Medical Ethic issue

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Joined: 13 Jan 2012, 16:27
Location: NSCR

Medical Ethic issue

Postby Liza » 22 Mar 2012, 12:27

According to the Medical Ethics Committee (VUmc) researchers are obliged to mention the chance of finding unintentional physical disabilities before informed consent is written by subjects and that when finding such disability researchers should communicate this with a physician. If subjects do not agree with this, they should be excluded from the study.

However, I was wondering whether researchers, who use the Vu-Ams, actually comply with this condition. And if so, does anyone have a standard description of this?

Posts: 9
Joined: 20 Jan 2012, 21:03

Re: Medical Ethic issue

Postby jcndegeus » 12 Apr 2012, 11:51

In all our current protocols with the METC the issue of chance findings has not surfaced because the VU-AMS does not yield results that have a bonafide clinical diagnostic status. The closest we get to detecting potential disease risk is the three lead ECG. However, unless my understanding is incorrect the unsupervised three-lead electrocardiography we use is not considered a valid instrument to detect pathology in cardiology, particularly in the hands of non-cardiologist reserachers.
What is fairly often encountered in ambulatory ECG recordings is frequent extrasystolic beats, and this is a source of anxiety for researchers.
See for instance
However, outside a setting of known heart disease and without self-reported clinical symptoms such extrasystoles are considered to have no clinical meaning.

In the rare event that severely distorted ECGs are found in combination with self-reported clinical symptoms, then just the latter would be sufficient to suggest a visit to the physician (if the subject is not already under treatment). One could indicate this in an IRB proposal. In the far majority of the cases, however, a non-trained researcher alerting the subject to a strange ECG would merely act to cause anxiety in the subject that will prove unfounded.

Should you venture on this path, do so only after sufficient self-study, but preferably contact a cardiologist.
There are many online courses on ECG that are of high quality, a single example is

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