Themes

Informed consent

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 (1).

Why is this important?

The idea of written informed consent is not new. It first appeared in the early 20th century, in Walter Reed research of yellow fever (2). Further development of human rights, particularly after the WW2, brought to life numerous declarations and rules regarding human experimentation (3). One of the basic concepts in human research ethics is informed consent. In order for informed consent to be valid, researchers have to provide enough information so that participant can make a decision. Such information has to be provided in an understandable way, regarding the language and educational level of the participant. This is called disclosure. A researcher must assess the capacity of the participant, to make sure that they have the ability to understand what the research is about, and the ability to make a reasonable decision. In the end, the researcher has to be sure that the participant makes such a decision freely, without pressure or manipulation (voluntariness) (4).

Before accepting a manuscript for publication, editors should make sure authors have all the necessary ethical board permissions and a signed informed consent form from all participants.

References

1. Cocanour CS. Informed consent-It's more than a signature on a piece of paper. Am J Surg. 2017;214(6):993-7.

2. Cutter L. Walter Reed, Yellow Fever, and Informed Consent. Mil Med. 2016;181(1):90-1.

3. Merz JF. The Nuremberg Code and Informed Consent for Research: JAMA. 2018 Jan 2;319(1):85-86. doi: 10.1001/jama.2017.17704.

4. Miracle VA. The Belmont Report: The Triple Crown of Research Ethics. Dimens Crit Care Nurs. 2016;35(4):223-8.

Ružica Tokalić contributed to this theme.

Latest contribution was May 29, 2019