Table 2

Patients' Perceptions about the Informed Consent

Question

Number

%


Who invited you to participate in the clinical trial?

My treating physician

30

86

A "new" doctor

4

11

A resident

1

3

Were you asked to read and sign an informed consent?

Yes

35

100

No

0

0

Do you know what a consent form is?

A document part of the protocol

23

65

A document that I have to sign before I can be admitted to the study

10

29

An explanation of the treatment

2

6

Do you know why you were asked to sign the informed consent?

To protect your rights as a patient

0

0

Because it is a new treatment and can have unwanted effects

8

23

To free the Institution and the doctors of any responsibility in case something bad happens

10

29

To have access to free treatment

16

46

Did you read the document?

Yes

20

57

No

15

43

If not explain why?

I don't know how to read

11

31

The doctor's explanation was enough

9

26

If yes

Once

8

23

More than once

7

20

At home

7

20

At the hospital

8

23

By myself

2

6

With my family

11

31

After reading the documented, your understanding about the study improved?

Yes

9

26

No

6

17

Do you have any comments about the document?

The document is too long

23

66

The document is difficult to understand

17

49

I could not understand it

17

49

I got bored and did not read it completely

10

29

The doctor explained it to me and i did not read it

11

31

It is a waste of time

12

34

If i don't get into the "protocol, i won't receive any treatment

16

46

I did not understood many of the words

17

49

Why did you decide to participate?

To help others

0

0

Because the treatment will help me

30

86

To get better

30

86

To increase the knowledge about my disease

0

0

Because I don't have money to have any other treatment

21

60

Because my Doctor asked me and he knows what is good for me

25

71

Because someone in my family told me

5

14

Because the treatment was free

21

60

I don't know

3

8


A selection of the relevant questions and answers given by the patients are shown (the complete questionnaires are shown in the appendix). The patients and a family member were provided with the questionnaire. It was answered in a quiet room; although study personnel were not present in the room at the time, staff members were available outside to answer questions. When required, the questionnaire was read to the illiterate patients involved in the research study; otherwise, the patient's family member read out the questions and checked off the selected answer.

Some patients, provided answers not present in the questionnaire.

Verástegui BMC Medical Ethics 2006 7:13   doi:10.1186/1472-6939-7-13

Open Data