ETHICAL CONCERNS

A. Are the risks of the subjects minimized by using procedures which

are consistent with sound research design and which do not
unnecessarily expose the subjects to risk and whenever
appropriate by using procedures already being performed on the
subjects for diagnostic or treatment purpose?
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B. Are the risks to the subjects reasonable in relation to:
i.

The benefits that might be reasonably expected as an

outcome to the subjects or to others?
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ii.

Provision for free treatment for research related injury:

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iii. Compensation of the subjects for disability or death
resulting from such injury (details as to how the
compensation if needed would be provided by the
Principal Investigator or by an insurance firm or by
funding agency):
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iv.

The importance of the knowledge that may reasonably be

expected to result from the research project:
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C. Will informed consent be sought from each positive subject or the

subjects legally authorized representative:

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D. Does the research plan make adequate provision for the

confidentiality and monitoring of the data collecte d to ensure
the safety of the subjects:
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