Table 2

Components required for a consent form as generated by the participants

Main themes mentioned by respondents
Frequency
Percent

Statement declaring that the participant clearly understood what the research project is about
15
51.7%
Statement about understanding the right to withdraw from the research at any point
12
41.4%
Statement that the refusal to participate will not affect the right for clinical care
8
27.6%
Space for the name, address and the signature of the participant
8
27.6%
Statement of being aware of the potential risks of participating in the study
8
27.6%
Declaration that the information leaflet has been explained or read thoroughly
6
20.7%
Statement that an assurance of confidentiality was given
6
20.7%
Declaring that the decision to participate is voluntary
5
17.2%
It should be in the appropriate language or all 3 languages used in Sri Lanka
4
13.8%
Statement that they understood the possible benefits of the research
4
13.8%
Statement agreeing to participate or giving consent
4
13.8%
Statement declaring that the participant understood this as a research project
3
10.3%
Statement that the participant understood what is expected from him/her
3
10.3%
Statement either receiving or not receiving any payment for participation
2
6.9%
Name(s) and signature(s) of the researchers involved
3
10.3%
Space for the signature of witnesses
3
10.3%
Title of the research project
1
3.4%
Space to put the date that consent was given
1
3.4%
No need for a separate consent form, it could be a continuation of the information leaflet
1
3.4%

Sumathipala et al. BMC Medical Ethics 2008 9:10   doi:10.1186/1472-6939-9-10