Table 6 Examples of ICP elements – vulnerable populations, the voluntary nature of research, and withdrawal

 The language in the Participant Information Sheet and Informed Consent Form/Informed Assent Form should be revised to make it appropriate to age and educational level.

X

X

X

 There should be separate forms for adults (aged >18 years) and persons aged 15–18 years.

X

 Please provide local-language Participant Information Sheets, Informed Consent Forms and Informed Assent Forms (Karen, Burmese, and Thai versions), because potential participants must have a very clear understanding before signing informed consent. Please also provide certified translations of these documents.

X

X

X

X

 Please elaborate further on the recruitment process. How many study participants in each village can speak and understand Thai? Please specify who will explain or translate the study to the participants. Please also provide a local-language Patient Information Sheet.

X

X

X

X

 With regard to the objective of the study, does this study need a sample size of 100, or is it too many? If the researchers want to draw blood simply to determine long-term culture, there is no need to conduct the study with children, and no need to draw >5 ml of blood.

X

X

 Is it necessary to perform venous blood collection with children aged >5 years? Can the PI increase the age of the participants and collect blood samples by finger prick? Please also consider decreasing the amount of blood for RT-PCR and blood smear tests to <2 ml, since each test does not require much blood.

X

X

 Drawing 5–10 drops of blood from the index finger of a small child may cause bruising, and may risk infection with a deeper puncture. Normal medical practice is to draw blood from the heel of a small child aged 6 months to pre-walking age.

X

X

 In the Informed Consent Form for children aged 13–18 years, please add “I fully understand that I can refuse to participate in this study; nobody is forcing me to enroll in this study, not even after my parents/guardians provide consent for me to participate”.

X

X

X

X

 The voluntary participation section (Informed Consent Form page 2) currently states “if you decide not to participate in this study, there will be no impact on any treatment that you will get…”. Please change this to “if you decide not to participate in this study, you have the right to do so…”, because this study is conducted among healthy students in school and no treatment is involved.

X

X

X

 The statement about study participation could start with “Participation in this study is voluntary. You can make your own decision freely. You can refuse to participate in this study. If you do so, you will not ….”

X

X

X

 Please consider changing the sentence “Your spouse has to give informed consent.” This sentence may be inferred to mean that the spouse is obliged (under some duress) to sign the Informed Consent Form.

X

X

 The researcher should inform the study participants that they have to right not to answer questions they feel are inappropriate.

X

X

 In the “withdrawal” section, if the participant asks to withdraw in the middle of the study, after specimen collection, how does the researcher plan to handle such specimens? Please detail clearly.

X

X

X

 In the 2nd sentence of the “withdrawal” section, “You have the right to withdraw any time without any penalty”, the words “without any penalty” are inappropriate and should be changed to “… and you will still receive standard treatment and care. Not participating will have no impact on your existing right to receive treatment and care.”

X

X

 The researcher should indicate that the owner of the specimen has the right to withdraw his/her specimen from the specimen bank.

X

X

 Please specify clearly: when patients withdraw from the trial, will the information in their medical records be used?

X

X