Expedited Studies
Expedited: Studies will be categorized Expedited if they have following characteristic as described in the Protection of Human Subjects Title 45 Code of Regulation part 46 (45 CFR 46.111).
- Risks to subjects are minimized (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.
- Selection of subjects is equitable.
- Informed consent will be sought from each prospective subject or subject's legally authorized representative in accordance with and to the extent required by 46.117.
- Informed consent will appropriately be documented, in accordance with and to the extent required by 46.117.
- When appropriate the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjects.
- When appropriate the research plan makes adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.