Table 2

Sample questions

Topic Areas and Examples of Questions from the Telephone Survey Instrument


Background

How many participants are included in the study?

What is the focus of the research?

What biological samples are collected from participants?

Does the research involve visits to participants' homes?


Recruitment

How are participants recruited?

Does recruitment take place at a single or multiple sites?


Consent & Assent

Describe the initial consent process with the parent(s)?

Describe any process for subsequent re-consent?

When, if at all, is assent sought from a child?

When, if at all, is a child considered to be capable of giving their own legally valid consent?


Confidentiality

Are participant samples and records coded?

How long will samples and other information be held?

Who has access to samples and information?


Sensitive Information

Do you have policies/procedures in place for handling situations where researchers may have concerns that a child is suffering from abuse or neglect?

Are you aware of any law in your jurisdiction that requires you to report concerns about child abuse/neglect?


Disclosure of Results

What results, if any, will be disclosed to participants?

Does your study have a written policy regarding the communication of results?


Withdrawal

What are the procedures for permitting a participant to withdraw from the cohort?

How are information and biological samples handled if a participant withdraws?


Ries et al. BMC Medical Ethics 2010 11:4   doi:10.1186/1472-6939-11-4

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