One of the phenomena associated with research is "incidental findings," that is, unexpected findings made during the research, and outside the scope of the research, which have potential health importance. One underappreciated risk of incidental findings is the potential loss of the research subject's insurability; or if a research subject fails to disclose incidental findings when applying for insurance, the insurance contract may be voidable by the insurer. In this article, we seek to explain the insurability risks associated with incidental findings and to make recommendations for how researchers and research ethics committees should address the issue of disclosure of these risks.
In recent years, human DNA sampling and collection has accelerated without the development of enforceable rules protecting the human rights of donors. The need for regulation of biobanking is especially acute in Iceland, whose parliament has granted a for-profit corporation, deCODE Genetics, an exclusive license to create a centralized database of health records for studies on human genetic variation. Until recently, how deCODE Genetics would get genetic material for its genotypic-phenotypic database remained unclear. However, in May 2000, the Icelandic Parliament passed the Icelandic Biobanks Act, the world's earliest attempt to construct binding rules for the use of biobanks in scientific research. Unfortunately, Iceland has lost an opportunity for bringing clear and ethically sound standards to the use of human biological samples in deCODE's database and in other projects: the Biobanks Act has extended a notion of "presumed consent" from the use of medical records to the use of patients' biological samples; worse, the act has made it possible--perhaps likely--that a donor's wish to withdraw his/her sample will be ignored. Inadequacies in the Act's legislative process help account for these deficiencies in the protection of donor autonomy.
Our goal for this supplemental issue of Pediatrics was to consider what practitioners, parents, patients, institutions, and policy-makers need to take into account to make good decisions about using complementary and alternative medicine (CAM) to treat children and to develop guidelines for appropriate use. We began by explaining underlying concepts and principles in ethical, legal, and clinical reasoning and then used case scenarios to explore how they apply and identify gaps that remain in practice and policy. In this concluding article, we review our major findings, summarize our recommendations, and suggest further research. We focus on several key areas: practitioner and patient/parent relationships; decision-making; dispute resolution; standards of practice; hospital/health facility policies; patient safety; education; and research. Ethical principles, standards, and rules applicable when making decisions about conventional care for children apply to decision-making about CAM as well. The same is true of legal reasoning. Although CAM use has seldom led to litigation, general legal principles relied on in cases involving conventional medical care provide the starting point for analysis. Similarly, with respect to clinical decision-making, clinicians are guided by clinical judgment and the best interests of their patient. Whether a therapy is CAM or conventional, clinicians must weigh the relative risks and benefits of therapeutic options and take into account their patient's values, beliefs, and preferences. Consequently, many of our observations apply to conventional and CAM care and to both adult and pediatric patients.
The literature on oral history methods has increased over the past decade. Yet, the issues in gaining consent warrant specific attention. The process of gaining consent in oral history interviews has unique features and varies from accepted procedures in qualitative research. The authors discuss the legalities and ethics of oral history interviews and provide examples regarding the consent process from an oral history project that they conducted. The researchers conclude that despite its complexity, presenting the transcribed interview to the interviewee contributes in an important way to the ethical integrity of the interview process.
In this article we explore decision-making about treatment when a child faces a life-threatening illness but conventional treatment presents substantial risk and uncertain benefit. When is it acceptable for parents to decide to use complementary and alternative medicine as an alternative, rather than a complement, to conventional care? We use the example of a young child suffering from progressive glycogen storage disease, for whom liver transplant offers the only prospect of a cure. Without a liver transplant, the disease usually results in death within a few years. However, experience using transplant to treat this illness has been limited, success is far from ensured, and the risks (including death and continued progression of the disease) are substantial. The child's parents, who are first-generation immigrants, consider the risks of the transplant unjustified because it still does not offer good prospects for a healthy future. They believe that traditional Chinese medicine could help remediate their daughter's disease. In the article we (1) review parents' obligation to make treatment decisions in the best interests of their child, (2) explain limits on parents' decision-making authority, (3) explore how "best interests" are determined, focusing on cases of serious illness for which conventional treatment is risky and benefit is possible but uncertain, (4) explain the standard of care that physicians must meet in advising about treatment, and (5) outline factors that clinicians and parents should take into account when making decisions.
A "Do-Not-Attempt-Resuscitation" (DNAR)-order can be ordered for a critically ill coronary patient. One question that arises is whether the patient should be informed about the DNAR-decision? The purpose of the present study was to investigate attitudes and experiences towards DNAR-orders of nurses working in Intensive Coronary Care Units (ICCUs) in Norway.
A web-based questionnaire.
The response rate was 60% (176/295). A total of 74% of the respondents thought the patient should be informed about a DNAR-order. Given a mentally competent and conscious patient, 50% answered that they "to a relatively high" or "a very high degree" had experienced non-informed patients with a DNAR-order.
The study revealed a positive attitude among respondents to inform patients about a DNAR-order. However, one half of the respondents had experienced that this information was not given. There may be several explanations for this discrepancy. Patients are treated individually and the right to know does not mean that every patient would want to know or needs to know. The timing of the information and the opportunity to provide it can also be a problem for such critically ill patients in the ICCU.
The article is based on a structured literature review. Practicing DNR orders in Denmark has not yet been described and there are no national guidelines. Generally patients must give informed consent before do-not-resuscitate (DNR) orders. Only 32% of competent patients are involved prior to the decision even though patients wish to talk about decisions regarding the end of life . In general doctors cannot predict patients' do-not-resuscitate preferences and doctors underestimate patients' self-estimated quality of life. Doctors rarely contact the Danish Living Will Registry. Patients with do-not-resuscitate orders may be subject to other therapeutic reductions. In conclusion, patient autonomy should also be respected in the case of do-not-resuscitate orders.