Frequently Asked Questions

Table of Contents

Who needs to get approval from the IRB?

All research involving human participants at Millersville University must be approved by the IRB. This includes research by anyone connected with the university even if subjects are not from the university and any research that is conducted by outside researchers that involves subjects from the university.

What are the deadlines for submitting proposals, and where do they need to go?

Proposals must be submitted ten days before the IRB meeting dates. One original copy of the protocol must be delived to Dr. Rene Munoz, Director of Sponsored Programs and Research Administration.  The proposal will be scanned and electronically routed to the IRB committee chair for his/her review and action.

Under what conditions is research exempt from IRB review?

Survey research is exempt if it is anonymous, does not involve protected populations, and does not deal with sensitive topics. Research conducted in established or commonly accepted educational settings, involving normal educational practices is also exempt. See Section 7, Exemptions of the Guidelines for more information.

How long does it take to get approval?

Research that is minimal risk can be approved by an expedited review process that takes at least two weeks. Proposals that require full IRB approval will be reviewed at the board’s monthly meetings. In most cases, the decision will be made within a week following the meeting. In exceptional situations the process may take longer.

Do students who are doing research with human subjects need to get approval from the IRB?

Undergraduate and graduate student research presenting more than minimal risk, involving protected populations, dealing with sensitive topics, and/or receiving university funding must get approval from the IRB. In all other cases, faculty advisors oversee student research and are responsible for ensuring that the student complies with IRB guidelines

What are protected populations?

The following are considered protected populations if involved in research: minors (under age 18), prisoners, mentally disabled, pregnant women, fetuses, and educationally or economically disadvantaged persons.

Where do I get more information and training on doing research with human subjects?

The Guidelines provide information on research with human subjects at Millersville University.

The Code of Federal Regulations (Title 45, Part 46) delineates basic government policy for the protection of human subjects. (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)

The National Cancer Institute offers a web based tutorial for members of research teams. (http://cme.nci.nih.gov)