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Exemption and Expedition

Deciding whether your IRB application meets the standards for an exempt or expedited review is not a simple decision.  In both cases, you are requesting a certain review procedure for a particular kind of research. The terminology may seem misleading. Neither means that your research does not require a review nor that the process will be quicker. Instead, fewer reviewers are required for approval. Visit the Department of Health and Human Services Department to find the official language about exempt applications and  expedited applications.  Please read the rest of this page for better understanding of what kinds of research qualify as exempt and expedited.

Other useful sites: 

University of South Carolina: Protection of Research Subjects  

Exempt Review

Research is reviewed for Exempt status (Level I review), by an IRB committee member if it involves very minimal or no risk. There are several types of research that may qualify for Exempt status and are noted in the next section.

In general, research which does not propose to disrupt or manipulate the normal life experiences of subjects, incorporate any form of intrusive procedures, or involve deception will be exempt from full Committee review. Projects that involve more than very minimal risk and those that include any degree of deception do not qualify for Exempt status.

Please note that all of the rights and protection afforded to human subjects in research are required in Exempt status cases. Researchers engaged in human subjects research that qualifies for Exempt status must still complete a full application form and prepare an informed consent statement. Researchers must engage in practices that minimize risk, maximize benefit and ensure privacy.

Any research involving protected classes or vulnerable populations of subjects (such as prisoners, pregnant women, mentally disabled persons, research by a faculty member on his/her own students) is never Exempt. 

Types of Exempt Research

In order to be considered for Exempt (Level I) status, research must fall into one of the categories listed below. However, even for these types of research, the IRB may determine that an Expedited (Level II) or Full (Level III) review is necessary because the research has risk or there are potential ethical concerns. The checklist at the bottom of this page can help you determine whether your research qualifies for Exempt status.

Cateogries of research that qualify for Exempt status:

  1. Normal Educational Practices.
    Research conducted in established or commonly accepted educational settings involving normal educational practices, such as:
     
    1. research on regular and special educational instructional strategies
    2. research on the effectiveness of or a comparison among instructional techniques, curricula, or classroom management methods.
    3. If the research involves individuals under the age of 18, the project will not qualify as Exempt; it will require either Expedited or Full Review. Furthermore, an assent form is required for minors as well as a consent form to be signed by a parent/guardian.
  2. Educational Tests.
    Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) unless:
      
    1. the research involves minors;
    2. information taken from these sources is recorded in such a manner that the subjects can be identified;
    3. any disclosure of the subject's responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.
  3. Survey/Interview Procedures.
    Research involving survey or interview procedures with legally competent noninstitutionalized adults, except where any of the following situations exist:
     
    1. responses are recorded in such a manner that the subject can be identified, either directly or through identifiers linked to the subjects;
    2. the subject's responses, if they become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation within the community;
    3. the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, use of alcohol, drugs or other addictive products;
    4. questions that ask about sexual attitudes, preferences, practices;
    5. questions that request information pertaining to a subject's psychological well-being or mental health. 

 
Non-Exempt Survey Research 

Other areas may be considered sensitive due to specific cultural values or other factors. Such areas may include:

  1. Survey research that involves HIV status information, either with the general public or with vulnerable populations is subject to full Committee review. This is based on recent federal guidelines declaring persons with HIV status to be members of a vulnerable population and that attitudes or information about HIV status is stressful. Any survey that is likely to cause stress in the subject population requires Full Review.
  2. Any survey of or interview with children (minors under 18 years of age or adults of diminished mental capacity) requires Full Review. This includes research with school children concerning their attitudes or perceptions regarding the school system. In most cases, you will need to develop a consent form to be signed by the parent/guardian and an age-appropriate assent form for the child.
  3. Observation.
    Research involving the observation of public behavior of legally competent noninstitutionalized adults, except where the conditions explained in 3. a., b., and c. above exist. No active consent is required for observation of public behavior. You must obtain consent, however, if you will take photographs, films or videotapes of subjects.
  4. Secondary Use of Data.
    Research involving the collecting or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a manner that subjects cannot be identified. For example, the review of medical records or student school records where subject identifier numbers are available is subject to full Committee review unless the data is gathered by an employee who has legitimate access to the records and who turns over "blinded" data to the investigator.
  5. Evaluation of Federal Research and Programs.
    Research and demonstration projects which are designed to study, evaluate or otherwise examine public benefit or service programs.
  6. Taste Tests.
    Research involving taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed. 

 
Expedited Review

An expedited review, is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the entire IRB. The term "expedited" can be misleading: reviews of this type are not "quicker" or conducted with less rigor, but fewer reviewers are required for approval. There are several types of research that may qualify for Expedited review.

In general, research may be considered for Expedited review if it involves no more than minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate consent procedures. Expedited review may also be used when minor changes have been made to a previously approved research project during the period (of one year or less) for which approval is authorized.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those encountered in daily life or during the performance of routine physical or psychological examinations or tests. Please keep in mind that research does not count as having "minimal risk" simply because it involves minimal physical risk or is non-invasive. There are many kinds of risk including financial risk, employment risk, criminal/civil liability, stigmatization, insurability and embarrassment. It is important to consider all of these when assessing risk.

Researchers engaged in human subjects research that qualifies for Expedited (Level II) review must still complete a full application form and prepare an informed consent statement. Researchers must engage in practices that minimize risk, maximize benefit and ensure privacy.

 
Types of Expedited Reviews

  1. Clinical studies of drugs and medical devices only when: 
     
    1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
    2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from:
     
    1. healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week;
    2. other adults considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
  3. Prospective collection of biological specimens for research purposes by noninvasive means.
    Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid at time of rupture of the membrane or prior to or during delivery.
  4. Collection of data on subjects 18 years of age or older through noninvasive procedures routinely employed in clinical practice, excluding procedures involving x-rays or microwaves as well as procedures involving general anesthesia or sedation. Where medical devices are employed, they must be cleared/approved for marketing.
     
    Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes such as medical treatment or diagnosis.
  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
  7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior); or Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
  8. Continuing review of research previously approved by the entire IRB as follows:
     
    • where the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions, and the research remains active only for long-term follow-up of subjects; or
    • where no subjects have been enrolled and no additional risks have been identified; or
    • where the remaining research activities are limited to data analysis.
  9. Continuing review of research in which the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
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