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False
This statement is false. A research ethics committee is made up of both researchers and non-researchers such as clinical staff and lay members of the public. However, all of them are knowledgeable about the ethical issues that research can raise. Together, they offer a broad range of perspectives when it comes to reviewing a research study.
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True
This statement is true. This is to ensure that researchers have made all the necessary provisions to protect subjects’ rights, safety and welfare before they come into contact with potential subjects. What ‘research involving human subjects’ means will be discussed in the following page.
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False
This statement is false. The decision of a REC to approve or disapprove a study is independent and lies only with REC members who have voting rights.
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True
This statement is true. Other than approving or rejecting a study, the REC also provides advice for modifications or improvements.
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True
This statement is true. The REC is responsible for continuous monitoring of a research after initial ethics approval has been given. This can include conducting an inspection on a study site and looking through all relevant study documents to ensure that the initially approved plan is adhered to.
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True
This statement is true. All research subjects should be given the contact details of the REC for this purpose.
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False
This statement is false. The REC does not have power to impose punishments. However, it can terminate ethics approval for a study and report unethical behaviours to the relevant authorities for further actions.
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False
This statement is false. Having ethics approval does not mean that researchers are free from responsibilities if a study leads to harm.