Human subjects research means any activity intended to obtain and record information from or about individuals for research purposes. Some examples are:
Use of certain types of data may not need UCAIHS review and approval:
Consultancy does not qualify as “research” and so does not require review and approval by UCAIHS. See the UCAIHS policy on Employees as Subjects in Applied Research.
Under the University's Federal Wide Assurance, all research activities involving human subjects (funded or non-funded) must be approved by the UCAIHS prior to the commencement of the research, if:
Research activities include:
Oral history projects that are considered research need UCAIHS approval. For details, see Clarification on Oral History.
There are issues that require attention when employees are used as subjects. See the UCAIHS policy on Employees as Subjects in Applied Research.
The federal Office for Human Research Protections (OHRP) provides decision charts to assist investigators and others in deciding if an activity is research involving human subjects that must be reviewed by an IRB under current federal regulations. The charts will assist investigators in determining:
If the decision charts do no provide enough information provide a clear-cut answer to any of the above criteria, please consult the UCAIHS staff for a determination.