From: Informed consent in Sri Lanka: A survey among ethics committee members
WHO Recommendations | Responses by participants | |||
---|---|---|---|---|
 | Extremely important | Important | Not important | Not sure |
Should separate consent forms be developed for different levels of questionnaires or procedures? | 6(22.2%) | 11(40.7%) | 6(22.2%) | 4(14.8%) |
Should the information leaflets written in lay persons' language? | 23(85.2%) | 0(0%) | 2(7.4%) | 2(7.4%) |
Should it be made clear that the proposed study is a research? | 20(74.1%) | 7(25.9%) | 0(0%) | 0(0%) |
Should it describe the purpose & duration of the research? | 11(40.7%) | 15(55.6%) | 1(3.7%) | 0(0%) |
Should it describe the procedures to be carried out? | 18(66.7%) | 9(33.3%) | 0(0%) | 0(0%) |
Should it provide information on risks & discomforts to participants? | 25(92.6%) | 2(7.4%) | 0(0%) | 0(0%) |
Should it describe the benefits for the research participants, if any & for others? | 14(51.9%) | 11(40.7%) | 1(3.7%) | 1(3.7%) |
Should it include the procedures to be followed to ensure confidentiality of the research participants and the information provided by them? | 19(70.4%) | 7(25.9%) | 1(3.7%) | 0(0%) |
Should it describe the nature of any compensation or reimbursement to be provided? | 13(48.1%) | 10(37.0%) | 1(3.7%) | 2(7.4%) |
Should it specifically mention that participation is voluntary & refusal to participate will involve no penalty or loss of medical benefits to which the participant was otherwise entitled? | 23(85.2%) | 3(11.1%) | 1(3.7%) | 0(0%) |
Should it describe alternatives to the participation? | 6(22.2%) | 8(29.6%) | 4(14.8%) | 9(33.3%) |
Should it provide the name & contact information of a person who can provide more information about the research project at any time? | 10(37.0%) | 16(59.3%) | 0(0%) | 1(3.7%) |
Should it conclude with a personal statement | 14(51.9%) | 10(37.0%) | 0(0%) | 2(7.4%) |
Should provision be made for the subjects incapable of reading & signing the written consent form? | 16(59.3%) | 11(40.7%) | 0(0%) | 0(0%) |
Should provision be made for subjects incapable of giving personal consent? | 19(70.4%) | 6(22.2%) | 0(0%) | 1(3.7%) |