Introduction

DHHS regulations (45 CFR 46.101) describe six categories of research that may qualify for exempt status. Exempt status means that the activities meet the federal definition of human research but pose so little risk that they need not undergo a complete IRB review and approval process.

At UT Southwestern, proposed studies falling into one or more of the exempt categories are required to undergo review by an IRB Chair or designee to verify that the research meets the criteria for exemption. Click here to review the criteria for Exempt Categories.

Please review the criteria carefully. Research will be verified as exempt only when all the activities involving human subjects fall into one or more of these categories. The IRB may not expand or create new categories of exempt research.

Examples

1. A retrospective chart review study (with waiver of informed consent) to extract research data in such a manner that subjects cannot be identified by the research team.
   
   
2. An anonymous questionnaire with waiver of consent documentation (consent implied by completion of questionnaire).
   
   
3. A survey by interview when the data to be collected could not reasonably put the subjects at risk (e.g. criminal prosecution, deportation, job loss, etc.)
   
   
4. Secondary analyses of existing human specimens when provided to the investigator without identifiers and without the possibility of obtaining identifiers.

Important Exceptions

Research involving survey or interview procedures in children are not exempt.

Research involving observations of public behavior in children are not exempt unless the investigator(s) do not participate in the activities being observed.

Research involving individuals who are or who become prisoners is not permitted under any of the exempt categories.

Submission Instructions

To submit a study for IRB verification of exempt status, please send a letter to the IRB Chair at mail code 8843. In order for the IRB Chair or designee to confirm exempt status, it is important that the investigator thoroughly explain the proposed activities involving living humans or information about living humans (this includes biologicial specimens).

Please include the following information in the memo:

• study title;
• a brief description of the proposed study, and how the study meets one or more of the exempt criteria;
• the source(s) of all research materials;
• methods used to maintain confidentiality of the information collected (if applicable);\\
• list of other research personnel and their institutional affiliations;
• training dates for human subject protection and HIPAA Research training for the PI and all study personnel (Note: for more information on required training please see IRB website at: http://www8.utsouthwestern.edu/utsw/cda/dept27777/files/68335.html); and
• study sites, funding sources, other facilities involved and their role(s) in the study.
• The memo should be signed by the PI. The Department Chair’s signature is not required for exempt studies. (Note: please see the policy regarding PI eligibility at: http://www8.utsouthwestern.edu/utsw/cda/dept27777/files/282171.html)

Other Information to Include with Your Submission:

• If applicable, include any data collection sheets, questionnaires, surveys, interview scripts or recruitment materials.
• Studies that meet the exempt criteria do not necessarily qualify for waivers of informed consent or exemption from HIPAA requirements. If applicable, please include the informed consent or provide justification for a waiver of informed consent, or waiver of documentation of informed consent (i.e. verbal consent). If individually identifiable information will be collected, please also include a HIPAA Authorization or Waiver of Authorization. These templates/forms may be found at: http://www8.utsouthwestern.edu/utsw/cda/dept27777/files/55431.html.
• If you are requesting approval to collect or study existing data or biological specimens (i.e. Category 4) that are coded or linked to identifiers, please provide a letter from the investigator or entity providing the coded data or specimens stating that the key to decipher the code will not be disclosed to the research team under any circumstances. (Otherwise the study will not qualify for exemption and will have to be reviewed via the expedited or full-board mechanisms.)
• If data and/or specimens originally were collected under a different IRB-approved research protocol or for a repository, please include the IRB number of the study for which the data and/or specimens originally were obtained.

IRB Review

Exempt submissions are first reviewed by the IRB Coordinator. If there are missing documents or if further information is required, the IRB Coordinator will contact the PI and/or Research Coordinator. Once the file is complete, the IRB Chair will review the submission and either verify that the exempt criteria are met, request changes or additional information, or require review under expedited or full-board review procedures. This process generally takes 10 business days.

Study Management

Exempt research is not subject to annual continuing review requirements. However, if the research requires any modifications after the initial IRB approval, the submission and approval of a modification is required prior to implementation. More information about modifications may be found at:
http://www8.utsouthwestern.edu/utsw/cda/dept27777/files/68302.html

Please notify the IRB by e-mail or memo when the study is complete and may be closed.

For More Information
Please contact the IRB Exempt/Expedite Coordinator at 214-648-3060 if further assistance is needed.