79C3C34C52B45572883A05D425EB0F82
V-4, Decree on the Request to Issue Approval to Conduct Biomedical Research, the Application Form and the Biomedical Research Ethical Assessment Form (2016)
https://leaux.net/URLS/General/Lithuania_V-4_Decree_on_the_Request_to_Issue_Approval_to_Conduct_Biomedical_Research_the_Application_Form_and_the_Biomedical_Research_Ethical_Assessment_Form_2016.pdf
http://leaux.net/URLS/ConvertAPI Text Files/D169D1163A29C567CE6B8576E36A0213.en.txt
Examining the file media/Synopses/D169D1163A29C567CE6B8576E36A0213.html:
This file was generated: 2020-12-01 07:06:58
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): must submit documents, the lists of which are approved by the Minister of Health.
p.(None): 2. At the meeting of the Biomedical Research Expert Group of the Lithuanian Bioethics Committee, the documents that
p.(None): received no later than twenty working days before the scheduled meeting date. Documents shall be considered at the meeting if:
p.(None): the sponsor, his authorized representative, or the principal investigator provided all relevant information to the Minister of Health
p.(None): the documents specified in the approved list and executed in accordance with the requirements specified in Paragraph 4 of this Description of the Procedure.
p.(None): 3. Information on the dates of the next meetings shall be published on the website of the Lithuanian Bioethics Committee.
p.(None): The sponsor, his authorized representative or the principal investigator shall also have the right to know the information of the next of kin
p.(None): dates of meetings in the Lithuanian Bioethics Committee (Vilniaus St. 16, LT-01402, Vilnius) or by phone (8 ~ 5) 212 45 65).
p.(None): 4. All documents submitted must be signed and copies of the documents submitted must be certified
p.(None): notary or person (s) signing the application. Application for Biomedical Research and Biomedical Research Ethics
p.(None): the evaluation questionnaire, as well as the ethical evaluation questionnaire of the Clinical Medicinal Product Investigation
p.(None): each principal investigator individually.
p.(None): 5. The signatory of the application and the documents (annexes to the application) are responsible for the authenticity of the submitted documents.
p.(None): the person (s) who submitted it.
p.(None): 6. In cases where the opinion of the regional ethics committee (s) for biomedical research is required, the Lithuanian
p.(None): additional sets of required documents (originals or copies) shall be submitted to the Bioethics Committee for
p.(None): Regional Ethics Committee (s) for Biomedical Research and, where
p.(None): the conclusion of the Service for Health Care Activities under the Ministry of Health - additional required
p.(None): a set of documents (originals or copies) for State accreditation of health care activities
p.(None): service under the Ministry of Health.
p.(None): Item changes:
p.(None): No. V-3, 15/01/2016, published in TAR 2016-01-19, i. k. 2016-01180
p.(None): 7. Documents shall be submitted to the Lithuanian Bioethics Committee by applying directly to the Lithuanian Bioethics Committee
p.(None): (Vilniaus St. 16, LT-01402, Vilnius) at the time set by the Lithuanian Bioethics Committee, which can be found by phone (8 ~ 5)
p.(None): 212 45 65, electronically via the public electronic services portal (Electronic Government Gateway Internet
p.(None): website www.epaslaugos.lt) or remotely (by sending an e-mail, signing a secure e-mail
p.(None): signature, post or courier).
p.(None): Item changes:
p.(None): No. V-3, 15/01/2016, published in TAR 2016-01-19, i. k. 2016-01180
p.(None): Changes:
p.(None): 1.
p.(None): Lithuanian Bioethics Committee, Order
p.(None): No. V-3, 15/01/2016, published in TAR 2016-01-19, i. k. 2016-01180
p.(None): Regarding the Director of the Lithuanian Bioethics Committee in 2014. 31 December order no. V-24 βββOn the Documents You Have
p.(None): submitted by the client of a clinical trial of a medicinal product or another biomedical study, authorized by him
p.(None): representative or principal investigator to obtain approval for a clinical trial of a medicinal product
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| opinion | philosophical differences/differences of opinion |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
Applicable Type / Vulnerability / Indicator Overlay for this Input