Criteria for CUSHR Approval of Research
CUHSR reviews and has the authority to approve, require modification (to receive approval) or disapprove all research activities covered by HHS guidelines. In order to approve a research project, CUHSR shall determine that all of the following requirements are satisfied (from 45 CFR 46.111):
- Risks to the subjects are minimized.
- Risks to the subjects are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may be reasonably expected to result.
- Selection of subjects is equitable.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
- Informed consent will be appropriately documented or appropriately waived.
- When appropriate, the research plan make adequate provision for monitoring the data collected to ensure the safety or subjects.
- Where appropriate, there are adequate provisions to protect privacy of subjects and to maintain the confidentiality of data.
- Broad consent for storage, maintenance and secondary research use of identifiable private information or identifiable biospecimens is obtained.
- Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individual with impaired decision-making capacity or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
CUHSR shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with its requirements or that has been associated with unexpected serious harm to subjects.
CUHSR regulations require that research involving any level of deception be followed by an appropriate debriefing of all subjects. Debriefing procedures should be specified in the CUHSR application form.