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In this article, we will briefly review the legal and ethical issues pertaining to recruitment of human subjects, basic principles of informed consent and precautions to be taken during data and clinical research publications.
Legal and ethical issues in research.
Where identifying information is essential for scientific purposes (clinical photographs written informed consent must be obtained and the patient must be shown the manuscript before publication. Benefits in cash or in kind? Somali bride and groom, monica and Kuldip's Traditional Wedding.
5 Source documents (containing trial data) and clinical study report (results and interpretation of trial) form part of the essential documentation that must be retained for a length of time prescribed by the applicable local legislation. Updated on 2016 Apr 26; cited on 2016 Aug. 3 rd Revised Edition.
Scott-Lichter D, the Editorial Policy Committee, Council of Science Editors.
4 Sponsors of clinical trials must allow all study investigators and manuscript authors access to the full study data set and the right to use all study data for publication. 1 The potential subjects must be informed of the right to refuse to participate or withdraw consent to participate at any time without reprisal and without affecting the patient-physician relationship.
Duplicate and salami publications. 11 The Guidelines for GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials.
Pediatr Clin N Am 2008;55:187-209. Data Protection Act United Kingdom monograph on the Internet.
The purpose of a clinical research is to systematically collect and analyse data from which conclusions are drawn, that may be generalisable, so as to improve the clinical practice and benefit patients in future.
Special case: Emergency research Emergency research studies occur where potential subjects are incapacitated and unable to give informed consent (acute head trauma, cardiac arrest). This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct.
How to cite this URL: Yip C, Han NLR, Sng. 18 Those who have contributed to the work but do not meet all four criteria should be acknowledged; some of these activities include provision of administrative support, writing assistance and proofreading.
Sharing clinical trial data: A proposal from the international committee of medical journal editors. Green and white blindian wedding party.
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International Ethical Guidelines for Biomedical Research Involving Human Subjects.