Ethics in Biomedical Engineering
Select Bibliography
Abreu, Eduardo L. et al. "Development of a program model to evaluate
the potential for reuse of single-use medical devices: Results of a pilot
test study". Biomedical Instrumentation and Technology 36.6
(Nov.- Dec. 2002): 389-404.
Black, J. "Thinking Twice about 'Tissue Engineering'".IEEE
Engineering in Medicine & Biology Magazine 16.4 (Jul.-Aug. 1997):
102-4.
Black, M. M. and C. Riley. "Moral Issues and Priorities in Biomedical
Engineering". Science Medicine and Man 1.1. (Apr. 1973): 67-74.
Blank, Robert H. and Andrea L. Bonnicksen. Medicine Unbound: The Human
Body and the Limits of Medical Intervention. Emerging Issues in Biomedical
Policy, Volume 3. New York: Columbia University Press, 1993.
Bledsoe, J. Gary. "Ethical discussions in an undergraduate tissue
engineering course". Proceedings of the 2002 IEEE Engineering in Medicine
and Biology 24th Annual Conference and the 2002 Fall Meeting of the Biomedical
Engineering Society (BMES / EMBS), Oct 23-26 2002, Houston, TX. Annual
International Conference of the IEEE Engineering in Medicine and Biology
- Proceedings 3 (2002): 2672-2673
Brennan, Mark G. and Mark A. Tooley. "Ethics and the Biomedical Engineer".
Engineering Science and Education Journal 9.1 (Feb. 2000): 5-7.
Brody, Baruch. The Ethics of Biomedical Research: An International
Perspective. New York: Oxford UP, 1998.
Brody, Eugene. Biomedical Technology and Human Rights. Aldershot,
England: UNESCO, 1993.
Bronzino, Joseph D., Ellen J. Flannery, and Maurice Wade. "Legal and
Ethical Issues in the Regulation and Development of Engineering Achievements
in Medical Technology - Part I". IEEE Engineering in Medicine and
Biology 9.1 (Mar. 1990): 79-81.
---. "Legal and Ethical Issues in the Regulation and Development of
Engineering Achievements in Medical Technology - Part II". IEEE
Engineering in Medicine and Biology 9.2 (Jun. 1990): 53-57.
Bulger, Ruth Ellen, Elizabeth Heitman, and Stanley Joel Reiser (eds). The
Ethical Dimensions of the Biological and Health Sciences. Cambridge:
Cambridge University Press, 2002.
Casada, Mark E. and James A. DeShazer. "Teaching Professionalism,
Design, & Communications to Engineering Freshmen". ASEE Annual
Conference Proceedings, v 1, "Investing in the Future" (1995):1381-1386.
Cram, Nicholas, John Wheeler, and Charles S. Lessard. "Ethical Issues
of Life-sustaining Technology". IEEE Technology and Society Magazine
14.1 (Spring 1995): 21-28.
Daniels, A.U. "Ethics Education at the Engineering/Medicine Interface".
Journal of Investigative Surgery 5.3 (Jul.-Sep. 1992):
209-18.
Davis, Michael. "Codes of Ethics, Professions, and Conflict of Interest:
A Case Study of an Emerging Profession, Clinical Engineering". Professional
Ethics 1.1-2 (Spring-Summer 1992):179-95.
Davis builds on his arguments in “Thinking Like an Engineer”
(above) to argue that for an emerging profession codes of ethics can:
1) supply moral guidance, sometimes by creating new moral obligations
in cases that previously were unclear;
2) help to constitute the occupation as a profession
He develops these points with respect to clinical engineering, which
is a specialty within biomedical engineering. (Jadran Lee 2004)
---. “Thinking Like an Engineer: The Place of a Code of Ethics in
the Practice of a Profession”. Philosophy and Public Affairs
20.2 (1991): 150-167.
In this classic paper, which he later expanded into a book of the same
name, Davis analyses the role of a code of ethics for engineers. He argues
first that a code of ethics can be understood as a convention between
members of a profession. The convention articulates certain ideals, and
helps members of the profession to resist pressure to diverge from those
ideals. Davis then asks why engineers have an ethical obligation to abide
by their code of ethics. His answer rests on a notion of fairness: if
an individual has chosen to reap the benefits created by other people’s
adherence to a code, then that individual ought to live up to the same
standards. Finally, Davis provides an example of how a code can give guidance
in a particular case. He argues that in the Challenger disaster, the engineer
Robert Lund failed to live up to obligations arising from his profession’s
code. (Jadran Lee 2004)
DeMets, David L. “Statistics and Ethics in Medical Research”.
Science and Engineering Ethics 1999 (5) pp. 97-117.
Using numerous examples, DeMets argues that both the design and analysis
of much biomedical research are spoiled by statistical errors. Flaws in
design include confusions between correlation and causation, and the use
of insufficiently large data sets. Flaws in interpretation include dredging
through a data set to find apparently significant conclusions, as well
as trimming data sets to make a conclusion seem stronger than is warranted.
DeMets argues that such practices are ethically unacceptable: medical
progress is being hampered, and volunteers are being placed at risk with
little prospect of contributing useful knowledge. To remedy the situation,
he proposes that researchers be given better training in statistics, and
that researchers view sound statistics as an integral part of ethical
conduct. (Jadran Lee 2004)
Eaton, Margaret. Ethics and the Business of Bioscience. Stanford,
CA: Stanford Business Books, 2004.
Enderle, John et al. “Moral and Ethical Issues”. Chapter 20
of Introduction to Biomedical Engineering, by John Enderle, Susan
Blanchard, and Joseph Bronzino. San Diego, CA: Academic Press, 2000.
This chapter from a textbook on biomedical engineering provides an overview
of the ethical concerns that arise in biomedical engineering. Perhaps
most valuable is its explanation of the legal and regulatory requirements
that govern BME research. (Jadran Lee 2004)
Farah, Martha. “Emerging Ethical Issues in Neuroscience.” Nature
Neuroscience 5.11 (2002) 1123-1129.
Farah, Martha. “Neuroethics: the practical and the philosophical.” Trends
in Cognitive Science 9.1 (Jan. 2005) 34-40.
Farah, Martha. “Social, Legal, and Ethical Implications of Cognitive
Neuroscience: “neuroethics” for short.” Journal of Cognitive
Neuroscience 19.3 (2007) 363-364.
Farah, Martha and A.S. Herberlein. “Personhood and Neuroscience:
naturalizing or nihilating?” American Journal of Bioethics 7.1 (2007)
37-48.
Farah, Martha, and P.R. Wolpe. “Monitoring and Manipulating Brain
Function: new neuroscience technologies and their ethical implications.” Hastings
Center Report 34.3 ( 2004) 35-45.
Fielder, J.H. "The Bioengineer's Obligations to Patients". Journal
of Investigative Surgery 5.3 (Sep. 1992): 201-8.
---. "Ethical Issues in Biomedical Engineering: The Bjork-Shiley Heart
Valve". IEEE Engineering in Medicine & Biology Magazine
10.1 (Mar. 1991): 76-8.
---. "Ethics and Professional Responsibility". IEEE Engineering
in Medicine & Biology Magazine 18.4 (Jul.-Aug. 1999): 116-7.
Fins, Joseph. “The Ethical Limits of Neuroscience.” Lancet
Neurology 1.4 (Aug. 2002) 213.
Fins, Joseph. “Neuromodulation, Free Will and Determinism: lessons
from the psychosurgery debate.” Clinical Neuroscience Research
4.1/2 (July. 2004) 113-118.
Fins, Joseph, A.R. Rezai and Benjamin Greenberg. “Psychosurgery:
avoiding an ethical redux while advancing a therapeutic future.” Neurosurgery
59.4 (Oct. 2006) 713-716
Ford, Paul J. “Neurosurgical Implants: clinical protocol considerations” Cambridge
Quarterly of Healthcare Ethics 16.3 (July, 2007) 308-311.
Ford, Paul J. and Jaimie Henderson. “The Clinical Ethics of
Neuromodulation” Neuromodulation 9.4 (2006) 250-252
Ford, Paul J. and C.S. Kubu. “Ethics in the Clinical Application
of Neural Implants.” Cambridge Quarterly of Healthcare Ethics
16.3 (July 2007) 317-321.
Golnik, Natalia and Tadeusz Palko. "Remarks on Ethical Issues in Biomedical
Engineering". Proceedings of the 2002 IEEE Engineering in Medicine
and Biology 24th Annual Conference and the 2002 Fall Meeting of the Biomedical
Engineering Society (BMES / EMBS), Oct 23-26 2002, Houston, TX. Annual
International Conference of the IEEE Engineering in Medicine and Biology
- Proceedings v. 3 (2002): 2674-2675.
Grundfest, Warren S. and Andrea K. Scott. "Ethical Issues in the Development
of Medical Devices: The Role of Education and Training in the Evaluation
of Safety and Efficacy". Critical Reviews in Biomedical Engineering
26.5-6 (1998): 378.
Guilbeau, Eric J. and Vincent B. Pizziconi. "Increasing Student Awareness
of Ethical, Social, Legal, and Economic Implications of Technology".
Journal of Engineering Education 87.1 (Jan. 1998): 35-44.
Heller, J.C. "Beyond a Code of Ethics for Bioengineers: The Role of
Ethics in an Integrated Compliance Program". Critical Reviews in
Biomedical Engineering 28.3-4 (2000): 507-11.
Katzir E. "XII International Conference on Medical and Biological
Engineering and V International Conference on Medical Physics. Ethical problems
facing the bioengineer and medical technologist today". Medical
Progress through Technology 7.2-3 (Jun 1980): 59-62.
Kwarteng, K.B. "Ethical Considerations for Biomedical Scientists and
Engineers: Issues for the Rank and File". Critical Reviews in Biomedical
Engineering 28. 3-4 (2000): 517-21.
Maehle, Andreas-Holger, and Johanna Geyer-Kordesch (eds.). Historical
and Philosophical Perspectives on Biomedical Ethics: From Paternalism to
Autonomy? Burlington, VT: Ashgate, 2002.
Moreno, Jonathon D. “Neuroethics: an agenda for neuroscience
and society.” Nature Reviews Neuroscience 4.2 (Feb. 2003) 149-153.
Napper, S.A. and P.N. Hale. "Teaching of Ethics in Biomedical Engineering".
IEEE Engineering in Medicine & Biology Magazine 12.4 (Dec.
1993): 100-5.
Naser, C.R. "What is Life, and What is a Machine? The Ontology of
Bioengineering". Critical Reviews in Biomedical Engineering
28.3-4 (2000):545-50.
Naurato, N. and T.J. Smith. "Ethical Considerations in Bioengineering
Research". Biomedical Sciences Instrumentation 39 (2003):
573-8.
Pienkowski, D. "The Need for a Professional Code of Ethics in Biomedical
Engineering: A Lesson from History". Critical Reviews in Biomedical
Engineering 28.3-4 (2000): 513-6.
"Proceedings of the 18th Southern Biomedical Engineering Conference
and the 2nd International Conference on Ethical Issues in Biomedical Engineering.
Clemson, South Carolina, USA. May 21-23, 1999". Critical Reviews
in Biomedical Engineering 28.3-4 (2000): 349-665.
Rai, Arti K. and Rebecca S. Eisenberg. “Bayh-Dole Reform and the
Progress of Biomedecine”. American Scientist Volume 91, (Jan.-Feb.
2003): 52-59.
This article addresses the changes in U.S. intellectual property brought
by the passage, in 1980, of the Bayh-Dole Act. (The Act permitted grantees
to patent the results of their government-sponsored research.) This article
traces the rise in patents awarded to universities, and points out that
some of these patents are for fundamental scientific advances (such as
new gene sequences). Rai & Eisenberg contend that universities’
actions to defend their patents may be slowing scientific research. The
authors propose remedying the situation by fine-tuning the act, to
1) liberalize the conditions in which a funding agency may prevent its
grantee from retaining title to an invention
2) “modify the regulation that a funding agency’s authority
to compel licensing of university patents be held in abeyance until all
court appeals are exhausted”
(Jadran Lee 2004)
Roco, Mihail C. and William Sims Bainbridge (eds). Converging
Technologies for Improving Human Performance: Nanotechnology, Biotechnology
and Cognitive Science. NSF/DOC-sponsored report. Arlington, VA.
June 2002.
Saha, Subrata. “Ethical Questions in Biomedical Engineering Research”.
Annual International Conference of the IEEE Engineering in Medicine
and Biology Society 12.5 (1990): 1981-82.
---. "Teaching Bioethics for Biomedical Engineering Students: A Case
Studies Approach". Proceedings of the 2002 IEEE Engineering in Medicine
and Biology 24th Annual Conference and the 2002 Fall Meeting of the Biomedical
Engineering Society (BMES / EMBS), Oct 23-26 2002, Houston, TX. Annual
International Conference of the IEEE Engineering in Medicine and Biology
- Proceedings v. 3 (2002): 2602.
Saha, Subrata and Pamela Saha. "Biomedical Ethics and the Biomedical
Engineer: A Review". Critical Reviews in Biomedical Engineering
25.2 (1997): 163-201.
---. "Biomedical Research: Some Ethical Challenges". Critical
Reviews in Biomedical Engineering 26.5-6 (1998): 380.
---. "Ethical Responsibilities of the Clinical Engineer". Journal
of Clinical Engineering 11.1 (Jan.-Feb. 1986): 17-25.
---. “Introduction of New Medical Technologies: An International
and Ethical Perspective”. Proceedings of the 20th Annual International
Conference of the IEEE Engineering in Medicine and Biology Society 20.6
(1998): 3357-58.
Satris, S. "Ethical Consciousness in Bioengineering". Critical
Reviews in Biomedical Engineering 25.2 (1997): 151-61.
Schwartz, Lewis B. "The Dilemma of Bioengineering Research on Human
Subjects". Proceedings of the 2002 IEEE Engineering in Medicine and
Biology 24th Annual Conference and the 2002 Fall Meeting of the Biomedical
Engineering Society (BMES / EMBS), Oct 23-26 2002, Houston, TX. Annual
International Conference of the IEEE Engineering in Medicine and Biology
- Proceedings v. 3 (2002): 2668-2669.
Scott, Andrea K. "Conflicts of Interest and the Clinical Engineer".
Proceedings of the 15th Annual International Conference of the IEEE Engineering
in Medicine and Biology Society, Oct 28-31 1993, San Diego, CA. Proceedings
of the Annual Conference on Engineering in Medicine and Biology v.
15, n pt 2 (1993): 687-688.
Stirrat, G.M. "Education in Ethics". Clinics in Perinatology
30.1 (March 2003):1-15.
Thoma, H. "Some Aspects of Medical Ethics from the Perspective of
Bioengineering". Theoretical Medicine 7.3 (Oct. 1986): 305-17.
Weatherall, David. “Problems for Biomedical Research at the Academia-Industrial
Interface”. Science and Engineering Ethics 2003 (9) pp. 43-48.
Weatherall views collaboration between academic researchers and biomedical
firms as vital for promoting research. But he argues that this collaboration
has brought a number of problems, including
the neglect of long-term research in favor of short-term projects,
the curtailing of free dissemination of research…and the biasing
of clinical trials by the financial interests of the investigators
To tackle these problems, Weatherall proposes that biomedical researchers
be given ongoing training in research ethics. He also suggests that academics
and private companies agree to have disputes resolved by an external review
board. Finally, he calls on journals to tighten the conflict-of-interest
rules they impose on authors. (Jadran Lee 2004)
Wueste, Daniel E. "Professions, Professional Ethics, and Bioengineering".
Critical Reviews in Biomedical Engineering 25.2 (1997): 127-49.
---. "Wrongdoing in Biomedical Research: An Ethical Diagnosis and
Prescription". Critical Reviews in Biomedical Engineering
26.5-6 (1998): 378-380.
Syllabi
Syllabus
Exchange Catalog, from the National Reference Center for Bioethics Literature
(Georgetown/Kennedy Institute of Ethics). Can order syllabi for $3 each.
Ethics
and Public Health: Model Curriculum, organized by modules, from the
Association of Schools of Public Health
Directories
Bioethics
Resources on the Web, from the National
Insitutes of Health
Centers & Institutes for biomedical ethics / bioethics
The Hastings
Center
Kennedy
Institute of Ethics, Georgetown University
Center for Biomedical
Ethics, Stanford University
National Library of Medicine, Current
Bibliographies in Medicine 99-3: Ethical Issues in Research Involving Human
Participants (detailed biblio by extensive subject area)
American Medical Association
Ethics
Resource Center
Institute
for Ethics
Council
on Ethical and Judicial Affairs
Center
for Biomedical Ethics, University of Virginia Health System
Other links
Biomedical Engineering Society
