Exempt Review Process
Exempt Review Process
Although the category is called Exempt Review, this type of research does require IRB review and registration. There are no deadlines for IRB applications categorized as Exempt Review. Research Integrity and Compliance (RIC) or the IRB chairperson conducts Exempt Reviews to ensure the study meets the ethical standards of Texas State University using the following criteria:
- The research involves no more than minimal risk to subjects.
- If subjects will be enrolled, selection is equitable.
- If there are interactions with subjects, there will be a consent process that will disclose such information as:
- Activity involving research
- The purpose of the research
- A description of the procedures
- The amount of time required for the research
- How data is maintained and secured
- Risks of participating in the study
- Benefits of participating in the study
- Participation is voluntary
- Name and contact information for the Investigator
- Contact information for the Texas State IRB
- Adequate provisions to maintain the privacy interests of subjects
- If the IRB Reviewer requires additional information or modifications, the IRB Reviewer will contact the PI via e-mail. The IRB Reviewer will review the PI’s response upon receipt. If the PI does not respond within 30 days, the study will be closed out.
- When the initial application or requested revisions are insufficient, RIC may request additional revisions.
- Once the review and/or revision process is complete, a letter will be sent to the researcher notifying him/her of the result of the Exempt Review. The letter will include the specific category of review.
- If it is determined that the study does not qualify for Exempt Review, the study will be referred for Expedited or Full Board Review as applicable.
- Exempt Review studies do not expire; therefore, Continuing Review Reports (Renewals) are not required.
- If a researcher wants to make a change to an Exempt study, the researcher must submit an Amendment to the IRB. RIC will review the proposed change to ensure that the activities in the study do not change the level of review.
- If the requested change does not fall within an Exempt category, the study will need to undergo an Expedited or Full Board Review prior to implementation.
- If the researcher has concerns about the IRB’s decision or recommendations, the researcher may address his/her concerns to the IRB in writing. This request should include a justification for changing the IRB’s decision. The researcher should send this request to RIC.
Exempt Review Categories
To qualify for review at the exempt level, the research must not be greater than minimal risk and must fall into one or more of the exempt categories described below.
Research not Eligible for Exempt Review
Human subject research that does not apply to one of the Exempt Review categories will undergo an Expedited or Full Board Review Process.
Research is not eligible for an Exempt Review if it:
- is greater than minimal risk
- uses vulnerable populations as research subjects (less than 18 years of age)
- involves collection of identifiable information from subjects
- involves administration or use of drugs or devices
- involves deception
- involves the audio or video recording of research participants in a non- anonymous manner
- involves exercise