From: Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico
Questions | No | % |
---|---|---|
What is the purpose of the informed consent? | Â | Â |
   To inform the patient about the treatment | 20 | 100 |
   A requirement of the hospital authorities | 20 | 100 |
   A requirement of the Mexican health authorities | 0 | 0 |
   A requirement of the international sponsors | 20 | 100 |
   A requirement of the Clinical Research Organizations (CRO) | 20 | 100 |
Have you been involved in designing the informed consent? | Â | Â |
   Yes | 0 | 0 |
   No | 20 | 100 |
Are you familiar with the International regulations applied for developing the informed consent procedure? | Â | Â |
   Yes | 0 | 0 |
   No | 20 | 100 |
Is the IC a requirement present in the: Mexican LGS; Mexican Regulation for Research or is it an international request?)* | Â | Â |
   Is present in the Mexican LGS | 20 | 100 |
   Is present in the Mexican Regulation of Research | 0 | 0 |
   It is an international requirement | 20 | 100 |
   It is present in all of them | 0 | 0 |
Which of the following statements best describes purpose of the informed consent? | Â | Â |
   A document required for biomedical research | 15 | 75 |
   Guidelines to prepare the informed consent | 13 | 65 |
   A document that will "protect" the physician/researcher in case of legal procedure | 15 | 75 |
   A document to emphasize the "shared" responsibility between doctors and patients | 17 | 85 |
   Not sure | 5 | 25 |
Do you know what makes a patient vulnerable? | Â | Â |
   Being a prisoner | 20 | 100 |
   Being poor | 0 | 0 |
   Being sick | 0 | 0 |
   Not having medical care | 20 | 100 |
Do you think that the patients admitted to the hospital are vulnerable? | Â | Â |
   Yes | 3 | 15 |
   No | 17 | 85 |
Which of the following conditions may influence the informed consent procedure? | Â | Â |
   Being the treating physician | 0 | 0 |
   If the patient is vulnerable | 0 | 0 |
   Conflict of interest of the physician | 20 | 100 |
When conducting a clinical trial, are you involved in the patients' treatment before the trial? | Â | Â |
   Never | 0 | 0 |
   Sometimes | 1 | 5 |
   Always | 19 | 95 |
Did you receive financial compensation from the sponsor company (additional salary, trip, congresses)? | Â | Â |
   Yes | 17 | 85 |
   No | 3 | 15 |
Do you think there is a conflict of interest because of this? | Â | Â |
   Yes | 0 | 0 |
   No | 20 | 100 |
Do you think the patient understands the wording of the informed consent? | Â | Â |
   Yes | 7 | 35 |
   No | 13 | 65 |