PMC:3897848 / 10825-13192
Annnotations
{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/3897848","sourcedb":"PMC","sourceid":"3897848","source_url":"https://www.ncbi.nlm.nih.gov/pmc/3897848","text":"Bioethics and Safety in Biobanks\nInformed consent is getting a patient to sign a written consent form and is the process of communication between a patient and a medical doctor. In medical diagnosis and treatment, including invasive procedures, a doctor or a researcher must give sufficient information to the patient. Informed consent can be given based on a clear understanding of the process, implications, and consequences of an action. The consent process should include sufficient explanation about how individual information would be handled [18]. The consent process includes the impact of research results on the lives of participants, their families, and their communities [19]. Explanations should be on confidentiality, participants' rights of withdrawal, and specifications [20].\nDue to the difficulties of securing specific informed consent, broad consent is a more general form of consent in which individuals agree to have their biosamples and personal information collected and stored in the biobank and for future, unspecified research [21]. Further issues have been discussed recently, such as privacy, confidentiality and data protection, controlling data access, accessibility to biospecimens, benefit sharing, commercialization, intellectual property rights, and genetic discrimination [22].\nIn order to ensure bioethics and bioethical safety in the life sciences and biotechnologies, each of the institutions should set up its own Institutional Review Board (IRB). When a genetic testing or research institution obtains written informed consent from a test subject concerning the use of specimens for research purposes, it may provide the specimens to either a person conducting research on genes or an institution licensed to open a biobank in Korea [1].\nIn Korea, the Bioethics and Safety Act was completely revised to reinforce research ethics, including biobanks, and the law took effect in 2013. The number of biobanks within university-affiliated hospitals will increase. This law encourages biobanks to strengthen ethical use of biospecimens, and the law assesses biobanks' responsibility to obtain informed consent from donors and is supervised by the IRB. The law also encourages individual researchers to deposit and use biospecimens at any biobank instead of collecting their own sample collection and distribution processes [1, 14].","divisions":[{"label":"Title","span":{"begin":0,"end":32}}],"tracks":[{"project":"2_test","denotations":[{"id":"24465232-21190750-44839999","span":{"begin":550,"end":552},"obj":"21190750"},{"id":"24465232-20346094-44840000","span":{"begin":684,"end":686},"obj":"20346094"},{"id":"24465232-19888293-44840001","span":{"begin":788,"end":790},"obj":"19888293"},{"id":"24465232-18087293-44840002","span":{"begin":1309,"end":1311},"obj":"18087293"},{"id":"24465232-24159540-44840003","span":{"begin":2363,"end":2365},"obj":"24159540"}],"attributes":[{"subj":"24465232-21190750-44839999","pred":"source","obj":"2_test"},{"subj":"24465232-20346094-44840000","pred":"source","obj":"2_test"},{"subj":"24465232-19888293-44840001","pred":"source","obj":"2_test"},{"subj":"24465232-18087293-44840002","pred":"source","obj":"2_test"},{"subj":"24465232-24159540-44840003","pred":"source","obj":"2_test"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"2_test","color":"#93ece5","default":true}]}]}}