Frequently Asked Questions

When do I need to submit a proposal to the IRB?

All proposed research that involves the use of human subjects requires review and approval by the IRB prior to grant submission (if applicable) and initiation of the research.

What is research?

Research is defined by the federal regulations as "a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge."

What form(s) are needed to apply to do a study involving human subjects?

The IRB Protocol Review Request Form (DOH 1871), is required for initial protocol review. Signature of the principal investigator and center director is required. Forms can be found on the IRB website or by contacting the IRB.

Is some research exempt from review?

No! All human subject research must be reviewed. There is a category of research called "Exempt" which means that an IRB Chair has reviewed the research protocol and determined that it falls into one of six categories of research that is exempt from full IRB review (for example, anonymous surveys generally fall into such an exemption category). But, only the IRB can determine whether a particular research project is exempt from IRB review. However, it is the Department’s policy to conduct continuing annual review on all research that qualifies as Exempt.

If my research is not funded -- do I still need IRB approval?

Yes, it still needs to be reviewed. Based on the level of risk to subjects, your protocol will be reviewed as Exempt, Expedited or Full Board.

What is minimal risk?

The Office for Human Research Protections (OHRP) defines Minimal Risk as:

"The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

The informed consent process is central to the ethical conduct of research. It is an on-going conversation between the human research subject and the researchers which begins before consent is given and continues until the end of the subject's involvement in the research.

The consent document is a written summary of the information that should be provided to the subject. Many investigators use the consent document as a guide for the verbal explanation of the study. The subject's signature provides documentation of agreement to participate in a study.

The informed consent document must contain the basic elements of informed consent as identified in and required by the US regulations regarding the protection of human subjects (45 CFR 46). As required by this regulation, the informed consent must be reviewed and approved by an Institutional Review Board.