Shaken baby syndrome and the risk of losing scientific scrutiny.

A systematic review of shaken baby syndrome by the Swedish Agency for Health Technology Assessment and Assessment of Social Services generated numerous reactions from professional organisations, even before the review was published. There was also a lively debate after a paper summarising its findings were published in Acta Paediatrica The various responses are worth debating further, as they raise several important issues with regard to research ethics, having an open debate and publishing scientific findings. CONCLUSION: The responses to the shaken baby syndrome report indicate that scientific scrutiny risks being lost when researchers and organisations are not open to challenging established ideas.

Teaching medical ethics: what is the impact of role models? Some experiences from Swedish medical schools.

The goal of the present study was to elucidate what influences medical students' attitudes and interests in medical ethics. At the end of their first, fifth and last terms, 409 medical students from all six medical schools in Sweden participated in an attitude survey. The questions focused on the students' experience of good and poor role models, attitudes towards medical ethics in general and perceived effects of the teaching of medical ethics. Despite a low response rate at some schools, this study indicates that increased interest in medical ethics was related to encountering good physician role models, and decreased interest, to encountering poor role models. Physicians involved in the education of medical students seem to teach medical ethics as role models even when ethics is not on the schedule. The low response rate prevents us from drawing definite conclusions, but the results could be used as hypotheses to be further scrutinised.

Should physicians fake diagnoses to help their patients?

Are fake diagnoses and false or misleading certificates permissible means of helping patients? This question is examined in relation to four examples from Swedish health care: the sterilisation case, the asylum case, the virginity case, and the adoption case. We argue that both consequentialist and deontological ethical theories, to be reasonable, need to balance values, principles, and interests such as wellbeing, truthfulness, autonomy, personal integrity, trust in the medical profession, and abidance by national legislation. We conclude that it can be justifiable for physicians to fake diagnoses and write false or misleading certificates in order to help patients when not doing so has dire consequences. However, physicians must also consider the long-term effects of making exceptions to honest, non-deceitful behaviour based on the best empirical evidence available. Otherwise valuable social practices might erode and public confidence in physicians be threatened.

Decision making in a life-threatening cerebral condition: a comparative study of the ethical reasoning of intensive care unit physicians and neurosurgeons.

AIM: To study the support for the arguments of neurosurgeons and intensive care unit (ICU) physicians for and against life-sustaining treatment of critically ill patients, and whether neurosurgeons are less inclined to emphasize quality-of-life aspects than ICU physicians. METHODS: A postal questionnaire was sent to a random sample of ICU physicians in Sweden (n= 298) and all neurosurgeons in Sweden (n= 112). The respondents evaluated and prioritized different arguments for and against withholding neurosurgery, withdrawing life-sustaining treatment and providing drugs which may hasten death. RESULTS: The response rate was 62.5% for neurosurgeons and 73.5% for ICU physicians. Quality-of-life aspects were stressed as an important argument by the majority of both neurosurgeons and ICU physicians (76.8% vs. 54.0%); however, significantly more neurosurgeons regarded this argument as the most important (P < 0.001). A minority in both groups, although more ICU physicians (P < 0.001), supported a patient's previously expressed wish of not ending in a persistent vegetative state as the most important argument. As the case clinically progressed, a consensus regarding the arguments for decision making evolved. CONCLUSIONS: No support was found for the hypothesis that ICU physicians care more about the quality of life of a severely ill patient. Indeed, significantly more neurosurgeons emphasized the quality-of-life aspects in this particular setting. Compared with neurosurgeons, significantly more ICU physicians considered the patient's own wishes to be important.

Quantitative aspects of informed consent: considering the dose response curve when estimating quantity of information.

Information is usually supposed to be a prerequisite for people making decisions on whether or not to participate in a clinical trial. Previously conducted studies and research ethics scandals indicate that participants have sometimes lacked important pieces of information. Over the past few decades the quantity of information believed to be adequate has increased significantly, and in some instances a new maxim seems to be in place: the more information, the better the ethics in terms of respecting a participant's autonomy. The authors hypothesise that the dose-response curve from pharmacology or toxicology serves as a model to illustrate that a large amount of written information does not equal optimality. Using the curve as a pedagogical analogy when teaching ethics to students in clinical sciences, and also in engaging in dialogue with research institutions, may promote reflection on how to adjust information in relation to the preferences of individual participants, thereby transgressing the maxim that more information means better ethics.

Informed consent in two Swedish prisons: a study of quality of information and reasons for participating in a clinical trial.

OBJECTIVES: To study the quality of informed consent in two samples of prisoners participating in a therapeutic trial. RESULTS: All participants (n=43) were aware of the fact that they had participated in a research project, that they were free to abstain from participation, and that they were free to withdraw from participation at any time. All but six were aware of the objective of the clinical trial and all but three understood the implications of participating. Twenty individuals did not consider the pros and cons. When making their respective decisions, no one felt that they had been subjected to undue persuasion or force. Concerning the reasons for participating, a majority (n=35) supposed that participation would benefit themselves' as the primary reason. Some (n=11) considered the benefits for future patients and science. No differences concerning gender or age were discerned. CONCLUSIONS: The results do not indicate that the informed consent procedure in general was inadequately performed. Rather, the answers provided and the subjects who withdrew indicate that participation was perceived as fully voluntary.

Research ethics committees: a comparative study of assessment of ethical dilemmas.

Research ethics committees (REC) constitute an important instrument for the regulation of biomedical research involving human beings. The purposes of this work were to study the ethical reasoning in RECs and to ascertain whether the composition of RECs has any bearing on the decisions subsequently made by them. We used a postal questionnaire, containing authentic cases of research ethical dilemmas, sent to the ten RECs in Sweden (n = 124) and to comparison groups consisting of 200 randomly selected medical researchers, 200 randomly selected healthcare politicians and 200 randomly selected district nurses. The average response rate was 68%. A difference was found in how REC members assess a project in comparison with researchers, healthcare politicians and district nurses. Differences depended on the type of project assessed. The study indicates that membership in RECs may exert a normative influence on its members. It is proposed that this investigation should be followed up by a study with a qualitative design.

Fraud, misconduct or normal science in medical research--an empirical study of demarcation.

OBJECTIVES: To study and describe how a group of senior researchers and a group of postgraduate students perceived the so-called "grey zone" between normal scientific practice and obvious misconduct. DESIGN: A questionnaire concerning various practices including dishonesty and obvious misconduct. The answers were obtained by means of a visual analogue scale (VAS). The central (two quarters) of the VAS were designated as a grey zone. SETTING: A Swedish medical faculty. SURVEY SAMPLE: 30 senior researchers and 30 postgraduate students. RESULTS: Twenty of the senior researchers and 25 of the postgraduate students answered the questionnaire. In five cases out of 14 the senior researchers' median was found to be clearly within the interval of the grey zone, compared with three cases for the postgraduate students. Three examples of experienced misconduct were provided. Compared with postgraduate students, established researchers do not call for more research ethical guidelines and restrictions. CONCLUSION: Although the results indicate that consensus exists regarding certain obvious types of misconduct the response pattern also indicates that there is no general consensus on several procedures.

Loyalty conflicts in medical practice. A comparative study of general practitioners', paediatricians' and gynaecologists' assessments of three cases.

OBJECTIVE: To shed light on attitudes towards loyalty conflicts among general practitioners (GPs) compared with related specialists such as gynaecologists and paediatricians. DESIGN: A postal questionnaire containing three case histories with arguments for and against different ways of acting in loyalty conflicts. The medical problems of the clinical cases varied, but the ethical ones were in principle similar. SETTING: A random sample of all Swedish GPs, gynaecologists, and paediatricians. SUBJECTS: GPs (n = 313), paediatricians (n = 197), and gynaecologists (n = 236). RESULTS: On average 71% of the doctors replied. The gynaecologists differed from the other groups by being markedly loyal to the individual patient especially in one case. The paediatricians tended to reply most consistently and they seemed to favour the family perspective, compared with the other doctors. The GPs' response pattern fell in between the other two groups. CONCLUSIONS: The study indicates that ethical reasoning depends on the doctors' different medical background with regard to specialty. This study should be followed by others in order to give further explanation of the findings.

When others decide: reasons for allowing patients with Alzheimer's disease to participate in nontherapeutic research.

The quality of information given to family members of patients with Alzheimer's disease was studied. The patients had participated in a pharmacological investigation. The relatives were generally satisfied with the information given, and perceived it as adequate. The reasons given for allowing the patients to participate in the investigation were mainly altruistic.