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Investigators also should honor any other commitments that were agreed to as part of the approved research, for example, providing information about the study results to research subjects, or honoring commitments for compensation to research subjects for research participation.

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ICH, and the clinical trial agreement.

Be able to indicate approval or disapproval for study enrollment. Data Safety Monitoring Board or Committee, and regulatory requirements. FDA recommends that a child not be used as a translator, even if the child is fluent in English and may be able to assent. IRB members generally include health care personnel such as doctors, nurses, and pharmacists. Media advertisements such as newspapers, television, radio, and internet website postings.

The final decision about any appeal will rest with the IRB Chair. If the irb and university and blood samples may choose to date of informed consent process must identify these record. Regularly meets with project team to keep them informed of the status of project activities. Site Final Report should also be filed in the event of cancellation or termination of a study.

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When disclosing appropriate alternative procedures or courses of treatment, FDA believes a description of any reasonably foreseeable risks or discomforts and potential benefits associated with these alternatives must be disclosed.

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Often, when one of these issues is first identified, a study may be temporarily suspended while the issue is investigated.

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Assures that key personnel are well trained in federal regulations and university policies and procedures related to export controls.

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