC-based treatments are tested on a wider basis and come to be accepted as safe and effective treatments for many medical situations. A major challenge will be to ensure that they areavailable to patients of all means. This is a questionof the payment system for health care. Persons with means may be able to obtain experimental treatmentsbefore others. But if ESC-based treatments are shown to be safe and effective, then they will be part of ordinary care and covered to the same extent and with the same limitations as are other treatments.[iv]

Another issue will be to respect the views of persons who morally object to destroying embryos in research or using them in treatment. Right-to-life pro activists may object to receiving treatments using ESCs or their derivatives. ESC-derived treatments should be labelled as such so that persons with conscientious objections to their use may decline them for themselves. It would not follow, however, that they should have a legal rightto decline them for minor children or incompetent persons over whom they have decisional authority becausethe best interests of those patients would take priority. Limits will also need to be set on the right of doctors, nurses, and other health care providers to refuseto deliver or participate in treatments because they involve ESCs or have been derived from them. Some treatments may be so far removed from direct use of stem cells that their right of refusal does not come into play. In other cases the obligations as doctors, nurses, and health care providers must give way to the needs of patients dependent on their services.

After over 10 years of debate and controversy with ESCs,the ethical issues have now been thoroughly aired and the path is open to rapid development. Ethical issues will remain, but they are the issues that arise in bringing any new discovery out of the lab into clinical research and then clinical use. Differing perceptionsof the moral status of the early embryo will still be important, but they appear no longer to be the major stumbling block that they have been. One can be more optimistic than earlier that the long-awaited payoffs from ESC discoveries may eventually come to pass.

To summarise the discussion in this article, it can be said that while there has been a severe debate on the ethical, moral and legal aspect of the use of stem cells as a potential cure, it is hard to ignore its potential benefits. In the current scenario where the embryo must be destroyed in order to obtain the stem cell, it is advisable to look for an alternate resolution to this.

The alternate resolution can be found in the form of “induced pluripotent stem cells” (iPSC’s), this is a form of reprogrammed cell. It reduces the destruction of human embryos by instead using adult stem cells and changing their characteristics to suit those of Human embryonic Stem Cell (hESC). This new advent though untested, if successful will open the gates to a new era, providing a cure for some of the incurable diseases of now.

And to answer the primary question of this article,

“Whether the killing of embryos is a violation of the basic and fundamental rights, the right to life”

The answer to this question is clear. If the killing of an unfertilised embryo helps save the life of another being, it doesn’t seem too ethically wrong. This research provides an opportunity to cure countless and ease the pain of the many that suffer from potentially incurable ailments.

The problem for funding for this research is also being solved now and it seems like people are finally beginning to accept the potential of Stem Cells.

‘Nothing that you do in science is guaranteed to result in benefits for mankind. Any discovery, I believe, is morally neutral and it can be turned either to constructive ends or destructive ends. That’s not the fault of science.’

-Arthur W. Galston

Reference List

  1. Siegel Andrew, “Ethics of Stem Cell Research”, The Stanford Encyclopedia of Philosophy (Spring 2013 Edition), Edward N. Zalta (ed.),

Found at : http://plato.stanford.edu/entries/stem-cells/

  1. Anonymous, “Human Embryonic Stem Cell Research (hESR)”, Lousiana Right to life Federation,

Found at : http://www.prolifelouisiana.org/education/cloning/human-embryonic-stem-cell-research-hesr.html

  1. Cell Press (2009, February 6). Adult Stem Cells Convert Into Embryonic-like Stem Cells, With Single Factor. ScienceDaily.

Found at : http://www.sciencedaily.com/releases/2009/02/090205133744.htm

  1. A. Robertson, “Embryo Stem Cell Research: Ten Years of Controversy”,

Found at : http://www.utexas.edu/law/faculty/jrobertson/JLME-10-year-survery-Robertson-final.pdf

  1. Ariff Bongso and Mark Richards, “History and perspective of stem cell research”,

Found at : http://www.ualberta.ca/~dcl3/Stem%20Cell%20Reviews/review_SC+history+ba sics+of+rsch.pdf

  1. Tyler, “Stem Cell Research Timeline” , Stem Cell History ,

Found at : http://www.stemcellhistory.com/stem-cell-research-timeline/

  1. “EU to fund embryo cell research”, BBC News,

Found at : http://news.bbc.co.uk/2/hi/europe/5209106.stm

  1. “Stem Cell Basics”, National Institute of Health,

Found at : http://stemcells.nih.gov/info/basics/pages/basics6.aspx

  1. “Should the government fund embryonic stem cell research?”, Annenberg Classroom,

Found at : http://www.annenbergclassroom.org/speakouts.aspx?name=should-the-government-fund-embryonic-stem-cell-research&AspxAutoDetectCookieSupport=1

Edited by Sinjini Majumdar

[i]Siegel, Andrew, “Ethics of Stem Cell Research”, The Stanford Encyclopedia of Philosophy (Spring 2013 Edition), Edward N. Zalta (ed.)

[ii] Accredited to Mike Jones from Wikipedia, additional text by LART

[iii]Anonymous author, “Human Embryonic Stem Cell Research (hESR)”, published in Louisiana Right to Life Federation, found at http://www.prolifelouisiana.org/education/cloning/human-embryonic-stem-cell-research-hesr.html

[iv] John.A. Robertson, “Embryo Stem Cell Research: Ten Years of Controversy”, found at http://www.utexas.edu/law/faculty/jrobertson/JLME-10-year-survery-Robertson-final.pdf

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