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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%