Informed consent: Issues and challenges

Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant vol...

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Published in:	Journal of advanced pharmaceutical technology and research Vol. 4; no. 3; pp. 134 - 140
Main Authors:	Nijhawan, Lokesh, Janodia, Manthan, Muddukrishna, B, Bhat, K, Bairy, K, Udupa, N, Musmade, Prashant
Format:	Journal Article
Language:	English
Published:	India Medknow Publications Pvt Ltd 01.07.2013 Medknow Publications and Media Pvt. Ltd Medknow Publications & Media Pvt. Ltd Medknow Publications & Media Pvt Ltd Wolters Kluwer Medknow Publications
Subjects:	CFR Clinical trials Compensation Decision making Ethics Human subjects Informed consent Informed consent (Medical law) institutional review board Participation Psychiatry Review Studies Validity Waivers India Human subjects informed consent institutional review board
ISSN:	2231-4040, 0976-2094
Online Access:	Get full text
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Abstract	Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.
AbstractList	Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article. Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.
Audience	General
Author	Janodia, Manthan Bhat, K Udupa, N Bairy, K Musmade, Prashant Nijhawan, Lokesh Muddukrishna, B
AuthorAffiliation	Department of Advanced Pharmaceutical Studies, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India 1 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India 3 Kasturba Medical College, Manipal University, Manipal, Karnataka, India 2 Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India
AuthorAffiliation_xml	– name: 3 Kasturba Medical College, Manipal University, Manipal, Karnataka, India – name: Department of Advanced Pharmaceutical Studies, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India – name: 1 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India – name: 2 Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India
Author_xml	– sequence: 1 givenname: Lokesh surname: Nijhawan fullname: Nijhawan, Lokesh organization: Department of Advanced Pharmaceutical Studies, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka – sequence: 2 givenname: Manthan surname: Janodia fullname: Janodia, Manthan organization: Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka – sequence: 3 givenname: B surname: Muddukrishna fullname: Muddukrishna, B organization: Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka – sequence: 4 givenname: K surname: Bhat fullname: Bhat, K organization: Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka – sequence: 5 givenname: K surname: Bairy fullname: Bairy, K organization: Department of Pharmaceutical Quality Assurance, Kasturba Medical College, Manipal University, Manipal, Karnataka – sequence: 6 givenname: N surname: Udupa fullname: Udupa, N organization: Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka – sequence: 7 givenname: Prashant surname: Musmade fullname: Musmade, Prashant organization: Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/24083200$$D View this record in MEDLINE/PubMed
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StartPage	134
SubjectTerms	CFR Clinical trials Compensation Decision making Ethics Human subjects Informed consent Informed consent (Medical law) institutional review board Participation Psychiatry Review Studies Validity Waivers
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Title	Informed consent: Issues and challenges
URI	http://www.japtr.org/article.asp?issn=2231-4040;year=2013;volume=4;issue=3;spage=134;epage=140;aulast=Nijhawan;type=0 https://www.ncbi.nlm.nih.gov/pubmed/24083200 https://www.proquest.com/docview/2210973753 https://www.proquest.com/docview/1540109812 https://pubmed.ncbi.nlm.nih.gov/PMC3777303 https://doaj.org/article/71bb5a06397744c08b05a61afa2eb2d7
Volume	4
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