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1.  Attitudes of African American parents about biobank participation and return of results for themselves and their children 
Journal of medical ethics  2012;38(9):561-566.
Biobank-based research is growing in importance. A major controversy exists about the return of aggregate and individual research results.
We used a mixed-method approach in order to study parents' attitudes toward the return of research results regarding themselves and their children. Participants attended four two-hour, deliberative-engagement sessions held on two consecutive Saturdays. Each session consisted of an educational presentation followed by focus-group discussions with structured questions and prompts. This manuscript examines discussions from the second Saturday which focused on the benefits and risks of returning aggregate and individual research results regarding both adults (morning session) and children (afternoon session). Attitudes were assessed in pre- and post-engagement surveys.
We recruited 45 African-American adults whose children received medical care at two health care facilities on the South Side of Chicago that serve different socioeconomic communities. Three dominant themes were identified. First, most participants stated that they would enroll themselves and their children in a biobank, although there was a vocal minority opposed to enrolling children, particularly children unable to participate in the consent process. Second, participants did not distinguish between the results they wanted to receive regarding themselves and their children. Supplemental survey data found no attitudinal changes pre- and post-engagement. Third, participants believed that children should be allowed access to their health information, but they wanted to be involved in deciding when and how the information was shared.
Participant attitudes are in tension with current biobank policies. An intensive educational effort had no effect on their attitudes.
PMCID: PMC4260924  PMID: 22573882
child; parent; biobank; genetic research; return of results; deliberative engagement
2.  Multiplex parenting: IVG and the generations to come 
Journal of Medical Ethics  2014;40(11):752-758.
Recent breakthroughs in stem cell differentiation and reprogramming suggest that functional human gametes could soon be created in vitro. While the ethical debate on the uses of in vitro generated gametes (IVG) was originally constrained by the fact that they could be derived only from embryonic stem cell lines, the advent of somatic cell reprogramming, with the possibility to easily derive human induced pluripotent stem cells from any individual, affords now a major leap in the feasibility of IVG derivation and in the scope of their potential applications. In this paper we develop an ethical framework, rooted in recent scientific evidence, to support a robust experimental pipeline that could enable the first-in-human use of IVG. We then apply this framework to the following objectives: (1) a clarification of the genetic parenting options afforded by IVG, along with their ethical underpinnings; (2) a defence of the use of IVG to remedy infertility, broadening their scope to same-sex couples; (3) an assessment of the most far-reaching implications of IVG for multiplex parenting. These include, first, the liberation of parenting roles from the constraints of biological generations in vivo, allowing multiple individuals to engage in genetic parenting together, thus blurring the distinction between biological and social generations. Second, we discuss the conflation of IVG with sequencing technology and its implications for the possibility that prospective parents may choose among a hitherto unprecedented number of potential children. In view of these perspectives, we argue that, contrary to the exhausted paradigm according to which society lags behind science, IVG may represent instead a salient and most visible instance where biotechnological ingenuity could be used in pursuit of social experimentation.
PMCID: PMC4215291  PMID: 24608087
artificial gametes; synthetic gametes; multiplex parenting; in vitro produced gametes; stem-cell derived gametes
3.  Psychiatric diagnosis: the indispensability of ambivalence 
Journal of Medical Ethics  2014;40(8):526-530.
The author analyses how debate over the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders has tended to privilege certain conceptions of psychiatric diagnosis over others, as well as to polarise positions regarding psychiatric diagnosis. The article aims to muddy the black and white tenor of many discussions regarding psychiatric diagnosis by moving away from the preoccupation with diagnosis as classification and refocusing attention on diagnosis as a temporally and spatially complex, as well as highly mediated process. The article draws on historical, sociological and first-person perspectives regarding psychiatric diagnosis in order to emphasise the conceptual—and potentially ethical—benefits of ambivalence vis-à-vis the achievements and problems of psychiatric diagnosis.
PMCID: PMC4112451  PMID: 24515564
psychiatric diagnosis; DSM–5; sociology; personal narratives
4.  Unrealistic Optimism and the Ethics of Phase I Cancer Research 
Journal of medical ethics  2012;39(6):403-406.
One of the most pressing ethical challenges facing Phase I cancer research centers on the process of informed consent. Historically, most scholarship has been devoted to redressing therapeutic misconception—i.e., the conflation of the nature and goals of research with those of therapy. While therapeutic misconception continues to be a major ethical concern, recent scholarship has begun to recognize that the informed consent process is more complex than merely a transfer of information and therefore cannot be evaluated only according to how well an individual understands such information. Other components of decision making operate independently of understanding and yet still may compromise the quality of informed consent. Notable among these components is unrealistic optimism, an event-specific belief that one has a better chance of receiving benefit than others similarly situated. In this article, we consider responses to interviews with parents who had recently completed an informed consent conference for enrolling their child in a Phase I cancer clinical trial to examine how this influence manifests and how investigators might address it during informed consent.
PMCID: PMC3697015  PMID: 23118468
unrealistic optimism; Phase I; clinical trials; research ethics; cancer
5.  Conscientious refusals to refer: Findings from a national physician survey 
Journal of medical ethics  2011;37(7):397-401.
Regarding controversial medical services, many have argued that if physicians cannot in good conscience provide a legal medical intervention for which a patient is a candidate, they should refer the requesting patient to an accommodating provider. This study examines what US physicians think a doctor is obligated to do when the doctor thinks it would be immoral to provide a referral.
We conducted a cross-sectional survey of a random sample of 2000 U.S. physicians from all specialties. Our primary criterion variable was agreement that physicians have a professional obligation to refer patients for all legal medical services for which the patients are candidates, even if the physician believes that such a referral is immoral.
Of 1895 eligible physicians, 1032 (55%) responded. Fifty-seven percent of physicians agreed that doctors must refer patients regardless of whether or not the doctor believes the referral itself is immoral. Holding this opinion was independently associated with being more theologically pluralistic, describing oneself as sociopolitically liberal, and indicating that respect for patient autonomy is the most important bioethical principle in one’s practice (multivariable odds ratios, 1.6 to 2.4).
Physicians are divided about a professional obligation to refer when the physician believes that referral itself is immoral. These data suggest there is no uncontroversial way to resolve conflicts posed when patients request interventions that their physicians cannot in good conscience provide.
PMCID: PMC4019379  PMID: 21335574
Principle-Based Ethics; Conscience; Referral and Consultation; Treatment Refusal
6.  Re-consenting human subjects: ethical, legal and practical issues 
Journal of medical ethics  2009;35(11):656-657.
PMCID: PMC3971530  PMID: 19880699
7.  Increasing the amount of payment to research subjects 
Journal of medical ethics  2008;34(9):e14.
This article discusses some ethical issues that can arise when researchers decide to increase the amount of payment offered to research subjects to boost enrollment. Would increasing the amount of payment be unfair to subjects who have already consented to participate in the study? This article considers how five different models of payment—the free market model, the wage payment model, the reimbursement model, the appreciation model, and the fair benefits model—would approach this issue. The article also considers several practical problems related to changing the amount of payment, including determining whether there is enough money in the budget to offer additional payments to subjects who have already enrolled, ascertaining how difficult it will be to re-contact subjects, and developing a plan of action for responding to subjects who find out they are receiving less money and demand an explanation.
PMCID: PMC3966192  PMID: 18757614
8.  Participants’ responsibilities in clinical research 
Journal of medical ethics  2012;38(12):746-750.
Discussions on the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions and institutional review boards, but very little about the responsibilities of research participants. In this article, we discuss the responsibilities of participants in clinical research. We argue that competent adult participants are responsible for complying with study requirements and fulfilling other obligations they undertake when they make an informed choice to enrol in a study. These responsibilities are based on duties related to promise-keeping, avoiding harm to one’s self or others, beneficence and reciprocity. Investigators and research staff should inform participants about their responsibilities during the consent process, and should stress the importance of fulfilling study requirements. They should address any impediments to compliance, and they may provide participants with financial incentives for meeting study requirements. In very rare cases, coercive measures may be justified to prevent immanent harm to others resulting from non-compliance with study requirements.
PMCID: PMC3962011  PMID: 22822200
9.  Authorship policies of bioethics journals 
Journal of medical ethics  2011;37(7):424-428.
Inappropriate authorship is a common problem in biomedical research and may be becoming one in bioethics, due to the increase in multiple authorship. This paper investigates the authorship policies of bioethics journals to determine whether they provide adequate guidance for researchers who submit articles for publication, which can help deter inappropriate authorship. It was found that 63.3% of bioethics journals provide no guidance on authorship; 36.7% provide guidance on which contributions merit authorship, 23.3% provide guidance on which contributions do not merit authorship, 23.3% require authors to take responsibility for their contributions or for the article as a whole, 20% provide guidance on which contributions merit an acknowledgement but not authorship, 6.7% require authors to describe their contributions, and only 3.3% distinguish between authorship in empirical and conceptual research. To provide authors with effective guidance and promote integrity in bioethics research, bioethics journals should adopt authorship policies that address several important topics, such as the qualifications for authorship, describing authorship contributions, taking responsibility for the research and the difference between authorship in empirical and conceptual research.
PMCID: PMC3954630  PMID: 21266387
10.  How US institutional review boards decide when researchers need to translate studies 
Journal of medical ethics  2013;40(3):193-197.
Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees’ (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals—what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions.
PMCID: PMC3864149  PMID: 23475805
11.  Health Care Providers’ Knowledge and Attitudes about Rapid Tissue Donation (RTD): Phase one of Establishing a Rapid Tissue Donation Program in Thoracic Oncology 
Journal of medical ethics  2013;40(2):139-142.
In preparation for the development of a Rapid Tissue Donation (RTD) program, we surveyed health care providers (HCP) in our institution about knowledge and attitudes related to RTD with lung cancer patients. A 31-item web based survey was developed collecting data on demographics, knowledge and attitudes about RTD. The survey contained 3 items measuring participants’ knowledge about RTD, 5 items assessed attitudes about RTD recruitment, and 6 items assessed HCPs’ level of agreement with factors influencing decisions to discuss RTD. Response options were presented on a 5-point Likert scale. Ninety-one HCPs participated in the study. 66% indicated they had never heard of RTD prior to the survey, 78% rated knowledge of RTD as none or limited, and 95.6% reported not having ethical or religious concerns about discussing RTD with patients. The majority were either not comfortable (17.8%) or not sure if they felt comfortable discussing RTD with cancer patients (42.2%). 56.1% indicated their knowledge of RTD would plays an integral role in their decision to discuss RTD with patients. 71.4% reported concerns with RTD discussion and the emotional state of the patient. Physicians and nurses play an important role in initiating conversations about recruitment and donation to research that can ultimately influence uptake. Increasing HCP knowledge about RTD is a necessary step towards building and RTD program. Our study provides important information about characteristics associated with low levels of knowledge and practice related to RTD where additional education and training may be warranted.
PMCID: PMC3924895  PMID: 23557908
Survey; Health Care Providers; Tissue Donation; Oncology; Lung Cancer
12.  Ethical considerations in targeted pediatric neurosurgery missions 
Journal of medical ethics  2012;39(1):10.1136/medethics-2012-100610.
Within the context of global health development approaches, surgical missions to provide care for underserved populations remain the least studied interventions with regard to their methodology. Because of the unique logistical needs of delivering operative care surgical missions are often described solely in terms of cases performed, with a paucity of discourse on medical ethics. Within surgery, subspecialties that serve patients on a non-elective basis should, it could be argued, create mission strategies that involve a didactic approach and the propagation of sustainable surgical care. The ethical considerations have yet to be described for pediatric neurosurgical outreach missions. We present here the perspectives of neurosurgeons who have participated in surgical outreach missions in Central America, South America, Eastern Europe, and Sub-Saharan Africa from the vantage point of both the visiting mission team and the host team that accommodates the mission efforts.
PMCID: PMC3883460  PMID: 23001919
Pediatrics; Surgery; Education for Health Care Professionals
13.  Preventive Misconception and Adolescents’ Knowledge about HIV Vaccine Trials 
Journal of medical ethics  2013;39(12):10.1136/medethics-2012-100821.
Adolescents have had very limited access to research on biomedical prevention interventions despite high rates of HIV acquisition. One concern is that adolescents are a vulnerable population, and trials carry a possibility of harm, requiring investigators to take additional precautions. Of particular concern is preventive misconception, or the overestimation of personal protection that is afforded by enrollment in a prevention intervention trial.
As part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16–19 year olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semi-structured interview about their understanding and opinions related to enrollment in a HIV vaccine trial. A grounded theory analysis looked for shared concepts, and focused on the content and process of adolescent participants’ understanding HIV vaccination and the components of preventive misconception, including experiment, placebo and randomisation.
Across interviews, adolescents demonstrated active processing of information, in which they questioned the interviewer, verbally worked out their answers based upon information provided, and corrected themselves. We observed a wide variety of understanding of research concepts. While most understood experiment and placebo, fewer understood randomisation. All understood the need for safer sex even if they did not understand the more basic concepts.
Education about basic concepts related to clinical trials, time to absorb materials and assessment of understanding may be necessary in future biomedical prevention trials.
PMCID: PMC3677956  PMID: 23355050
Preventive Misconception; Adolescent; HIV; Bioethics; Clinical Trial; Vaccine; Qualitative
Journal of medical ethics  2010;36(10):10.1136/jme.2009.035220.
A curriculum was designed to shape biomedical graduate students into researchers with a high commitment to professionalism and social responsibility, and to provide students with tools to navigate the complex, rapidly evolving academic and societal environments with a strong ethical commitment. Problem-Based Learning (PBL) pedagogy was chosen because it is active, learner-centered, and focuses on skill and process development. Additionally, the small group format provides a high degree of socialization around professional norms. Two courses were developed.
Scientific Professionalism
Scientific Integrity addressed discipline-specific and broad professional norms and obligations for the ethical practice of science and responsible conduct of research (RCR).
Scientific Professionalism
Bioethics and Social Responsibility focused on current ethical and bioethical issues within the scientific profession and implications of research for society. Each small-group session examined case scenarios that included: (1) learning objectives for professional norms and obligations; (2) key ethical issues and philosophies within each topic area; (3) one or more of the RCR instructional areas; and (4) at least one type of moral reflection. Cases went beyond covering overt research misconduct to emphasize professional standards, obligations, and underlying philosophies for the ethical practice of science, competing interests of stakeholders, and oversight of science (internal and external). To our knowledge this was the first use of PBL to teach scientific integrity and ethics. Both faculty and students at Wake Forest endorsed the orientation of professionalism, active learning, and acquiring skills in contrast to a compliance-based approach that emphasizes learning rules and regulations.
PMCID: PMC3809997  PMID: 20797979
15.  Development of a Research Ethics Knowledge and Analytical Skills Assessment 
Journal of medical ethics  2011;38(4):236-242.
The goal of this of this project was to develop and validate a new tool to evaluate learners’ knowledge and skills related to research ethics.
A core set of 50 questions from existing computer based on-line teaching modules were identified, refined and supplemented to create a set of 74 multiple-choice, true/false and short answer questions. The questions were pilot tested and item discrimination (ID) calculated for each question. Poorly performing items were eliminated or refined. Two comparable assessments were created. These assessments were administered as a pre-test and post-test to a cohort of 58 Indian junior investigators before and after exposure to a new course on research ethics. Half of the investigators were exposed to the course on-line, the other half in person. Item discrimination (ID) was calculated for each question and Cronbach’s Alpha for each assessment. A final version of the assessment that incorporated the best questions from the pre-/post-test phase was used to assess retention of research ethics knowledge and skills three months after course delivery.
The final version of the REKASA includes 41 items. The final version of the REKASA had a Cronbach’s alpha of .837.
The results illustrate, in one sample of learners, the successful, systematic development and use of a knowledge and skills assessment in research ethics capable of reliably assessing the application of important analytic and reasoning skills, without reliance on essay or discussion-based examination.
PMCID: PMC3801183  PMID: 22052994
16.  Effect of ethnicity, gender and drug use history on achieving high rates of affirmative informed consent for genetics research: impact of sharing with a national repository 
Journal of medical ethics  2011;37(6):374-379.
Genetic research representative of the population is crucial to understanding the underlying causes of many diseases. In a prospective evaluation of informed consent we assessed the willingness of individuals of different ethnicities, gender and drug dependence history to participate in genetic studies in which their genetic sample could be shared with a repository at the National Institutes of Health.
Potential subjects were recruited from the general population through the use of flyers and referrals from previous participants and clinicians with knowledge of our study. They could consent to 11 separate choices so that they could specify how and with whom their genetic sample could be shared. Rates of affirmative consent were then analysed by gender, ethnicity and drug dependence history.
Of 1416 volunteers enrolled, 99.7% gave affirmative informed consent for studies of addiction conducted in our laboratory. No significant difference was found for participation in genetic studies conducted in our laboratory by gender, ethnicity or drug dependence history. Over all 11 questions, individuals with a history of drug use were more likely to agree to consent to participate in our study than were healthy volunteers.
A high percentage of each category of gender, ethnicity and drug history, gave affirmative consent at all levels. The level of detail in and the amount of time spent reviewing the informed consent, and a relationship of trust with the clinical investigator may contribute to this outcome.
PMCID: PMC3789247  PMID: 21266386
Journal of medical ethics  2010;36(10):620-626.
A process evaluation was conducted to assess whether the newly developed Problem-Based Learning (PBL) curriculum designed to teach professionalism and ethics to biomedical graduate students was achieving its objectives. The curriculum was chosen to present realistic cases and issues in the practice of science, to promote skill development and to acculturate students to professional norms of science.
The perception to which the objectives for the curriculum and courses were being reached was assessed using 5-step Likert-scaled questions, open-ended questions and interviews of students and facilitators.
Process evaluation indicated that both facilitators and students perceived course objectives were being met. For example, active learning was preferred over lectures; both faculty and students percieved that the curriculum increased their understanding of norms, role obligations, and responsibilities of professional scientists; their ability to identify ethical situations was increased; skills in moral reasoning and effective group work were developed.
Information gathered was used to improve course implementation and instructional material. For example, a negative perception as an “ethics” course was addressed by redesigning case debriefing activities that reinforced learning objectives and important skills. Cases were refined to be more engaging and relevant for students, and facilitators were given more specific training and resources for each case. The PBL small group strategy can stimulate an environment more aware of ethical implications of science and increase socialization and open communication about professional behavior.
PMCID: PMC3752918  PMID: 20663754
18.  A renewed, ethical defense of placebo-controlled trials of new treatments for major depression and anxiety disorders 
Journal of medical ethics  2009;35(6):384-389.
The use of placebo as a control condition in clinical trials of major depressive disorder and anxiety disorders continues to be an area of ethical concern. Typically, opponents of placebo controls argue that they violate the beneficent-based, “best proven diagnostic and therapeutic method” that the original Helsinki Declaration of 1964 famously asserted participants are owed. A more consequentialist, oppositional argument is that participants receiving placebo might suffer enormously by being deprived of their usual medication(s). Nevertheless, recent findings of potential for suicidality in young people treated with antidepressants, along with meta-analyses suggesting that antidepressants add no significant clinical benefit over placebos, warrant a re-evaluation of the arguments against placebo. Furthermore, the nature of placebo treatment in short-term clinical trials is often not well understood, and lack of understanding can foster opposition to it. This paper will show how scientific justifications for placebo use are morally relevant. The fundamental ethical importance of placebo controls is discussed in relation to several aspects of clinical trials, including detection of adverse events, accurate assessment of clinical benefit, advancing understanding of the heterogeneity of depression and anxiety disorders and respecting informed consent requirements. Prohibiting the use of placebo controls is morally concerning in that such prohibitions allow for the possibility of serious adverse public health consequences. Moral worries that research participants receiving placebo are being unduly jeopardised will be shown to be exaggerated, especially in relation to the net benefits for end-users to be gained from the quality of data resulting from using placebo controls.
PMCID: PMC3711824  PMID: 19482985
19.  Comprehension of a simplified assent form in a vaccine trial for adolescents 
Journal of medical ethics  2013;39(6):410-412.
Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general.
Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative.
123 youth completed the questionnaire (mean age=15 years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly.
Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking.
PMCID: PMC3655100  PMID: 23349510
20.  Conflict and emotional exhaustion in obstetrician-gynaecologists: a national survey 
Journal of medical ethics  2010;36(12):731-735.
Conflicts over treatment decisions have been linked to physicians' emotional states.
To measure the prevalence of emotional exhaustion and conflicts over treatment decisions among US obstetrician/gynaecologists (ob/gyns), and to examine the relationship between the two and the physician characteristics that predict each.
Mailed survey of a stratified random sample of 1800 US ob/gyn physicians. Criterion variables were levels of emotional exhaustion and frequency of conflict with colleagues and patients. Predictors included physicians' religious characteristics and self-perceived empathy.
Response rate among eligible physicians was 66% (1154/1760). 36% of ob/gyns reported high levels of emotional exhaustion, and majorities reported conflict with colleagues (59%) and patients (61%). Those reporting conflict were much more likely to report emotional exhaustion (58% vs 29% who never conflict, OR, 95% CI 2.8, 1.6 to 4.8 for conflict with colleagues; 55% versus 26%, OR, 95% CI 2.2, 1.4 to 3.5 for conflict with patients). Physicians with lower self-perceived empathy were more likely to report physician-patient conflicts (65% vs 58% with higher empathy, OR, 95% CI 1.4, 1.0 to 1.9), as were female ob/gyns (66% vs 57% of males, OR, 95% CI 1.5, 1.1 to 2.0). Foreign-born physicians were less likely to report such conflicts (47% vs 64% of US born, OR, 95% CI 0.5, 0.4 to 0.8). Physicians' religious characteristics were not significantly associated with reporting conflict.
Conflicts over treatment decisions are associated with physicians' empathy, gender, immigration history and level of emotional exhaustion. With respect to the latter, conflict in the clinical encounter may represent an overlooked source or sign of burnout among ob/gyns.
PMCID: PMC3632257  PMID: 21112936
21.  How IRBs view and make decisions about coercion and undue influence 
Journal of medical ethics  2012;39(4):224-229.
Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored.
I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members.
IRBs wrestled with defining of ‘coercion’ and ‘undue inducement’, most notably in deciding about participant compensation. IRBs often use these terms synonymously and define undue inducement in varying ways, often wrestling with these issues, relying on ‘gut feelings’, and seeking compromises. Ambiguities arose, partly reflecting underlying tensions: whether subjects should ‘get paid’ versus ‘volunteer’ (ie, whether subjects should be motivated by compensation vs altruism), and whether subjects should be paid differently based on income, given possible resultant selection bias. Lack of consistent standards emerged between and even on single IRBs. Questions arose concerning certain aspects and types of studies; for example, how to view and weigh providing free care in research, whether and how recruitment flyers should mention compensation, and how to avoid coercion in paediatric, developing world, or students research.
These data, the first to probe qualitatively how IRBs view and approach questions about coercion, undue influence and participant compensation, and to examine how IRBs have reviewed actual cases, reveal several critical ambiguities and dilemmas, and have vital implications for future practice, education, policy and research.
PMCID: PMC3604028  PMID: 22982492
22.  Risk of disclosure of participating in an internet-based HIV behavioral risk study of men who have sex with men (MSM) 
Journal of medical ethics  2011;37(12):768-769.
As the frequency of internet-based research has increased, it is important for researchers to consider how the conditions in which data are collected may influence the risks to participants. In particular, because internet-based data collection often occurs outside a clinical or research setting, there may be unintentional disclosures of a participant’s involvement in a research study of which the researcher is unaware. The current analysis examined the responses of men who have sex with men participating in an internet-based HIV behavioral risk study when queried about the possible disclosure of their participation in the study. Fewer than 2% of participants indicated that their participation in the research study was disclosed, and all but one indicated no negative outcomes associated with the disclosure. As the field of online research continues to expand, it is important to consider risks that are unique to internet-based research, and to monitor these risks to ensure that the confidentiality of research subjects is maintained.
PMCID: PMC3593712  PMID: 21708832
23.  A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions 
Journal of medical ethics  2011;37(6):368-373.
If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods.
The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages.
Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions.
The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.
PMCID: PMC3571710  PMID: 21429960
24.  Provider, Patient, and Public Benefits from a NICE Appraisal of Bevacizumab (Avastin) 
Journal of medical ethics  2011;38(3):187-189.
There are several good reasons for UK Department of Health to recommend appraisal of bevacizumab for treatment of eye conditions by the National Institute for Health and Clinical Excellence. These reasons will extend to other drugs when similar situations arise in future.
PMCID: PMC3541520  PMID: 21947806
25.  Research, Engagement, and Public Bioethics: Promoting Socially Robust Science 
Journal of medical ethics  2011;37(11):698-701.
Citizens today are increasingly expected to be knowledgeable about and prepared to engage with biomedical knowledge. In this article, I wish to reframe this ‘public understanding of science’ project, and place fresh emphasis on public understandings of research: an engagement with the everyday laboratory practices of biomedicine and its associated ethics, rather than of specific scientific facts. This is not based on an assumption that non-scientists are ‘ignorant’ and are thus unable to ‘appropriately’ use or debate science; rather, it is underpinned by an empirically-grounded observation that some individuals may be unfamiliar with certain specificities of particular modes of research and ethical frameworks, and, as a consequence, have their autonomy compromised when invited to participate in biomedical investigations. Drawing on the perspectives of participants in my own sociological research on the social and ethical dimensions of neuroscience, I argue that public understandings of biomedical research and its ethics should be developed both at the community level and within the research moment itself, in order to enhance autonomy and promote more socially robust science. Public bioethics will have play a key role in such an endeavour, and indeed will contribute in important ways to the opening up of new spaces of symmetrical engagement between bioethicists, scientists, and wider publics – and hence to the democratisation of the bioethical enterprise.
PMCID: PMC3540974  PMID: 21673017
Neuroscience; Public Bioethics; Public Engagement; Public Understanding of Science; Research Ethics

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