Table 1 Requirements for an information leaflet
From: Informed consent in Sri Lanka: A survey among ethics committee members
Main themes mentioned by respondents | Frequency | Percent |
|---|---|---|
Description of the research project -What one is doing | 19 | 65.5% |
Potential risks involved in participating | 14 | 48.3% |
Possible benefits of the research project to participant or community | 14 | 48.3% |
Methodology -How you're doing it | 13 | 44.8% |
Right to withdraw from the research at any time without giving reasons | 13 | 44.8% |
Objectives -Why it is done | 10 | 34.5% |
Statement assuring voluntary nature of participation | 10 | 34.5% |
Assurance of confidentiality | 9 | 31.0% |
Stating that refusal to participate will not affect the clinical care | 7 | 24.1% |
If any illness that may require intervention is identified, what would be the follow-up action | 5 | 17.2% |
Title of the research project | 4 | 13.8% |
Who the researchers are | 4 | 13.8% |
Contact details of the researchers | 4 | 13.8% |
What is expected from research participants | 3 | 10.3% |
The time expected to be spent participating in the research | 2 | 6.9% |
The source of funding | 2 | 6.9% |
Introduction about the research | 1 | 3.4% |
Statement saying that it is a research project | 1 | 3.4% |