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Table 3 Participant agreement on the WHO checklist on informed consent

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%)