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Research activities involving greater than minimal risk (physical, social, psychological, and financial) to the participants must be reviewed at a convened meeting of the HIC, as part of the approval process.
Research activities involving no more than minimal risk and where the only involvement of human participants is in one or more of the Expedited Categories found in HIC policy Expedited Review of Research may receive Expedited Review by the HIC.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
The Expedited Review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
Research activities in which the only involvement of human participants is in one or more of the Exempt Categories found in the HIC policy Research Exempt from Full HIC Review are eligible for Exemption from review by the HIC.
If an investigator believes that a protocol qualifies for Exemption, a completed Exemption Request Form should be submitted to the HIC for review.
Investigators cannot exempt themselves.
A research project cannot start until after "concurrence" by the HIC. Retroactive "concurrence" or review cannot occur.
If identifiers that can be linked directly to an individual research subject (e.g. names, social security number, birth date, hospital number, specimen number) are to be retained as part of the data set, the protocol does not qualify for Exemption and the investigator must submit the protocol for Expedited or Full Board Review.