Frequently Asked Questions

What kinds of projects require IRB approval?

All research projects involving human subjects must be approved by the IRB before the project begins. This includes survey/questionnaire research, interviews, and experiments, regardless of whether the research is conducted on or off campus.

Observational studies may require IRB approval. Discuss the matter with the IRB chair before submitting a formal application.

Ordinarily, observational studies of public behavior do not involve human subjects as defined by the regulations because there is no intervention or interaction and the behavior is not private. If, however, there is an assumption of privacy or the observation includes interactions or interventions with subjects or identification of subjects, IRB approval is necessary. Contact the IRB chair.

How long does the review take?

IRB review can take between 3-6 weeks, depending on the type of project and demands on the panel.

Do I need to get informed consent?

Under most circumstances, informed consent is a necessary aspect of all research, including surveys and interviews, in which human subjects are involved.

There are possible exemptions for obtaining written informed consent. In cases where documentation of consent is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. Possible exemptions include:

The IRB may waive the requirement to obtain a signed consent form for some or all subjects if:

  • A. There are potential confidentiality problems due to informed consent and both of these conditions are met:
    1. the only record linking the subject and the research would be the consent document and the principal risk would be harm resulting from breach of confidentiality
    2. the research presents no more than minimal risk and involves no procedure for which written consent is normally required.
  • B. Even if your project meets the exemption criteria, your project must be reviewed by the IRB.

How is informed consent obtained?

There are many elements to informed consent. “Informed consent” means knowing consent. The person giving consent must be able to choose, freely and knowingly, to participate.

Here are some of the elements required to obtain informed consent.

What is minimal risk?

According to the federal guidelines, minimal risk means “the risk of harm anticipated is not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

What is harm?

According to the federal guidelines, harm refers to an injury to the rights, welfare, or safety of the participant.

What is expedited review?

Federal guidelines allow certain kinds of research to be be exempt from full review. IRB review and approval are still necessary, but only a subset of the board must review the work. Click here for a description of the kinds of research that fall under expedited review policies.

Note, the standard requirements for informed consent apply regardless of the type of review utilized by the IRB

How do I find the appropriate consent forms?

Do I need training?

According to a federal mandate on human participants protection training, all investigators and key research personnel involved in research with human participants must complete a training program if the research is supported by the DHHS (list of agencies). Some of these agencies have affiliated institutes, offices, and centers. For example, over 20 are affiliated with NIH.