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1.  Editorial 
Interventional Neuroradiology  2001;6(4):269-276.
Summary
The 20 key points of the AP-HP document (Assistance Publique des Hopitaux de Paris)
1) Hospital doctors must provide health care recipients with information in compliance with standards laid down by the medical code of ethics.
2) Radiographers and nursing staff must contribute to the provision of information within the framework of their assigned responsibilities and in compliance with their professional rules.
3) Doctors must draft prescriptions clearly, ensure that the patient and immediate family circle understand them and encourage compliance.
4) Doctors have a duty when examining, treating or advising to provide clear, appropriate and fair information regarding the patienťs condition and the investigations and treatment proposed. During the course of the illness, physicians must take into account their patients' individual personalities when providing explanation and ensure these are understood.
5) Unless the condition places others at risk, a particularly grave diagnosis or prognosis may be withheld from a patient if the doctor, in good faith and for legitimate reasons, believes this to be in the best interests of the patient.
6) A patient should be informed of a fatal illness only after due consideration by the physician. Close relatives must always be informed, however, unless the patient has previously forbidden this or designated third parties to impart the information.
7) When several doctors collaborate on a diagnostic or treatment procedure, they must keep each other updated on the case. Each practitioner shall assume personal responsibility and inform the patient within the realm of his/her competence.
8) Oral information is priority and must be clear; fair, understandable and ordered.
9) The duty to inform is continuous. Consistent and constant information must be provided at all stages and, where possible, by the same physician.
10) Information must be provided on the benefits expected from a procedure and possible serious attendant risks; however exceptional.
11) Where possible, the practitioner should always verify that the information imparted has been properly understood.
12) It is recommended that:
- hospital doctors accompany oral information with printed leaflets where these aid understanding;
- departments set down a list of those invasive procedures requiring information leaflets. This practice will also help to standardise presentation of the risks and benefits.
13) Patients should not be requested to sign information sheets.
14) It is recommended that for each patient, one member of the medical team be designated, with responsibility for informing the patient and close relatives.
15) On patient admission, details of the family members to be informed must be systematically collected. Similarly, parents or guardians must be systematically contacted on the admission of children.
16) What information is to be given the patient and close family must be discussed by the medical group and the decisions taken recorded in the patient's file.
17) Each department shall define rules on giving information over the telephone to the family or immediate circle. These rules must be set down in writing and understood by all staff concerned.
18) Any information given to the patient must be noted in the medical file. It is to be presumed that only the details noted have been communicated. In this way, the patients' medical record serves as a communication tool for the various members of the medical team regarding the information given to the patient.
19) Obtaining written patient consent (permission to operate and similar documents) is neither compulsory nor recommended, except where required by law. The law demands that written consent be obtained for the following: biomedical research, fertility treatment, termination of pregnancy, genetic research, harvesting of organs from a living donor; certain organ harvesting from a deceased person, surgical procedures on a child.
20) In the event of litigation centring around failure to inform, no evidence, not even written evidence, is a watertight guarantee that the doctor has fulfilled his obligation. Whether information has been correctly imparted or not will be assessed on the basis of a range of elements such as: the period allowed the patient to take an informed decision, the number of visits, practitioners consulted before proceeding, the systematic provision of information leaflets and the notes made on the patient record.
PMCID: PMC3679700  PMID: 20667205
information to patients, consent, legal issues, radiology, interventional procedures, French hospitals
2.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
3.  Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture 
BMC Medical Ethics  2014;15:8.
Background
Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture.
Discussion
Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient’s best interest, and doing no harm in decision-making for patients.
There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features.
Summary
Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner.
doi:10.1186/1472-6939-15-8
PMCID: PMC3923408  PMID: 24495473
Informed consent; Japanese culture; Ethical principles; Ethical issues; Misuse; Healthcare professionals
4.  Emerging issues in paediatric health research consent forms in Canada: working towards best practices 
BMC Medical Ethics  2013;14:5.
Background
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.
Methods
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.
Results
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.
Conclusions
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.
doi:10.1186/1472-6939-14-5
PMCID: PMC3571865  PMID: 23363554
Children; Confidentiality; Consent; ELSI; Paediatric research; Research ethics; Return of results; Withdrawal
5.  How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials 
BMC Medical Ethics  2013;14:45.
Background
In 2008 UK legislation was amended to enable the use of deferred consent for paediatric emergency care (EC) trials in recognition of the practical and ethical difficulties of obtaining prospective consent in an emergency situation. However, ambiguity about how to make deferred consent acceptable to parents, children and practitioners remains. In particular, little is known about practitioners’ views and experiences of seeking deferred consent in this setting.
Methods
As part of a wider study investigating consent methods in paediatric emergency care trials (called CONNECT), a 20 item online questionnaire was sent by email inviting practitioners (doctors and nurses) who were involved in talking with families about children’s and young people’s (aged 0–16 years) participation in UK EC trials. To ensure those with and without experience of deferred consent were included, practitioners were sampled using a combination of purposive and snowball sampling methods. Simple descriptive statistics were used to analyse the quantitative data, whilst the constant comparative method was used to analyse qualitative data. Elements of a symbiotic empirical ethics approach was used to integrate empirical evidence and bioethical literature to explore the data and draw practice orientated conclusions.
Results
Views on deferred consent differed depending upon whether or not practitioners were experienced in this consent method. Practitioners who had no experience of deferred consent reported negative perceptions of this consent method; these practitioners were concerned about the impact that deferred consent would have upon the parent-practitioner relationship. In contrast, practitioners experienced in deferred consent described how families had been receptive to the consent method, if conducted sensitively and in a time appropriate manner. Experienced practitioners also described how deferred consent had improved recruitment, parental decision-making capacity and parent-practitioner relationships in the emergency care setting.
Conclusions
The views of practitioners with first-hand experience of deferred consent should be considered in the design and ethical review of future paediatric EC trials; the design and ethical review of such trials should not solely be informed by the beliefs of those without experience of using deferred consent. Further research involving parents and children is required to inform practitioner training and normative guidance on the use and appropriateness of deferred consent in emergency settings.
doi:10.1186/1472-6939-14-45
PMCID: PMC4228267  PMID: 24195717
6.  Informed consent: Issues and challenges 
Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.
doi:10.4103/2231-4040.116779
PMCID: PMC3777303  PMID: 24083200
Human subjects; informed consent; institutional review board
7.  Barriers to Provider-Initiated Testing and Counselling for Children in a High HIV Prevalence Setting: A Mixed Methods Study 
PLoS Medicine  2014;11(5):e1001649.
Rashida Ferrand and colleagues combine quantitative and qualitative methods to investigate HIV prevalence among older children receiving primary care in Harare, Zimbabwe, and reasons why providers did not pursue testing.
Please see later in the article for the Editors' Summary
Background
There is a substantial burden of HIV infection among older children in sub-Saharan Africa, the majority of whom are diagnosed after presentation with advanced disease. We investigated the provision and uptake of provider-initiated HIV testing and counselling (PITC) among children in primary health care facilities, and explored health care worker (HCW) perspectives on providing HIV testing to children.
Methods and Findings
Children aged 6 to 15 y attending six primary care clinics in Harare, Zimbabwe, were offered PITC, with guardian consent and child assent. The reasons why testing did not occur in eligible children were recorded, and factors associated with HCWs offering and children/guardians refusing HIV testing were investigated using multivariable logistic regression. Semi-structured interviews were conducted with clinic nurses and counsellors to explore these factors. Among 2,831 eligible children, 2,151 (76%) were offered PITC, of whom 1,534 (54.2%) consented to HIV testing. The main reasons HCWs gave for not offering PITC were the perceived unsuitability of the accompanying guardian to provide consent for HIV testing on behalf of the child and lack of availability of staff or HIV testing kits. Children who were asymptomatic, older, or attending with a male or a younger guardian had significantly lower odds of being offered HIV testing. Male guardians were less likely to consent to their child being tested. 82 (5.3%) children tested HIV-positive, with 95% linking to care. Of the 940 guardians who tested with the child, 186 (19.8%) were HIV-positive.
Conclusions
The HIV prevalence among children tested was high, highlighting the need for PITC. For PITC to be successfully implemented, clear legislation about consent and guardianship needs to be developed, and structural issues addressed. HCWs require training on counselling children and guardians, particularly male guardians, who are less likely to engage with health care services. Increased awareness of the risk of HIV infection in asymptomatic older children is needed.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Over 3 million children globally are estimated to be living with HIV (the virus that causes AIDS). While HIV infection is most commonly spread through unprotected sex with an infected person, most HIV infections among children are the result of mother-to-child HIV transmission during pregnancy, delivery, or breastfeeding. Mother-to-child transmission can be prevented by administering antiretroviral therapy to mothers with HIV during pregnancy, delivery, and breast feeding, and to their newborn babies. According to a report by the Joint United Nations Programme on HIV/AIDS published in 2012, 92% of pregnant women with HIV were living in sub-Saharan Africa and just under 60% were receiving antiretroviral therapy. Consequently, sub-Saharan Africa is the region where most children infected with HIV live.
Why Was This Study Done?
If an opportunity to prevent mother-to-child transmission around the time of birth is missed, diagnosis of HIV infection in a child or adolescent is likely to depend on HIV testing in health care facilities. Health care provider–initiated HIV testing and counselling (PITC) for children is important in areas where HIV infection is common because earlier diagnosis allows children to benefit from care that can prevent the development of advanced HIV disease. Even if a child or adolescent appears to be in good health, access to care and antiretroviral therapy provides a health benefit to the individual over the long term. The administration of HIV testing (and counselling) to children relies not only on health care workers (HCWs) offering HIV testing but also on parents or guardians consenting for a child to be tested. However, more than 30% of children in countries with severe HIV epidemics are AIDS orphans, and economic conditions in these countries cause many adults to migrate for work, leaving children under the care of extended families. This study aimed to investigate the reasons for acceptance and rejection of PITC in primary health care settings in Harare, Zimbabwe. By exploring HCW perspectives on providing HIV testing to children and adolescents, the study also sought to gain insight into factors that could be hindering implementation of testing procedures.
What Did the Researchers Do and Find?
The researchers identified all children aged 6 to 15 years old at six primary care clinics in Harare, who were offered HIV testing as part of routine care between 22 January and 31 May 2013. Study fieldworkers collected data on numbers of child attendances, numbers offered testing, numbers who underwent HIV testing, and reasons why HIV testing did not occur. During the study 2,831 children attending the health clinics were eligible for PITC, and just over half (1,534, 54.2%) underwent HIV testing. Eighty-two children tested HIV-positive, and nearly all of them received counselling, medication, and follow-up care. HCWs offered the test to around 75% of those eligible. The most frequent explanation given by HCWs for a diagnostic test not being offered was that the child was accompanied by a guardian not appropriate for providing consent (401 occasions, 59%); Other reasons given were a lack of available counsellors or test kits and counsellors refusing to conduct the test. The likelihood of being offered the test was lower for children not exhibiting symptoms (such as persistent skin problems), older children, or those attending with a male or a younger guardian. In addition, over 100 guardians or parents provided consent but left before the child could be tested.
The researchers also conducted semi-structured interviews with 12 clinic nurses and counsellors (two from each clinic) to explore challenges to implementation of PITC. The researchers recorded the factors associated with testing not taking place, either when offered to eligible children or when HCWs declined to offer the test. The interviewees identified the frequent absence or unavailability of parents or legal guardians as an obstacle, and showed uncertainty or misconceptions around whether testing of the guardian was mandatory (versus recommended) and whether specifically a parent (if one was living) must provide consent. The interviews also revealed HCW concerns about the availability of adequate counselling and child services, and fears that a child might experience maltreatment if he or she tested positive. HCWs also noted long waiting times and test kits being out of stock as practical hindrances to testing.
What Do These Findings Mean?
Prevalence of HIV was high among the children tested, validating the need for PITC in sub-Saharan health care settings. Although 76% of eligible attendees were offered testing, the authors note that this is likely higher than in routine settings because the researchers were actively recording reasons for not offering testing and counselling, which may have encouraged heath care staff to offer PITC more often than usual. The researchers outline strategies that may improve PITC rates and testing acceptance for Zimbabwe and other sub-Saharan settings. These strategies include developing clear laws and guidance concerning guardianship and proxy consent when testing older children for HIV, training HCWs around these policies, strengthening legislation to address discrimination, and increasing public awareness about HIV infection in older children.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001649.
This study is further discussed in a PLOS Medicine Perspective by Davies and Kalk
The Joint United Nations Programme on HIV/AIDS publishes an annual report on the global AIDS epidemic, which provides information on progress towards eliminating new HIV infections
The World Health Organization has more information on mother-to-child transmission of HIV
The World Health Organization's website also has information about treatment for children living with HIV
Personal stories about living with HIV/AIDS, including stories from young people infected with HIV, are available through Avert, through NAM/aidsmap, and through the charity website Healthtalkonline
doi:10.1371/journal.pmed.1001649
PMCID: PMC4035250  PMID: 24866209
8.  Quality of informed consent for invasive procedures in central Saudi Arabia 
Background
Informed consent is considered the most important step in clinical interventions. The aims of this study were (1) to assess the quality of informed consent for invasive procedures with regard to consent process and information given about risks and alternative treatments, and (2) to determine patients’ attitude toward informed consent at King Abdulaziz Medical City, Riyadh, Saudi Arabia.
Methods
A cross-sectional study was conducted of 162 adult patients in different wards after undergoing surgery or invasive procedures within 1–2 days of signing the informed consent, using a previously validated interview questionnaire. Data on patients’ characteristics, type of invasive procedure, and some informed consent-related issues were collected. Multiple linear regression analysis was used to identify the predictors of the percentage mean score of quality of informed consent, and significance was considered at P ≤ 0.05.
Results
The quality of informed consent was generally poor (% mean score = 50.98 ± 17.49). About two-thirds of patients were told during the informed consent process that they have to sign merely as routine, 48% thought that if they refused the treatment plan they would lose the interest of the treating physician to help them, 42% thought that by saying no they would lose the good relationship with their physician, and 42.6% were not interested in having a copy of the informed consent document. Significantly higher quality was predicted when the physicians were the ones who explained the informed consent (t = 4.15, P < 0.001) and when informed consent was explained to younger patients (t = 2.754, P = 0.007). The overall attitude of the patients toward the process of informed consent was satisfactory (% mean score = 76.31 ± 7.63).
Conclusion
The results suggest either that patients are not aware of their rights or that physician paternalism is practiced in Saudi Arabia. Cultural barriers should not be an argument to diminish the role of informed consent. Further studies should focus on how the value of autonomy can be appreciated in the Saudi culture.
doi:10.2147/IJGM.S29599
PMCID: PMC3325015  PMID: 22505825
informed consent; quality; invasive procedure; Saudi Arabia
9.  Towards ethical guidelines for dealing with unsolicited patient emails and giving teleadvice in the absence of a pre-existing patient-physician relationship — systematic review and expert survey 
Background
Many health information providers on the Internet and doctors with email accounts are confronted with the phenomenon of receiving unsolicited emails from patients asking for medical advice. Also, a growing number of websites offer "ask-the-doctor" services, where patients can ask questions to health professionals via email or other means of telecommunication. It is unclear whether these types of interactions constitute medical practice, and whether physicians have the ethical obligation to respond to unsolicited patient emails.
Objective
To improve the quality of online communication between patients and health professionals (physicians, experts) in the absence of a pre-existing patient-physician relationship or face-to-face communication, by preparing a set of guiding ethical principles applicable to this kind of interaction.
Methods
Systematic review of the literature, professional, and ethical codes; and consultation with experts.
Results
Two different types of patient-physician encounters have to be distinguished. "Traditional" clinical encounters or telemedicine applications are called "Type B" interactions here (Bona fide relationship). In comparison, online interactions lack many of the characteristics of bona fide interactions; most notably there is no pre-existing relationship and the information available to the physician is limited if, for example, a physician responds to the email of a patient who he has never seen before. I call these "Type A" consultations (Absence of pre-existing patient-physician relationship). While guidelines for Type B interactions on the Internet exist (Kane, 1998), this is not the case for Type A interactions. The following principles are suggested: Physicians responding to patients' requests on the Internet should act within the limitations of telecommunication services and keep the global nature of the Internet in mind; not every aspect of medicine requires face-to-face communication; requests for help, including unsolicited patient questions, should not be ignored, but dealt with in some appropriate manner; informed consent requires fair and honest labeling; health professionals and information providers must maintain confidentiality; health professionals should define internal procedures and perform quality control measures.
Conclusions
Different media are appropriate at each point on the continuum between dispensing general health information and handling patient problems that would require the practice of medicine to solve. For example, email is a sufficiently capable medium for giving out general health information, while diagnosis and treatment usually requires at least advanced telemedical technology. Patients have to be educated that it is unethical to diagnose and treat over the Internet in the absence of a pre-existing patient-physician relationship, and if the interaction is limited to a single email. More research is needed to establish more evidence regarding situations in which teleadvice is beneficial and efficient.
doi:10.2196/jmir.2.1.e1
PMCID: PMC1761847  PMID: 11720920
Internet; Ethics; Quality of Health Care; Referral and Consultation; Remote Consultation; Physician-Patient Relations; Professional-Patient Relations; Medical History Taking; Teleadvice; Electronic Mail; Chat; Newsgroup
10.  The Dead Donor Rule: Can It Withstand Critical Scrutiny? 
Transplantation of vital organs has been premised ethically and legally on “the dead donor rule” (DDR)—the requirement that donors are determined to be dead before these organs are procured. Nevertheless, scholars have argued cogently that donors of vital organs, including those diagnosed as “brain dead” and those declared dead according to cardiopulmonary criteria, are not in fact dead at the time that vital organs are being procured. In this article, we challenge the normative rationale for the DDR by rejecting the underlying premise that it is necessarily wrong for physicians to cause the death of patients and the claim that abandoning this rule would exploit vulnerable patients. We contend that it is ethical to procure vital organs from living patients sustained on life support prior to treatment withdrawal, provided that there is valid consent for both withdrawing treatment and organ donation. However, the conservatism of medical ethics and practical concerns make it doubtful that the DDR will be abandoned in the near future. This leaves the current practice of organ transplantation based on the “moral fiction” that donors are dead when vital organs are procured.
doi:10.1093/jmp/jhq019
PMCID: PMC3916748  PMID: 20439355
causing death; medical ethics; organ donation
11.  Bioethics Principles, Informed Consent, and Ethical Care for Special Populations: Curricular Needs Expressed by Men and Women Physicians-in-Training 
Psychosomatics  2005;46(5):440-450.
Objective
Physicians-in-training today are learning in an ethical environment that is unprecedented in its complexity. There is a call for new approaches in preparing medical students and residents for the ethical and professional issues they will encounter. The perspectives of physicians-in-training at different levels regarding the level of curricular attention needed for emerging bioethics concepts, practical informed consent considerations, and the care of special populations are unknown.
Method
The authors performed a hypothesis-driven, confidential survey study to assess perceived needs and preferences among medical students and residents related to medical ethics education at the University of New Mexico School of Medicine.
Results
A total of 336 physicians-in-training volunteered (62% response rate). Overall, strong interest was expressed for increased curricular attention to the domains of bioethics principles, informed consent, and care of special populations. Women students expressed greater interest generally. For certain domains, clinical students expressed relatively less curricular need and psychiatry and primary care residents expressed relatively greater curricular need. Two of the four hypotheses were supported, a third received partial support, and a fourth was not supported by the findings.
Discussion
To be valuable and effective, new ethics curricular approaches must be responsive to the current complex ethical environment and attentive to the preferences of medical students and residents of both genders, at different stages of training, with different patient care responsibilities. This hypothesis-driven study provides guidance for the inclusion of novel and important ethics domains in training curricula across medical school and diverse residency programs.
doi:10.1176/appi.psy.46.5.440
PMCID: PMC1599853  PMID: 16145189
12.  Information disclosure in clinical informed consent: “reasonable” patient’s perception of norm in high-context communication culture 
BMC Medical Ethics  2014;15:3.
Background
The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients’ norm perception of information disclosure in other cultures.
Methods
We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners’ details, benefits, risks, complications’ management, available alternatives, procedure’s description, and post-procedure’s issues.
Results
Respondents’ mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee’s name). Overall, items related to benefits and post-procedure’s issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure’s name) to 13.9% (lead practitioner’s training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009).
Conclusions
1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure’s issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a “reasonable” patient’s standard is to be met.
doi:10.1186/1472-6939-15-3
PMCID: PMC3930349  PMID: 24406055
Clinical informed consent; Middle East; Information disclosure; Norm perception; Current practice; Gender; Age; High-context communication; Blunting-style coping; Reasonable patient’s standard
13.  Postmortem procedures in the emergency department: using the recently dead to practise and teach. 
Journal of Medical Ethics  1993;19(2):92-98.
In generations past, it was common practice for doctors to learn lifesaving technical skills on patients who had recently died. But this practice has lately been criticised on religious, legal, and ethical grounds, and has fallen into disuse in many hospitals and emergency departments. This paper uses four questions to resolve whether doctors in emergency departments should practise and teach non-invasive and minimally invasive procedures on the newly dead: Is it ethically and legally permissible to practise and teach non-invasive and minimally invasive procedures on the newly dead emergency-department patient? What are the alternatives or possible consequences of not practising non-invasive and minimally invasive procedures on newly dead patients? Is consent from relatives required? Should doctors in emergency departments allow or even encourage this use of newly dead patients?
PMCID: PMC1376195  PMID: 8331644
14.  When is informed consent required in cluster randomized trials in health research? 
Trials  2011;12:202.
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice?
We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation.
doi:10.1186/1745-6215-12-202
PMCID: PMC3184061  PMID: 21906277
15.  Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations 
Obtaining informed consent in psychiatry clinical research involving subjects with diminished mental abilities and impaired consent capacity has been a challenge for researchers, posing many ethical concerns and procedural hurdles due to participants’ cognitive deficits and impaired ability to judge reality. Regulations seem inadequate and provide limited guidance, not sufficient to address all the ethical issues inherent in different situations related to obtaining consent from decisionally impaired persons. Researchers are struggling to find a balance between risk-benefit ratio, research advancement, and autonomy of study subjects. Inspired to improve the consent process in psychiatry clinical research, many studies have been conducted focusing on various informed consent-related ethical concerns, with the aim of developing appropriate strategies and optimizing the informed consent procedure in psychiatry clinical research, overcoming the ethical concerns. This article critically reviews the various ethical issues and consent challenges, their underlying reasons, and investigates the appropriate strategies and practices needed to be adopted while obtaining informed consent from subjects with impaired consent capacity, participating in psychiatry clinical research.
doi:10.4103/2229-3485.92301
PMCID: PMC3275995  PMID: 22347696
Clinical research; clinical trials; ethics; informed consent; psychiatry
16.  Ethics, patient rights and staff attitudes in Shanghai's psychiatric hospitals 
BMC Medical Ethics  2012;13:8.
Background
Adherence to ethical principles in clinical research and practice is becoming topical issue in China, where the prevalence of mental illness is rising, but treatment facilities remain underdeveloped. This paper reports on a study aiming to understand the ethical knowledge and attitudes of Chinese mental health professionals in relation to the process of diagnosis and treatment, informed consent, and privacy protection in clinical trials.
Methods
A self-administered survey was completed by 1110 medical staff recruited from Shanghai’s 22 psychiatric hospitals. Simple random selection methods were used to identify target individuals from the computerized registry of staff.
Results
The final sample for analysis consisted 1094 medical staff (including 523 doctors, 542 nurses, 8 pharmacologists and 21 other staff). The majority reported that their medical institutions had not established an Ethics Committee (87.8%) and agreed that Ethics Committees should be set up in their institutions (72.9%). Approximately half (52%) had not received systematic education in ethics, and almost all (89.1%) of the staff thought it was necessary. Nearly all participants (90.0%) knew the Shanghai Mental Health Regulations which was the first local regulations relating to mental health in China, but only 11% and 16.6% respectively knew of the Nuremberg Code and the Declaration of Helsinki. About half (51.8%) thought that the guardian should make the decision as to whether the patient participated in clinical trials or not.
Conclusions
The study indicates that most psychiatric hospitals in Shanghai have no Medical Ethics Committee. More than half the medical staff had not received systematic education and training in medical ethics and they have insufficient knowledge of the ethical issues related to clinical practice and trials. Training in ethics is recommended for medical staff during their training and as ongoing professional development.
doi:10.1186/1472-6939-13-8
PMCID: PMC3467163  PMID: 22595041
Psychiatric hospital; Bioethics; Hospital Ethics Committees; Health Care Surveys; China
17.  Knowledge, attitudes and practice of healthcare ethics and law among doctors and nurses in Barbados 
BMC Medical Ethics  2006;7:7.
Background
The aim of the study is to assess the knowledge, attitudes and practices among healthcare professionals in Barbados in relation to healthcare ethics and law in an attempt to assist in guiding their professional conduct and aid in curriculum development.
Methods
A self-administered structured questionnaire about knowledge of healthcare ethics, law and the role of an Ethics Committee in the healthcare system was devised, tested and distributed to all levels of staff at the Queen Elizabeth Hospital in Barbados (a tertiary care teaching hospital) during April and May 2003.
Results
The paper analyses 159 responses from doctors and nurses comprising junior doctors, consultants, staff nurses and sisters-in-charge. The frequency with which the respondents encountered ethical or legal problems varied widely from 'daily' to 'yearly'. 52% of senior medical staff and 20% of senior nursing staff knew little of the law pertinent to their work. 11% of the doctors did not know the contents of the Hippocratic Oath whilst a quarter of nurses did not know the Nurses Code. Nuremberg Code and Helsinki Code were known only to a few individuals. 29% of doctors and 37% of nurses had no knowledge of an existing hospital ethics committee. Physicians had a stronger opinion than nurses regarding practice of ethics such as adherence to patients' wishes, confidentiality, paternalism, consent for procedures and treating violent/non-compliant patients (p = 0.01)
Conclusion
The study highlights the need to identify professionals in the workforce who appear to be indifferent to ethical and legal issues, to devise means to sensitize them to these issues and appropriately training them.
doi:10.1186/1472-6939-7-7
PMCID: PMC1524795  PMID: 16764719
18.  Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis 
PLoS Medicine  2013;10(8):e1001498.
Background
Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care.
Methods and Findings
To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained.
Conclusions
Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines.
Please see later in the article for the Editors' Summary
Editors’ Summary
Background
In the past, doctors tended to rely on their own experience to choose the best treatment for their patients. Faced with a patient with dementia (a brain disorder that affects short-term memory and the ability tocarry out normal daily activities), for example, a doctor would use his/her own experience to help decide whether the patient should remain at home or would be better cared for in a nursing home. Similarly, the doctor might have to decide whether antipsychotic drugs might be necessary to reduce behavioral or psychological symptoms such as restlessness or shouting. However, over the past two decades, numerous evidence-based clinical practice guidelines (CPGs) have been produced by governmental bodies and medical associations that aim to improve standards of clinical competence and professionalism in health care. During the development of each guideline, experts search the medical literature for the current evidence about the diagnosis and treatment of a disease, evaluate the quality of that evidence, and then make recommendations based on the best evidence available.
Why Was This Study Done?
Currently, CPG development manuals do not address how to include ethical issues in CPGs. A health-care professional is ethical if he/she behaves in accordance with the accepted principles of right and wrong that govern the medical profession. More specifically, medical professionalism is based on a set of binding ethical principles—respect for patient autonomy, beneficence, non-malfeasance (the “do no harm” principle), and justice. In particular, CPG development manuals do not address disease-specific ethical issues (DSEIs), clinical ethical situations that are relevant to the management of a specific disease. So, for example, a DSEI that arises in dementia care is the conflict between the ethical principles of non-malfeasance and patient autonomy (freedom-to-move-at-will). Thus, healthcare professionals may have to decide to physically restrain a patient with dementia to prevent the patient doing harm to him- or herself or to someone else. Given the lack of guidance on how to address ethical issues in CPG development manuals, in this thematic text analysis, the researchers assess the representation of ethical issues in CPGs on general dementia care. Thematic text analysis uses a framework for the assessment of qualitative data (information that is word-based rather than number-based) that involves pinpointing, examining, and recording patterns (themes) among the available data.
What Did the Researchers Do and Find?
The researchers identified 12 national CPGs on dementia care by searching guideline databases and by contacting national psychiatric associations. They developed a framework for the assessment of the ethical content in these CPGs based on a previous systematic review of ethical issues in dementia care. Of the 31 DSEIs included by the researchers in their analysis, the proportion that were explicitly addressed by each CPG ranged from 22% (Switzerland) to 77% (USA); on average the CPGs explicitly addressed half of the DSEIs. Four DSEIs—adequate consideration of advanced directives in decision making, usage of GPS and other monitoring techniques, covert medication, and dealing with suicidal thinking—were not addressed in at least 11 of the CPGs. The inclusion of recommendations on how to deal with DSEIs ranged from 10% of DSEIs covered in the Swiss CPG to 71% covered in the US CPG. Overall, national guidelines differed substantially with respect to which ethical issues were included, whether ethical recommendations were included, whether justifications or citations were provided to support recommendations, and to what extent the ethical issues were clearly explained.
What Do These Findings Mean?
These findings show that national CPGs on dementia care already address clinical ethical issues but that the extent to which the spectrum of DSEIs is considered varies widely within and between CPGs. They also indicate that recommendations on how to deal with DSEIs often lack the evidence that health-care professionals use to justify their clinical decisions. The researchers suggest that this situation can and should be improved, although more research is needed to determine how ethical issues and recommendations should be addressed in dementia guidelines. A more systematic and transparent inclusion of DSEIs in CPGs for dementia (and for other conditions) would further support the concept of medical professionalism as a core element of CPGs, note the researchers, but is also important for patients and their relatives who might turn to national CPGs for information and guidance at a stressful time of life.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001498.
Wikipedia contains a page on clinical practice guidelines (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US National Guideline Clearinghouse provides information on national guidelines, including CPGs for dementia
The Guidelines International Network promotes the systematic development and application of clinical practice guidelines
The American Medical Association provides information about medical ethics; the British Medical Association provides information on all aspects of ethics and includes an essential tool kit that introduces common ethical problems and practical ways to deal with them
The UK National Health Service Choices website provides information about dementia, including a personal story about dealing with dementia
MedlinePlus provides links to additional resources about dementia and about Alzheimers disease, a specific type of dementia (in English and Spanish)
The UK Nuffield Council on Bioethics provides the report Dementia: ethical issues and additional information on the public consultation on ethical issues in dementia care
doi:10.1371/journal.pmed.1001498
PMCID: PMC3742442  PMID: 23966839
19.  The moral code in Islam and organ donation in Western countries: reinterpreting religious scriptures to meet utilitarian medical objectives 
End-of-life organ donation is controversial in Islam. The controversy stems from: (1) scientifically flawed medical criteria of death determination; (2) invasive perimortem procedures for preserving transplantable organs; and (3) incomplete disclosure of information to consenting donors and families. Data from a survey of Muslims residing in Western countries have shown that the interpretation of religious scriptures and advice of faith leaders were major barriers to willingness for organ donation. Transplant advocates have proposed corrective interventions: (1) reinterpreting religious scriptures, (2) reeducating faith leaders, and (3) utilizing media campaigns to overcome religious barriers in Muslim communities. This proposal disregards the intensifying scientific, legal, and ethical controversies in Western societies about the medical criteria of death determination in donors. It would also violate the dignity and inviolability of human life which are pertinent values incorporated in the Islamic moral code. Reinterpreting religious scriptures to serve the utilitarian objectives of a controversial end-of-life practice, perceived to be socially desirable, transgresses the Islamic moral code. It may also have deleterious practical consequences, as donors can suffer harm before death. The negative normative consequences of utilitarian secular moral reasoning reset the Islamic moral code upholding the sanctity and dignity of human life.
doi:10.1186/1747-5341-9-11
PMCID: PMC4047256  PMID: 24888748
Death; Organ donation; Organ procurement; Transplantation; Islamic moral code; Religion; Culture
20.  What to Disclose? Revisiting Informed Consent 
Background
The requirement of obtaining informed consent before medical procedures is well established. With patients having greater access to information through information technology and owing to other factors, disclosure that goes beyond the traditional elements of the risks, benefits, and alternatives to an intervention is demanded from physicians.
Questions/purposes
We asked if modern informed consent doctrine encompasses such physician-specific variables like professional experience, health, disability, training, qualifications, disciplinary history, FDA-regulatory status pertaining to a medical device, physician research and financial interests, and statistics related to medical outcomes.
Methods
We searched two major legal databases and identified court opinions and legal reviews that have examined the scope of physician disclosure while obtaining informed consent. From this information, we summarized the prevailing state of informed consent law.
Results
Despite the expansion of information available to patients, courts have been hesitant to expand the informed consent doctrine to encompass physician-specific variables. Exceptions involve cases in which such variables directly impacted medical care and the patient could demonstrate their relevance in the informed consent process.
Conclusions
Judicial decisions have subtly expanded the doctrine of informed consent beyond its traditional limits, at least in some cases. As informed consent law continues to develop, physicians should ask if information would be material to a reasonable patient while making medical decisions; if so, such information should be disclosed.
doi:10.1007/s11999-011-2232-0
PMCID: PMC3314757  PMID: 22215479
Medicine & Public Health; Conservative Orthopedics; Orthopedics; Sports Medicine; Surgery; Surgical Orthopedics; Medicine/Public Health, general
21.  Surgery for Fractured Neck of Femur – are Patients Adequately Consented? 
INTRODUCTION
Obtaining valid consent is a legal and ethical obligation when performing any procedure in clinical practice. This study was performed to identify the validity and effectiveness of the new consent form and any potential improvement that could be made when taking consent.
PATIENTS AND METHODS
Case notes of 173 patients undergoing surgery for fractured neck of femur were retrospectively reviewed. Risks and complications of the surgery as listed on the consent form were noted. Sixty-five cases were excluded from the study as they had either old consent forms with no risks recorded or a consent form signed by a consultant due to patient inability to consent. Six of the consent forms could not be located in the notes. This left 102 consent forms to be analysed.
RESULTS
The number of risks documented on each form ranged from 0–8 (mean, 3.92). No risks were recorded in 2 of these 102 forms. Most commonly recorded risks were infection (95.1%), DVT/PE (81.4%) and failure of procedure (59.8%). It was shown that many of the consent forms analysed did not have all the serious or frequently occurring risks recorded on them and that a large proportion of the forms had acronyms or phrases that may mean nothing to the patient. Comparison of documented risks for different hip surgery were made using Fisher's exact test showing no significant difference between the risks recorded on the forms for each type of procedure.
CONCLUSIONS
Although documentation of risks has been improved compared to old consent forms, patients are not necessarily given the most appropriate information to ensure consent is valid. Further refining of consent forms may be necessary to ensure that all major risks are explained and understood by patients and that there is satisfactory recording of this information.
doi:10.1308/003588407X160846
PMCID: PMC1963537  PMID: 17316526
Consent forms; Fracture; Neck of femur; Hip surgery
22.  Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya 
BMC Medical Ethics  2010;11:13.
Background
The potential contribution of community engagement to addressing ethical challenges for international biomedical research is well described, but there is relatively little documented experience of community engagement to inform its development in practice. This paper draws on experiences around community engagement and informed consent during a genetic cohort study in Kenya to contribute to understanding the strengths and challenges of community engagement in supporting ethical research practice, focusing on issues of communication, the role of field workers in 'doing ethics' on the ground and the challenges of community consultation.
Methods
The findings are based on action research methods, including analysis of community engagement documentation and the observations of the authors closely involved in their development and implementation. Qualitative and quantitative content analysis has been used for documentation of staff meetings and trainings, a meeting with 24 community leaders, and 40 large public and 70 small community group meetings. Meeting minutes from a purposive sample of six community representative groups have been analysed using a thematic framework approach.
Results
Field workers described challenges around misunderstandings about research, perceived pressure for recruitment and challenges in explaining the study. During consultation, leaders expressed support for the study and screening for sickle cell disease. In community meetings, there was a common interpretation of research as medical care. Concerns centred on unfamiliar procedures. After explanations of study procedures to leaders and community members, few questions were asked about export of samples or the archiving of samples for future research.
Conclusions
Community engagement enabled researchers to take account of staff and community opinions and issues during the study and adapt messages and methods to address emerging ethical challenges. Field workers conducting informed consent faced complex issues and their understanding, attitudes and communication skills were key influences on ethical practice. Community consultation was a challenging concept to put into practice, illustrating the complexity of assessing information needs and levels of deliberation that are appropriate to a given study.
doi:10.1186/1472-6939-11-13
PMCID: PMC2918624  PMID: 20633282
23.  Patients’ perceived purpose of clinical informed consent: Mill’s individual autonomy model is preferred 
BMC Medical Ethics  2014;15:2.
Background
Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes.
Methods
We surveyed 488 adults who were planning to undergo or had recently undergone written informed consent-requiring procedures. Perceptions of informed consent purpose (from norm and current practice perspectives) were explored by asking respondents to rank (1 = most reflective) 10 randomly-presented statements: “meaningless routine”, “courtesy gesture” “litigation protection”, “take away compensation rights”, “inform patient’, “make sure patient understand”, “document patient’s decision”, “discover patient’s preferences”, “have shared decision”, and “help patient decide”.
Results
Respondents’ mean (SD) age was 38.3 (12.5); 50.4% were males, 56.8% had ≥ college education, and 37.3% had undergone a procedure. From the norm perspective, the least reflective statement was “meaningless routine” (ranked 1–3 by 2.6% of respondents) and the most reflective statements were “help patient decide”, “make sure patient understand”, and “inform patient” (ranked 1–3 by 65%, 60%, and 48% of respondents with median [25%,75%] ranking scores of 2 [1,5], 3 [2,4], and 4 [2,5], respectively). Compared to their counterparts, males and pre-procedure respondents ranked “help patient decide” better, whereas females and post-procedure respondents ranked “inform patient” better (p = 0.007 to p < 0.001). Age was associated with better ranking of “help patient decide” and “make sure patient understand” statements (p < 0.001 and p = 0.002, respectively), which were ranked 1–3 by only 46% and 42% of respondents from the current practice perspective (median ranking score 4 [2,6], p < 0.001 vs. norm perspective for both).
Conclusions
1) the informed consent process is important to patients, however, patients vary in their views of its purpose with the dominant view being enabling patients’ self decision-making, 2) males, pre-procedure, and older patients more favor a self decision-making purpose, whereas females and post-procedure patients more favor an information disclosure purpose, and 3) more self decision-making and more effective information disclosure than is currently practiced are desired. An informed consent process consistent with Mill’s individual autonomy model may be suitable for most patients.
doi:10.1186/1472-6939-15-2
PMCID: PMC3897892  PMID: 24406020
Informed consent; Middle East; Norm perception; Current practice; Gender difference; Autonomy
24.  Challenges in conducting psychiatry studies in India 
A large number of psychiatry studies are conducted in India. Psychiatry studies are complex and present unique challenges in the Indian setting. Ethical issues pertaining to the risk of worsening of illness, use of placebo and validity of informed consents are commonly faced. Site selection can be difficult due to the relative paucity of ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) trained psychiatry investigators in India. Recruitment can be challenging due to issues such as strict eligibility criteria, (lack of) availability of caregiver, illness-related considerations, etc. Assessment of the consent capacity of patients is not simple, while structured assessments are not commonly employed. As the illness fluctuates, the consent capacity may change, thus requiring continued assessment of consent capacity. Study patients run the risk of worsening of illness and suicide due to exposure to inactive treatments; this risk is counterbalanced by use of appropriate study designs, as well as the indirect psychotherapeutic support received. Psychiatry studies are associated with a high placebo response. This necessitates conduct of placebo-controlled studies despite the attendant difficulties. Also, the high placebo response is often the cause of failed trials. Rating scales are essential for assessment of drug response. Some rating instruments as well as some rater training procedures may not be suitable for the Indian setting. Technological advancements may increase the procedural complexity but improve the quality of ratings. Psychiatry studies present monitors and auditors with unique scenarios too. Utilization of psychiatry specific training and expertise is recommended to ensure successful conduct of these studies in India.
doi:10.4103/2229-3485.76284
PMCID: PMC3088958  PMID: 21584176
Challenges; India; informed consent; placebo; psychiatry; rating
25.  Pitfalls in computer housekeeping by doctors and nurses in KwaZulu-Natal: No malicious intent 
BMC Medical Ethics  2013;14(Suppl 1):S8.
Introduction
Information and communication technologies are becoming an integral part of medical practice, research and administration and their use will grow as telemedicine and electronic medical record use become part of routine practice. Security in maintaining patient data is important and there is a statuary obligation to do so, but few health professionals have been trained on how to achieve this. There is no information on the use of computers and email by doctors and nurses in South Africa in the workplace and at home, and whether their current computer practices meets legal and ethical requirements. The aims of this study were to determine the use of computers by healthcare practitioners in the workplace and home; the use and approach to data storage, encryption and security of patient data and patient email; and the use of informed consent to transmit data by email.
Methods
A self-administered questionnaire was administered to 400 health care providers from the state and private health care sectors. The questionnaire covered computer use in the workplace and at home, sharing of computers, data encryption and storage, email use, encryption of emails and storage, and the use of informed consent for email communication.
Results
193 doctors and 207 nurses in the private and public sectors completed the questionnaire. Forty (10%) of participants do not use a computer. A third of health professionals were the only users of computers at work or at home. One hundred and ninety-eight respondents (55%) did not know if the data on the computers were encrypted, 132 (36.7%) knew that the data were not encrypted and 30 (8.3%) individuals knew that the data on the computers they were using were encrypted. Few doctors, 58 (16%), received emails from patients, with doctors more likely to receive emails from patients than nurses (p = 0.0025). Thirty-one percent of individuals did not respond to the emails. Emails were saved by 40 (69%) recipients but only 5 (12.5%) doctors encrypted the messages, 19 (47.5%) individuals knowingly did not encrypt and 16 (40.0%) did not know if they encrypted the data. While 20% of health professionals have emailed patient data, but only 41.7% gained consent to do so.
Conclusions
Most health professionals as sampled in South Africa are not compliant with the National Health Act or the Electronic Communications Transactions Act of South Africa or guidelines from regulatory bodies when managing patient data on computers. Many appear ignorant or lack the ability to comply with simple data security procedures.
doi:10.1186/1472-6939-14-S1-S8
PMCID: PMC3878337  PMID: 24565043

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