|
Participant agreement on the WHO checklist on informed consent |
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| WHO Recommendations |
Responses by participants |
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|
|
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| Extremely important |
Important |
Not important |
Not sure |
|
|
|
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| 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%) |
Sumathipala et al. BMC Medical Ethics 2008 9:10 doi:10.1186/1472-6939-9-10 |
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