Informed consent is a formal agreement made by individuals to participate in research, having been fully advised of the potential benefits, risks, and the procedures or activities of research participation. In educational research, informed consent is almost always sought from potential participants before collecting any data unless there are specific [Page 822]reasons for not disclosing the details of a research project up front. Informed consent is considered an essential aspect of good research ethics practice and is mandated by universities, research funders, and organizations in many countries. This entry describes the origins of the term informed consent, how it is applied in educational research, and some of the debates that exist about whether and how informed consent can be achieved effectively.
Informed consent is underpinned by three core principles: (1) respect for persons, (2) beneficence, and (3) justice. These principles are known as the Belmont principles, after the 1979 report from the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was convened in the Belmont Conference Center in Maryland in the United States.
The principle of respect for persons states that human research participants should be treated as autonomous agents, be fully informed about the nature of the research they are asked to take part in, and that individuals with diminished autonomy should be protected. At the core of this principle is a moral judgment about the proposed research activities based on the question, “would you be happy to be treated in this way?” The principle of beneficence focuses on the consequences of research participation and asks researchers to ensure that the benefits of participation outweigh any harm. The principle of justice states that the selection of research participants should be fair and that those who are asked to bear the burden should also benefit.
In education research, these principles are typically translated into practice through written project information sheets that are given to potential research participants at the beginning of a research study. Project information sheets are designed to inform participants about key information including why the project is being carried out; who is doing the project, and how it is funded; why individuals are specifically being approached for participation; what participation in the research will entail; any risks and benefits for those taking part and for others; anonymity and confidentiality of participation and how personal data will be protected; and contact details of key personnel.
Information sheets are often accompanied by a consent form that participants are asked to sign if they agree to participate. The consent form generally asks individuals to confirm that they have read the information sheet and had the opportunity to ask questions, agree to take part voluntarily and can withdraw at any time, and understand their rights to confidentiality and anonymity. Together, the information sheet and consent form tend to be the key communication tools through which informed consent is gained. Information sheets, consent forms, and the research project protocols that guide their content are usually reviewed by panels of relevant stakeholders before being sent to potential participants. Common names for these panels are institutional review boards or research ethics committees.
The Belmont principles underpin the ethical conduct of contemporary research with human participants and are based on two highly influential sets of guidelines: the Nuremberg Code in 1947 and the Declaration of Helsinki in 1964. The Nuremberg Code established for the first time the fundamental rights of human research participants and the responsibilities of researchers wishing to include humans in their research. It followed from the Nuremberg trials where perpetrators of Nazi abuses in World War II were convicted, and executed, for their experimentation on human beings. Among other key principles, the Nuremberg Code established the importance of research participation being voluntary, with research participants able to withdraw from participation, and that benefits must outweigh risks. The Declaration of Helsinki, made by the World Medical Association (and updated periodically since 1964), supported these core principles and added that research should be subject to review by an independent committee and that the privacy and confidentiality of participants must be assured.
At the time when the Belmont principles were developed, the primary concern was with biomedical [Page 823]research, where researchers planned specific medical studies to intervene or implement a specific procedure and evaluate the consequences. In social science research, including education, many different research designs are used that do not follow the traditional assumptions of biomedical research. This has led to critiques of the application of research ethics principles derived from biomedical research to social science research.
In qualitative interpretive research, it is often not possible to know at the outset how research participation may change or develop over time or to judge what the risks or benefits might be; some participants may also wish for their identities to be made public. Some social science researchers argue that the overall risk of harm in social science research is likely to be much lower than in biomedical research and so the same level of scrutiny is not needed.
Another debate includes whether and how “vulnerable” participants should provide informed consent to participate in research and if proxy respondents can consent on their behalf. The concept of vulnerability is contested but is typically applied to children, the elderly, and those who may have reduced capacity to consent (e.g., individuals with intellectual disabilities). Proxy respondents often include parents, carers, or teachers. Other researchers have questioned whether the provision of information in primarily written forms is the most accessible way of supporting the comprehension of all research participants.
A further issue relates to opt in versus opt out consent: Opt in consent requires formal, usually signed, agreement to take part before data collection begins; opt out consent assumes that consent has been given if a consent form is not completed and returned to the research team. There are concerns as to whether opt out consent meets the core principle of respect for persons because it is not possible to know whether someone has actively agreed to participate in the research.
See also Assent; Belmont Report; Declaration of Helsinki; 45 CFR Part 46; Human Subjects Protections; Human Subjects Research, Definition of; Institutional Review Boards; Nuremberg Code; Qualitative Research Methods