Table 7 Examples of ICP elements – confidentiality and contact

 In the confidentiality section, the researcher should consider starting the section with “Your personal information will be kept confidential by ….”

X

X

 Please specify in the Participant Information Sheet and Informed Consent Form who will be authorized to have direct access to medical records.

X

X

 The Participant Information Sheet currently states that only persons in the pharmaceutical company (international) will have authorized access to pharmaco-genetics; this should be reconsidered, to include the IRB and other stakeholders at national level.

X

X

 The Informed Consent Form states “I give permission for authorized persons to access my medical records, such as the study team, representatives of the research sponsor, the Ethics Committee, and monitors.” Please specify precisely who are actually involved and their roles and responsibilities, after the words “such as.”

X

X

 The Informed Consent Form and Case Report Form may not include personal addresses.

X

X

 Is there permission to use data in the patient’s medical records? How does the researcher plan to handle the confidentiality of patient information?

X

X

X

 This study is a one-time cross-sectional survey with one blood draw; since there is no follow-up visit, why does the researcher want to collect data on study volunteers’ addresses (even though it is stated in the proposal that such data will be kept in a secure facility with limited access)?

X

X

 There should be no link from an individual to a specimen in this study. Each specimen should be coded with a code number. The proposal should state clearly who has access and who may retrieve data for the researcher, and what coding procedure will be used.

X

X

 Please explain the statement “All samples were kept in a bag without a clear label in each one”. What does this mean?

X

X

X

 Please specify for how long the data will be kept, and when they will be destroyed.

X

X

 If the plan is to keep leftover blood in additional locations, please specify where in both the research proposal and the Participant Information Sheet.

X

X

 In the Participant Information Sheet, there is no address for contacting the study doctor. Please add one of the investigating team as the contact person.

X

X

 Emergency contact information should be provided to all participants, with a mobile phone number. The phone number of the local physician should be provided.

X

X

 The contact person stated in the proposal is Dr. XXX, but in the Informed Consent Form and Assent Form it is Dr. YYY. Please make it clear. Do both of them speak Karen, Burmese and Thai? Is there a translator? Please specify.

X

X

 The contact person in the Participant Information Sheet is Dr. XXX, but her name is in the list of study investigators.

X

X