Informed Consent is a voluntary agreement to participate in academic research. It’s not simply a form that is signed, but a process. In which the research subject has an understanding of the research being undertaken and its risk. The purpose of the informed consent process is to offer sufficient information, so that a participant can make an informed decision about whether or not to sign up for a research study and/or to continue participation.
Social research ethics are closely aligned to medical research ethics (see Beauchamp & Childress, 2001). Following the evidence of abuse experienced by human research ‘subjects’ during the Second World War, frameworks for ethical medical research were developed and were enshrined first in the Nuremberg Code (1947) and later in the Helsinki Declaration (1964).
According to Beauchamp and Childress (2001), literature on informed consent agrees that the five fundamental elements of informed consent are: i) disclosure, ii) understanding, iii) voluntariness, iv) competence, and finally v) consent. Consent forms can be used as a tool to enhance subjects’ understanding of the research process and its consequences. Consent forms also ensure that researchers have addressed the basic requirements of informed consent with their subjects.
9 Elements of a Informed Consent Form
A complete informed consent form must contain the following information.
1) Purpose of the research.
2) Procedures involved in the research. 3) Alternatives to participation .
4) All foreseeable risks and discomforts to the subject. Please note that these consist of not only physical injury, but also likely psychological, social or economic harm, distress, or inconvenience.
5) Benefits of the academic research to society and possibly to the research subject.
6) Length of time the subject is expected to participate in the research.
7) Person to contact for answers to questions or in the event of a research‐related injury or emergency.
8) A statement indicating that participation is voluntary and that refusal to participate in the academic research will not result in any consequences or any loss of benefits that the subject is otherwise entitled to receive.
9) A statement regarding the subjects’ right to confidentiality and right to withdraw from the research study at any time without any consequences.
An informed consent form must be written in language easily understood by the participants. It should also minimize the likelihood of undue influence or coercion, and finally the subject must be given ample time to consider participation.
3 Informed Consent Form Samples
As earlier suggested informed consent is a process and the process of consenting is ongoing. You must make it clear to the subject that it is their right to “withdraw” or “opt‐out” of the study or procedure at any time, not just at the initial signing of paperwork. How you inform the study participants, answer their questions and present, and review the informed consent form with them are parts of the research process and should be built into your project design.
Informed Consent Process
Here are 3 great tips you can use to instrumetalize the consent process into your research methodology.
- Ask the participants to repeat back to you what the project is about and what participation will involve, as a check that they’ve understood the consent process.
- Before a research interview, teach the participants keywords that can be used to skip questions. “Pass” is a fantastic keyword to teach your participant to use when they don’t want to answer a question.
- Ask your participants to choose their own pseudonyms. This is a great way for you to respect issues of anonymity, confidentiality and empowerment.
Beauchamp T and Childress J (2001) Principles of Biomedical Ethics 5th Edition Oxford University Press