Severe adult burn survivors. What information about skin allografts?

During the acute phase of a severe burn, surgery is an emergency. In this situation, human skin allografts constitute an effective temporary skin substitute. However, information about the use of human tissue can not be given to the patients because most of the allografted patients are unconscious due to their injury. This study explored the restitution of information on skin donation to patients who have been skin allografted and who have survived their injury. A qualitative study was conducted due to the limited number of patients in ability to be interviewed according to our medical and psychological criteria. 12 patients who had been treated between 2002 and 2008 were interviewed. Our results show that 10 of them ignored that they had received skin allografts. One of the two patients who knew that they had received allografts knew that skin had been harvested from deceased donor. All patients expressed that there is no information that should not be delivered. They also expressed their relief to have had the opportunity to discuss their case and at being informed during their interview. Their own experience impacted their view in favor of organ and tissue donation.     

What research participants want to know about genetic research results: the impact of "genetic exceptionalism"

The disclosure of individual genetic results has generated an ongoing debate about which rules should be followed. We aimed to identify factors related to research participants' preferences about learning the results of genomic studies using their donated tissue samples. We conducted a cross-sectional survey of 279 patients from the United States and Spain who had volunteered to donate a sample for genomic research. Our results show that 48% of research participants would like to be informed about all individual results from future genomic studies using their donated tissue, especially those from the U.S. (71.4%) and those believing that genetic information poses special risks (69.7%). In addition, 16% of research participants considered genetic information to be riskier than other types of personal medical data. In conclusion, our study demonstrates that a high proportion of participants prefer to be informed about their individual results and that there is a higher preference among those research subjects who perceive their genetic information as riskier than other types of personal medical data.     

'Hitting you over the head': oncologists' disclosure of prognosis to advanced cancer patients

The disclosure of prognosis to terminally ill patients has emerged as a recent concern given greater demands for patient involvement in medical decision-making in the United States. As part of the informed consent process, American physicians are legally and ethically obligated to provide information to such patients about the risks, benefits, and alternatives of all available treatment options including the use of experimental therapies. Although not legally required, the disclosure of a terminal prognosis is ethically justified because it upholds the principle of self-determination and enables patients to make treatment decisions consistent with their life goals. To understand oncologists' attitudes about disclosing prognostic information to cancer patients with advanced disease, we interviewed fourteen oncologists and conducted one focus group of medical fellows. Although oncologists reported to disclose prognosis in terms of cancer not being curable, they tend to avoid using percentages to convey prognosis. Oncologists' reported reluctance to disclosing prognosis was conveyed through the use of metaphors depicting the perceived violent impact of such information on patients. Oncologists' reluctance to disclose prognosis and preserve patient hope are held in check by their need to ensure that patients have 'realistic expectations' about therapy. We discuss these data in light of the cultural, ethical, and legal dimensions of prognosis disclosure, patient hope and the doctor–patient relationship, and recommend ways to enhance the communication process.     

The Doctor-Patient Relationship: A Survey of Attitudes and Practices of Doctors in Singapore

This article reports the results of a survey, by mailed questionnaire, of the attitudes, values and practices of doctors in Singapore with respect to the doctor-patient relationship. Questionnaires were sent to a random sample of 475 doctors (261 general practitioners and 214 medical specialists), out of which 249 (52.4%) valid responses were completed and returned. The survey is the first of its kind in Singapore. Questions were framed around issues of medical paternalism, consent and patient autonomy. As the doctors were exposed to Western ethical concepts in their training, we were not surprised to find that they would mostly allow patients some say in decision-making and keep patients reasonably informed. In respecting patient autonomy, they would usually seek to influence patient choice by persuasion. However, the residual 'Asian-ness' of doctors in Singapore gives rise to some inconsistencies between values and practices. Many doctors still believe that a number of their patients are incapable of rational choice. There is some lack of openness in telling patients the whole truth. When patients choose to refuse treatment, many doctors are prepared to involve family members in making a consensus decision.
Doctors were also asked how they made ethical judgements in the face of dilemmas, and how they would like disputes with patients to be resolved. By and large, the doctors prefer to make their own judgements rather than to rely on rules. They also wish to keep the law courts out of disputes with patients, preferring less public ways of settling disputes.     

How informed is patients' consent to release of medical information to insurance companies?

A study was conducted to assess how informed the consent of patients is to the release of confidential information to insurance companies. Questionnaires were sent to 226 consecutive patients from four practices whose general practitioners had received requests to complete a personal medical attendant''s report for an insurance company. In total 195 patients returned the questionnaire, whose six questions required only a yes or no answer. More than half of the patients (102 (52%] could not recall having given their consent and 79 (40%) had one or more objections to the questions commonly asked by insurance companies. Questions about sexually transmitted diseases and AIDS led to the greatest proportion of objections (85% (67/79) and 80% (63/79) respectively). Over half (111 (57%) of the 195 respondents expected their doctor to withhold sensitive information. Of the 93 patients who gave their informed consent, 63 (68%) did not expect that their doctor would be asked to answer one or more of the common questions. In most cases the consent of patients to the release of confidential information to insurance companies is neither knowingly given nor informed.     

Charitable State-Controlled Foundation Human Tissue and Cell Research: Ethic and Legal Aspects in the Supply of Surgically Removed Human Tissue For Research in the Academic and Commercial Sector in Germany

Tissue engineering using human cells and tissue has one of the greatest scientific and economical potential in the coming years. There are public concerns during the ongoing discussion about future trends in life sciences and if ethic boundaries might be respected sufficiently in the course of striving for industrial profit and scientific knowledge. Until now, the legal situation of using human tissue material for research is not clear. Accordingly, transparency of action and patients' information are a central component when handling patient material inside and outside of the patient-specific treatment. Whereas in the field of therapeutic use of tissue (e.g. transplantation) there is an emergency situation by the shortage of organs with the risk of the premature death of the potential recipient, this cannot be claimed for tissue donation for research. The basis of every surgical operation is the treatment contract, which places the doctor under obligation to the careful exercise of medical treatment containing the patient's informed consent. This contract only covers the treatment that is intended to cure the patient and the medical measures that are necessary therefor. The further scientific use of body-substances, which are discarded after an operation, are not included. Therefore a personal and independent written enlightenment of the patient and a declaration of informed consent is necessary. Examples of guidelines for tissue supply, Patients information and consent were worked out by theologists, lawyers, scientists and physicians reflecting their practical experience in transplant surgery and liver cell research. As a consequence to cover the ethical and legal aspect of tissue donation in Germany a charitable state-controlled foundation Human Tissue and Cell Research (HTCR) was introduced and established.     

Ethical aspects of genetic testing.

No research study or significant medical treatment can be done involving patients without their informed consent. In workplaces and environmental settings, individuals are often exposed to mutagenic or carcinogenic substances, usually without their knowledge, and not with their informed consent. Such exposures can lead to evermore easily documentable genetic changes. As genetic testing becomes more widespread, there are significant ethical implications regarding employment, insurance coverage, and confidentiality regarding medical information. With an increased ability to detect genetic changes, or 'unfavorable' genetic polymorphisms, this information should not be used to deny employment or increase insurance rates. Rather, such information should be used to increasingly provide appropriately safe workplaces, and place workers in less hazardous settings.     

Informed Consent and Genetic Information

In the last 25 years writing in bioethics, particularly in medical ethics, has generally claimed that action is ethically acceptable only if it receives informed consent from those affected. However, informed consent provides only limited justification, and may provide even less as new information technologies are used to store and handle personal data, including personal genetic data. The central philosophical weakness of relying on informed consent procedures for ethical justification is that consent is a propositional attitude, so referentially opaque: consent is given to specific propositions describing limited aspects of a situation, and does not transfer even to closely related propositions. Assembling genetic data in databases creates additional difficulties for ethical justification. This is not because genetic information is intrinsically exceptional, but because the merger of genetic and information technologies make it possible to assemble massive quantities of complex information that defeat individuals' best efforts to grasp what is at stake, or to give or withhold informed consent. The future agenda for bioethics will need to take account of both these limitations of appeals to informed consent.     

Informed consent in clinical research at a general hospital in Mexico: opinions of the investigators

In Mexico informed consent is a legal requirement that ensures that patients who are invited to participate in clinical trials are provided with all the information needed to decide whether to participate, or not, in a research protocol. To improve our understanding of the problems physicians in developing countries encounter, when obtaining informed consent (IC), we examined their opinion on the importance of IC in clinical research, the quantity and quality of the information provided to the participant, and the conditions in which the IC is obtained. Investigators considered that IC was useful to the patients, providing information that helped the patient to make a decision about his/her participation. Nevertheless, they felt that for some aspects of the research, like drug development in general, the use of placebos, and the randomization process, many of the patients were not capable of fully understanding the information provided, referring to the complexity of the information and illiteracy as the main reasons. Many investigators were not acquainted with some of the guidelines established in the Mexican General Law of Health,(1) 36% of them admitting to not having completed their IC letters. Most investigators gave only minutes to the patient to make a decision and 20% of ICs were obtained while the patient was hospitalized. Except for one investigator, all of them considered that specific training in medical ethics would be useful for the daily clinical work.     

Assessment of cardiotocographs

In recent years advances in medical electronic equipment for monitoring, diagnosis and treatment of patients have led to a large increase in the number and variety of instrumentation available to the medical profession. There is a considerable amount of duplication of equipment and in the absence of readily available information buyers are unlikely to make informed decisions about the ideal instrument for their particular circumstances. One method of increasing the users' awareness is a comparative, independent assessment of equipment, with the results disseminated to the interested parties. This paper describes the essential qualities of cardiotocographs: how they are assessed as part of the UK Department of Health's evaluation programme and the measures to inform users of the latest evaluation information.     

Academic physician specialists’ views toward the unproven stem cell intervention industry: areas of common ground and divergence

Background and AimsPremature commercialization of unproven stem cell interventions (SCIs) has received significant attention within the regenerative medicine community. Patients considering SCIs may encounter misinformation and seek out guidance from their physicians who are trusted brokers of health information. However, little is known about the perspectives of academic physician specialists toward the SCI industry. The purpose of this study was to capture the attitudes of physician specialists with experience addressing patient questions about unproven SCIs.MethodsThe authors undertook 25 semi-structured interviews with academic physicians in cardiology, ophthalmology, orthopedics, pulmonology and neurology primarily from one academic center.ResultsThe authors identified two major themes: concerns and mediators of appropriateness of offering SCIs as therapies to patients. Specialists were generally aware of the industry and reported scientific and commercial concerns, including the scientific uncertainty of SCIs, medical harms to patients, misleading marketing and its impact on patient informed consent and economic harms due to large out-of-pocket costs for patients. All specialists outside of orthopedics voiced that it was inappropriate to be offering SCIs to patients today. These views were informed by previously expressed concerns surrounding safety and properly informing patients, levels of evidence needed prior to offering SCIs therapeutically and desired qualifications for clinicians. Among the specialties, orthopedists reported that under certain conditions, SCIs may be appropriate for patients with limited clinical options but only when safety is adequate, expectations are managed and patients are well informed about the risks and chances of benefit. Most participants expressed a desire for phase 3 studies and Food and Drug Administration approval prior to marketing SCIs, but some also shared the challenges associated with upholding these thresholds of evidence, especially when caring for out-of-option patients.ConclusionsThe authors’ results suggest that medical specialists are aware of the industry and express several concerns surrounding SCIs but differ in their views on the appropriateness and clinical evidence necessary for offering SCIs currently to patients. Additional educational tools may help physicians with patient engagement and expectation management surrounding SCIs.     

Informing participants of allocation to placebo at trial closure: postal survey

ObjectivesTo assess whether and how investigators of placebo controlled randomised trials inform participants of their treatment allocation at trial closure and to assess barriers to feedback.DesignPostal survey with a semistructured questionnaire.ParticipantsAll investigators who published a placebo controlled randomised trial in 2000 in five leading medical journals, and a random sample of 120 trials listed in the national research register database.Results45% of investigators informed either all or most participants of their treatment allocation, and 55% did not inform any participant or only informed those who asked. The main reasons for not informing participants were that the investigators never considered this option (40%) or to avoid biasing results at study follow up (24%).ConclusionFurther research is required to examine sensitive ways to communicate treatment information to trial participants.

What is already known on this topic

Information is poor on the nature, extent, and effect of informing participants of placebo controlled randomised trials about their treatment allocation at trial closureLess than 50% of participants receiving placebo are informed about their treatment allocation

What this study adds

No standard procedure is available for informing patients of their treatment arm or of study results at the end of a trialEffective and sensitive ways of communicating treatment allocation to participants are required, as is information on the effects on placebo responders     

Couples facing death. II--Unsatisfactory communication.

Forty-one couples facing the prospect of separation by death were interviewed about how the nature and prognosis of their illness had been discussed with them by their general practitioner hospital staff, and the staff of the continuing care unit to which they were admitted. Communication between husband and wife and how they coped with telling their parents and their children was also assessed. Treatment was given when they were anxious or dissatisfied about the quality of communication in any of these areas. The couples found hospital doctors least successful at communication. Almost all who were dissatisfied wanted more information, not less. The wish to protect dependent relatives conflicted with the wish to be open, making decisions very difficult. Considerable suffering is caused by poor communication, and much of this is avoidable.     

Models for truth‐telling in physician‐patient encounters: What can we learn from Yoruba concept of Ooto?

Empirical studies have now established that many patients make clinical decisions based on models other than Anglo American model of truth‐telling and patient autonomy. Some scholars also add that current medical ethics frameworks and recent proposals for enhancing communication in health professional‐patient relationship have not adequately accommodated these models. In certain clinical contexts where health professional and patients are motivated by significant cultural and religious values, these current frameworks cannot prevent communication breakdown, which can, in turn, jeopardize patient care, cause undue distress to a patient in certain clinical contexts or negatively impact his/her relationship with the community. These empirical studies have now recommended that additional frameworks developed around other models of truth‐telling; and which take very seriously significant value‐differences which sometimes exist between health professional and patients, as well as patient's cultural/religious values or relational capacities, must be developed. This paper contributes towards the development of one. Specifically, this study proposes a framework for truth‐telling developed around African model of truth‐telling by drawing insights from the communitarian concept of oot?? amongst the Yoruba people of south west Nigeria. I am optimistic that if this model is incorporated into current medical ethics codes and curricula, it will significantly enhance health professional‐patient communication.     

Research ethical committees in Scotland.

A questionnaire was sent to 41 ethical committees in Scotland requesting information about their constitution and supervision of clinical research. Thirty-four (83%) replies were received. Committees varied in size from one to 73 members, most of whom were medical. Ten had no nurse members and only three had lay members without direct NHS connections. Sixteen saw their role as advisory rather than supervisory. Thirteen had not met in the past year whereas two had held 10 or more meetings. Limited use (12) was made of standard protocols, and only six had formal procedures for monitoring research in progress. Only seven of 370 proposals were rejected outright. Risk/benefit dilemmas and difficulties relating to informed consent were the commonest problems encountered. The committees provide only limited safeguards for patients and research workers, and more effective, standardised procedures are indicated.     

The consent problem within DNA biobanks

Large prospective biobanks are being established containing DNA, lifestyle and health information in order to study the relationship between diseases, genes and environment. Informed consent is a central component of research ethics protection. Disclosure of information about the research is an essential element of seeking informed consent. Within biobanks, it is not possible at recruitment to describe in detail the information that will subsequently be collected because people will not know which disease they will develop. It will also be difficult to describe the specific research that will be performed using the biobank, other than to stipulate categories of research or diseases that are not included. Potential subjects can only be given information about the sorts of research that will be performed and by whom. Organisations responsible for biobanks usually argue that this disclosure of information is adequate when seeking informed consent, especially if coupled with a right to withdraw, as it would not be feasible or it would be too expensive to seek consent renewal on a regular basis. However, there are concerns about this 'blanket consent' approach'. Consent waivers have also been proposed in which research subjects entrust their consent with an independent third party to decide whether subsequent research using the biobank is consistent with the original consent provided by the subject.     

Acceptance and Perception of Nigerian Patients to Medical Photography

The aim of the study was to determine the acceptance and perception of Nigerian patients to medical photography. A self‐administered questionnaire was distributed among Nigerian patients attending oral and maxillofacial surgery and plastic surgery clinics of 3 tertiary health institutions. Information requested included patients' opinion about consent process, capturing equipment, distribution and accessibility of medical photographs. The use of non‐identifiable medical photographs was more acceptable than identifiable to respondents for all purposes (P = 0.003). Most respondents were favourably disposed to photographs being taken for inclusion in the case note, but opposed to identifiable photographs being used for other purposes most especially in medical websites and medical journals. Female respondents preferred non‐identifiable medical photographs to identifiable ones (P = 0.001). Most respondents (78%) indicated that their consent be sought for each of the outline needs for medical photography. Half of the respondents indicated that identifiable photographs may have a negative effect on their persons; and the most commonly mentioned effects were social stigmatization, bad publicity and emotional/psychological effects. Most of the respondents preferred the use of hospital‐owned camera to personal camera/personal camera‐phone for their medical photographs. Most respondents (67.8%) indicated that they would like to be informed about the use of their photographs on every occasion, and 74% indicated that they would like to be informed of the specific journal in which their medical photographs are to be published. In conclusion, non‐identifiable rather than identifiable medical photography is acceptable to most patients in the studied Nigerian environment. The use of personal camera/personal camera‐phone should be discouraged as its acceptance by respondents is very low. Judicious use of medical photography is therefore advocated to avoid breach of principle of privacy and confidentiality in medical practice.     

Altruistic surrogacy and informed consent

A crucial premise in many recent arguments against the moral permissibility of surrogate motherhood arrangements is the claim that a woman cannot autonomously consent to gestating and relinquishing a child to another couple, because she cannot be fully informed about what her future emotional responses will be to the foetus developing within her, and to the giving up of the newborn infant to its social parents. When conjoined with some moral principle about the justifiable limits on the ways others can be expected to exercise their autonomy on our behalf, this claim is often taken to establish that various forms of surrogate motherhood arrangements are morally wrong. In this paper I want to show that there is a serious non sequitur in this kind of argument. That is, I want to show that even if women cannot in fact have this kind of information about what their future emotional responses to pregnancy and relinquishment will be, nothing follows about the wrongness or otherwise of surrogacy. For, when we consider what counts as informed consent in the context of other important ventures with uncertain consequences, it becomes clear that informed consent does not require having this kind of information about one's future emotional states. In putting these arguments, I also hope to clarify some of the connections which might be thought to hold between informed consent and autonomous decision-making generally.     

Perceived Quality of Informed Refusal Process: A Cross‐Sectional Study from Iranian Patients' Perspectives

Patients have the right to refuse their treatment; however, this refusal should be informed. We evaluated the quality of the informed refusal process in Iranian hospitals from patients' viewpoints. To this end, we developed a questionnaire that covered four key aspects of the informed refusal process including; information disclosure, voluntariness, comprehension, and provider‐patient relationship. A total of 284 patients who refused their treatment from 12 teaching hospitals in the Isfahan Province, Iran, were recruited and surveyed to produce a convenience sample. Patients' perceptions about the informed refusal process were scored and the mean scores of the four components were calculated. The findings showed that the practice of information disclosure (9.6 ± 6.4 out of 22 points) was perceived to be moderate, however, comprehension (2.3 ± 1.4 out of 4 points), voluntariness (8.7 ± 1.5 out of 12 points) and provider–patient relationship (10.2 ± 5.2 out of 16 points) were perceived to be relatively good. We found that patients, who refused their care before any treatment had commenced, reported a lower quality of information disclosure and voluntariness. Patients informed by nurses and those who had not had a previous related admission, reported lower scores for comprehension and relationship. In conclusion, the process of obtaining informed refusal was relatively satisfactory except for levels of information disclosure. To improve current practices, Iranian patients need to be better informed about; different treatment options, consequences of treatment refusal, costs of not continuing treatment and follow‐ups after refusal. Developing more informative refusal forms is needed.