Laboratory ethics concerns the pre-analytical, analytical, and post-analytical phases. If lab personnel are involved in sampling of specimens, informed consent must be obtained, and samples must be taken as noninvasively as possible to protect patient autonomy and well-being. Analyzing only suitable and intact specimens, adhering to testing standards, and avoiding any manipulation are elements of professional conduct that are based on ethical demands to ensure scientific integrity and fairness. Transparency with regard to possible errors, assisting in the interpretation of results, complying with data protection requirements, and proper handling of sample remains safeguard informed consent and privacy and contribute to proper patient care. With regard to research involving humans, ethical requirements are assessed by an ethics committee. The protocol should describe, for example, the aims of the study, methods, and exclusion and inclusion criteria, as well as procedures participants are subjected to and procedures in case of incidental findings. Information for potential study participants must be presented in a form and at a level of detail that allows participants to understand all the facts relevant to them. The written informed consent documents should be used in addition to oral conversation on study aims and burdens and risks with potential study participants.

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The Biomedical Lab, Ethics, and Obtaining Ethics Approval for Research

  • Joachim Boldt,
  • Dominik Koesling

摘要

Laboratory ethics concerns the pre-analytical, analytical, and post-analytical phases. If lab personnel are involved in sampling of specimens, informed consent must be obtained, and samples must be taken as noninvasively as possible to protect patient autonomy and well-being. Analyzing only suitable and intact specimens, adhering to testing standards, and avoiding any manipulation are elements of professional conduct that are based on ethical demands to ensure scientific integrity and fairness. Transparency with regard to possible errors, assisting in the interpretation of results, complying with data protection requirements, and proper handling of sample remains safeguard informed consent and privacy and contribute to proper patient care. With regard to research involving humans, ethical requirements are assessed by an ethics committee. The protocol should describe, for example, the aims of the study, methods, and exclusion and inclusion criteria, as well as procedures participants are subjected to and procedures in case of incidental findings. Information for potential study participants must be presented in a form and at a level of detail that allows participants to understand all the facts relevant to them. The written informed consent documents should be used in addition to oral conversation on study aims and burdens and risks with potential study participants.