The Purpose of the Consent Form(1,2)
Tada Yipintsoi MB*
Affiliation : * Member of Medical Association of Thailand
A while back, I asked one of my patients to sign a consent form to allow me to estimate his brain
natriuretic peptide after his routine blood electrolytes. While I was explaining that this extra test may not
result in alteration of his management, I noticed that he did not really listen. He took out his expensive pen,
signed and added that he was willing to volunteer for “any other” test. This put me back and made me think.
That is when I decided to write on this topic.
Personally, I consider an informed consent as a path towards a “dialogue” so that the subject has a
better understanding of his condition or really knows what he/she is consenting to have done. Often, one
notices that the informed consent, which had been screened from a very strict ethical committee or particularly,
from a pharmaceutical or an international trial, is full of terms or clauses couched in scientific words that
easily can and will confuse the lay person and is unlikely to provide understanding, however presented. The
“volunteer” (excluded those being paid) will consent simply because they trust the physician or hoped that
it will induce the physician to be more sympathetic. It is unlikely that the majority believe that his volunteering
will benefit mankind.
When I was working in the USA, one of the practices along this line was to tape-record the dialogue
with the patient the evening before coronary artery surgery. We interrogated a lawyer after the surgery as to
his recollection of the pre-surgery interview. He remembered very little even after listening to the playback
and further added that this will never be admissible in court if the subject objected.
From the above recollections, I wish to present the following thoughts for the institutional ethical
committee (whose job is really unenviable). This committee has to be all knowing. They have to protect the
subjects and, at the same time, encourage the endeavor of the investigator. The consent form has to be
tailored by providing the following guidelines as to the content and language:
a. The form must result in a dialogue (hence format it like a check list).
b. The language used has to be very simple for a lay person. As such, it can be read and understood
and/or the language is plain enough to stimulate intelligent queries. Translation into local language must
be done and understanding by verbal explanation must be ensured.
c. The consent form must not be overly detailed in the hope that such maneuver will protect the
investigator and his institution.
The ethical committee (as previously stated, is vital, but, unfortunately thankless duty), may wish to
follow my thoughts by interviewing the volunteers after or midway through the study. Hopefully, in the future,
I’ll not hear such comment from a physician-investigator: “the near complete study missed several consent
forms since I had no time and often the patients were too sick”.
Keywords : Consent form, Informed consent
