Ethics and clinical research.

This is the third version in the series of biomedical-research ethical guidelines issued by CIOMS since 1982. The members of redrafting group come from Africa, Asia, Latin America, Europe and Latin America, the United States and the CIOMS secretariat. Its core consists of 21 guidelines with commentaries. Like those of 1982 and 1993, the 2002 CIOMS guidelines are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects, applying ethical standards in local circumstances, and establishing or improving ethical review mechanisms.

International ethical guidelines for biomedical research involving human subjects

Aim
To systematically assess the existing literature on ethical aspects of human biobanks.

/pdf/ethical-aspects-of-human-biobanks-a-systematic-review-5cu5v9mli7.pdf

Ethical aspects of human biobanks: a systematic review.

The development of biomedical science requires the creation of biological material collections that allow for the search and discovery of biomarkers for pathological conditions, the identification of new therapeutic targets, and the validation of these findings in samples from patients and healthy people. Over the past decades, the importance and need for biobanks have increased considerably. Large national and international biorepositories have replaced small collections of biological samples. The aim of this work is to provide a basic understanding of biobanks and an overview of how biobanks have become essential structures in modern biomedical research.

/pdf/biobanks-a-platform-for-scientific-and-biomedical-research-znq3sntkbo.pdf

Biobanks-A Platform for Scientific and Biomedical Research.

Pharmacogenomics has an important role in the evolution of personalized medicine, and its wide- spread uptake may ultimately depend on the interests and perspectives of key players in health care. Our aim was to summarize studies on stakeholder perspectives and attitudes toward pharmacogenomic testing. Thus, we conducted a review of original research studies that reported stakeholder views on pharmacogenomic testing using a structured approach in PubMed, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature, and EMBASE. A standardized data abstraction form was developed that included stakeholder group of interest—patients, general public, providers, and payers. Stakeholder views regarding barriers to pharmacogenetic implementation were organized into the following themes: ancillary information-related, clinical, economic, educa- tional, ethical or legal, medical mistrust, and practicality. Of 34 studies that met our inclusion criteria, 37 perspectives were reported (15 on providers, 9 on the general public, 9 on patients, and 4 on pay- ers). The most common topics that arose in studies of providers related to clinical usefulness of genetic data (n=11) and educational needs (n=11). Among the general public, the most common con- cerns were medical mistrust (n=5), insufficient education (n=5), and practicality (n=5). The most pre- valent issues from the patient perspective were ethical or legal (n=6) and economic (n=5) issues. Among payers, leading issues were practicality (n=4) and clinical usefulness (n=3). There was overlap in the topics and concerns across stakeholder perspectives, including lack of knowledge about phar- macogenomic testing. Views on issues related to privacy, cost, and test result dissemination varied by stakeholder perspective. Limited research had been conducted in underrepresented groups. Efforts to address the issues raised by stakeholders may facilitate the implementation of pharmacogenomic test- ing into clinical practice.

Stakeholder views on pharmacogenomic testing.

Pharmacogenomics: Dont Forget the Children

Background: This paper presents the results of an exploratory qualitative study that assesses Canadian pediatric researchers’ perceptions of a pre-selected group of ethical issues r

/pdf/researchers-perceptions-of-the-ethical-implications-of-27ou1vl8w2.pdf

Researchers' perceptions of the ethical implications of pharmacogenomics research with children.

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Pharmacogenomics: Dont Forget the Children

Researchers' perceptions of the ethical implications of pharmacogenomics research with children.