Table 4 Examples of ICP elements – purposes and procedures

 Stating the overall aim in the Participant Information Sheet as “to make pregnancy safer” may be too ambitious, because this study rarely involves pregnancy.

X

X

 Please state the objectives of the study clearly in the Participant Information Sheet, ensuring they are the same as the proposal, but using simpler and more easily understandable wording.

X

X

X

 In the Participant Information Sheet objectives, it is stated: “We are trying to find the lowest dose at which we can stop you from passing malaria to mosquitoes.” Please revise this sentence as it may confuse some participants.

X

X

X

 Rearrange the Participant Information Sheet according to the various aspects of the research activities. Please explain each part clearly, such as what will be done in the genetic study, molecular marker testing, and PK study.

X

X

X

 Add check boxes in the Informed Consent Form to indicate in which part of the study the participants would consent to participate, since there are several objectives for the study, including participating in resistant parasite clearance study, participating in PK study, participating in genetic determination/molecular marker, consent for home visit and data collection for GIS. Also provide a separate check box when asking for permission to keep leftover blood (if any) for future study.

X

X

 In the Informed Consent Form, there should be a statement that the study participant has been informed of and understood the study objectives and procedures thoroughly, and it should also mention that the participant has the opportunity to ask any questions and get satisfactory answers.

X

X

 In the treatment section, specify clearly how the dose escalation will be performed; the researcher should also mention that some of the patients may receive less than or more than 75 mg of the drug.

X

X

 The study is rather complex, mixing different groups of study participants and different types of specimen collection. Please explain separately what will be done: for patients – the study participant recruitment and the informed consent process that will be conducted; for the general population in the community – informing the community leader and recruitment process; and for the hospital director – permission to use left-over specimen(s).

X

X

X

 In the research proposal, it was mentioned that the patients will be monitored using the Holter Monitoring tool; this should also be mentioned in the Participant Information Sheet.

X

X

 In the procedure section about “What will happen to your child”, state the specific frequency of visits instead of “regularly”. Also describe the procedures to be undertaken at each visit.

X

X

X

 It was stated in the risk section that, “before receiving primaquine, the research team will always test your blood”. However, primaquine will be administered after Day 3 or Day 5. How does the research team plan to handle patients who are not admitted to the study site? Please describe clearly the procedure for follow-up and the performance of hemolysis in such cases.

X

X

X

 Specify the risks for all medications used in the study and state them clearly in both the research proposal and the Participant Information Sheet.

X

X

X

 Specify clearly how to measure the treatment dose, who will measure it, and where the treatment is monitored.

X

X

X

 How will volunteers for the PK study be selected?

X

X

 Please detail the process by which immigrants will be invited to participate in the research study.

X

X

X

 The method for approaching participants is inappropriate. The Principal Investigator should invite patients presenting at the clinic [to be involved] and ask for their permission before accessing their electronic clinical records. Is there a translator responsible for meeting the participants and explaining the study, since all of the research team is foreign? Please explain.

X

X

X

 In the informed consent process, describe clearly who will explain and answer queries about the study procedures. The patients have to understand fully that “the research procedures are different from routine treatment and care services”.

X

X

X

 The Participant Information Sheet for healthy volunteers and for those with acute febrile illness should be separate, as the content and procedures involved are different.

X

X

 The Participant Information Sheet states that the total participants will comprise 30 adult males. This conflicts with the inclusion/exclusion criteria in the proposal.

X

X

 Check and confirm the number of participants to be recruited. In the Participant Information Sheet, the number is 500; however, in the methodology section of the research proposal, it is 70–100.

X

X

 Informed Consent Form Page 2/3, Remark 2: stated that “The person explaining or reading the statement must not be a doctor”. The words “a doctor” should be “the doctor administering treatment”.

X

X

 Since blood will be drawn 24 times consecutively (total = 140 ml), the researcher should clearly inform the study participants of the relevant procedures.

X

X

 How much blood will the research team collect from the participants? How many times? The figures are conflicting both in the protocol and the Participant Information Sheet. Please make it clear and consistent. Specify how many participants will give blood for this study.

X

X

X

 Why should blood be drawn 13 times (in weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24) – especially for young children? If there is no re-infection, the antibody will not change much; please reconsider a blood draw of no more than once every 1 or 2 months. Re-infection can be detected from other clinical symptoms.

X

X

 Regarding the follow-up outcome assessment for any study volunteer who falls pregnant during the trial period, please state explicitly for how long the pregnant volunteer is withdrawn from taking the testing drug in the study.

X

X

X

 Specify clearly that the research team will interview only the head of the household.

X

X

 The researcher should tell the study participants that their medical records will be examined and they will be interviewed using a structured questionnaire, and that the healthcare provider will visit their house to collect household information.

X

X

X

 How does the researcher intend to collect leftover patient blood from hospitals under the Thai Ministry of Public Health? The Director of each participating hospital must provide permission in writing.

X

X

 Why is a genetic sample collected at Visit 1 (screening visit)? This type of sample should be collected at Visits 2–7 (enrollment and follow-up visits), because some volunteers may not be selected for participation in the study. Otherwise, a specimen from an individual who does not pass the screening test will not be used in the study at all. This procedure should be clearly explained in the Participant Information Sheet and Informed Consent Form. There should also be a separate Participant Information Sheet/Informed Consent Form or separate check box for this (genetic sample) study objective.

X

X

X