Co-Chair, Stanford Hospital and Clinics Ethics Committee (2003 - Present)
Co-Director, Scholarly Concentration in Biomedical Ethics and Medical Humanities (2003 - Present)
Chair, Program in Regenerative Medicine Sub-Committee on Bioethics and Conflict of Interest (2005 - Present)
Director, Stanford Center for Biomedical Ethics (2003 - Present)
Thomas A. Raffin Chair, Medicine and Biomedical Ethics, Stanford University (2010 - Present)
Honors & Awards
Moral and Social Consequences of the Human Genome Project, Oregon State University (2001)
Woodrow Wilson Convocation Speaker, Clarkson University (2002)
Arnold G. Wedum Memorial Lecture, American Biological Safety Association (2003)
Best New Journal Award, Council of Editors of Learned Journals for the American Journal of Bioethics (2004)
E.G. Young Seminar, Chemical Institute of Canada (2000)
Committee on Biological Confinement of Genetically Engineered Organisms (Member), National Research Council of the Academies (2002-2003)
Secretary of Agriculture's Advisory Committee on Biotechnology and the 21st Century (Member), Agriculture Advisory Committee (2003)
Expert for World Bank on Food Security and Biotechnology, The World Bank (2000)
Ph.D., Stanford University, Philosophy
B.A., UC Riverside, Philosophy
Current Research and Scholarly Interests
Genetic testing, gene therapy, genetically engineered organisms, and the history of eugenics. Stem cell research and cloning, and egg procurement. Examining ethical issues in reproductive technologies. Organ transplantation including donation after cardiac death, ethics of listing decisions. End of life issues in both adults and children.
- Ethics in Bioengineering
BIOE 131, ETHICSOC 131X (Spr)
- Foundations of Bioethics
HUMBIO 174 (Spr)
- Health Care, Ethics, and Justice
THINK 56 (Win)
- Medical Ethics I
PEDS 251A (Win)
Independent Studies (7)
- Directed Reading in Pediatrics
PEDS 299 (Aut, Win, Spr, Sum)
- Directed Reading/Special Projects
HUMBIO 199 (Aut, Win, Spr)
- Early Clinical Experience
PEDS 280 (Aut, Win, Spr, Sum)
- Graduate Research
PEDS 399 (Aut, Win, Spr, Sum)
- Independent Studies in Ethics in Society
ETHICSOC 199 (Aut, Win, Spr)
- Medical Scholars Research
PEDS 370 (Aut, Win, Spr, Sum)
- Undergraduate Directed Reading/Research
PEDS 199 (Aut, Win, Spr, Sum)
- Directed Reading in Pediatrics
Prior Year Courses
- Ethics in Bioengineering
BIOE 131 (Spr)
- Foundations of Bioethics
HUMBIO 174 (Spr)
- Health Care, Ethics, and Justice
THINK 56 (Win)
- Medical Ethics I
PEDS 251A (Win)
- Bioethical Challenges of New Technology
THINK 11 (Win)
- Ethics in Bioengineering
BIOE 131 (Spr)
- Foundations of Bioethics
HUMBIO 174 (Spr)
- Medical Ethics I
PEDS 251A (Win)
- Medical Ethics II
PEDS 251B (Aut)
- Ethics in Bioengineering
- Early Experience With the California End of Life Option Act: Balancing Institutional Participation and Physician Conscientious Objection. JAMA internal medicine 2017
A comparison of institutional review board professionals' and patients' views on consent for research on medical practices.
2016; 13 (5): 555-565
In the context of research on medical practices, which includes comparative effectiveness research and pragmatic clinical trials, empirical studies have begun to raise questions about the extent to which institutional review boards' interpretations and applications of research regulations align with patients' values. To better understand the similarities and differences between these stakeholder groups, we compare and contrast two surveys: one of institutional review board professionals and one of patients, which examine views on consent for research on medical practices.We conducted online surveys of two target populations between July 2014 and March 2015. We surveyed 601 human subjects research professionals out of 1500 randomly selected from the Public Responsibility in Medicine and Research membership list (40.1% response rate), limiting analysis to 537 respondents who reported having had institutional review board experience. We also surveyed 120 adult patients out of 225 approached at subspecialty clinics in Spokane, Washington (53.3% response rate). Our survey questions probed attitudes about consent in the context of research on medical practices using medical record review and randomization. The patient survey included three embedded animated videos to explain these concepts.A majority of institutional review board professionals distinguished between consent preferences for medical record review and randomization, ranked clinicians as the least preferred person to obtain participant consent (54.6%), and viewed written or verbal permission as the minimum acceptable consent approach for research on medical practices using randomization (87.3%). In contrast, most patients had similar consent preferences for research on medical practices using randomization and medical record review, most preferred to have consent conversations with their doctors rather than with researchers for studies using randomization (72.6%) and medical record review (67.0%), and only a few preferred to see research involving randomization (16.8%) or medical record review (13.8%) not take place if obtaining written or verbal permission would make the research too difficult to conduct. Limitations of our post hoc analysis include differences in framing, structure, and language between the two surveys and possible response bias.Our findings highlight a need to identify appropriate ways to integrate patient preferences into prevailing regulatory interpretations as institutional review boards increasingly apply research regulations in the context of research on medical practices. Dialogue between institutional review boards and research participants will be an important part of this process and should inform future regulatory guidance.
View details for DOI 10.1177/1740774516648907
View details for PubMedID 27257125
A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent.
Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices.We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms.There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p < .0001). There was no difference between informational aids with a character-driven story component (animated videos and comics) and those without.Our results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can improve participant knowledge more effectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the potential to improve informed consent for research on medical practices using multimedia aids that include simplified language and visual metaphors.
View details for PubMedID 27625314
Can Destination Therapy be implemented in children with heart failure? A study of provider perceptions.
2016; 20 (6): 819-824
DT is an established final therapeutic choice in adult patients with severe heart failure who do not meet criteria for cardiac transplantation. Patients are given VADs, without the prospect of care escalation to transplantation. VADs are now established therapy for children and are currently used as a bridge until transplantation can be performed or heart failure improves. For children who present in severe heart failure but do not meet transplantation criteria, the question has emerged whether DT can be offered. This qualitative study aimed to elicit the perspectives of early adopters of DT at one of the few institutions where DT has been provided for children. Responses were recorded and coded and themes extracted using grounded theory. Interviewees discussed: envisioning of the DT candidate; approach to evaluation for DT; contraindications to choosing DT; and concerns about choosing DT. Providers articulated two frameworks for conceptualizing DT: as a long bridge through resolution of problems that would initially contraindicate transplantation or, alternatively, as a true destination instead of transplantation. True destination, however, may not be the lasting concept for long-term VAD use in children given improvement in prognosis for current medical contraindications and improving VAD technology.
View details for DOI 10.1111/petr.12747
View details for PubMedID 27357389
Randomized n-of-1 Trials: Quality Improvement, Research, or Both?
2016; 138 (2)
The regulatory demarcations between clinical research and quality improvement (QI) are ambiguous and controversial. Some projects that were undertaken as a form of QI were deemed by regulatory agencies to be research and thus to require institutional review board approval. In the era of personalized medicine, some physicians may ask some patients to participate in n-of-1 trials in an effort to personalize and optimize each patient's medical treatment. Should such activities be considered research, QI, or just excellent personalized medicine? Experts in research, research regulation, and bioethics analyze these issues.
View details for DOI 10.1542/peds.2016-1103
View details for PubMedID 27385811
- A Flawed Revision of the Common Rule. Annals of internal medicine 2016; 165 (2): 143-144
Compassionate deactivation of ventricular assist devices in pediatric patients
JOURNAL OF HEART AND LUNG TRANSPLANTATION
2016; 35 (5): 564-567
Despite greatly improved survival in pediatric patients with end-stage heart failure through the use of ventricular assist devices (VADs), heart failure ultimately remains a life-threatening disease with a significant symptom burden. With increased demand for donor organs, liberalizing the boundaries of case complexity, and the introduction of destination therapy in children, more children can be expected to die while on mechanical support. Despite this trend, guidelines on the ethical and pragmatic issues of compassionate deactivation of VAD support in children are strikingly absent. As VAD support for pediatric patients increases in frequency, the pediatric heart failure and palliative care communities must work toward establishing guidelines to clarify the complex issues surrounding compassionate deactivation. Patient, family and clinician attitudes must be ascertained and education regarding the psychological, legal and ethical issues should be provided. Furthermore, pediatric-specific planning documents for use before VAD implantation as well as deactivation checklists should be developed to assist with decision-making at critical points during the illness trajectory. Herein we review the relevant literature regarding compassionate deactivation with a specific focus on issues related to children.
View details for DOI 10.1016/j.healun.2016.03.020
View details for Web of Science ID 000376951900004
View details for PubMedID 27197773
Toward clinical genomics in everyday medicine: perspectives and recommendations.
Expert review of molecular diagnostics
2016; 16 (5): 521-532
Precision or personalized medicine through clinical genome and exome sequencing has been described by some as a revolution that could transform healthcare delivery, yet it is currently used in only a small fraction of patients, principally for the diagnosis of suspected Mendelian conditions and for targeting cancer treatments. Given the burden of illness in our society, it is of interest to ask how clinical genome and exome sequencing can be constructively integrated more broadly into the routine practice of medicine for the betterment of public health. In November 2014, 46 experts from academia, industry, policy and patient advocacy gathered in a conference sponsored by Illumina, Inc. to discuss this question, share viewpoints and propose recommendations. This perspective summarizes that work and identifies some of the obstacles and opportunities that must be considered in translating advances in genomics more widely into the practice of medicine.
View details for DOI 10.1586/14737159.2016.1146593
View details for PubMedID 26810587
Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.
AJOB empirical bioethics
2016; 7 (2): 125-134
Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research.We conducted six semi-structured, open-ended focus group discussions with IRB members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments.Our study revealed that IRB members are unclear or divided on the central questions at stake in the current policy debate over ethical oversight of ROMP: IRB members struggle to make a clear distinction between clinical research and medical practice improvement, lack consensus on when ROMP requires IRB review and oversight, and are uncertain about what constitutes incremental risk when patients are randomized to different treatments, any of which may be offered in usual care. They characterized the central challenge as a balancing act, between, on the one hand, making information fully transparent to patients and providing adequate oversight, and on the other hand, avoiding a chilling effect on the research process or harming the physician-patient relationship.Evidence-based guidance that supports IRB members in providing adequate and effective oversight of ROMP without impeding the research process or harming the physician-patient relationship is necessary to realize the full benefits of the learning health system.
View details for PubMedID 27917391
View details for PubMedCentralID PMC5130156
- Commentary on Kim Miller. Clinical trials 2015; 12 (6): 564-566
- Persistent Problems in Death and Dying AMERICAN JOURNAL OF BIOETHICS 2015; 15 (8): 1-2
Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey.
Annals of internal medicine
2015; 162 (10): 690-696
The U.S. Office for Human Research Protections has proposed that end points of randomized trials comparing the effectiveness of standard medical practices are risks of research that would require disclosure and written informed consent, but data are lacking on the views of potential participants.To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices.Cross-sectional survey conducted in August 2014.Web-based questionnaire.1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290).Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices.97% of respondents agreed that health systems should evaluate standard treatments. Most wanted to be asked for permission to participate in each of 3 scenarios (range, 75.2% to 80.4%), even if it involved only medical record review, but most would accept nonwritten (oral) permission or general notification if obtaining written permission would make the research too difficult to conduct (range, 70.2% to 82.7%). Most perceived additional risk from each scenario (range, 64.0% to 81.6%).Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population.Most respondents preferred to be asked for permission to participate in observational and randomized research evaluating usual medical practices, but they are willing to accept less elaborate approaches than written consent if research would otherwise be impracticable. These attitudes are not aligned with proposed regulatory guidance.National Center for Advancing Translational Sciences at the National Institutes of Health.
View details for DOI 10.7326/M15-0166
View details for PubMedID 25868119
- Attitudes Toward Risk and Informed Consent for Research on Medical Practices A Cross-sectional Survey ANNALS OF INTERNAL MEDICINE 2015; 162 (10): 690-?
- The Proper Locus of Professionalization: The Individual or the Institutions? AMERICAN JOURNAL OF BIOETHICS 2015; 15 (5): 1-2
Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations
2015; 90 (5): 615-620
The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.
View details for DOI 10.1097/ACM.0000000000000640
View details for Web of Science ID 000353879700022
View details for PubMedID 25607942
View details for PubMedCentralID PMC4414686
- The potential harms and benefits from research on medical practices. Hastings Center report 2015; 45 (3): 5-6
- Whole genome sequencing in critically ill children LANCET RESPIRATORY MEDICINE 2015; 3 (4): 264-266
- Research on medical practices and the ethics of disclosure. Pediatrics 2015; 135 (2): 208-210
- Clinical Ethics Consultation: A Need for Evidence AMERICAN JOURNAL OF BIOETHICS 2015; 15 (1): 1-2
- Genomics in the clinic: ethical and policy challenges in clinical next-generation sequencing programs at early adopter USA institutions PERSONALIZED MEDICINE 2015; 12 (3): 269-282
Wrongful Termination: Lessons From the Geron Clinical Trial
STEM CELLS TRANSLATIONAL MEDICINE
2014; 3 (12): 1398-1401
SUMMARYGeron Corporation is a publically traded company that launched a phase I clinical trial of a human embryonic stem cell-based therapy for spinal cord injury. The company enrolled the first patient in October 2010 and stopped the trial 1 year later. The fifth patient had been enrolled but not transplanted when the company announced the trial's end. After discussions with clinical staff and family, an agreement was reached to add her to the cohort and proceed with the transplant. Two and half years later, the research is still waiting to restart. With this background in mind, we discuss the major ethical and social questions raised by the Geron case. We offer recommendations for institutional review boards and clinical sites as they deliberate approvals of early-phase trials in frontier medicine.
View details for DOI 10.5966/sctm.2014-0147
View details for Web of Science ID 000346460900014
View details for PubMedID 25298371
- Compassion and Research in Compassionate Use AMERICAN JOURNAL OF BIOETHICS 2014; 14 (11): 1-2
- Innocent Fun or "Microslavery"? AN ETHICAL ANALYSIS OF BIOTIC GAMES HASTINGS CENTER REPORT 2014; 44 (6): 38-46
- Innocent fun or "microslavery"? An ethical analysis of biotic games. Hastings Center report 2014; 44 (6): 38-46
Quality of Communication in Interpreted Versus Noninterpreted PICU Family Meetings*.
Critical care medicine
2014; 42 (6): 1507-1517
To describe the quality of physician-family communication during interpreted and noninterpreted family meetings in the PICU.Prospective, exploratory, descriptive observational study of noninterpreted English family meetings and interpreted Spanish family meetings in the pediatric intensive care setting.A single, university-based, tertiary children's hospital.Participants in PICU family meetings, including medical staff, family members, ancillary staff, and interpreters.Thirty family meetings (21 English and nine Spanish) were audio-recorded, transcribed, de-identified, and analyzed using the qualitative method of directed content analysis.Quality of communication was analyzed in three ways: 1) presence of elements of shared decision-making, 2) balance between physician and family speech, and 3) complexity of physician speech. Of the 11 elements of shared decision-making, only four occurred in more than half of English meetings, and only three occurred in more than half of Spanish meetings. Physicians spoke for a mean of 20.7 minutes, while families spoke for 9.3 minutes during English meetings. During Spanish meetings, physicians spoke for a mean of 14.9 minutes versus just 3.7 minutes of family speech. Physician speech complexity received a mean grade level score of 8.2 in English meetings compared to 7.2 in Spanish meetings.The quality of physician-family communication during PICU family meetings is poor overall. Interpreted meetings had poorer communication quality as evidenced by fewer elements of shared decision-making and greater imbalance between physician and family speech. However, physician speech may be less complex during interpreted meetings. Our data suggest that physicians can improve communication in both interpreted and noninterpreted family meetings by increasing the use of elements of shared decision-making, improving the balance between physician and family speech, and decreasing the complexity of physician speech.
View details for DOI 10.1097/CCM.0000000000000177
View details for PubMedID 24394631
- Accepting brain death. New England journal of medicine 2014; 370 (10): 891-894
- The SUPPORT Controversy and the Debate Over Research Within the Standard of Care AMERICAN JOURNAL OF BIOETHICS 2013; 13 (12): 1-2
A content analysis of posthumous sperm procurement protocols with considerations for developing an institutional policy.
Fertility and sterility
2013; 100 (3): 839-843
OBJECTIVE: To identify and analyze existing posthumous sperm procurement (PSP) protocols in order to outline central themes for institutions to consider when developing future policies. DESIGN: Qualitative content analysis. SETTING: Large academic institutions across the United States. PATIENT(S): N/A. INTERVENTION(S): We performed a literature search and contacted 40 institutions to obtain nine full PSP protocols. We then performed a content analysis on these policies to identify major themes and factors to consider when developing a PSP protocol. MAIN OUTCOME MEASURE(S): Presence of a PSP policy. RESULT(S): We identified six components of a thorough PSP protocol: Standard of Evidence, Terms of Eligibility, Sperm Designee, Restrictions on Use in Reproduction, Logistics, and Contraindications. We also identified two different approaches to policy structure. In the Limited Role approach, institutions have stricter consent requirements and limit their involvement to the time of procurement. In the Family-Centered approach, substituted judgment is permitted but a mandatory wait period is enforced before sperm use in reproduction. CONCLUSION(S): Institutions seeking to implement a PSP protocol will benefit from considering the six major building blocks of a thorough protocol and where they would like to fall on the spectrum from a Limited Role to a Family-Centered approach.
View details for DOI 10.1016/j.fertnstert.2013.05.002
View details for PubMedID 23773314
- A content analysis of posthumous sperm procurement protocols with considerations for developing an institutional policy. Fertility and sterility 2013; 100 (3): 839-843 e6
Best ethical practices for clinicians and laboratories in the provision of noninvasive prenatal testing.
2013; 33 (7): 656-661
OBJECTIVE: The goal of this study is to provide an ethical framework for clinicians and companies providing noninvasive prenatal testing using cell-free fetal DNA or whole fetal cells. METHOD: In collaboration with a National Institutes of Health-supported research ethics consultation committee together with feedback from an interdisciplinary group of clinicians, members of industry, legal experts, and genetic counselors, we developed a set of best practices for the provision of noninvasive prenatal genetic testing. RESULTS: Principal recommendations include the amendment of current informed consent procedures to include attention to the noninvasive nature of new testing and the potential for a broader range of results earlier in the pregnancy. We strongly recommend that tests should only be provided through licensed medical providers and not directly to consumers. CONCLUSION: Prenatal tests, including new methods using cell-free fetal DNA, are not currently regulated by government agencies, and limited professional guidance is available. In the absence of regulation, companies and clinicians should cooperate to adopt responsible best ethical practices in the provision of these tests. © 2013 John Wiley & Sons, Ltd.
View details for DOI 10.1002/pd.4144
View details for PubMedID 23613322
- Overthrowing the tyranny of the journal impact factor. American journal of bioethics 2013; 13 (7): 1-2
- Risk, consent, and SUPPORT. New England journal of medicine 2013; 368 (20): 1864-1865
Parental refusal of vaccination and transplantation listing decisions: A nationwide survey.
2013; 17 (3): 244-250
Many professional societies and research studies recommend complete vaccination before pediatric solid organ transplantation. Nevertheless, incompletely vaccinated children often receive transplants. As the number of parents refusing to vaccinate children for nonmedical reasons increases, pediatric transplantation programs face difficult listing decisions. Given the importance of psychosocial criteria in listing decisions, this study explores how parental refusal of vaccination affects those listing decisions. Surveys were emailed to individuals at 195 pediatric solid organ transplantation programs in the United States, with a 71% response rate. Forty-four respondents (39%) reported that their programs have had cases involving parental refusal of vaccination. In response to hypothetical scenarios, 93 respondents (82%) would list a child not vaccinated for medical reasons, whereas only 54 respondents (47%) would list a child whose parents refused vaccination. Only five respondents (4%) reported that their programs had written policies regarding parental refusal of vaccination. These data reveal inconsistencies across pediatric transplantation programs regarding how parental refusal of vaccination affects listing decisions and raise the issue of whether and how the reason for incomplete vaccination should be factored into listing decisions. We recommend further discussion and the development of written guidelines to unify programs' assessments of incompletely vaccinated pediatric transplantation candidates.
View details for DOI 10.1111/petr.12046
View details for PubMedID 23347536
- Can Informed Consent Go Too Far? Balancing Consent and Public Benefit in Research AMERICAN JOURNAL OF BIOETHICS 2013; 13 (4): 1-2
- Suicide and the sufficiency of surrogate decision makers. American journal of bioethics 2013; 13 (3): 1-2
- 100th Issue Anniversary Editorial AMERICAN JOURNAL OF BIOETHICS 2013; 13 (1): 1-2
- Customers or research participants?: Guidance for research practices in commercialization of personal genomics GENETICS IN MEDICINE 2012; 14 (10): 833-835
Informational risk, institutional review, and autonomy in the proposed changes to the common rule.
2012; 34 (3): 17-19
View details for PubMedID 22830179
Triggers for Research Ethics Consultation
SCIENCE TRANSLATIONAL MEDICINE
2012; 4 (118)
Research ethics consultation services are designed to help scientists address ethical and societal issues that may not be considered in the context of existing regulatory frameworks, such as institutional review boards. Here, we identify some types of biomedical research for which the research process can benefit from consultation with ethicists.
View details for DOI 10.1126/scitranslmed.3002734
View details for Web of Science ID 000299539500001
View details for PubMedID 22277965
- Duty-Free: The Non-Obligatory Nature of Preimplantation Genetic Diagnosis AMERICAN JOURNAL OF BIOETHICS 2012; 12 (4): 1-2
- The Instrumental Role of Hospital Ethics Committees in Policy Work AMERICAN JOURNAL OF BIOETHICS 2012; 12 (11): 1-2
Medical and graduate students' attitudes toward personal genomics
GENETICS IN MEDICINE
2011; 13 (5): 400-408
Medical schools are being approached by direct-to-consumer genotyping companies about genotyping faculty or trainees as a method to "teach" them about the potential implications of genotyping. In thinking about the future incorporation of genotyping into a graduate level genetics course, the purpose of this study was 2-fold: first, to assess knowledge, attitudes, and beliefs of students toward personal genomics as it related to themselves as both as customers and future physicians and as it related to consumers at large, and second, to determine the impact of the course (as taught without genotyping) on knowledge, attitudes, and beliefs.We surveyed first-year medical students and graduate students before and after a core genetics course.After the course, students were less likely to believe that genotyping information would be useful to physicians, patients, or consumers; genotyping would provide information to improve their own personal health; or personal genomic testing services are diagnostic of medical conditions. They were more likely to answer knowledge questions accurately after the course but still had difficulty with clinical interpretation. Despite these changes, a slight majority of students were, and remained, interested in undergoing genotyping themselves. Of note, the number who believed genotyping "would help them understand genetic concepts better than someone else's data" decreased. General curiosity was the most commonly chosen reason for interest in undergoing genotyping, and approximately 50% of respondents expressed concern about confidentiality of results.In conclusion, even without the genotyping process, an educational program about genotyping increased knowledge, particularly about the clinical limitations of genotyping, but student interest in genotyping did not significantly change. Institutions thinking about offering genotyping to their students as part of a learning experience should consider the pros and cons of doing so.
View details for DOI 10.1097/GIM.0b013e31820562f6
View details for Web of Science ID 000290435700005
View details for PubMedID 21270640
- Beyond the IRB: Local Service Versus Global Oversight AMERICAN JOURNAL OF BIOETHICS 2011; 11 (5): 1-2
- Sexless Reproduction: A Status Symbol AMERICAN JOURNAL OF BIOETHICS 2011; 11 (3): 1-1
- Can the Dead Donor Rule be Resuscitated? AMERICAN JOURNAL OF BIOETHICS 2011; 11 (8): 1-1
Translating Stem Cell Research: Challenges at the Research Frontier
JOURNAL OF LAW MEDICINE & ETHICS
2010; 38 (2): 267-?
This paper will address the translation of basic stem cell research into clinical research. While "stem cell" trials are sometimes used to describe established practices of bone marrow transplantation or transplantation of primary cells derived from bone marrow, for the purposes of this paper, I am primarily focusing on stem cell trials which are far less established, including use of hESC derived stem cells. The central ethical challenges in stem cell clinical trials arise in frontier research, not in standard, well-established areas of research.
View details for Web of Science ID 000279534400011
View details for PubMedID 20579250
- Empirical Methods in Bioethics: A Cautionary Tale ANNALS OF INTERNAL MEDICINE 2010; 152 (6): 396-?
- The History of The American Journal of Bioethics AMERICAN JOURNAL OF BIOETHICS 2010; 10 (10): 3-3
Emergency Innovation: Implications for the Trauma Surgeon
JOURNAL OF TRAUMA-INJURY INFECTION AND CRITICAL CARE
2009; 67 (6): 1443-1447
Experimentation involving human subjects requires careful attention to the protection of their rights. Beginning with the Belmont Report in 1979, the United States has developed various sets of rules and regulations that identify the requirements for performing human subject research. In addition, these standards attempt to define the fundamental difference between what constitutes research versus clinical treatment versus innovation. We explore the intersection between two areas of independent bioethics, surgical innovation and emergency research; the point we refer to as emergency innovation.A systematic literature review in each of the fields of emergency research and surgical innovation was completed. The ethical principles involved in each field were identified. In addition, a recent case of surgical innovation within the context of emergency treatment is evaluated for the ethics invoked.One of the great challenges in emergency innovation is that the main protection offered in innovation (heightened informed consent) is not possible in the emergency context where in fact informed consent is waived. Interestingly, the rest of the protections outlined for each field are not mutually exclusive. They can and should be utilized in any project that takes place at this intersection. However, as there are no strict regulations in place for the collision of these two fields, the possibility of having the majority of the involved ethical principles misinterpreted or ignored is very real.For emergency innovation, where it is unclear what ethical principles and regulatory powers apply, it is imperative to be unambiguous about the purpose of the investigation, to adhere to all applicable ethical principles, and to have utmost consideration for protection of the research subject. To determine intent, the goals of the study must be outlined precisely - and if those include the prospect of publication, institutional review board (IRB) approval should be involved early. If, however, the innovation is subtle and the goal geared toward improved patient care, a small feasibility trial would be an appropriate first step before transitioning to a formal larger study approved by an IRB. In either case, the degree of the change in practice must be carefully evaluated and the vulnerability of the research subjects respected. With careful attention paid to all applicable ethical principles at the emergency innovation intersection, medical progress can continue at minimized risk to the human subject participants.
View details for DOI 10.1097/TA.0b013e3181bba255
View details for Web of Science ID 000272658100060
View details for PubMedID 20009701
Use of neurodevelopmental delay in pediatric solid organ transplant listing decisions: Inconsistencies in standards across major pediatric transplant centers
2009; 13 (7): 843-850
Children with NDD present for organ transplant evaluation, but the role of NDD as a listing criterion itself is poorly described. Therefore, we sought to investigate how major pediatric solid organ transplant programs use NDD as a criterion in their listing decisions. We developed a survey that was sent via post to active pediatric solid organ transplant programs across the United States investigating transplant listing decision-making for neurodevelopmentally delayed children. Respondents were medical/surgical directors and transplant coordinators. Descriptive statistics summarize the findings. Programs inconsistently use NDD in listing decisions. Thirty-nine percent of programs stated that they "rarely" or "never" consider NDD in their decisions, whereas 43% of programs "always" or "usually" do. Sixty-two percent of programs report that informal processes guide their use of NDD, and no programs describe their process as "formal, explicit, and uniform." The degree of delay is an additional source of discordance among programs, with 14% of programs reporting mild or moderate NDD as a relative contraindication to listing and 22% reporting that NDD was "irrelevant" to the listing decision. The use of NDD in pediatric solid organ transplant listing decisions is varied and inconsistent across active programs.
View details for DOI 10.1111/j.1399-3046.2008.01072.x
View details for Web of Science ID 000270666600010
View details for PubMedID 19067911
- Direct-to-consumer genetic tests: beyond medical regulation? GENOME MEDICINE 2009; 1
Direct-to-consumer genetic tests: beyond medical regulation?
2009; 1 (2): 17-?
The availability of personalized genomic tests, ordered directly by consumers, is rapidly growing. These tests are unlike other genetic or biochemical tests in the sheer amount of data they provide, but interpretation of these genome-wide analyses for health remains uncertain because of the lack of information about environmental and other factors, and because for the vast majority of genetic loci the associations with disease are weak. Although these tests could provide value to customers by offering tools for social networking or genealogy, there are questions about whether and how to regulate these tests and about the extent to which they provide medical information.
View details for DOI 10.1186/gm17
View details for PubMedID 19341488
Research ethics consultation: the Stanford experience.
2008; 30 (6): 1-6
View details for PubMedID 19119757
Strangers at the Benchside: Research ethics consultation
AMERICAN JOURNAL OF BIOETHICS
2008; 8 (3): 4-13
Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program.
View details for DOI 10.1080/15265160802109322
View details for Web of Science ID 000257030400004
View details for PubMedID 18570086
- The green revolution in bioethics AMERICAN JOURNAL OF BIOETHICS 2008; 8 (8): 1-2
Federalism & bioethics - States and moral pluralism
HASTINGS CENTER REPORT
2007; 37 (6): 24-35
Bioethicists are often interested mostly in national standards and institutions, but state governments have historically overseen a wide range of bioethical issues and share responsibility with the federal government for still others. States ought to have an important role. By allowing for multiple outcomes, the American federal system allows a better fit between public opinion and public policies.
View details for Web of Science ID 000251116100020
View details for PubMedID 18179102
- Blood, sweat and tears AMERICAN JOURNAL OF BIOETHICS 2006; 6 (3): 1-2
- Research conduct - Lessons of the stem cell scandal SCIENCE 2006; 311 (5761): 614-615
- A commentary on oocyte donation for stem cell research in South Korea AMERICAN JOURNAL OF BIOETHICS 2006; 6 (1): W23-W24
- Stem cell research: The California experience HASTINGS CENTER REPORT 2006; 36 (1): 26-28
- Issues in oocyte donation for stem cell research SCIENCE 2005; 308 (5729): 1747-1748
- Stem cell research should be more than a promise HASTINGS CENTER REPORT 2004; 34 (5): 35-36
Politics and peer review.
American journal of bioethics
2004; 4 (1): 7-8
View details for PubMedID 15035920
- New life forms: New threats, new possibilities HASTINGS CENTER REPORT 2003; 33 (6): 7-7
In focus. Core faculty and their publications at bioethics centers in the United States.
American journal of bioethics
2002; 2 (4): W20-?
View details for PubMedID 12778940
Evaluating graduate programs in bioethics: what measures should we use?
American journal of bioethics
2002; 2 (4): 1-2
View details for PubMedID 12784805
The meaning of graduate education for bioethics.
American journal of bioethics
2002; 2 (4): 10-12
View details for PubMedID 12762912
- Is there a bioethicist in your company? Should there be? DRUG DISCOVERY TODAY 2002; 7 (7): 385-387
Protecting subjects' interests in genetics research
AMERICAN JOURNAL OF HUMAN GENETICS
2002; 70 (4): 965-971
Biomedical researchers often assume that sponsors, subjects, families, and disease-associated advocacy groups contribute to research solely because of altruism. This view fails to capture the diverse interests of many participants in the emerging research enterprise. In the past two decades, patient groups have become increasingly active in the promotion and facilitation of genetics research. Simultaneously, a significant shift of academic biomedical science toward commercialization has occurred, spurred by U.S. federal policy changes. The concurrent rise in both the roles that subjects play and the commercial interests they have presents numerous ethical challenges. We examine the interests of different research participants, finding that these interests are not addressed by current policies and practices. We conclude that all participants should be given a voice in decisions affecting ownership, access to, and use of commercialized products and services, and that researchers and institutions should negotiate issues relating to control of research results and the sharing of benefits before the research is performed.
View details for Web of Science ID 000174252100013
View details for PubMedID 11870592
- Who Owns Life? 2002
- NAS cloning hearing disappoints participants SCIENCE 2001; 294 (5547): 1651-1651
Reason and repugnance.
Medical ethics (Burlington, Mass.)
View details for PubMedID 15584188
- Bioethics programs evolve as they grow - With bioethics squarely in the news comes new scrutiny on exactly what it takes to train a bioethicist. NATURE BIOTECHNOLOGY 2001; 19 (10): 991-992
American journal of bioethics
2001; 1 (3): 1-?
View details for PubMedID 11954574
- The AJOB Experiment. American journal of bioethics 2001; 1 (1): 1-?
Ethical issues: from genome to therapy.
Novartis Foundation symposium
2000; 229: 122-125
View details for PubMedID 11084937
Policy forum: genetics. Ethical considerations in synthesizing a minimal genome.
1999; 286 (5447): 2087-?
View details for PubMedID 10617419
- What is immoral about eugenics? BRITISH MEDICAL JOURNAL 1999; 319 (7220): 1284-U19
- What is immoral about eugenics? WESTERN JOURNAL OF MEDICINE 1999; 171 (5-6): 335-337
- Disease gene patenting: The clinician's dilemma CAMBRIDGE QUARTERLY OF HEALTHCARE ETHICS 1998; 7 (4): 433-435
BEHAVIORAL AND BRAIN SCIENCES
1990; 13 (1): 26-?
View details for Web of Science ID A1990CT38000020