scholarly journals Consent in psychiatric biobanks for pharmacogenetic research

2013 ◽  
Vol 16 (3) ◽  
pp. 677-682 ◽  
Author(s):  
Frederieke H. van der Baan ◽  
Rose D. C. Bernabe ◽  
Annelien L. Bredenoord ◽  
Jochem G. Gregoor ◽  
Gerben Meynen ◽  
...  

Abstract In psychiatric practice, pharmacogenetics has the potential to identify patients with an increased risk of unsatisfactory drug responses. Genotype-guided treatment adjustments may increase benefits and reduce harm in these patients; however, pharmacogenetic testing is not (yet) common practice and more pharmacogenetic research in psychiatric patients is warranted. An important precondition for this type of research is the establishment of biobanks. In this paper, we argue that, for the storage of samples in psychiatric biobanks, waiving of consent is not ethically justifiable since the risks cannot be considered minimal and the argument of impracticability does not apply. An opt-out consent procedure is also not justifiable, since it presumes competence while the decisional competence of psychiatric patients needs to be carefully evaluated. We state that an enhanced opt-in consent procedure is ethically necessary, i.e. a procedure that supports the patients’ decision-making at the time when the patient is most competent. Nevertheless, such a procedure is not the traditional exhaustive informed consent procedure, since this is not feasible in the case of biobanking.

Author(s):  
N. V. Semenova ◽  
M. G. Yanushko ◽  
A. Iu. Iakovleva

Te procedure of obtaining the informed consent plays the crucial role in biomedical studies. Psychiatric patients refer to the vulnerable category of subjects, as there is an obvious conflict exists between the necessity of compliance to the subject’s autonomy rules and the restrictions of this autonomy caused by the illness. Schizophrenia patients suffer from cognitive dysfunction in different domains, which influence their ability to comprehend the information and to make decisions. From the other hand, arguing the appropriateness of informed consent obtaining in patients with severe mental disorders (e.g. with schizophrenia) and, thus, limitation of their ability to participate in clinical trials, can be considered as an equitable limitation of their access to the latest achievements of medical science. Potential difculties in obtaining informed consent in schizophrenia subjects can be divided into three categories: 1) subject related; 2) protocol related; 3) investigator/physician related; Both the investigators and the physicians must be acquainted with the potential ethical issues that can influence the decision making ability in schizophrenia subjects due cognitive dysfunction and the decline in subject’s autonomy level.


2019 ◽  
Vol 5 (1) ◽  
pp. 90
Author(s):  
Elly Kristiani Purwendah ◽  
Elisabet Pudyastiwi

Konvensi ini memang tidak langsung memberikan efek yang signifikan namun dengan meratifikasi konvensi ini akan memberikan pengaruh terhadap kelangsungan ekspor bahan mentah terlebih sumber daya alam seperti bahan obat-obatan, bahan pangan dan bahan lainnya yang terkontaminasi oleh bahan kimia dan pestisida berbahaya. Ratifikasi konvensi ini akan mempersempit kemungkinan menurunnya kualitas keanekaragaman hayati yang sering dimanfaatkan untuk kebutuhan hidup. Selain itu adanya konvensi ini akan mencegah munculnya masalah terhadap lapangan pekerjaan bagi pihak-pihak yang terkontaminasi limbah maupun bahan kimia dan pestisida yang berbahaya seperti para petani, nelayan dan masyarakat pada umumnya. Jika ditelaah secara mendalam jumlah ekpor pada sektor pertanian setiap tahun terus mengalami penurunan, hal ini disebabkan oleh menurunya kualitas ekosistem persawahan akibat pemakaian pestisida yang berlebihan. Kata kunci : Konvensi Rotterdam, ratifikasi, hukum lingkungan. 


2014 ◽  
Vol 98 (11) ◽  
pp. 1134-1143 ◽  
Author(s):  
Kirsten Kortram ◽  
Jeffrey A. Lafranca ◽  
Jan N.M. IJzermans ◽  
Frank J.M.F. Dor

2018 ◽  
Vol 6 (5) ◽  
pp. 13 ◽  
Author(s):  
Carlos Miguel Ferreira ◽  
Sandro Serpa

Informed consent is a critical procedure for the fulfilment of the ethical dimension in scientific research in social sciences. On the basis of a stance centred in Sociology research practices developed by the authors, this paper reflects on informed consent, its relevance in research, and procedures involved in its production and its concomitant implications. The reflection on the research process is stressed, emphasising the need to not consider the informed consent procedure as something that is fulfilled only once, but rather as something that integrates both the research process and its product and that, therefore, should be continuously considered and assessed throughout research.


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