Begell House Inc.
Ethics in Biology, Engineering and Medicine: An International Journal
EBEM
2151-805X
3
1-3
2012
Preface: 7th International Conference on Ethical Issues in Biomedical Engineering
ix
10.1615/EthicsBiologyEngMed.2013007159
Subrata
Saha
Affiliate Professor, Department of Restorative Dentistry; Affiliate Professor, Department of Oral and Maxillofacial Surgery, University of Washington, Seattle, WA, USA; Distinguished Adjunct Professor, Saveetha Institute of Medical and Technical Sciences, Chennai, India; President, Biomedical Research and Services Inc., Seattle, WA, 98125 USA
Electronic Medical Records (EMRs): Patient Safety and Ethical Considerations
3-8
10.1615/EthicsBiologyEngMed.2013006933
Monique
Frize
Systems and Computer Engineering, Carleton University; School of Electrical Engineering and Computer Science, University of Ottawa, Ottawa, ON, Canada
EMRs
benefits
barriers
patient safety
ethical considerations
The main reason for implementing EMRs is the fast and thorough access to patient information, especially in emergency cases. Instant access to a patient's history can prevent delays in diagnosis and development of a treatment plan, especially where patients have chronic diseases.
A debate which needs to be resolved is the question of patients' access to the EMR and who owns the information. Points of view are divided on this question and several aspects need to be considered. Another issue is related to patient privacy and confidentiality. Ethical considerations can be assessed with respect to the principles of autonomy, beneficence and non-maleficence, and justice. These questions and issues are discussed in the paper.
Cryonic Life Extension: Scientific Possibility or Stupid Pipe Dream?
9-28
10.1615/EthicsBiologyEngMed.2013006985
D. John
Doyle
Department of General Anesthesiology, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA
Cryonics
cryopreservation
death
moral standing
reanimation
The central quest in cryonics is to preserve brain-encoded information essential to personhood after cryonic preservation. Advocates of cryonics seek to use cryoprotectants, vitrification, and extreme cold to extend the life of an individual when conventional methods fail. This means of life extension is employed for an intended period of decades, or even centuries, until safe reversal of the preservation process, as well as treatment for the underlying medical condition, becomes feasible.
Such an undertaking is predicated on three principles, only one being well established. The first is that life can be suspended as long as attention is directed at preserving the basic biological structures upon which life is based. The second is that technology will become available to extend the first principle to human organisms. The third is that post-thawing cellular damage might be repaired, for example using nanomedicine.
However, a number of problematic scenarios may emerge as the required innovations are developed. Consider some possible outcomes where only the head is cryopreserved: (1) failure to reanimate the individual, (2) existence as a reanimated head attached to a new body, and (3) existence as a reanimated head existing independently from a body. Additional issues emerge: What moral standing does the cryopreserved individual now have? What is the legal and moral status of individuals who end up technically alive but with severe neurological damage? And finally, who should be responsible for the care of a thawed patient who requires complex medical care?
Maternity at Advanced Ages. Ethical Concerns Related to the Assisted Reproductive Technology from a Scientific and Religious Perspective
29-50
10.1615/EthicsBiologyEngMed.2013007002
Mircea
Leabu
"Carol Davila" University of Medicine and Pharmacy, Research Centre in Applied Ethics, University of Bucharest, Romania; Principal Investigator, "Victor Babeș" National Institute of Pathology, 99-101 Splaiul Independenței, Sector 5, 050096 Bucharest, Romania
bioethics
in vitro fertilization
principlism
Kantian ethics
Christianity
Judaism
Islam
globalization
sustainable development
The current spectacular advancement of assisted reproductive technologies (ARTs) has finally made parenthood at advanced ages possible, though not necessarily safer. Physicians and older patients all around the world are willing to undergo various painstaking in vitro fertilization protocols. Several motivations may determine both physicians and older patients to make such a decision. Beyond the layer of subjectivity specific to one case or another, there are ethical concerns which must be carefully considered by stakeholders. This contribution aims to address the ethical connotations related to the use of reproductive technology on women of advanced age, by adopting multiple perspectives: those of the patients, those of the physicians, and those of civil society. Scientific points of view and religious convictions are also considered to illustrate important lessons and to identify the moral principles that should govern the attitude of each stakeholder. The context of a multicultural society, targeted sustainable development, and the globalization trend are all taken into account. Herein, I defend the right of humans to make use of any new progress registered by biomedical science and technology, but I express concern regarding the risks of their misuse.
Autonomy and Exploitation in Clinical Research: What the Proposed Surfaxin Trial Can Teach Us about Consent
51-56
10.1615/EthicsBiologyEngMed.2013007018
Mark L.
Bourgeois
Northwestern University, Biomedical Engineering, 2145 Sheridan Rd. E310 Evanston IL
Bioethics
consent
autonomy
exploitation
surfactants
international trials
clinical research
Kant
Surfaxin
RDS
developing world
Latin America
It is well recognized that clinical research in resource-poor developing world environments presents ethical complications beyond those normally encountered in developed world clinical research. For example, the proposed Bolivian trial of the surfactant drug Surfaxin in 2001 intended to use a placebo control for a potentially fatal condition because the standard treatment was unaffordable there. This was thought to be exploitative and, as a result, the trial was redesigned and relocated. Closely examining the basis for these kinds of ethical objections reveals important truths about the foundational principles of clinical research ethics applicable to all contexts, whether the developing or developed world. Among these is a more complete understanding of the conditions for truly autonomous consent. Such consent is seen to require not only acquiescence, but for all ends to be mutually endorsed by all parties.
What Did You Find in My Genes? Using Participant Preferences when Revealing Biobank Individual Research Results
57-73
10.1615/EthicsBiologyEngMed.2013006924
Brendan
Parent
Department of Medical Ethics, New York University Langone Medical Center, 227 E. 30th St, 7th Floor, NY, NY
Incidental findings
informed consent
research ethics
return of results
participant preferences
personal health information
Biobanks provide efficient means for genetic research, but do not employ adequate measures for communicating personal health information to individual participants who contribute de-identified tissue samples. There is growing consensus that biobanks should implement systems for reporting personal health information to participants based on clinical utility. But relevant recommendations do not acknowledge the participant's interest in deciding the types of health information that she finds worth knowing. This paper addresses current biobanking protocol, and reasons for and against incorporating participant preferences into practices of delivering personal health information. It proposes a classification system for personal information discovered during research, which informed participants would use to specify their preferences before they provide tissue samples. This system would use degrees of clinical validity and utility to define categories of returnable information. Such a system would set a value threshold for personal information to prevent unnecessary costs to biobank research. In conjunction, this paper recommends refinement of participant informed consent by including genetic education and knowledge demonstration prior to tissue provision. These modifications to biobanking practices would ensure respect and empowerment for the participant, acknowledge her status as a stakeholder in genetic research, and align with democratic governance of the research endeavor.
Ethical Issues to Consider for Microchip Implants in Humans
75-86
10.1615/EthicsBiologyEngMed.2013007009
Roger
Achille
Alan Shawn Feinstein Graduate School, Johnson & Wales University, Providence, RI
Christine
Perakslis
College of Management, Johnson & Wales University, Providence, Rhode Island
Katina
Michael
School of Information Systems and Technology, University of Wollongong, Wollongong, New South Wales, Australia
bodily integrity; ethics and ethical considerations for implants; ICT implants; legislation; microchips; Millennials; regulation or standards for implants; RFID implants; radio frequency identification; RFID standards; small business; SME; surgically implanted
The purpose of this article is to explore the changing equation of the ethics perspective of the generation known as Millennials (born 1981-2000) when considering such emerging technologies as microchip implants in humans. We have utilized a philosophical research approach with intellectual analyses to support value judgments. This technology, also known as radio frequency identification (RFID) chip implants, or information and communications technology (ICT) implants, is used in various settings and for a variety of purposes. However, concerns abound relative to this technology concerning such issues as human dignity, the privacy of individuals, bodily integrity, and data usage. We conducted a review of the literature, including an overview of the state of this technology, ethical issues surrounding implants, legislation in the European Union and the United States, the political clout of small businesses, key traits of the Millennial generation that may affect their ethics perspective, recent research relative to implants, and the opinions of Millennials. Recently, researchers have reported more openness to this technology in Millennials compared to other generations. Shifts in Millennials over a 5-year period toward more willingness relative to undergoing implantation of microchips have also been reported. Considering all factors, we consider affects of the Millennial's shifting attitudes and values toward implantation when legislation or standards are enacted relative to the emergence of this particular invasive technology.
Ethical and Policy Considerations in Patent Law for Medical Procedures
87-96
10.1615/EthicsBiologyEngMed.2013007066
Trent A.
Kirk
N/A
patent
medical procedure
medical method
infringement
Physician's Immunity Statute
The U.S. Constitution grants an inventor exclusivity to their patent rights to promote the progress of science and useful arts. In particular, a patent provides an inventor the right to exclude others from making, using, selling, or importing the invention for a period of time in exchange for public disclosure of the invention. Patents may be obtained for a variety of machines, articles of manufacture, compositions, and methods. Indeed, the Supreme Court has held that "anything under the sun that is made by man" is patentable with some limitations. Patents in the medical industry present unique issues in that some medical procedures that utilize patented technology further the health and well-being of society. Although there are some medical or surgical procedures that are immune from an infringement action, granting patents for such procedures creates an ethical conflict. Medical device manufacturers and inventors will argue that patents facilitate the development and innovation of new procedures that further the advancement of treatment while rewarding the inventors for their contributions. In the converse, health-care professionals will contend that preventing others from practicing particular methods of treating patients hinders their ability to provide the highest quality of care and sacrifices the integrity of the medical community. This article addresses these ethical concerns and the balance between patenting and furthering the well-being of society with respect to medical and surgical methods of treatment.
Sovereign Wrongs: Ethics in the Governance of Pathogenic Genetic Resources
97-114
10.1615/EthicsBiologyEngMed.2013007001
Catherine
Rhodes
Institute for Science, Ethics and Innovation, Faculty of Life Sciences, University of Manchester, Stopford Building, Oxford Road, Manchester, M13 9PL, UK
Avian influenza; international law; Pandemic Influenza Preparedness Framework
Genetic resources are a key resource for much biomedical research. Pathogenic genetic resources are of value in the identification, surveillance, understanding, and development of vaccines, treatments, and other responses to major public threats such as pandemic influenza outbreaks. Significant attempts have been made to improve the international governance of infectious disease over the last decade, but the handling of pathogenic genetic resources remains contentious and problematic.
The need to address the deficiencies in current arrangements (e.g., the World Health Organization's Pandemic Influenza Preparedness Framework) is urgent because future outbreaks are likely to revert to the past situation in which developed states secured vaccine supplies for their own populations while leaving developing countries vulnerable to the pandemic. Thereby, the collaboration of developed countries with vital international systems such as the Global Influenza Surveillance and Response System is disincentivized.
The current international approach to pathogenic genetic resources is based on the sovereign rights of states and access and benefit-sharing arrangements that stem from those rights. While this approach is consistent with international rules on other types of genetic resources, herein I argue that this is an inappropriate approach to pathogens on both political (serving public health goals) and ethical grounds (e.g., equity and justice). Instead I argue for a (modified) common heritage approach to pathogenic genetic resources, based on their intrinsic qualities (e.g., rapid mutation, easy transmissibility) and their value to global efforts to respond to disease outbreaks. I will further argue for de-linking access to these resources from benefit-sharing requirements; explaining that while there are strong justifications for both, their linkage (particularly for pathogenic genetic resources) is problematic and detrimental to the achievement of its intended goals (i.e., ensuring equitable benefit-sharing in return for access being granted).
Ethical Considerations Translational Genomics: The Case of Emerging Cancer Therapeutics
115-121
10.1615/EthicsBiologyEngMed.2013007122
Alan C.
Warner
Research Coordinator, Mount Sinai Hospital, Toronto, ON M5G 1X5 Canada; Masters of Science Student - Union Graduate College/Mount Sinai Medical Centre New York
ethics; translational genomics; public awareness; advocacy groups; health professionals; education
Research in genomics is to a large extent publicly funded and is likely to affect the future health care of many of us, yet few people understand its purpose or potential. Bioethics is one way to act as a bridge between public needs, understanding, and ongoing scientific research, especially at the point of change that many technologies create. In this article, I will discuss how "translational" genomics can be a process by which information from emerging technologies in medicine can be made understandable to the public and take results from the lab to the bedside in a more coherent fashion. Within this definition of transitional genomics there are two important distinctions. The first is knowledge translation−utilization of nuanced methods for quality improvement and closing the gaps from knowledge to practice. The second is clinical application, which is the implementation of technologies at the bedside. I will look at why improvement of communication matters by focusing on key stakeholders including the public, health professionals, and advocacy groups. The challenges of autonomy, true informed consent, and distributive justice will then be explored in relation to a new class of therapeutics known as synthetic antibodies.
Ethical Issues in a Case Control Study of Maternal Periodontal Health Status and Low Birth Weight Babies in North India
123-130
10.1615/EthicsBiologyEngMed.2013007010
Pavitra
Rastogi
King George's Medical University, C-5 Sector-E Aliganj Lucknow U.P. India
Sujata
King George's Medical University, C-5 Sector-E Aliganj Lucknow U.P. India
Rameshwari
Singhal
King George's Medical University, C-5 Sector-E Aliganj Lucknow U.P. India
Shally
Avasthi
King George's Medical University, C-5 Sector-E Aliganj Lucknow U.P. India
maternal oral health
PTLBW
ethics
periodontal disease
Low birth weight infants remain a major public health concern because it has been a foremost reason for neonatal demise and long-standing health tribulations. Health care for extremely immature preterm low birth weight infants at the margins of viability is ethically, professionally, and emotionally complicated. There is a rising consensus that remote infections from oral cavity may influence preterm low birth weight babies. The objective was to analyze the ethical issues arising in a case control study of maternal periodontal health status and low birth weight babies. Women 20−35 years of age, who delivered low birth weight babies (<2.5kg) were included as cases and those with normal weight babies (>2.5kg) as controls. Maternal oral clinical parameters were evaluated in a total number of 350 women (175 cases and 175 controls) and measured. During comparison of periodontal health parameters between cases and controls, it was found that for all the three oral health parameters, mean values were significantly higher in cases as compared to controls (p < 0.05). This led to evaluation of awareness among the treating gynecologists. Hence, a questionnaire was formulated to assess the importance of periodontal health checkups in pregnant women. Mean values were statistically analyzed. The results show that 86% of gynecologists were aware of the fact that remote infections from oral cavity may influence preterm low birth weight babies, but it was observed that proper guidelines for maintenance of oral hygiene were not being followed. Ethical diversions from the normal protocol were observed. The findings in the present assessment suggest that maternal periodontal diseases can influence adverse pregnancy outcomes and good oral health can ensure a healthier progeny. Gynecologists can be better motivators for the good oral hygiene in pregnant women for superior pregnancy outcomes.
The significance of Fear as an "Equal Opportunity Component" in the Articulation & Acceptance of Informed Consent in Dentistry
131-138
10.1615/EthicsBiologyEngMed.2013007212
Boyd W.
Shepherd
Department of General Practice and Dental Public Health, University of Texas Health Science Center at Houston, School of Dentistry, 7500 Cambridge St., Houston TX 77054
fear component
informed consent
dentistry
The doctrine of informed consent addresses the adequacy of information given to a patient to enable them to make a knowledgeable choice regarding whether to undergo treatment. The average patient, who knows little about dentistry or medicine, typically can turn to no one other than their doctor for advice in making an informed decision. The obligation for dentists to obtain informed consent before treatment is grounded in the ethical principle of patient autonomy, which provides that every adult of sound mind has the right of self-determination as to what shall be done with his or her body, as well as in state licensure regulations, the general rule of which is that a dentist must disclose the risks or hazards that could influence a reasonable person in making a decision to give or withhold consent. The individual giving consent needs to be in possession of all of their faculties and without any impairment of judgment at the time of consenting. Nevertheless, the communication and comprehension of the elements that constitute legal and ethical informed consent often are obscured by a common component shared by both the dentist and the patient: fear. For the dentist, there is fear that providing all of the information necessary for the patient to consider before consenting to treatment may add to the patient's already elevated apprehension. For the patient, the aforementioned inherent or acquired apprehension is compounded by the realization that treatment is necessary and unavoidable relative to the consequences of no treatment, and therefore the patient will concede without making adequate inquiry before giving consent for treatment. This article, therefore, seeks to explore the significance of fear as an "equal opportunity component" that works to undermine both the articulation and acceptance of ethical and legal informed consent in dentistry.
Sources and Resolutions of Ethical Conflicts in Health Care
139-161
10.1615/EthicsBiologyEngMed.2013006997
Larry L.
Hench
Department of Materials Science and Engineering, University of Florida, Gainesville, Florida, USA 32615
Michael B.
Fenn
Department of Biomedical Engineering, Center for Applied Optimization, Particle Engineering Research Center, University of Florida, Gainesville, Florida, USA
end-of-life care
tissue engineering
regenerative medicine
implants
prostheses
bioactive glass
bio-Raman spectroscopy
stem cells
diagnosis
healthcare revolution
survivability of medical devices
In this article, we examine the hypothesis that "ethical dilemmas arise from a conflict of uncertainties," and we discuss the uncertainties in five important areas of health care: medical implants, care of the terminally ill, stem cell technology, tissue engineering, and personalized versus statistically based diagnosis and therapy. These examples are used to justify application of new minimally invasive technology that can produce patient-specific cell-based data to minimize conflicts regarding quality versus length of life and especially the end of life−a major ethical issue of our times.
Role of Periosteal Pedicle Graft as an Autogenous Guided Tissue Membrane in Periodontal Regeneration: An Ethical Perspective
163-171
10.1615/EthicsBiologyEngMed.2013007016
Rameshwari
Singhal
King George's Medical University, C-5 Sector-E Aliganj Lucknow U.P. India
Sumit
Kumar
King George's Medical University; C-5 Sector-E Aliganj Lucknow U.P. India
Pavitra
Rastogi
King George's Medical University, C-5 Sector-E Aliganj Lucknow U.P. India
Divya
Mehrotra
King George's Medical University; C-5 Sector-E Aliganj Lucknow U.P. India
Regeneration
ethics
questionnaire
Background: The principles of ethics are the aspiration goals of any profession. While planning a regenerative study, various ethical issues must be addressed from its conception to its execution and throughout the assessment of results.
Methods: Twenty interproximal intrabony two-walled defects in healthy nonsmoking patients with chronic periodontitis were randomly divided into a control group (Group 1: Periosteum alone) and an experimental group (Group 2: Periosteum with Alloplastic graft material). Measurements of probing pocket depth (PD) and clinical attachment levels (CAL) and radiographic bone defect area (BDA) were performed at baseline and at 6 months post surgery. Ethical issues were considered during enrollment, allocation of treatment, follow-up, and analysis of results.
Results: The results were affirmed according to the five parameters of ADA: patient autonomy, nonmaleficence, beneficence, justice, and veracity. The 6-month post operative assessments showed clinical and radiographic improvements with PD reduction, CAL gain, and changes in BDA in both the groups, which was statistically significant compared to the baseline (p<0.05). However, BDA reduction was statistically greater in Group 2 (48.88 ± 18.61%) compared to Group 1 (14.08 ± 12.97%) at the 6-month follow-up; (p=0.009).
Conclusion: Principles of ethics provide guidance and offer justification for the code of professional conduct and for advisory opinions regarding regenerative studies.
Ethical Issues Surrounding Direct-to-Consumer Advertising of Neurotechnology
173-184
10.1615/EthicsBiologyEngMed.2013007012
Donna
Hanrahan
Columbia University
Neuroethics
Direct-to-Consumer Advertising (DTCA)
Neuromarketing
Neurotechnology
Privacy
Autonomy
While society stands to benefit from the diverse application of neurotechnology, the increasing presence of such technology calls for further examination of the ethical questions surrounding its use. The current wave of neurotechnological innovations necessitates greater
federal regulation over the direct-to-consumer advertising (DTCA) of such devices. While the FDA has set detailed parameters for drug advertising, there are scarce formal regulations to guide medical device firms. There exists a distinct regulatory gap for neurotechnologies with
non-therapeutic and non-diagnostic commercial purposes. Bearing in mind the unique ethical considerations surrounding neurological function, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) must work together to protect consumers and develop
comprehensive marketing guidelines. The commercial development of neurotechnologies deserves greater regulatory attention because of the exceptional ethical considerations they evoke, particularly concerning the right to privacy, notions of identity and moral agency, the
reporting of incidental findings, potential stigma and discrimination, and conflicts of interest.
This paper assesses the challenges of the federal regulation of unrestricted medical devices, explores ethical concerns of technologies affecting the brain, and offers policy suggestions for the DTCA of neurotechnologies.
What Does It Mean to be Human?
185-193
10.1615/EthicsBiologyEngMed.2013007134
George D.
Catalano
Department of Bioengineering, State University of New York at Binghamton (SUNY), Binghamton, NY
Ethical code
complex systems
differentiation
communion
subjectivity
What does it mean to be human? More specifically, what are our ethical responsibilities in bioengineering? Consider, for example, two advances in bioengineering: somatic gene therapy and germ-line gene engineering, with the latter being of particular interest. As our technology rapidly advances, accompanied by our abilities to change the
various conditions of life and then to modify and mold life, this question takes on far greater importance than ever before. This article begins a much-needed conversation about these aspects related to these technologies that includes a new complex systems approach for making ethical decisions based on the laws of differentiation, communion, and subjectivity.