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Pacific Center Co-Director Interviewed on Reform of Federal Regulations to Protect Research Subjects
In 1991, responding to recommendations made a decade earlier by the President's bioethics commission, all federal departments and agencies that support research involving human beings issued a "Common Rule" on the standards and procedures for prior ethical review of such research. Many changes have occurred in research methods and the resulting physical, psychological and social risks over the past quarter century. It is widely agreed-among researchers, institutions, ethicists, and federal officials-that changes are needed in the Common Rule. But the proposals put forward-first in a lengthy "Advanced Notice of Proposed Rulemaking" in 2011, and then in the "Notice of Proposed Rulemaking" (NPRM) issued in 2015, have met with criticism in many quarters. Indeed, in June, a panel of the National Academies of Sciences, Engineering, and Medicine panned the revisions and asked the President to appoint a new commission to start the process of reconsidering the regulations afresh. In an interview published in August 2016, Alexander Capron, co-director of the Pacific Center, agreed that the current NPRM is a flawed document that would bring about sweeping changes without an adequate basis for believing that they would improve either the efficiency or quality of ethical review. He argued that the major roadblock to good reform is the false belief that getting the many government agencies to agree is so difficult that reforms have to be comprehensive. This belief accounts for the long period since the last revision, but insisting on comprehensive reform merely reinforces the sense that any revision is difficult because it makes it harder to get agreement when so many changes are on the table at once. Instead, he urged rule-proposers to tackle discrete problems with the present regulations, starting with those that cause the most difficulties. He also said that experience shows that the end product is better when the revision process includes publicly accountable review bodies that openly debate-and receive written and oral comments from the public-about all changes being considered.
International Stand against Countries Giving Financial Rewards to Families who Donate Organs for Transplantation
Governmental and private programs that pay next of kin who give permission for the removal of their deceased relative's organs for transplantation exist in a number of countries. Such payments, which may be given to the relatives or paid directly for funeral expenses or hospital bills unrelated to being a donor, aim to increase the rate of donation. Professor Alex Capron recently led an international group of leaders in the field of organ transplantation in setting forth the harm that countries do to their system of organ procurement by trying to induce deceased donation through financial rewards. In an article forthcoming in Transplantation, and available online prior to publication, they argue that payment programs are unwise because they produce a lower rate of donations than in countries with voluntary, unpaid programs; associate deceased donation with being poor and marginal in society; undermine public trust in the determination of death; and raise doubts about fair allocation of organs. Most important, allowing families to receive money for donation from a deceased person, who is at no risk of harm, will make it impossible to sustain prohibitions on paying living donors, who are at risk. Payment programs are also unethical. Tying coverage for funeral expenses or healthcare costs to a family allowing organs to be procured is exploitative, not "charitable." Using payment to overcome reluctance to donate based on cultural or religious beliefs especially offends principles of liberty and dignity. Finally, while it is appropriate to make donation "financially neutral"-by reimbursing the added medical costs of evaluating and maintaining a patient as a potential donor-such reimbursement may never be conditioned on a family agreeing to donate. A. M. Capron, Francis L. Delmonico, B. Dominguez-Gil, D. E. Martin, G.M. Danovitch, and J. Chapman, "Statement of the Declaration of Istanbul Custodian Group Regarding Payments to Families of Deceased Organ Donors," Transplantation (forthcoming 2016).
Physician-Assisted Suicide: Proceeding with Our Eyes Open
In 1992, California voters rejected Proposition 161, which would have allowed physicians to perform euthanasia at the request of dying patients. Seven times in the succeeding decades, bills that would have had California follow the model chosen by Oregon in 1994 died in the legislature. But following the highly publicized choice in the fall of 2014 of a young Californian with an incurable brain tumor, Brittany Maynard, to move to Oregon and end her life, several members of the California Senate introduced S.B. 128, the "End of Life Option Act." This bill would legalize "aid in dying," on a basis very similar to the one approved in Oregon in 1994: competent adult patients with a prognosis of death within six months could obtain a prescription for lethal drugs, which they can self-administer. On April 29, 2015, Alex Capron took part in a discussion of S.B. 128 moderated by Stephanie O'Neill, health care correspondent for Southern California Public Radio at KPCC's "Crawford Family Forum" in Pasadena, along with Toni Broaddus, California Campaign Director for Compassion & Choices, Norma Vescovo, Executive Director of the Independent Living Center of Southern California, Inc., and Kenneth D. Murray, MD, a retired family practitioner and author of "How Doctors Die." Noting that the bill is likely to become law, Professor Capron urged people to be clear that the physician-assisted suicide (PAS) authorized by the stature may have spill-over effects, that many of the unintended consequence are things the "safeguards" in the bill cannot avoid (such as the difficulties poorer patients face in making use of palliative care alternatives to PAS), and that if the major purpose of the bill is to give patients more control over their life and medical care, courts may decide that the six-month prognosis requirement impermissibly discriminates against patients with certain diseases (such as Parkinson's and Alzheimer disease).
Organ Markets: Problems Beyond Harms to Vendors
The October 2014 issue of the American Journal of Bioethics includes an open peer commentary, "Organ Markets: Problems Beyond Harms to Vendors," by Pacific Center co-director Alex Capron and two colleagues, Gabriel Danovitch, MD, and Francis Delmonico, MD, that elaborates on the thesis advanced by Julian Koplin in his article in the same issue that allowing organ sales cannot be justified based simply on respecting the contractual freedom of organ sellers, given the clear evidence of harm to sellers. Capron and his co-authors present three additional reasons for rejecting a "regulated market" in organs. First, regulated organ markets would be very expensive and complex to administer and risk creating real or perceived unfairness. Second, ample evidence exists that the form of regulated organ purchases being proposed would not increase the net supply of organs for transplantation. Finally, regulated markets contain theseeds of their own undoing and would soon devolve intounregulated markets. For these reasons, legislators should not eliminate the prohibitions in the National Organ Transplant Act of 1984 on providing "valuable consideration" in exchange for organs, and no "pilot studies" either need to be undertaken (because of the extensive existing data) or should be (because any "experiment" would turn out to be irreversible, as the proponents recognize).
Co-Director Participates in "Room for Debate" on a market in kidneys, online in New York Times on August 21
Alex Capron of the Pacific Center and Francis L. Delmonico, MD, Executive Director of the Declaration of Istanbul Custodian Group, argued in a contribution to a New York Times online "Room for Debate," that removing disincentives and obstacles to voluntary, unpaid organ donation would produce better, more sustainable, and more defensible policy for kidney transplantation than would eliminating the federal ban on payments to donors. The latter would a very controversial step, while the former would be something the entire community could support, along with removing the three-year limitation on Medicare coverage of the immunosuppressive medications that are essential to prevent organ rejection and increasing the supply of organs from deceased donors by efficiently using donor consent registries throughout the country and by recovering and transplanting more kidneys from donors after circulatory death.
Should We Lift the Ban on Buying and Selling Human Organs for Transplantation?
On March 25, 2014, Pacific Center Co-Director Alex Capron presented a lecture in the Chapman Dialogue series at Chapman University Law School in Orange, CA, regarding the arguments for and against removing the ban on organ sales in the United States. He described the history of transplantation and the development of the prohibition on organ sales, first in this country and then around the world. He noted that a change in the prohibitions in the US would probably undermine the efforts to eliminate organ trafficking and transplant tourism in a number of developing countries where these practices have been prevalent until recent years, always with very bad effects on poor people.
Death, Life-Support and the Protection of the Unborn: The End to a Tragedy in Texas
On January 26, 2014, physicians at the John Peter Smith Hospital in Fort Worth, Texas, disconnected Marlise Munoz from the mechanical ventilator. She'd entered the hospital's emergency department two months earlier, brought there by ambulance after her husband found her unconscious on their kitchen floor. After two days attempting to treat her, physicians at the hospital determined on November 28th that she met the criteria for determining death based on having lost all functions of the brain. But they didn't pronounce her dead or cease the external support at that time because she was 14 weeks pregnant, and someone at the hospital had concluded that despite her death and her husband's insistence that she would not want to be artificially sustained even if she were alive (but lacked any prospect of recovery), the artificial support of her biological functioning had to be continued because the Texas Advanced Directives Act renders ineffective a pregnant patient's (or surrogate decision maker's) directions to end life-support. Only after the District Court for Tarrant County ruled that the Act doesn't apply to dead bodies-and ordered the hospital to pronounce her dead-were the medical interventions ceased and her body turned over to her family for burial.
Professor Alex Capron, the Pacific Center's co-director, discusses the court decision and the questions that it leaves in doubt in a symposium on the Munoz case on the Bioethics Program blog.
The Continuing Problem of Organ Trafficking and Transplant Tourism:
Although organ transplantation has, from its earliest days in the mid-1950s, depended on altruism-originally of living, related donors, then beginning in the late-1960s of deceased donors and their next-of-kin, and in recent decades again of living donors, including those who are not related by biology or friendship with their recipients-the shortage of organs has led in some locales to the use of "donors" who are paid or coerced as well as to the use of condemned prisoners as a source for other organs as well. Such practices have been illegal in the United States since 1984 and have been condemned on a number of occasions by the World Health Assembly. Most recently, in 2010 the WHA endorsed the "WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation," a revision of a document first approved in 1991 that was influential in leading many other countries to outlaw organ sales and to condemn "transplant tourism," which involves patients from wealthy countries coming to hospitals in developing countries to obtain a transplant of an organ typically sourced from a poor local resident or executed prisoner. Pacific Center Co-Director Alex Capron has continued to play a leading role in WHO's work on this topic since returning in September 2006 from directing WHO's Department of Ethics, Trade, Human Rights and Health Law. He has also been a leader in the creation and implementation of the Declaration of Istanbul, which was adopted in May 2008 as a means of expressing healthcare professionals' opposition to transplant tourism and organ trafficking. Professor Capron has addressed these topics in academic presentations on many occasions, most recently at:
Â· WHO and the Control of Organ Trafficking and Transplant Tourism, Harvard Law School Symposium on the Globalization of Health Care, Cambridge, MA, May 20-21, 2011, Panel on "Transplant Tourism is Different than Medical Tourism"
Â· The Legal and Ethical Underpinnings of Organ Transplantation, UCLA Division of Nephrology, Kidney Transplant Program, Los Angeles, CA, June 1, 2011 (click here for slides)
In addition, on April 23, 2011, Prof. Capron and Prof. Nikola Biller-Andorno of the University of Zurich published in The Lancet (377:1390-91; originally published on-line Oct.10, 2010) a short critique of the arguments advanced for giving organ vendors financial rewards. In March 2010, he joined with a number of colleagues in an article analyzing the issues raised by donation of organs after circulatory determination of death (DCDD) in patients from whom artificial life-support has been withdrawn.
Ethical Issues in Governing Biobanks: Global Perspectives
New book looks at the global ethical and regulatory issues in 'biobanks' and genetic databases.
Alex Capron is co-editor of a new book, B. Elger, N. Biller-Andorno, A. Mauron & A. Capron, eds, Ethical Issues in Governing Biobanks: Global Perspectives, published in December 2008 by Ashgate. The book grew out of a project that originated while Professor Capron was the Director of Ethics, Trade, Human Rights and Health Law for the World Health Organization in Geneva (2002-06). Population genomics research drawing on genetic databases (sometimes called "biobanks") has expanded rapidly around the world in the past decade. Managing this information in an appropriate way presents highly complex ethical problems in the health policy arena. Capron and his colleagues from the universities of Geneva and Zurich examine the conditions under which genetic databases can be established, kept, and made use of in an ethically acceptable way. In addition to a comprehensive review of the scientific literature and a comparative analysis of existing normative frameworks, they present the results of in-depth interviews with nearly 90 experts around the world concerning the most unresolved and controversial issues, built around their responses to four "scenarios" on practices concerning biobanks. The results of that study, combined with their normative analysis, leads to recommendations for a better international framework.
Table of Contents
- Introduction: biobanks, genomics, and research - a nightmare for public policy makers?, Alex Mauron
Part I Research Biobanks: Current Status and Debates
- Biobanks in the literature, Bartha Maria Knoppers and Ma'n H. Abdul-Rahman
- Guidelines on biobanks: emerging consensus and unresolved controversies, Effy Vayena, Agomoni Ganguli-Mitra and Nikola Biller-Andorno
Part II Consensus and Controversies Among International Experts Concerning Issues Raised by Genetic Databases
- Ethical issues regarding research biobanks: aims, methods, and main results of a qualitative study among international and US experts, Nikola Biller-Andorno, Andrea Boggio, Bernice Elger, Agomoni Ganguli-Mitra, Alex Capron and Alex Mauron
- Consent and use of samples, Bernice Elger
- Consent to research involving human biological samples obtained during medical care, Bernice Elger
- Collective consent, Agomoni Ganguli-Mitra
- Withdrawal of consent and destruction of samples, Bernice Elger
- Anonymization and coding, Bernice Elger
- Informing participants about research results, Andrea Boggio
- Ownership of samples and data and territorial restrictions concerning data and samples beyond national boundaries, Andrea Boggio
- Public domain sharing, patents, and fees resulting from research involving genetic databases, Andrea Boggio
- Benefit-sharing and remuneration, Agomoni Ganguli-Mitra
- Transfer of samples and sharing of results: requirements imposed on researchers, Andrea Boggio
Part III Shaping the Future Legal and Ethical Development of Genetic Databases
- Towards an international framework: results of a meeting of an international group of scholars and scientists involved in legal and practical issues of biobanks, Alex Mauron
- Biobanks and genomic research: what shape the future?, Alex Capron
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