Federal regulations allow the IRB to categorize research studies according to the risks associated with the research and to provide different levels of review based on the degree of risk. There are three types of review, Exempt, Expedited Review, and Full Review. In this situation “expedited” does not mean “faster”; it simply refers to specific categories of research. The first step in the process is for you (as principle investigator/project director) to study the definitions of the three types of review and determine under which category your research falls. Regardless of which category of review you decide is warranted, you have to complete certain forms and submit them to the IRB Chair. 

Exempt Review:

There are six categories of review that meet the federal definition of exempt. Most research projects conducted by TTC faculty, staff or students constitute little or no risk to participants and will be deemed exempt from a full review by the IRB.

Expedited Review:

Federal regulations provide for expedited review (administrative review not involving a full IRB) if the research involves no more than minimal risk and falls within one of the nine specific categories of expedited research.

To determine whether or not your research falls under the category of exempt or expedited and therefore qualifies for administrative review by the IRB chairperson or designated reviewer, rather than the full IRB Board, complete the TTC form entitled, Exemption Screening Questions and thoroughly review one or more of the following websites:

The Department of Health and Human Services Office for Human Research Protections Decision Tree 

College of Charleston Applicability Chart

If you determine that your project falls under the category of Exempt or Expedited, complete the Request for Administrative Review of Human Research form and send it directly to the Chair of the IRB at least 14 workdays prior to the date the research activity is to begin.

Even if a project is determined exempt or expedited, consent forms should be obtained from all research participants (or the signed informed consent of parents or legal guardian if the participant is less than 18 years of age.) The Trident Technical College Elements of Informed Consent contains a sample consent form that you may modify to suit your individual project and a Consent Form Checklist.

Full Review:

If your project does not qualify for an administrative review, you must follow the protocol for applying for a full board review.  A full review is necessary for research that exposes subjects to risks greater than those normally encountered in daily life or in routine medical, dental, or psychological examinations. If your research involves this level of risk, complete the Request for Full IRB Review.  A Full Review must be conducted at a properly convened and attended meeting of the IRB.

Proposals considered to need Full Review should be sent directly to the IRB at least 28 workdays prior to the date the research activity is to begin.