Legal Surrogate Research Articles

Consent and anonymization in research involving biobanks: differing terms and norms present serious barriers to an international framework.

Biological samples—such as tissues, blood and cells—are an increasingly important tool for research into human diseases and their genetic and physiological causes. To ease their storage and access, many of these samples are now stored in biobanks. The number of human biological samples in such collections amounted to several hundred million in 1999 in the USA alone—about one sample per US citizen (Eiseman, 2000; Azarow et al , 2003)—and is increasing rapidly. Three‐quarters of the clinical trials that drug companies submit to the US Food and Drug Administration (Rockville, MD, USA) for approval now include a provision for sampling and storing human tissue for future genetic analysis (Abbott, 2003). At the same time, there is a boom of population biobanks, as more and more countries establish new sample collections (Kaiser, 2002). Among the best known are: the Icelandic Health Sector Database; the Estonian Genome Project; the UK Biobank; the CARTaGENE Project in Quebec, Canada; the Banco Nacional de ADN in Spain; the International HapMap Project; and several US biobanks, such as the National Children's Study, the Marshfield Clinic's Personalized Medicine Research Project and the National Health and Nutrition Examinations Surveys. ![][1] This boom of biobanks has spawned a ‘boomlet’ of regulations and guidelines, which has created controversies, particularly about the importance and definition of informed consent. The consent of participants is usually required before biobank samples can be used in research, but the nature of this consent, and how it is obtained, vary widely. Many European guidelines take the view that general consent is acceptable to use samples for future, as yet unspecified, research projects; US and Canadian policy follows a more rigorous standard of consent. Until 2004, both Europe and the USA considered coded and linked anonymized samples—in which a code links the sample to its donor—as identifiable and therefore … [1]: /embed/graphic-1.gif

Psychological factors in gastro-oesophageal reflux disease.

<h3>Summary</h3> When critically ill neurologic patients are cognitively incapacitated, decisions about treatment options are delegated to surrogates, usually family members. We conducted qualitative interviews with 20 Dutch neurologists and residents in neurology varying in age, work experience, and workplace to investigate how they involve their patients9 family members in decision-making. Their reports revealed that they ascribed 3 different, yet tightly interwoven roles to families: (1) informants about values and preferences of patients, (2) participants in care and care planning, and (3) sufferers themselves. Neurologists regarded decision-making as an integral part of end-of-life care rather than an isolated process, changing the meaning of what decision-making entails. All different roles of family members were important in end-of-life care and decision-making, instead of the single one of legal surrogate. Neurologists need to support family members in these various roles.

Withdrawing life support. How is the decision made?

Withholding and withdrawal of life support in intensive care units (ICUs) has become the norm rather than the exception in the United States since the mid 1980s. 1,2 We are all familiar with the tremendous impact of the Karen Ann Quinlan case in 1976, the report of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in 1983, and the subsequent flurry of position statements from a multitude of individuals and professional organizations (for example, the American Thoracic Society) underscoring the fundamental right of patients or legal surrogates to refuse unwanted medical therapies. 3-5 Several clinical studies during the past few years have revealed that 40% to 65% of ICU deaths have been preceded by decisions to withhold or withdraw life support. In some cases, the percentage is even higher. 6,7 Health care professionals are responsible for informing patients, families, and surrogates about