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(Section 46.111)
In order to approve research covered by these regulations the HSRB shall
determine that all of the following requirements are satisfied:
1.
Risks to subjects are minimized.
2. Risks to subjects are
reasonable in relation to anticipated benefits, if any, and to the
importance of the knowledge that may be expected to result.
3.
The worthiness of the research and the rigor of the research design
minimize potential harm to participants, including the harm resulting from
wasting participants’ time.
4.
Informed consent is sought from each prospective subject or the subject's
legally authorized representative and consent is appropriately documented.
5. The research plan makes adequate
provision for monitoring the data collected to ensure the safety and the
anonymity or confidentiality of subjects.
6. The research plan
gives particular consideration to participants belonging to vulnerable
populations, such as children, prisoners, pregnant women, disabled
persons, or economically or educationally disadvantaged persons. When
subjects belonging to these populations are likely to be vulnerable to
coercion or harm, additional safeguards are included in the study to
protect the rights and welfare of these subjects.
Go to Basic Elements of
Informed Consent
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