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What is Informed Consent

Chapter 9
Ethics in Research Practice and Innovation
a process of providing the participants in the research with all the necessary information in order to deliberate and voluntarily decide to participate or not in the research, and/or to withdraw from the research. Informed consent is expressed by signing a document containing all that information agreed upon, called “informed consent form”.
Published in Chapter:
Informed Consent in Research Involving Human Subjects
Antonio Sandu (University of Suceava, Romania & LUMEN Research Center in Social and Humanistic Sciences, Romania) and Ana Frunza (LUMEN Research Center in Social and Humanistic Sciences, Romania)
Copyright: © 2019 |Pages: 21
DOI: 10.4018/978-1-5225-6310-5.ch009
Abstract
Informed consent (IC) in research is a key element in ensuring the ethical character of any research involving human subjects, either bio-medical or psychosocial. IC involves three elements: validity, communication of information, and deliberation. Obtaining IC is a dynamic process of ethical reflection in order to facilitate the expression of autonomy of the subject involved in research. The process of obtaining the IC must be accompanied by the administrative procedure for completing a consent form signed by both the participant and the researcher. If the participant cannot sign—either because he is a minor or because of the medical condition—a delegated consent signed by the legal representatives of the subject is required.
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Chapter 31
Predictive Genetic Testing,Uncertainty, and Informed Consent
Informed consent is a “special kind of autonomous action: an autonomous authorization by a patient or subject” ( Faden & Beauchamp, 1986 , 274). Although informed consent also has to do with legal or institutional procedures through which effective authorization is obtained, it should not be reduced to mere formal procedures. In fact, moral acceptability of procedures must depend on the extent “to which they serve to maximize the likelihood that the conditions of an autonomous authorization will be satisfied” ( Faden & Beauchamp, 1986 , 294).
Published in Chapter: Predictive Genetic Testing,Uncertainty, and Informed Consent; From: Handbook of Research on Technoethics
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Chapter 8
Ethical Principles, Challanges, and Methodological Issues in Cross-Cultural Research: Implementations, Examples, and Recommendations
Pertains to the involvement of participants in the research process under ethical guidelines that remain consistent.
Published in Chapter: Ethical Principles, Challanges, and Methodological Issues in Cross-Cultural Research: Implementations, Examples, and Recommendations; From: Methodologies and Ethics for Social Sciences Research
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Chapter 7
Addressing Research Ethics in Clinical Trials in Four of the Former Communist European Countries: A Shared Responsibility
Term used for medical treatment but also in research- refers to an autonomous authorization (respect for persons, autonomy, liberty interests) and to social rules of consent (i.e., consent for minors, witnesses); in essence has to disclose the nature of the proposed intervention, procedures and alternatives, potential risks and benefits, assurance that participation is voluntary, and protection of confidentiality, all concisely explained and written in a document understandable by a person with basic education.
Published in Chapter: Addressing Research Ethics in Clinical Trials in Four of the Former Communist European Countries: A Shared Responsibility; From: Ethics in Research Practice and Innovation
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Chapter 12
Ethical Issues in Couple and Family Research and Therapy
The permission that is given by the client or by the participant before a therapeutic process or a research.
Published in Chapter: Ethical Issues in Couple and Family Research and Therapy; From: Ethics in Research Practice and Innovation
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Chapter 4
Ethical Issues in Research Conducted With the Participation of Children
Informed consent is an agreement that includes informing participants about the research, ensuring that they understand the research, and explaining any possible risks ( Coyne et al., 2009 ).
Published in Chapter: Ethical Issues in Research Conducted With the Participation of Children; From: Methodologies and Ethics for Social Sciences Research
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Chapter 30
Research Ethics in E-Public Administration
Any person involved in a research process have to be informed in advance about the nature and content of the research, its objectives, the methods and procedures to be followed, who is doing it, who pays it, what type of results will be produced, how will the results be published and disseminate and should also be aware of all other relevant impacts.
Published in Chapter: Research Ethics in E-Public Administration; From: Handbook of Research on Public Information Technology
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Chapter 15
Certification and Medico-Legal Aspects of Neurodevelopmental Disorders in India
Permission granted in full knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits.
Published in Chapter: Certification and Medico-Legal Aspects of Neurodevelopmental Disorders in India; From: Emerging Trends in the Diagnosis and Intervention of Neurodevelopmental Disorders
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Chapter 8
Ethical Benefits and Drawbacks of Digitally Informed Consent
Informed consent is a fundamental ethical practice in biomedical research. It is the process of providing meaningful information to the potential participant in order to enable an autonomous well-informed decision on whether or not they wish to participate in the research study
Published in Chapter: Ethical Benefits and Drawbacks of Digitally Informed Consent; From: Applied Ethics in a Digital World
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Chapter 3
Data Ownership: Legalities Concerning Wearable Technologies
The concept of providing stakeholders with all relevant information they need to make informed decisions.
Published in Chapter: Data Ownership: Legalities Concerning Wearable Technologies; From: Privacy Concerns Surrounding Personal Information Sharing on Health and Fitness Mobile Apps
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Chapter 228
Ethical Issues in Conducting Online Research
An individual’s freely given consent to participate in research based on information provided by the researcher(s) about the research, possible risks associated with the research, and the voluntary nature of participation. Informed consent must be obtained without coercion or undue influence.
Published in Chapter: Ethical Issues in Conducting Online Research; From: Encyclopedia of Information Science and Technology, Second Edition
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Chapter 9
Social and Ethical Aspects of Biomedical Research
A process by which a subject voluntarily confirms his or her willingness to participate in a particular research project, after having been informed of all aspects of the research that are relevant to the subject´s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
Published in Chapter: Social and Ethical Aspects of Biomedical Research; From: Handbook of Research on Technoethics
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Chapter 8
Ethics Review on Externally- Sponsored Research in Developing Countries
The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants.
Published in Chapter: Ethics Review on Externally- Sponsored Research in Developing Countries; From: Handbook of Research on Technoethics
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Chapter 11
Libraries in a World of Data: How to Move Forward While Protecting Users
The obligation of a researcher/data analyst to inform data subjects about how data will be collected, stored, shared, and analyzed, their rights as participants, and their ability to opt-out of the data collection, accompanied by the data subject’s agreement to these terms.
Published in Chapter: Libraries in a World of Data: How to Move Forward While Protecting Users; From: Technological Advancements in Library Service Innovation
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Chapter 1
Ethics and Privacy Considerations for Systems Biology Applications in Predictive and Personalized Medicine
Is a legal phrase to indicate that a person has given consent based upon a clear appreciation and understanding of the facts, implications, and future consequences of an action.
Published in Chapter: Ethics and Privacy Considerations for Systems Biology Applications in Predictive and Personalized Medicine; From: Handbook of Research on Computational and Systems Biology: Interdisciplinary Applications
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Chapter 1
SHARE: A European Healthgrid Roadmap
A legal term referring to a situation where a person can be said to have given their consent based upon an appreciation and understanding of the facts and implications of an action.
Published in Chapter: SHARE: A European Healthgrid Roadmap; From: Handbook of Research on Computational Grid Technologies for Life Sciences, Biomedicine, and Healthcare
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Chapter 7
DNA Databases for Criminal Investigation
A manifestation of free will and informed in writing under which the holder accepts that their personal data are processed.
Published in Chapter: DNA Databases for Criminal Investigation; From: Handbook of Research on Digital Crime, Cyberspace Security, and Information Assurance
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Chapter 7
A Comprehensive Consent Management System for Electronic Health Records in the Healthcare Ecosystem
It is the expressed agreement given by the patient or their authorized entity to HRP on sharing of specified health records with a HRU that includes contextual information like operation, intended purpose(s) and validity of consent.
Published in Chapter: A Comprehensive Consent Management System for Electronic Health Records in the Healthcare Ecosystem; From: Information Security and Privacy in Smart Devices: Tools, Methods, and Applications
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Chapter 202
Mobile Communications Privacy
Means that the data subject must have the necessary information regarding the identity of the data controller who is processing their personal data and the right to know what type of personal data is being processed and for what purpose the data are intended to be used, in order to form an accurate judgment before consent to the process of the data.
Published in Chapter: Mobile Communications Privacy; From: Encyclopedia of Information Science and Technology, Third Edition
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Chapter 22
Education Research with Electronic Focus Groups
The process by which a person voluntarily confirms in writing, his or her willingness to participate in a particular research activity.
Published in Chapter: Education Research with Electronic Focus Groups; From: Handbook of Research on Digital Information Technologies: Innovations, Methods, and Ethical Issues
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