Informed Consent in Research Involving Human Subjects

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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Introduction

The practice of obtaining informed consent (IC) in research conducted with the participation of human subjects comes as a response to scientific communication to the danger of involving some people in research that may endanger their life, health or quality of life without knowing what is, or may be, likely to happen to them, and without actually expressing their consent. CI in research has developed mainly at the level of bio-medical research - an area where the risks to which participants may be subjected are increased, and where the effects of unethical research have been evident, gradually expanding into other areas of scientific research, for example in psycho-social research. IC in research is conceptualized and theorized in parallel with IC for more or less invasive therapy or intervention. The IC concept first appeared in 1957, being really debated ever since 1972.

As far as IC is concerned, the bioethics literature considers it necessary to gather the following elements, so that informed consent (both in medical or psychosocial intervention and research) is considered valid:

  • 1.

    Disclosure

  • 2.

    Understanding

  • 3.

    Volunteering

  • 4.

    Competence

  • 5.

    (Actual consent) - a person gives the IC for an intervention if he / she will be exposed to the whole procedure, will understand the information received, will act voluntarily and be competent to act, to consent (Meisel & Roth, 1981)

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From the administrative point of view - technically, informed consent - in clinical research “is the written, signed and dated decision of a person capable of giving consent or, if it is a person unable to do so, by its legal representative to participate in a voluntary and informed clinical trial after having received all the necessary information on the nature, significance, consequences and possible risks and the necessary documentation” (Purcaru, Lazăr, Purcaru, & Rogozea, 2012).

IC for research is the process where the research participant gives his / her agreement to participate in the research after being informed about procedures, risks and benefits (Bulger, Heitman, & Reiser, 2002).

The concept of informed consent defines at the same time the process of obtaining the agreement of the subject on its participation, fully voluntary, and carried out on the basis of its own informed decision, the research - or the therapeutic act - at the same time a process, as well as a document signed by the consenting person or his / her legal representative when he / she is prevented from agreeing (Purcaru et al., 2012).

Faden and Beauchamp (1986) define the process of obtaining informed consent as an expression of care for the protection and facilitation of autonomous or self-determined choices of patients and subjects (n.n.). IC can be transformed into a normative compliance tool in terms of human rights when the practice of obtaining the IC is interpreted in a formalistic manner by reference to strict rules of obtaining the IC and formalizing them (Maclean, 2009). Consent has the role of creating a legal barrier to control permission, allowing for an illegitimate act to be perpetrated (Alexander, 1996).

Key Terms in this Chapter

Agent Capacity: the ability to understand and appreciate the nature of one’s own condition and how the act of participating in the research could affect his/her own health status or quality of life.

Informed Consent: 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”.

Autonomy: a philosophical concept underlying the idea of informed consent, meaning the subject’s capacity to deliberate upon his situation and decide upon his/her own person based on the most complete and accurate information he/she could receive.

Research on Human Subjects: a type of research involving human participants. The research could be in the bio-medical field, but also in psychology, sociology, anthropology, economy and so on. Such research requires a special consideration on the human rights and dignity, estimating the risk the participants might experience and cannot be conducted without the expressed informed consent of the participant(s) or their legal representative.

Broad Consent: a type of consent where a participant expresses his/her general consent that his own personal information, including bio-medical or health-related information and/or tissue sample can be used in further research, without a new explicit consent from his/her side.

Assent: a form of expressing the intention to participate in the research, of a person who is incapable of consenting due to reasons of age or mental state. For this approval to be valid, it must be accompanied by the written consent of the legal representative.

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