There is scarce information in literature about the decisions made by ethics committees concerning the clinical studies they have reviewed. A retrospective, detailed review of 666 applications, their amendments and the ethics committees' statements was undertaken. All protrocols of clinical studies on medicinal products submitted to and reviewed by the ethics committees of two university hospitals during the years 1992, 1994, 1996 and 1998 were investigated. Most of the studies were international (50%), multicenter (71%), phase III trials (41%) on a new clinical entity, (38%). Validity of the clinical drug study applications was acceptable in more than half of the cases (364; 55%), while 91 (14%) were approved with advisory comments, 153 (23%) had to be amended, 35 (5%) were left pending and 23 (3%) were rejected. Most of the questions pertained to informed consent and the study protcol. In accordance with precious results, our findings support the opinion that the submitted documents need to be improved, especially with regard to informed consent and study protocols, in order to gain better Good Clinical Practice (GCP) compliance. Well-defined, documented operating procedures of the ethics committees would have facilitated the practical issues in the review process.
This decade is witnessing the proliferation of large-scale population-based biobanks. Many biobanks have reached the stage of offering access to their collection of data and samples to the scientific community. This, however, requires that access arrangements be established to govern the relationship between biobanks and users. Access arrangements capture the convergence of all normative elements in the life cycle of a biobank: policies, laws, common practices, commitments made by the biobank to participants, the expectations of funders, and the needs of the scientific community. Furthermore, access arrangements shape new legal agreements between 'biobankers' and researchers to ensure appropriate, regulated and efficient use of biobank materials. This paper begins by examining the particularities of access arrangements, identifying the key elements of these new regulatory instruments. Second, the paper looks at various strategies used by biobanks to regulate access and surveys the underlying motivations of these strategies and the impact they can have on potential international collaboration. Third, an example of the challenges encountered in creating access policy is illustrated using the case of CARTaGENE, a biobank based in Montreal, Canada. Last, the paper presents how Public Population Project in Genomics (P(3)G) facilitates the work of biobankers and improves collaboration throughout the international human genomics research community.
BACKGROUND: The aim of this study was to describe the kinds of ethical dilemmas surgeons face during practice. METHODS: Five male and five female surgeons at a University hospital in Norway were interviewed as part of a comprehensive investigation into the narratives of physicians and nurses about ethically difficult situations in surgical units. The transcribed interview texts were subjected to a phenomenological-hermeneutic interpretation. RESULTS: No gender differences were found in the kinds of ethical dilemmas identified among male and female surgeons. The main finding was that surgeons experienced ethical dilemmas in deciding the right treatment in different situations. The dilemmas included starting or withholding treatment, continuing or withdrawing treatment, overtreatment, respecting the patients and meeting patients' expectations. The main focus in the narratives was on ethical dilemmas concerning the patients' well-being, treatment and care. The surgeons narrated about whether they should act according to their own convictions or according to the opinions of principal colleagues or colleagues from other departments. Handling incompetent colleagues was also seen as an ethical dilemma. Prioritization of limited resources and following social laws and regulations represented ethical dilemmas when they contradicted what the surgeons considered was in the patients' best interests. CONCLUSION: The surgeons seemed confident in their professional role although the many ethical dilemmas they experienced in trying to meet the expectations of patients, colleagues and society also made them professionally and personally vulnerable.