Table 3

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

Open Data