Pre-procedure discussions relating to consent always consist of two parts. The first part concerns the technical/factual content of the consent form, as was explained and evaluated in detail in the article (1). The second part relates to the patient’s competence to give consent.
The question therefore is: is the patient able to understand/comprehend the consent form, and is s/he able to act on her/his understanding of their own free will? Competence to consent is taken for granted by the legislator in medical law, in the same way as legal competence is in the civil code. The lack of such competence has to be proved, for example, in geriatric or palliative medicine. In the article, I found only one place where this was referred to: in Table 2 (item 5, line 6): “[…] that the patient has understood the information.”
A patient’s ability to consent needs to be documented in the consent form. This does not require input from a psychiatrist—common sense usually suffices.
Another question is: how much time does the completion of a consent form take the doctor? The less time spent, with the result being equal, the better the consent form. The necessary time taken to achieve this is a crucial quality criterion.
Footnotes
Conflict of interest statement
The author declares that no conflict of interest exists.
References
- 1.Lühnen J, Mühlhauser I, Steckelberg A. The quality of informed consent forms—a systematic review and critical analysis. Dtsch Arztebl Int. 2018;115:377–383. doi: 10.3238/arztebl.2018.0377. [DOI] [PMC free article] [PubMed] [Google Scholar]