IP1.1

Ethical Research Guidelines

Institutional Review Board (IRB)

All research done on humans must be reviewed and approved by an IRB before research can

begin. An IRB reviews and approves all research that involves using human subjects, to ensure

that it is conducted in accordance with federal and ethical guidelines. If the research involves

university faculty or students, then research may need IRB approval.

What is a Human Subject?

A human subject is defined by federal regulations as an individual about whom a researcher

obtains (1) information through interaction or (2) identifiable private information.

Human subjects may participate in a study in various ways:

• They may respond to surveys or interviews.

• Data about human subjects may be gathered from existing datasets or medical records.

Exempt Research

Research may be declared exempt if it is considered low-risk, such as:

1. Research is conducted in commonly accepted educational settings that involves normal educational practices.

2. Research uses anonymous or no-risk tests, surveys, interviews or observations (anonymous is not the same as confidential).

3. Research that collects or studies preexisting data, if it is publicly available.

Non-Human Research: Oral history is not required to undergo IRB review if it meets the

ethical guidelines of the Oral History Association. This includes their requirement to gain

informed consent prior, to conducting an interview, along with a signed legal release, at the

conclusion of the interview. This can be found in the Oral History Association's Principles and

Standards and Evaluation Guidelines.

Federal IRB Source

For more information, please visit the U.S. Office for Human Research at:

https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html