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.
Survey; Health Care Providers; Tissue Donation; Oncology; Lung Cancer
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.
Pediatrics; Surgery; Education for Health Care Professionals
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.
Preventive Misconception; Adolescent; HIV; Bioethics; Clinical Trial; Vaccine; Qualitative
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 Integrity addressed discipline-specific and broad professional norms and obligations for the ethical practice of science and responsible conduct of research (RCR).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Neuroscience; Public Bioethics; Public Engagement; Public Understanding of Science; Research Ethics
From the perspective of investigators conducting research involving pregnant women and fetuses, a woman's decision about whether to have an abortion can sometimes be relevant to the suitability of the woman and fetus as research subjects. However, prominent ethicists disagree over whether it is permissible for a woman's decision about abortion to be an inclusion or exclusion criterion for participation in research. A widely-held view is that fetuses to be aborted and fetuses to be carried to term should be treated equally as research subjects. Some hold that this principle implies that a woman's decision about whether to have an abortion should not be an inclusion or exclusion criterion. This paper identifies types of research in which investigators might want to have inclusion or exclusion criteria based on decisions about abortion. It examines the arguments for and against having the woman's decision about abortion as such criteria. It is argued that there are types of research in which such criteria are ethically permissible.
abortion; research ethics; prenatal research; fetus; in utero gene transfer
We examined all 208 closed cases involving official findings of research misconduct published by the US Office of Research Integrity from 1992 to 2011 to determine how often scientists mention in a retraction or correction notice that there was an ethical problem with an associated article. 75 of these cases cited at least one published article affected by misconduct for a total of 174 articles. For 127 of these 174, we found both the article and a retraction or correction statement. Since eight of the 127 published statements consisted of simply the word ‘retracted,’ our analysis focused on the remaining 119 for which a more detailed retraction or correction was published. Of these 119 statements, only 41.2% mentioned ethics at all (and only 32.8% named a specific ethical problem such as fabrication, falsification or plagiarism), whereas the other 58.8% described the reason for retraction or correction as error, loss of data or replication failure when misconduct was actually at issue. Among the published statements in response to an official finding of misconduct (within the time frame studied), the proportion that mentioned ethics was significantly higher in recent years than in earlier years, as was the proportion that named a specific problem. To promote research integrity, scientific journals should consider adopting policies concerning retractions and corrections similar to the guidelines developed by the Committee on Publication Ethics. Funding agencies and institutions should take steps to ensure that articles affected by misconduct are retracted or corrected.
While quizzing during informed consent for research to ensure understanding has become commonplace, it is unclear whether the quizzing itself is problematic for potential participants. In this study, we address this issue in a multinational HIV prevention research trial enrolling injection drug users in China and Thailand.
Enrollment procedures included an informed consent comprehension quiz. An informed consent survey (ICS) followed.
525 participants completed the ICS (Heng County, China=255, Xinjiang, China=229, Chiang Mai, Thailand=41). Mean age was 33 and mean educational level was 8 yrs. While quizzing was felt to be a good way to determine if a person understands the nature of clinical trial participation (97%) and participants did not generally find the quiz to be problematic, minorities of respondents felt pressured (6%); anxious (5%); bored (5%); minded (5%); and did not find the questions easy (13%). ). In multivariate analysis, lower educational level was associated with not minding the quizzing (6–10 yrs versus 0–5 yrs: OR=0.27, p=0.03; more than 11 yrs versus 0–5 yrs: OR=0.18, p=0.03). There were also site differences (Heng County versus Xinjiang) in feeling anxious (OR=0.07; p=<0.01), not minding (OR=0.26; p=0.03), being bored (OR=0.25; p =0.01), and not finding the questions easy (OR=0.10; p=<0.01).
Quizzing during the informed consent process can be problematic for a minority of participants. These problems may be associated with the setting in which research takes place and educational level. Further research is needed to develop, test and implement alternative methods of ensuring comprehension of informed consent.
clinicaltrials.gov number NCT00270257.
informed consent; research ethics; ethics; attitudes
Ethics; research; developing countries; Thailand; Burma; genetics; genetics research ethics; ethics theory; clinical ethics
So-called ‘anonymous’ tissue samples are widely used in research. Because they lack externally identifying information, they are viewed as useful in reconciling conflicts between the control, privacy and confidentiality interests of those from whom the samples originated and the public (or commercial) interest in carrying out research, as reflected in ‘consent or anonymise’ policies. High level guidance documents suggest that withdrawal of consent and samples and the provision of feedback are impossible in the case of anonymous samples. In view of recent developments in science and consumer-driven genomics the authors argue that such statements are misleading and only muddle complex ethical questions about possible entitlements to control over samples. The authors therefore propose that terms such as ‘anonymised’, ‘anonymous’ or ‘non-identifiable’ be removed entirely from documents describing research samples, especially from those aimed at the public. This is necessary as a matter of conceptual clarity and because failure to do so may jeopardise public trust in the governance of large scale databases. As there is wide variation in the taxonomy for tissue samples and no uniform national or international standards, the authors propose that a numeral-based universal coding system be implemented that focuses on specifying incremental levels of identifiability, rather than use terms that imply that the reidentification of research samples and associated actions are categorically impossible.
Increasingly a focus of research as well as media reports and online forums, the use of placebos in clinical medicine extends beyond sugar pills and saline injections. Physician surveys conducted in various countries invariably report that placebos are routinely used clinically, impure placebos more frequently than the pure ones, and that physicians consider them to be of legitimate therapeutic value. Inconsistent study methodologies and physician conceptualisations of placebos may complicate the interpretation of survey data, but hardly negate the valuable insights these research findings provide. Because impure placebos are often not recognised as such by practitioners, they remain at the fringe of many placebo-related debates, hence quietly absent from discussions concerning policy and regulation. The apparent popularity of impure placebos used in clinical practice thus presents unresolved ethical concerns and should direct future discussion and research.
Clinical ethics; education for healthcare professionals; healthcare for specific diseases/groups
Informed consent is perhaps more relevant to surgical specialties than to other clinical disciplines. Fundamental to this concept is the provision of relevant information for the patient to make an informed choice about a surgical intervention. The opinions of surgeons in Nigeria about informed consent in their practice were surveyed.
A cross-sectional survey of surgeons in Nigeria was undertaken in 2004/5 using self-administered semistructured questionnaires.
There were 102 respondents, 85.3% of whom were men and 58.8% were aged 31–40 years. 43.1% were consultants and 54.0% were surgical trainees. 27.4% were in surgical subspecialties, 26.5% in general surgery and 21.6% were obstetricians and gynaecologists. 54.9% agreed that sufficient information is not provided to patients while obtaining their consent for surgical procedures. They listed medicolegal reasons (70.6%), informing patients about benefits, risks and alternatives (64.7%) and hospital policy (50.0%) as some reasons for obtaining consent for surgical procedures. When patients decline to give consent for surgery, 84.3% of them thought that poor communication between surgeons and patients may be contributory. They identified taking a course in bioethics during surgical training and compulsory communication skills course as some ways to improve communication between surgeons and patients.
Most Nigerian surgeons seemed to have a good knowledge of the informed consent requirements and process but fall short in practice. There is a need to improve the surgeon–patient relationship in line with modern exigencies to provide interactive environments for fruitful patient communication and involvement.
Medical Ethics has many unsung heros and heroines. Here we celebrate one of these and on telling part of her story hope to place modern medical ethics and bioethics in the UK more centrally within its historical and human contex.
Medical ethics; suicide/assisted suicide; rights; right to refuse treatment; resource allocation; bioethics
Adult; Aged; Attitude of Health Personnel; Decision Making; ethics; Euthanasia; ethics; legislation & jurisprudence; psychology; Female; France; Humans; Infant, Newborn; Intensive Care Units, Neonatal; ethics; legislation & jurisprudence; Male; Medical Staff, Hospital; psychology; Middle Aged; Nursing Staff, Hospital; psychology; Parents; psychology; Young Adult; neonatal intensive care; ethical dilemmas; legislation; professionals; EURONIC; qualitative research
The ability to sequence individual genomes is leading to the identification of an increasing number of genetic risk factors for serious diseases. Knowledge of these risk factors can often provide significant medical and psychological benefit, but also raises complex ethical and social issues. This paper focuses on one area of rapid progress: the identification of mutations causing long QT syndrome and other cardiac channel disorders, which can explain some previously unexplained deaths in infants (SIDS) and children and adults (SUDS) and prevent others from occurring. This genetic knowledge, discovered posthumously in many cases, has implications for clinical care for surviving family members who might carry the same mutations. The information obtained from genetic testing, in the context of personal and family history, can guide individually tailored interventions that reduce risk and save lives. At the same time, obtaining and disclosing genetic information raises difficult issues about confidentiality and decision making within families. We draw on the experience of the Montefiore-Einstein Center for Cardiogenetics, which has played a leading role in the genetic diagnosis and clinical management of cardiac channel diseases, to explore some of the challenging ethical questions arising in affected families with adolescent children. We focus on the related issues of (1) family confidentiality, privacy and disclosure and (2) adolescent decision making about genetic risk, and argue for the value of interdisciplinary dialogue with affected families in resolving these issues.