Language:

Ethics review in compassionate use

BMC medicine, 2017-07, Vol.15 (1), p.136-136, Article 136 [Peer Reviewed Journal]

COPYRIGHT 2017 BioMed Central Ltd. ;COPYRIGHT 2017 BioMed Central Ltd. ;Copyright BioMed Central 2017 ;The Author(s). 2017 ;ISSN: 1741-7015 ;EISSN: 1741-7015 ;DOI: 10.1186/s12916-017-0910-9 ;PMID: 28735571

Full text available

Citations Cited by

Actions
1. Add to My Research
2. Remove from My Research
3. E-mail
4. Print
5. Permalink
6. Citation
7. EasyBib
8. EndNote
9. RefWorks
10. Delicious
11. Export RIS
12. Export BibTeX

Title:
Ethics review in compassionate use
Author: Borysowski, Jan ; Ehni, Hans-Jörg ; Górski, Andrzej
Subjects: Biomedical Research ; Cancer ; Care and treatment ; Clinical medicine ; Clinical trial ; Clinical trials ; Committees ; Compassionate use ; Compassionate Use Trials - ethics ; Councils ; Criteria ; Drug addiction ; Drugs ; Ethical Review ; Ethical standards ; Ethics ; Ethics committees ; Ethics Committees, Research ; Ethics, Research ; Expanded access ; Forecasts and trends ; Humans ; Informed Consent ; Institutional review board ; International organizations ; Laws, regulations and rules ; Medical ethics ; Medical personnel ; Medical research ; Opinion ; Patient Selection ; Patients ; Pharmaceutical industry ; Physicians ; Powers and duties ; Regulations ; Research ethics committee ; Safety
Is Part Of: BMC medicine, 2017-07, Vol.15 (1), p.136-136, Article 136
Description: Compassionate use is the use of unapproved drugs outside of clinical trials. So far, compassionate use regulations have been introduced in the US, Canada, many European countries, Australia and Brazil, and treatment on a compassionate use basis may be performed in Japan and China. However, there are important differences between relevant regulations in individual countries, particularly that approval by a research ethics committee (institutional review board) is a requirement for compassionate use in some countries (e.g. the US, Spain, and Italy), but not in others (e.g. Canada, the UK, France, and Germany). The main objective of this article is to present aspects of compassionate use that are important for the discussion of the role of research ethics committees in the review of compassionate use. These aspects include the nature of compassionate use, potential risks to patients associated with the use of drugs with unproven safety and efficacy, informed consent, physicians' qualifications, and patient selection criteria. Our analysis indicates that the arguments for mandatory review substantially outweigh the arguments to the contrary. Approval by a research ethics committee should be obligatory for compassionate use. The principal argument against mandatory ethical review of compassionate use is that it is primarily a kind of treatment rather than biomedical research. Nonetheless, compassionate use is different from standard clinical care and should be subject to review by research ethics committees. First, in practice, compassionate use often involves significant research aspects. Second, it is based on unapproved drugs with unproven safety and efficacy. Obtaining informed consent from patients seeking access to unapproved drugs on a compassionate use basis may also be difficult. Other important problems include the qualifications of the physician who is to perform treatment, and patient selection criteria.
Publisher: England: BioMed Central Ltd
Language: English
Identifier: ISSN: 1741-7015
EISSN: 1741-7015
DOI: 10.1186/s12916-017-0910-9
PMID: 28735571
Source: GFMER Free Medical Journals
MEDLINE
PubMed Central
Springer Nature OA/Free Journals
ROAD: Directory of Open Access Scholarly Resources
ProQuest Central
DOAJ Directory of Open Access Journals

Back to results list


INSPIRE LIBRARY - TON DUC THANG UNIVERSITY	(84-028) 37 755 057	Feedback
19 Nguyen Huu Tho St. Dist.7, HCM	thuvien@tdtu.edu.vn	Feedback

Ethics review in compassionate use

COPYRIGHT 2017 BioMed Central Ltd. ;COPYRIGHT 2017 BioMed Central Ltd. ;Copyright BioMed Central 2017 ;The Author(s). 2017 ;ISSN: 1741-7015 ;EISSN: 1741-7015 ;DOI: 10.1186/s12916-017-0910-9 ;PMID: 28735571

Searching Remote Databases, Please Wait