What is this about?
Informed consent is a process of acquiring permission from potential participants, before conducting some sort of medical intervention, collection of personal data or enrollment in a study.
- Cocanour CS. Informed consent-It's more than a signature on a piece of paper. Am J Surg. 2017;214(6):993-7.
Why is this important?
For whom is this important?
What are the best practices?
The idea of written informed consent is not new. It first appeared in the early 20th century in Walter Reed’s research of yellow fever. The development of human rights after the second World War brought to life numerous declarations and rules (e.g., the Nuremberg Code) regarding human experimentation.
In order for informed consent to be valid, four conditions need to be met:
- Voluntariness: subjects should not be coerced. This could be a tricky condition sometimes, especially when subjects have no alternative choice (e.g., when a terminally ill patient is offered to join an experiment that might save their life)
- Capacity: subjects should have the capacity to understand and judge provided information. This could become a thorny issue when dealin with vulnerable subjects (e.g., children) or patients with mental problems (e.g., those suffering from illnesses such as dimensia)
- Information: subjects should be provided with adequate amount of information. These may include methodology, process, duration of the experiment, but also research goals, beneficiaries, data retention schedule, others uses of extracted data (e.g., publication of research articles, use of material in tangent projects, etc.).
- Comprehension: subjects should understand the provided information. Relevant considerations include using straightforward language that is understandable for the least advantaged members of the target group, and avoding the use of scientific jargon.
Before accepting a manuscript for publication, editors should make sure authors have all the necessary research ethics permissions and signed informed consent forms from all participants.
- Cutter L. Walter Reed, Yellow Fever, and Informed Consent. Mil Med. 2016;181(1):90-1.
- Merz JF. The Nuremberg Code and Informed Consent for Research: JAMA. 2018 Jan 2;319(1):85-86. doi: 10.1001/jama.2017.17704.
- Beauchamp, T. L., & Childress, J. F. (2009). Principles of Biomedical Ethics. Oxford University Press.
The Embassy Editorial team, Iris Lechner, Mohammad Hosseini, Ružica Tokalić contributed to this theme. Latest contribution was Mar 25, 2021