|
Doctors' Responses |
||
| Questions |
No |
% |
|
|
||
| What is the purpose of the informed consent? |
||
| 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? |
||
| Yes |
0 |
0 |
| No |
20 |
100 |
| Are you familiar with the International regulations applied for developing the informed consent procedure? |
||
| 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?)* |
||
| 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? |
||
| 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? |
||
| 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? |
||
| Yes |
3 |
15 |
| No |
17 |
85 |
| Which of the following conditions may influence the informed consent procedure? |
||
| 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? |
||
| Never |
0 |
0 |
| Sometimes |
1 |
5 |
| Always |
19 |
95 |
| Did you receive financial compensation from the sponsor company (additional salary, trip, congresses)? |
||
| Yes |
17 |
85 |
| No |
3 |
15 |
| Do you think there is a conflict of interest because of this? |
||
| Yes |
0 |
0 |
| No |
20 |
100 |
| Do you think the patient understands the wording of the informed consent? |
||
| Yes |
7 |
35 |
| No |
13 |
65 |
|
The questionnaires were sent out by e-mail or were delivered in a sealed envelope. The answers were submitted anonymously. Three weeks after sending the questionnaire and if a response had not arrived; the physicians were contacted to see if they had sent their responses. Although 70 questionnaires were sent out, only 20 physicians responded. * The Mexican Regulation for Research is the document that describes the IC document and tried to document. The purpose of this question was to learn about the doctors knowledge about the Mexican regulations, and if they had ever read the regulation. | ||
Verástegui BMC Medical Ethics 2006 7:13 doi:10.1186/1472-6939-7-13 |
||