Human subjects research means any activity intended to obtain and record information from or about individuals for research purposes. Some examples are:
- in-person and telephone surveys
- educational tests
- observation of public or private behavior, including classroom observation
- interviews and focus groups
- evaluation and research components of demonstration and training programs
- the collection or study of existing data (e.g., medical or school records)
Research Not Requiring Approval
Use of certain types of data may not need UCAIHS review and approval:
- Public Use Data
- Biological Specimens and Patient Data
- De-Identified Data Not Derived From Other Research Projects
To determine whether the data for your proposed study meets the criteria for any of these categories complete the Checklist for Determining Whether a Project Involves Human Subjects Research.
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.
Research Requiring Approval
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:
- the research is sponsored by the University; or
- the research is conducted by or under the direction of any University employee or agent (e.g., faculty member, researcher, or student) in connection with his/her other institutional responsibilities, no matter where the research is conducted; or
- the research is conducted by or under the direction of any University employee or agent (e.g., faculty member, researcher, or student) using any University property or facility; or
- the research involves the use of the University's non-public information to identify or contact human research subjects (or prospective subjects) or to provide data for the research; or
- the research involves the use of the University's students, employees, or facilities.
Research activities include:
- Master's theses,
- Pilot studies,
- Class projects,
- Non-funded faculty-directed research.
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.
OHRP Decision Charts
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:
- whether an activity is research that must be reviewed by an IRB
- whether the review may be performed by expedited procedures, and
- whether informed consent or its documentation may be waived.
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.