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