Mats G. Hansson

Should donors be allowed to give broad consent to future biobank research

Large international biobank studies can make substantial contributions to scientific research by validation of the biological importance of previous research and by identification of previously unknown causes of disease. However, regulations for patient consent that are too strict and discrepancies in national policies on informed consent might hinder progress. Therefore, establishment of common ground for ethical review of biobank research is essential. In this essay, broad consent is defined on a scale between strictly specified (eg, for a specific study) and blanket consent (ie, with no restrictions regarding the purpose of the research). Future research includes that which might not be planned or even conceptualised when consent is obtained. In conclusion, broad consent and consent for future research are valid ethically and should be recommended for biobank research provided that: personal information related to research is handled safely; donors of biological samples are granted the right to withdraw consent; and new research studies or changes to the legal or ethical authority of a biobank are approved by an ethics-review board.

Ethical framework for previously collected biobank samples

973 criterion in the GM301 trial3 of Genasense plus dacarbazine versus dacarbazine alone in advanced melanoma because it is the best known prognostic marker in this disease. Unfortunately, the substantial therapeutic accomplishments of Genasense in a randomized, global, 771-patient trial in advanced melanoma (and specifically among 508 patients with a normal baseline LDH level, which showed statistically significant benefits in survival (P = 0.018), progression-free survival (P = 0.0007) and response rate (P = 0.009)) were ignored by Potera in favor of open-label, preliminary, phase 2 human data, and an additional single data set that involved antisense therapeutics in sick penguins. The most accurate assessment of the current situation in oligonucleotide therapeutics in Potera’s article came from John Rossi, who stated that “There’s a place for RNAi and antisense.” I hope that Potera takes careful note of this opinion, especially with respect to human cancer, and most importantly, that she takes greater care in her reporting of facts and their assessment. Readers should note that although I am not a Genta stockholder and have no contractual relationships with the company, I was formerly a member of their scientific advisory board (but have not been since 2005).

Coping style, psychological distress, risk perception, and satisfaction in subjects attending genetic counselling for hereditary cancer

It has been known for some time that cancer is more common in some families than in others.1 The rapid development of human genetics research has shown two highly penetrant breast and ovarian cancer susceptibility genes, BRCA1 and BRCA2 .2,3 Approximately 5% of all breast cancers are the result of inherited genetic mutations of these genes.4 Among colorectal cancers, between 2 and 10% are the result of known genetic mutations.5 The most common genetic mutations are located in the APC gene, which causes familial adenomatous polyposis (FAP) and in the DNA mismatch repair genes, predisposing to hereditary non-polyposis colorectal cancer (HNPCC). However, the genetic mutations are still unknown in a large number of families with hereditary breast and colorectal cancers. As a result of the recent developments in DNA testing and the knowledge that cancer can be hereditary, it is now possible to offer genetic counselling to people within identified “cancer families”, and to inform them about their assumed increased risk for developing cancer. One of the most important components in genetic counselling is the provision of information. Extensive research was performed early on principles for providing patient information in a general medical setting.6 This type of information is usually fairly simple and concerns mainly the patient him/herself. In contrast, the information in genetic counselling is often highly complex, including risk estimates and aspects of heredity involving family members. The recall of risk estimates after counselling among women with a family history of cancer has been found to be poor.7,8 Studies have been performed of the psychological impact of informing subjects about their risk for developing hereditary cancer,9 showing that their psychological reactions are not related directly to the risk estimates.10,11 In subjects who were DNA tested for Huntington’s …

Patients’ refusal to consent to storage and use of samples in Swedish biobanks: cross sectional study

Objectives To estimate how many people object to storage of biological samples collected in health care in Sweden and to their use in research and how many withdraw previous consent. Design Cross sectional study of register data. Setting Biobanks used in Swedish health care, 2005-6. Population Data on refusal to consent were obtained for 1.4 million biobank samples per year from 20 of 21 counties. Main outcome measures Rates of preliminary refusal to consent, confirmed refusal, and withdrawal of consent. Results Patients refused consent to either storage or use of their samples in about 1 in 690 cases; about 1 in 1600 confirmed their decision by completing a dissent form. Rather than having the samples destroyed, about 1 in 6200 patients wanted to restrict their use. Of those who had previously consented, about 1 in 19 000 withdrew their consent. Conclusions Refusal to consent to biobank research in Sweden is rare, and the interests of individuals and research interests need not be at odds. The Swedish healthcare organisation is currently obliged to obtain either consent or refusal to each potential use of each sample taken, and lack of consent to research is used as the default position. A system of presumed consent with straightforward opt out would correspond with people’s attitudes, as expressed in their actions, towards biobank research.

For the safety and benefit of current and future patients.

Pathology biobanks are vital assets for medical care and treatment of current and future patients. In association with good clinical data they are also useful for biomedical research regarding the underlying mechanisms of human disease. Recent regulations have suggested the obtainment of a specific and explicit informed consent as a prerequisite for using human tissue samples with these ends in mind. However, the choice and strict use of informed consent for balancing conflicting interests associated with biobank-related research can in practice be detrimental to patient safety with regard to diagnosis, medical care and treatment. In this article I argue that a ‘safety principle’ should have priority and suggest how this could be implemented in clinical practice and in association with biomedical research.

Ethics Takes Time - But not That Long

BackgroundTime and communication are important aspects of the medical consultation. Physician behavior in real-life pediatric consultations in relation to ethical practice, such as informed consent (provision of information, understanding), respect for integrity and patient autonomy (decision-making), has not been subjected to thorough empirical investigation. Such investigations are important tools in developing sound ethical praxis.Methods21 consultations for inguinal hernia were video recorded and observers independently assessed global impressions of provision of information, understanding, respect for integrity, and participation in decision making. The consultations were analyzed for the occurrence of specific physician verbal and nonverbal behaviors and length of time in minutes.ResultsAll of the consultations took less than 20 minutes, the majority consisting of 10 minutes or less. Despite this narrow time frame, we found strong and consistent association between increasing time and higher ratings on all components of ethical practice: information, (β = .43), understanding (β = .52), respect for integrity (β = .60), and decision making (β = .43). Positive nonverbal behaviors by physicians during the consultation were associated particularly with respect for integrity (β =.36). Positive behaviors by physicians during the physical examination were related to respect for childrens integrity.ConclusionTime was of essence for the ethical encounter. Further, verbal and nonverbal positive behaviors by the physicians also contributed to higher ratings of ethical aspects. These results can help to improve quality of ethical practice in pediatric settings and are of relevance for teaching and policy makers.

Commentary: isolated stem cells--patentable as cultural artifacts?

This article argues that an isolated embryonic stem cell basically represents a cultural artifact that has no equivalent to cells of the embryo, and that it is likely that the isolation of adult stem cells has a similar consequence. An isolated stem cell could thus be distinguished as something other than the stem cell existing as part of a human body. Since isolation of stem cells implies modification, product patents should, where the results carry enough novelty, inventive step, and potential for industrial application, as a matter of principle be a viable option for patent authorities. Questions of morality, which may affect the patentability, should also be viewed in light of the distinction between isolated result and body part. At the same time, it is essential that patent authorities do not accept broad patent claims that will be detrimental to research.

The use of human tissue in epidemiological research; ethical and legal considerations in two biobanks in Belgium

This paper discusses the legal implications of setting up two new biobanks in Belgium. The first is hospital-based and will archive tissue from patients with haematologic cancer, whereas the second is linked to a general practice based morbidity registry and will involve storage of blood samples. To date, Belgium has no specific legislation that regulates storage of human tissue and related databases. Several issues concerning the protection of individuals with regard to the processing of personal medical data are discussed from the existing privacy legislation. We will address the principle of consent (broad versus specific) and the type of data recorded (anonymous, encoded and identifiable) for both biobanks.

Living with Multiple Endocrine Neoplasia Type 1: Decent Care-Insufficient Medical and Genetic Information A Qualitative Study of MEN 1 Patients in a Swedish Hospital

This qualitative study explores how 29 Swedish patients with Multiple Endocrine Neoplasia type 1 (MEN1) experience living with the condition, appraisal of the clinical follow-up program, and surveys their future expectations. The aim of this study is to build knowledge about this patient group in order to provide optimal care. The participants describe physical, psychological, and social limitations in their daily activities and how these limitations influence quality of life. Our findings indicate that a majority of patients have adjusted to their situation, describing themselves as being healthy despite physical symptoms and treatment. The participants received decent care in the clinical follow-up program, - however, greater effort should be put into patient information. These patients might benefit from genetic counseling. Health professionals involved should recognize their potential impact and influence on a patient’s ability to adjust to these circumstances. Antonovsky`s Sense of Coherence theory is used to discuss these findings.