Millions of people undergo displacement in the world. Internally displaced people (IDP) are especially vulnerable as they are not protected by special legislation in contrast to other migrants. Research conducted among IDPs must be correspondingly sensitive in dealing with ethical issues that may arise. Muslim IDPs in Puttalam district in the North-Western province of Sri Lanka were initially displaced from Northern Sri Lanka due to the conflict in 1991. In the backdrop of a study exploring the prevalence of common mental disorders among the IDPs, researchers encountered various ethical challenges. These included inter-related issues of autonomy, non-maleficence, beneficence, confidentiality and informed consent, and how these were tailored in a culture-specific way to a population that has increased vulnerability. This paper analyses how these ethical issues were perceived, detected and managed by the researchers, and the role of ethics review committees in mental health research concerning IDPs. The relevance of guidelines and methodologies in the context of an atypical study population and the benefit versus risk potential of research for IDPs are also discussed. The limitations that were encountered while dealing with ethical challenges during the study are discussed. The concept of post-research ethical conduct audit is suggested to be considered as a potential step to minimize the exploitation of vulnerable populations such as IDPs in mental health research.
Sri Lanka; Bioethics; Ethical challenges; Internally displaced people; Mental health research; Post-research ethics audit; Practical ethics; Developing world
The Netherlands is one of the few countries where euthanasia is legal under strict conditions. This study investigates whether Dutch newspaper articles use the term ‘euthanasia’ according to the legal definition and determines what arguments for and against euthanasia they contain.
We did an electronic search of seven Dutch national newspapers between January 2009 and May 2010 and conducted a content analysis.
Of the 284 articles containing the term ‘euthanasia’, 24% referred to practices outside the scope of the law, mostly relating to the forgoing of life-prolonging treatments and assistance in suicide by others than physicians. Of the articles with euthanasia as the main topic, 36% described euthanasia in the context of a terminally ill patient, 24% for older persons, 16% for persons with dementia, and 9% for persons with a psychiatric disorder. The most frequent arguments for euthanasia included the importance of self-determination and the fact that euthanasia contributes to a good death. The most frequent arguments opposing euthanasia were that suffering should instead be alleviated by better care, that providing euthanasia can be disturbing, and that society should protect the vulnerable.
Of the newspaper articles, 24% uses the term ‘euthanasia’ for practices that are outside the scope of the euthanasia law. Typically, the more unusual cases are discussed. This might lead to misunderstandings between citizens and physicians. Despite the Dutch legalisation of euthanasia, the debate about its acceptability and boundaries is ongoing and both sides of the debate are clearly represented.
Euthanasia; Media; Content analysis
The global expansion of biobanks has led to a range of bioethical concerns related to consent, privacy, control, ownership, and disclosure. As an opportunity to engage broader audiences on these concerns, bioethicists have welcomed the commercial success of Rebecca Skloot’s 2010 bestselling book The Immortal Life of Henrietta Lacks. To assess the impact of the book on discussion within the media and popular culture more generally, we systematically analyzed the ethics-related themes emphasized in reviews and articles about the book, and in interviews and profiles of Skloot.
We conducted a content analysis of a population of relevant English-language articles and transcripts (n = 125) produced by news organizations and publications in the U.S., Canada, Great Britain/Ireland, and Australia/New Zealand. We scored each article for the emphasis and appearance of 9 ethics-related themes. These were informed consent, welfare of the vulnerable, compensation, scientific progress, control/access, accountability/oversight, privacy, public education, and advocacy.
The informed consent theme dominated media discussion, with almost 39.2 percent of articles/transcripts featuring the theme as a major focus and 44.8 percent emphasizing the theme as a minor focus. Other prominent themes and frames of reference focused on the welfare of the vulnerable (18.4 percent major emphasis; 36.0 percent minor emphasis), and donor compensation (19.2 percent major; 52.8 percent minor). Ethical themes that comprised a second tier of prominence included those of scientific progress, control/access, and accountability/oversight. The least prominent themes were privacy, public education, and advocacy.
The book has been praised as an opportunity to elevate media discussion of bioethics, but such claims should be re-considered. The relatively narrow focus on informed consent in the media discussion generated by Skloot’s book may limit the ability of ethicists and advocates to elevate attention to donor control, compensation, patenting, privacy, and other ethical issues. Still, ethicists should view the book and a pending major TV film translation as opportunities to highlight through media outreach, consultation exercises and public forums a broader range of bioethical concerns that would otherwise be under-emphasized in news coverage. Such efforts, however, need to be carefully planned and evaluated.
A baby hatch called the “Stork’s Cradle” has been in place at Jikei Hospital in Kumamoto City, Japan, since May 10, 2007. Babyklappes were first established in Germany in 2000, and there are currently more than 90 locations. Attitudes regarding baby hatches are divided in Japan and neither opinions for nor against baby hatches have thus far been overwhelming. To consider the appropriateness of baby hatches, we present and examine the validity of each major objection to establishing baby hatches.
There are various objections to baby hatches as follows: It violates a child’s right to know the identity of his or her biological parents by allowing anonymous birth; it neglects fulfillment of the biological parents’ basic obligation to raise their child and its very availability induces abandonment of infants; some people abuse it for very selfish reasons; it cannot save babies’ lives; the rights of one parent can be ignored if the other surrenders a child without his or her consent; it puts a baby in medical jeopardy; and it has no clear legal basis. The authors would argue that there are many plausible refutations for each objection mainly based on priority of child’s right to life, pregnant women’s vulnerability and necessity of anonymity, social responsibility to protect and raise children, differences between dropping a child off at a baby hatch and child neglect, limited function of social childcare center, inevitability of abuse by a minority of people, necessary distinction between outcomes that occur only because baby hatches exist and those that occur regardless of their existence, important local direct and upmost measures for women in trouble, and difference between ambiguous legality and illegality.
We argue that a certain number of baby hatches should continue to be established as a last resort, in a form that can maintain anonymity if the parent dropping the child off so desires. It should be supported if it is initiated with good intentions; if the maximum possible effort is made at said facility to protect the interests, rights, and safety of the child; and if no clear evidence of harm exists.
Baby hatch; “Stork’s Cradle (Kounotori no Yurikago)”; Babyklappes; Japan; Child abuse; Child abandonment; Abortion
To identify motivational factors linked to child health status that affected the likelihood of parents’ allowing their child to participate in pediatric research.
Parents were invited to return their completed questionnaires anonymously to assess motivational factors and factors that might improve participation in pediatric research.
Of 573 eligible parents, 261 returned the completed questionnaires. Of these, 126 were parents of healthy children (group 1), whereas 135 were parents of sick children who were divided into two groups according to the severity of their pathology, i.e., 99 ambulatory children (group 2) and 36 nonambulatory children (group 3). The main factor motivating participation in a pediatric clinical research study was “direct benefits for their child” (87.7%, 100%, and 100% for groups 1, 2, and 3, respectively). The other factors differed significantly between the three groups, depending on the child’s health status (all p < 0.05). Factors that might have a positive impact on parental consent to the participation of their child in a pediatric clinical research study differed significantly (χ2 test, all p ≤ 0.04), depending on the child’s health status. The main factor was “a better understanding of the study and its regulation” for the healthy children and ambulatory sick children groups (31.2% and 82.1%, respectively), whereas this was the third factor for the nonambulatory sick children group (50%).
Innovative strategies should be developed based on a child’s health status to improve information provision when seeking a child’s participation in pediatric research. Parents would like to spend more time in discussions with investigators.
Ethics; Pediatric research; Parents’ acceptance; Motivation
In 2009, Dr. Paolo Zamboni proposed chronic cerebrospinal venous insufficiency (CCSVI) as a possible cause of multiple sclerosis (MS). Although his theory and the associated treatment (“liberation therapy”) received little more than passing interest in the international scientific and medical communities, his ideas became the source of tremendous public and political tension in Canada. The story moved rapidly from mainstream media to social networking sites. CCSVI and liberation therapy swiftly garnered support among patients and triggered remarkable and relentless advocacy efforts. Policy makers have responded in a variety of ways to the public’s call for action.
We present three different perspectives on this evolving story, that of a health journalist who played a key role in the media coverage of this issue, that of a health law and policy scholar who has closely observed the unfolding public policy developments across the country, and that of a medical ethicist who sits on an expert panel convened by the MS Society of Canada and the Canadian Institutes of Health Research to assess the evidence as it emerges.
This story raises important questions about resource allocation and priority setting in scientific research and science policy. The growing power of social media represents a new level of citizen engagement and advocacy, and emphasizes the importance of open debate about the basis on which such policy choices are made. It also highlights the different ways evidence may be understood, valued and utilized by various stakeholders and further emphasizes calls to improve science communication so as to support balanced and informed decision-making.
Multiple sclerosis; CCSVI; Liberation therapy; Priority setting; Public pressure; Media; Politics; Evidence
Obtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements.
Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed.
The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study.
The analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics.
Children; Confidentiality; Consent; ELSI; Paediatric research; Research ethics; Return of results; Withdrawal
Due to the important role of depression in major illnesses, screening measures for depression are commonly used in medical research. The protocol for managing participants with positive screens is unclear and raises ethical concerns. The aim of this article is to identify and critically discuss the ethical issues that arise when a positive screen for depression is detected, and offer some guidance on managing these issues.
Deciding on whether to report positive screens to healthcare practitioners is both an ethical and a pragmatic dilemma. Evidence suggests that reporting positive depression screens should only be considered in the context of collaborative care. Possible adverse effects, such as the impact of false-positive results, potentially inappropriate labelling, and potentially inappropriate treatment also need to be considered. If possible, the psychometric properties of the selected screening measure should be determined in the target population, and a threshold for depression that minimises the rate of false-positive results should be chosen. It should be clearly communicated to practitioners that screening scores are not diagnostic for depression, and they should be informed about the diagnostic accuracy of the measure. Research participants need to be made aware of the consequences of the detection of high scores on screening measures, and to be fully informed about the implications of the research protocol.
Further research is needed and the experiences of researchers, participants, and practitioners need to be collated before the value of reporting positive screens for depression can be ascertained. In developing research protocols, the ethical challenges highlighted should be considered. Participants must be agreeable to the agreed protocol and efforts should be made to minimise potentially adverse effects.
Depression; Screening; Ethics; Research
The knowledge of scientific dishonesty is scarce and heterogeneous. Therefore this study investigates the experiences with and the attitudes towards various forms of scientific dishonesty among PhD-students at the medical faculties of all Norwegian universities.
Anonymous questionnaire distributed to all post graduate students attending introductory PhD-courses at all medical faculties in Norway in 2010/2011. Descriptive statistics.
189 of 262 questionnaires were returned (72.1%). 65% of the respondents had not, during the last year, heard or read about researchers who committed scientific dishonesty. One respondent had experienced pressure to fabricate and to falsify data, and one had experienced pressure to plagiarize data. On average 60% of the respondents were uncertain whether their department had a written policy concerning scientific conduct. About 11% of the respondents had experienced unethical pressure concerning the order of authors during the last 12 months. 10% did not find it inappropriate to report experimental data without having conducted the experiment and 38% did not find it inappropriate to try a variety of different methods of analysis to find a statistically significant result. 13% agreed that it is acceptable to selectively omit contradictory results to expedite publication and 10% found it acceptable to falsify or fabricate data to expedite publication, if they were confident of their findings. 79% agreed that they would be willing to report misconduct to a responsible official.
Although there is less scientific dishonesty reported in Norway than in other countries, dishonesty is not unknown to doctoral students. Some forms of scientific misconduct are considered to be acceptable by a significant minority. There was little awareness of relevant policies for scientific conduct, but a high level of willingness to report misconduct.
Dishonesty; Fabrication; Falsification; Plagiarism; Misconduct
Waiving parent permission can be an option in some epidemiological and social research with adolescents. However, exemptions have not been uniformly considered or applied. Our aim is to critically assess the different factors that could be taken into account when making decisions about waiving active parental permission in observational research with adolescents.
In some cases alternatives to parental permission could be applied to protect the rights of both adolescents and parents and also to assure the benefits to adolescents as a group that can come from appropriately conducted studies. However, the criteria of ensuring minimal risk can be difficult to define and apply and a distinction between harm and discomfort is reviewed. Waiving active parental permission could be acceptable when the risk of harm is minimal; when the research questions are related to an activity for which adolescents are not legally considered to be children; when the risk of harm or discomfort may increase if parental permission is required; and when risk of discomfort is low because the questionnaire is not potentially offensive for some adolescents and/or for some parents.
Stringent rules concerning parental permission in some studies could be detrimental to adolescents. A framework and a decision tree guide are proposed to help researchers and Research Ethics Committees in their decisions on whether active parental permission must be obtained.
Adolescents; Parental consent; Research ethics; Observational research; Health surveys; Research subjects
The formulation and implementation of national ethical regulations to protect research participants is fundamental to ethical conduct of research. Ethics education and capacity are inadequate in developing African countries. This study was designed to develop a module for online training in research ethics based on the Nigerian National Code of Health Research Ethics and assess its ease of use and reliability among biomedical researchers in Nigeria.
This was a three-phased evaluation study. Phase one involved development of an online training module based on the Nigerian Code of Health Research Ethics (NCHRE) and uploading it to the Collaborative Institutional Training Initiative (CITI) website while the second phase entailed the evaluation of the module for comprehensibility, readability and ease of use by 45 Nigerian biomedical researchers. The third phase involved modification and re-evaluation of the module by 30 Nigerian biomedical researchers and determination of test-retest reliability of the module using Cronbach’s alpha.
The online module was easily accessible and comprehensible to 95% of study participants. There were significant differences in the pretest and posttest scores of study participants during the evaluation of the online module (p = 0.001) with correlation coefficients of 0.9 and 0.8 for the pretest and posttest scores respectively. The module also demonstrated excellent test-retest reliability and internal consistency as shown by Cronbach’s alpha coefficients of 0.92 and 0.84 for the pretest and posttest respectively.
The module based on the Nigerian Code was developed, tested and made available online as a valuable tool for training in cultural and societal relevant ethical principles to orient national and international biomedical researchers working in Nigeria. It would complement other general research ethics and Good Clinical Practice modules. Participants suggested that awareness of the online module should be increased through seminars, advertisement on government websites and portals used by Nigerian biomedical researchers, and incorporation of the Code into the undergraduate medical training curriculum.
Ethics education; Nigerian Code; Online ethics module; Research ethics
Next Generation Sequencing (NGS) is expected to help find the elusive, causative genetic defects associated with Bipolar Disorder (BD). This article identifies the importance of NGS and further analyses the social and ethical implications of this approach when used in research projects studying BD, as well as other psychiatric ailments, with a view to ensuring the protection of research participants.
We performed a systematic review of studies through PubMed, followed by a manual search through the titles and abstracts of original articles, including the reviews, commentaries and letters published in the last five years and dealing with the ethical and social issues raised by NGS technologies and genomics studies of mental disorders, especially BD. A total of 217 studies contributed to identify the themes discussed herein.
The amount of information generated by NGS renders individuals suffering from BD particularly vulnerable, and increases the need for educational support throughout the consent process, and, subsequently, of genetic counselling, when communicating individual research results and incidental findings to them. Our results highlight the importance and difficulty of respecting participants’ autonomy while avoiding any therapeutic misconception. We also analysed the need for specific regulations on the use and communication of incidental findings, as well as the increasing influence of NGS in health care.
Shared efforts on the part of researchers and their institutions, Research Ethics Boards as well as participants’ representatives are needed to delineate a tailored consent process so as to better protect research participants. However, health care professionals involved in BD care and treatment need to first determine the scientific validity and clinical utility of NGS-generated findings, and thereafter their prevention and treatment significance.
Bipolar disorder; Next generation sequencing; Consent form; Return of results; Incidental findings; Genetic counselling; Participants’ protection
Even though we are now well into the 21st century and notwithstanding all the abuse to individuals involved in clinical studies that has been documented throughout History, fundamental ethical principles continue to be violated in one way or another.
Here are some of the main factors that contribute to the abuse of subjects participating in clinical trials: paternalism, improper use of informed consent, lack of strict ethical supervision, pressure exerted by health institutions to increase the production of scientific material, and the absence of legislation regarding ethics in terms of health care and research. Are researchers ready to respect fundamental ethical principles in light of the ample window of information provided by individual genomes, while defending the rights of the subjects participating in clinical studies as a major priority?
As one of the possible solutions to this problem, education regarding fundamental ethical principles is suggested for participants in research studies as an initial method of cognitive training in ethics, together with the promotion of ethical behavior in order to encourage the adoption of reasonable policies in the field of values, attitudes and behavior.
Informed consent; Autonomy; Genomics; Ethical; Justice; Nonmaleficence; Beneficence
Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents.
Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others.
This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics.
Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines.
Non-therapeutic trials in which terminally ill cancer patients are asked to undergo procedures such as biopsies or venipunctures for research purposes, have become increasingly important to learn more about how cancer cells work and to realize the full potential of clinical research. Considering that implementing non-therapeutic studies is not likely to result in direct benefits for the patient, some authors are concerned that involving patients in such research may be exploitive of vulnerable patients and should not occur at all, or should be greatly restricted, while some proponents doubt whether such restrictions are appropriate. Our objective was to explore clinician-researcher attitudes and concerns when recruiting patients who are in advanced stages of cancer into non-therapeutic research.
We conducted a qualitative exploratory study by carrying out open-ended interviews with health professionals, including physicians, research nurses, and study coordinators. Interviews were audio-recorded and transcribed. Analysis was carried out using grounded theory.
The analysis of the interviews unveiled three prominent themes: 1) ethical considerations; 2) patient-centered issues; 3) health professional issues. Respondents identified ethical issues surrounding autonomy, respect for persons, beneficence, non-maleficence, discrimination, and confidentiality; bringing to light that patients contribute to science because of a sense of altruism and that they want reassurance before consenting. Several patient-centered and health professional issues are having an impact on the recruitment of patients for non-therapeutic research. Facilitators were most commonly associated with patient-centered issues enhancing communication, whereas barriers in non-therapeutic research were most often professionally based, including the doctor-patient relationship, time constraints, and a lack of education and training in research.
This paper aims to contribute to debates on the overall challenges of recruiting patients to non-therapeutic research. This exploratory study identified general awareness of key ethical issues, as well as key facilitators and barriers to the recruitment of patients to non-therapeutic studies. Due to the important role played by clinicians and clinician-researchers in the recruitment of patients, it is essential to facilitate a greater understanding of the challenges faced; to promote effective communication; and to encourage educational research training programs.
Non-therapeutic; Health professional; Bioethics; Consent; Interview; Terminally ill
Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries.
We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive.
Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p < 0.001), donor-only informed consent (5[3,7], p < 0.001), and presumed consent (7[3,10], p < 0.001). The addition of a financial or medical incentive, respectively, reduced ranking of mandated choice to 7[4,9], p < 0.001, and 5[3,8], p < 0.001; for donor-or-surrogate informed consent to 7[5,9], p < 0.001, and 5[3,7], p = 0.004; and for donor-only informed consent to 8[6,10], p < 0.001, and 5[3,7], p = 0.56. Distribution of ranking score of perception of norm and preference were similar except for no-organ donation (11[7,11] vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p < 0.001), more preferred mandated choice with financial incentive option (6[3,8] vs. 8[4,9], p < 0.001), and less preferred mandated choice with medical incentive option (7[4,9] vs. 5[2,7], p < 0.001). There was no association between consenting options ranking scores and age, health status, education level, or knowing an organ donor or recipient.
We conclude that: 1) most respondents were in favor of posthumous organ donation, 2) mandated choice system was the most preferred and presumed consent system was the least preferred, 3) there was no difference between preference and perception of norm in consenting systems ranking, and 4) financial (especially in females) and medical (especially in males) incentives reduced preference.
Organ donation; Islamic ethics; Preference; Norm perception; Mandated choice; Presumed consent; Informed consent; Medical incentives; Financial incentive; Gender difference
Following passage of the Patient Self Determination Act in 1990, health care institutions that receive Medicare and Medicaid funding are required to inform patients of their right to make their health care preferences known through execution of a living will and/or to appoint a surrogate-decision maker. We evaluated the impact of external factors and perceived patient preferences on physicians’ decisions to honor or forgo previously established advance directives (ADs). In addition, physician views regarding legal risk, patients’ ability to comprehend complexities involved with their care, and impact of medical costs related to end-of-life care decisions were explored.
Attendees of two Mayo Clinic continuing medical education courses were surveyed. Three scenarios based in part on previously court-litigated matters assessed impact of external factors and perceived patient preferences on physician compliance with patient-articulated wishes regarding resuscitation. General questions measured respondents’ perception of legal risk, concerns over patient knowledge of idiosyncrasies involved with their care, and impact medical costs may have on compliance with patient preferences. Responses indicating strength of agreement or disagreement with statements were treated as ordinal data and analyzed using the Cochran Armitage trend test.
Three hundred eighty-eight of 951 surveys were completed (41% response rate). Eighty percent reported they were likely to honor a patient’s AD despite its 5 year age. Fewer than half (41%) would honor the AD of a patient in ventricular fibrillation who had expressed a desire to “pass away in peace.” Few (17%) would forgo an AD following a family’s request for continued resuscitative treatment. A majority (52%) considered risk of liability to be lower when maintaining someone alive against their wishes than mistakenly failing to provide resuscitative efforts. A large percentage (74%) disagreed that patients could not appreciate complexities surrounding their care while 69% agreed that costs should never impact a physician’s decision as to whether to comply with a patient’s AD.
Our findings highlight the impact, albeit small, external factors have on physician AD compliance. Most respondents based their decision on the clinical situation at hand and interpretation of the patient’s initial wishes and preferences expressed by the AD.
Advance directive; Physician decision making; Patient preference
Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use.
The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context.
Results and Conclusion
Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system.
The danger of routinisation of consent is identified.
The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent.
Autonomy; Control; Health information; Health information systems; Informed consent; Routinisation
The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy.
The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms (n=18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study.
The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001).
Potential trial participants can be assisted to understand key clinical trial procedures, their justification and personal implications by using innovative tailored local narratives.
Assessment; Comprehension; Double-blinding; Informed consent; Intervention; Randomisation; Placebo; Malawi; Understanding
Continued advances in human microbiome research and technologies raise a number of ethical, legal, and social challenges. These challenges are associated not only with the conduct of the research, but also with broader implications, such as the production and distribution of commercial products promising maintenance or restoration of good physical health and disease prevention. In this article, we document several ethical, legal, and social challenges associated with the commercialization of human microbiome research, focusing particularly on how this research is mobilized within economic markets for new public health uses.
We conducted in-depth, semi-structured interviews (2009–2010) with 63 scientists, researchers, and National Institutes of Health project leaders (“investigators”) involved with human microbiome research. Interviews explored a range of ethical, legal, and social dimensions of human microbiome research, including investigators’ perspectives on commercialization. Using thematic content analysis, we identified and analyzed emergent themes and patterns.
Investigators discussed the commercialization of human microbiome research in terms of (1) commercialization, probiotics, and issues of safety, (2) public awareness of the benefits and risks of dietary supplements, and (3) regulation.
The prevailing theme of ethical, legal, social concern focused on the need to find a balance between the marketplace, scientific research, and the public’s health. The themes we identified are intended to serve as points for discussions about the relationship between scientific research and the manufacture and distribution of over-the-counter dietary supplements in the United States.
Commercialization; Human microbiome; Ethical legal and social implications (ELSI); Dietary supplements; Qualitative research
Interest in biobanking for collection of specimens for non-communicable diseases research has grown in recent times. This paper explores the perspectives of Nigerians on donation of specimen for the biobanking research.
We conducted 16 Focus Group Discussions (FGD) with individuals from different ethnic, age and socio-economic groups in Kano (North), Enugu (Southeast), Oyo States (Southwest) and Abuja, the Federal Capital Territory (Central) of Nigeria. We used topic guides and prompt statements to explore the knowledge and understanding of interviewees to general issues about biobanking of biospecimens, their use and specifically about role of biobanking in non-communicable diseases research.
A total of 123 individuals participated in 16 focus group discussions in 2011. Our participants had limited knowledge of the concept of biobanking but accepted it once they were educated about it and saw it as a worthwhile venture. Half of our study participants supported use of broad consent, a quarter supported restricted consent while the remaining quarter were in favour of tiered consent. Most discussants support shipment of their samples to other countries for further research, but they prefer those collaborations to be done only with competent, ethical researchers and they would like to receive feedback about such projects. The majority preferred health care as a benefit from participation, particularly for any unexpected condition that may be discovered during the course of the research instead of financial compensation. Participants emphasized the need to ensure that donated samples were not used for research that contradicts their religious beliefs.
Our study demonstrates that our participants accepted biobanking once they understand it but there were different attitudes to elements of biobanking such as type of consent. Our study highlights the need to carefully document population attitudes to elements of modern scientific research and the consenting process.
Biobanking; Non-communicable diseases; Public perspectives; Nigeria
Traditional top-down national regulation of internationally mobile doctors and nurses is fast being rendered obsolete by the speed of globalisation and digitisation. Here we propose a bottom-up system in which responsibility for hiring and accrediting overseas staff begins to be shared by medical employers, managers, and insurers.
In this model, professional Boards would retain authority for disciplinary proceedings in response to local complaints, but would lose their present power of veto over foreign practitioners recruited by employers who have independently evaluated and approved such candidates' ability. Evaluations of this kind could be facilitated by globally accessible National Registers of professional work and conduct. A decentralised system of this kind could also dispense with time-consuming national oversight of continuing professional education and license revalidation, which tasks could be replaced over time by tighter institutional audit supported by stronger powers to terminate underperforming employees.
Market forces based on the reputation (and, hence, financial and political viability) of employers and institutions could continue to ensure patient safety in the future, while at the same time improving both national system efficiency and international professional mobility.
Registration; Medical councils; Globalisation; Bureaucracy; CME/CPD; Revalidation
Research is fundamental to improving the quality of health care. The need for regulation of research is clear. However, the bureaucratic complexity of research governance has raised concerns that the regulatory mechanisms intended to protect participants now threaten to undermine or stifle the research enterprise, especially as this relates to sensitive topics and hard to reach groups.
Much criticism of research governance has focused on long delays in obtaining ethical approvals, restrictions imposed on study conduct, and the inappropriateness of evaluating qualitative studies within the methodological and risk assessment frameworks applied to biomedical and clinical research. Less attention has been given to the different epistemologies underlying biomedical and qualitative investigation. The bioethical framework underpinning current regulatory structures is fundamentally at odds with the practice of emergent, negotiated micro-ethics required in qualitative research. The complex and shifting nature of real world settings delivers unanticipated ethical issues and (occasionally) genuine dilemmas which go beyond easy or formulaic ‘procedural’ resolution. This is not to say that qualitative studies are ‘unethical’ but that their ethical nature can only be safeguarded through the practice of ‘micro-ethics’ based on the judgement and integrity of researchers in the field.
This paper considers the implications of contrasting ethical paradigms for the conduct of qualitative research and the value of ‘empirical ethics’ as a means of liberating qualitative (and other) research from an outmoded and unduly restrictive research governance framework based on abstract prinicipalism, divorced from real world contexts and values.
Qualitative research; Bioethics; Empirical ethics; Micro ethics; Principalism
Financial relationships between physicians and industry are extensive and public reporting of industry payments to physicians is now occurring. Our objectives were to describe physician recipients of large total payments from these seven companies, and to examine discrepancies between these payments and conflict of interest (COI) disclosures in authors’ concurrent publications.
The investigative journalism organization, ProPublica, compiled the Dollars for Docs database of payments to individuals from publically available data from seven US pharmaceutical companies during the period 2009 to 2010. We examined the cohort of 373 physicians in this database who each received USD $100,000 or more in the reporting period 2009 to 2010.
These physicians received a total of $52,600,624 during this period (mean payment per physician $141,020). The predominant specialties were internal medicine and psychiatry. 147 of these physicians authored a total of 134 publications in the first quarter of 2011 and 77% (103) of these publications provided a COI disclosure. 69% of the 103 publications did not contain disclosures of the payment listed in the Dollars for Docs database.
With increased public reporting of industry payments to physicians, it is apparent that large sums are being paid for services such as consulting and peer education. In over two-thirds of publications where COI disclosures were provided, the disclosures by physician authors did not include industry payments that were documented in the Dollars for Docs database.
Conflict of interest; Publication; Industry relationships; Physicians; Bias; Disclosure; Accuracy
International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings.
We sought to use mabaraza, traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts.
Our findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent.
Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research.
Community-based research; Sub-Saharan Africa; Ethics; Informed consent; Kenya