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Table 2 Components required for a consent form as generated by the participants

From: Informed consent in Sri Lanka: A survey among ethics committee members

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%