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Chapter-11 Ethical and Legal Issues in Research and Publication

BOOK TITLE: Medical Writing: A Guide for Medicos, Educators and Researchers

Author
1. Mahanta Putul
2. Yadav Mukesh
ISBN
9789352701810
DOI
10.5005/jp/books/14183_12
Edition
1/e
Publishing Year
2018
Pages
23
Author Affiliations
1. Tezpur Medical College, Tezpur, Assam, India
2. Journal of Indian Academy of Forensic Medicine; School of Medical Sciences and Research, Sharda University, Greater Noida, Uttar Pradesh, India, School of Medical Sciences and Research, Sharda University, Greater Noida, Uttar Pradesh, India, All India Institute of Medical Sciences, New Delhi, India, Rama Medical College, Hapur, Uttar Pradesh, India
Chapter keywords
Ethical issue, legal issue, research ethics, ethical principle, Indian Medical Council Regulations, clinical drug trial, ethical research, ethical guideline, biomedical research, Institutional Ethics Committee, terms of reference, review procedure, general principle, specific principle

Abstract

The chapter focusses on ethical and legal issues in research and publication. It covers a range of topics related to research ethics involving human participant, ethical principles of research, why ethics are important, history and background of ethics in research, recent international documents on ethics, the Indian Medical Council regulations, clinical drug trial and legal issues, principles in ethical research, ethical guidelines for biomedical research with its issues and features, Institutional Ethics Committee, terms of reference, review procedures, statement of general principles, and statement of specific principles. Statement of general principles enlists principles of essentiality, principles of voluntariness, informed consent and community agreement, principles of nonexploitation, principles of privacy and confidentiality, principles of precaution and risk minimization, principles of professional competence, principles of accountability and transparency, principles of the maximization of the public interest and of distributive justice, principles of institutional arrangements, principles of public domain, principles of totality of responsibility, and principles of compliance.

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