BMC Medical Ethics - Latest articles

Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting

2008-09-30

Background: Informed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process,particularly in Africa. Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial. The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of consent. Cross-sectional study conducted over a 4 month period. Methods: Consent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.). The recall (success in selecting the correct answers) and understanding (correctness of interpretation of statements presented) were measured. Results: The majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR) = 55%-77% and for understanding 75% (IQR=50%-87%). Most (79%) were aware of the risks and 64% knew that participation was voluntary. Participants who had completed Grade 7 at school and higher were almost five times (OR=4.94; 95% CI=1.57 - 15.55) more likely to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were almost three times (OR=2.62; 95% CI=1.35-5.07) more likely to obtain such scores for recall than those who were not. Conclusion: Notwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study can be considered acceptable for public health research. Education level of respondents and experience of research staff taking the consent were predictive of good quality informed consent.

Patients' perception and actual practice of informed consent, privacy and confidentiality in general medical outpatient departments of two tertiary care hospitals of Lahore

2008-09-25

Background: The principles of informed consent, confidentiality and privacy are often neglected during patient care in developing countries. We assessed the degree to which doctors in Lahore adhere to these principles during outpatient consultations.Material & MethodThe study was conducted at medical out-patient departments (OPDs) of two tertiary care hospitals (one public and one private hospital) of Lahore, selected using multi-stage sampling. 93 patients were selected from each hospital. Doctors' adherence to the principles of informed consent, privacy and confidentiality was observed through client flow analysis performed by trained personnel. Overall patient perception was also assessed regarding these practices and was compared with the assessment made by our data collectors. Results: Some degree of informed consent was obtained from only 9.7% patients in the public hospital and 47.8% in the private hospital. 81.4% of patients in the public hospital and 88.4% in the private hospital were accorded at least some degree of privacy. Complete informational confidentiality was maintained only in 10.8% and 35.5% of cases in public & private hospitals respectively. Informed consent and confidentiality were better practiced in the private compared to the public hospital (two-sample t-test > 2, p value < 0.05). There was marked disparity between the patients' perspective of these ethical practices and the assessment of our trained data collectors. Conclusion: Observance of medical ethics is inadequate in hospitals of Lahore. Doctors should be imparted formal training in medical ethics and national legislation on medical ethics is needed. Patients should be made aware of their rights to medical ethics.

A survey of community members' perceptions of medical errors in Oman

2008-07-29

Background: Errors have been the concern of providers and consumers of health care services. However, consumers' perception of medical errors in developing countries is rarely explored. The aim of this study is to assess community members' perceptions about medical errors and to analyse the factors affecting this perception in one Middle East country, Oman. Methods: Face to face interviews were conducted with heads of 212 households in two villages in North Al-Batinah region of Oman selected because of close proximity to the Sultan Qaboos University (SQU), Muscat, Oman. Participants' perceived knowledge about medical errors was assessed. Responses were coded and categorised. Analyses were performed using Pearson's χ2, Fisher's exact tests, and multivariate logistic regression model wherever appropriate. Results: Seventy-eight percent (n = 165) of participants believed they knew what was meant by medical errors. Of these, 34% and 26.5% related medical errors to wrong medications or diagnoses, respectively. Understanding of medical errors was correlated inversely with age and positively with family income. Multivariate logistic regression revealed that a one-year increase in age was associated with a 4% reduction in perceived knowledge of medical errors (CI: 1% to 7%; p = 0.045). The study found that 49% of those who believed they knew the meaning of medical errors had experienced such errors. The most common consequence of the errors was severe pain (45%). Of the 165 informed participants, 49% felt that an uncaring health care professional was the main cause of medical errors. Younger participants were able to list more possible causes of medical errors than were older subjects (Incident Rate Ratio of 0.98; p < 0.001). Conclusion: The majority of participants believed they knew the meaning of medical errors. Younger participants were more likely to be aware of such errors and could list one or more causes.

Understanding and retention of the informed consent process among parents in rural northern Ghana

2008-06-19

Background: The individual informed consent model remains critical to the ethical conduct and regulation of research involving human beings. Parental informed consent process in a rural setting of northern Ghana was studied to describe comprehension and retention among parents as part of the evaluation of the existing informed consent process. Methods: The study involved 270 female parents who gave consent for their children to participate in a prospective cohort study that evaluated immune correlates of protection against childhood malaria in northern Ghana. A semi-structured interview with questions based on the informed consent themes was administered. Parents were interviewed on their comprehension and retention of the process and also on ways to improve upon the existing process. Results: The average parental age was 33.3 years (range 18–62), married women constituted a majority (91.9%), Christians (71.9%), farmers (62.2%) and those with no formal education (53.7%). Only 3% had ever taken part in a research and 54% had at least one relation ever participate in a research. About 90% of parents knew their children were involved in a research study that was not related to medical care, and 66% said the study procedures were thoroughly explained to them. Approximately, 70% recalled the study involved direct benefits compared with 20% for direct risks. The majority (95%) understood study participation was completely voluntary but only 21% recalled they could withdraw from the study without giving reasons. Younger parents had more consistent comprehension than older ones. Maternal reasons for allowing their children to take part in the research were free medical care (36.5%), better medical care (18.8%), general benefits (29.4%), contribution to research in the area (8.8%) and benefit to the community (1.8%). Parental suggestions for improving the consent process included devoting more time for explanations (46.9%), use of the local languages (15.9%) and obtaining consent at home (10.3%). Conclusion: Significant but varied comprehension of the informed consent process exists among parents who participate in research activities in northern Ghana and it appears the existing practices are fairly effective in informing research participants in the study area.

Cesarean delivery on maternal request: Can the ethical problem be solved by the principlist approach?

2008-06-17

In this article, we use the principlist approach to identify, analyse and attempt to solve the ethical problem raised by a pregnant woman's request for cesarean delivery in absence of medical indications.We use two different types of premises: factual (facts about cesarean delivery and specifically attitudes of obstetricians as derived from the EUROBS European study) and value premises (principles of beneficence and non-maleficence, respect for autonomy and justice).Beneficence/non-maleficence entails physicians' responsibility to minimise harms and maximise benefits. Avoiding its inherent risks makes a prima facie case against cesarean section without medical indication. However, as vaginal delivery can have unintended consequences, there is a need to balance the somewhat dissimilar risks and benefits. The principle of autonomy poses a challenge in case of disagreement between the pregnant woman and the physician. Improved communication aimed to enable better informed choice may overcome some instances of disagreement. The principle of justice prohibits unfair discrimination, and broadly favours optimising resource utilisation.Available evidence supports vaginal birth in uncomplicated term pregnancies as the standard of care. The principlist approach offered a useful framework for ethical analysis of cesarean delivery on maternal request, identified the rights and duties of those involved, and helped reach a conclusion, although conflict at the individual level may remain challenging.

Informed consent in Sri Lanka: A survey among ethics committee members

2008-05-20

Background: Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods: We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Results: Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form.The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. Conclusion: The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.

Clinical research without consent in adults in the emergency setting: a review of patient and public views

2008-04-29

Background: In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and facilitate acute research with adults who are unable to give consent have been developed with little involvement of the lay public. This paper reviews research examining public opinion regarding RWC for research in emergency situations, and whether the rules and regulations permitting research of this kind are in accordance with the views of those who ultimately may be the most affected. Methods: Seven electronic databases were searched: Medline, Embase, CINAHL, Cochrane Database of Systematic Reviews, Philosopher's Index, Age Info, PsychInfo, Sociological Abstracts and Web of Science. Only those articles pertaining to the views of the public in the US, Canada and EU member states were included. Opinion pieces and those not published in English were excluded. Results: Considering the wealth of literature on the perspectives of professionals, there was relatively little information about public attitudes. Twelve studies employing a range of research methods were identified. In five of the six questionnaire surveys around half the sample did not agree generally with RWC, though paradoxically, a higher percentage would personally take part in such a study. Unfortunately most of the studies were not designed to investigate individuals' views in any depth. There also appears to be a level of mistrust of medical research and some patients were more likely to accept an experimental treatment 'outside' of a research protocol. Conclusion: There are too few data to evaluate whether the rules and regulations permitting RWC protects – or is acceptable to – the public. However, any attempts to engage the public should take place in the context of findings from further basic research to attend to the apparently paradoxical findings of some of the current surveys.

What is presumed when we presume consent?

Barbara K Pierscionek — 2008-04-25

Background: The organ donor shortfall in the UK has prompted calls to introduce legislation to allow for presumed consent: if there is no explicit objection to donation of an organ, consent should be presumed. The current debate has not taken in account accepted meanings of presumption in law and science and the consequences for rights of ownership that would arise should presumed consent become law. In addition, arguments revolve around the rights of the competent autonomous adult but do not always consider the more serious implications for children or the disabled.DiscussionAny action or decision made on a presumption is accepted in law and science as one based on judgement of a provisional situation. It should therefore allow the possibility of reversing the action or decision. Presumed consent to organ donation will not permit such reversal. Placing prime importance on the functionality of body organs and their capacity to sustain life rather than on explicit consent of the individual will lead to further debate about rights of ownership and potentially to questions about financial incentives and to whom benefits should accrue. Factors that influence donor rates are not fully understood and attitudes of the public to presumed consent require further investigation. Presuming consent will also necessitate considering how such a measure would be applied in situations involving children and mentally incompetent adults.SummaryThe presumption of consent to organ donation cannot be understood in the same way as is presumption when applied to science or law. Consideration should be given to the consequences of presuming consent and to the questions of ownership and organ monetary value as these questions are likely to arise should presumed consent be permitted. In addition, the implications of presumed consent on children and adults who are unable to object to organ donation, requires serious contemplation if these most vulnerable members of society are to be protected.

Is the qualitative research interview an acceptable medium for research with palliative care patients and carers?

Marjolein Gysels, Cathy Shipman and Irene J Higginson — 2008-04-24

Background: Contradictory evidence exists about the emotional burden of participating in qualitative research for palliative care patients and carers and this raises questions about whether this type of research is ethically justified in a vulnerable population. This study aimed to investigate palliative care patients' and carers' perceptions of the benefits and problems associated with open interviews and to understand what causes distress and what is helpful about participation in a research interview. Methods: A descriptive qualitative study. The data were collected in the context of two studies exploring the experiences of care of palliative care patients and carers. The interviews ended with questions about patients' and carers' thoughts on participating in the studies and whether this had been a distressing or helpful event. We used a qualitative descriptive analysis strategy generated from the interviews and the observational and interactional data obtained in the course of the study. Results: The interviews were considered helpful: sharing problems was therapeutic and being able to contribute to research was empowering. However, thinking about the future was reported to be the most challenging. Consent forms were sometimes read with apprehension and being physically unable to sign was experienced as upsetting. Interviewing patients and carers separately was sometimes difficult and not always possible. Conclusion: The open interview enables the perspectives of patients and carers to be heard, unfettered from the structure of closed questions. It also enables those patients or carers to take part who would be unable to participate in other study designs. The context is at least as important as the format of the research interview taking into account the relational circumstances with carers and appropriate ways of obtaining informed consent. Retrospective consent could be a solution to enhancing participants control over the interview.

How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

Carl H Coleman and Marie-Charlotte Bouësseau — 2008-03-28

Background: Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals. Conclusion: Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?