RSP 201–03: Human Subjects in Research—Exemption and Expedited Review

To identify exempt categories and allow expedited review of research activities that may not require full committee review

45 Code of Federal Regulations § 46 (2005)

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, April 18, 1979

All research projects that involve human subjects must be submitted to the Research Compliance Office for review by the ASU Human Subjects Institutional Review Board (IRB). Some research may be exempt from full committee review or may qualify for expedited review, according to federal guidelines.

Laws, regulations, policies and procedures, The Belmont Report, and pertinent information such as periodicals, newsletters, and books are maintained in the Research Compliance Office for researchers to use.

Investigators should use the Application for Exempt Research for research projects that fall under any exempt category as defined by 45 Code of Federal Regulations 46.101 (b). No studies involving vulnerable populations may be classified as exempt from review. The IRB may classify research activities as exempt from review if the only involvement of human subjects will be in one or more of the following categories:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
   
   1. research on regular and special education instructional strategies

      or

   2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement), survey procedures, interview procedures, or observation of public behavior unless:
   
   1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects

      and

   2. any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

   Note:

   Questionnaires should be accompanied by a cover letter advising potential subjects that their participation is voluntary and that their privacy will not be violated. A sample of an appropriate cover letter is available from the Research Compliance Office.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, if:
   
   1. the human subjects are elected or appointed public officials or candidates for public office

      or

   2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

   Note:

   Questionnaires should be accompanied by a cover letter advising potential subjects that their participation is voluntary and that their privacy will not be violated. A sample of an appropriate cover letter is available from the Research Compliance Office.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects that are conducted by or subject to the approval of department of agency heads, and that are designed to study, evaluate, or otherwise examine:
   
   1. public benefit or service programs
   2. procedures for obtaining benefits or services under those programs
   3. possible changes in or alternatives to those programs or procedures

      or

   4. possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies, if:
   
   1. wholesome foods without additives are consumed

      or

   2. a food is consumed that contains a food ingredient at or below the level for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

The IRB may use an expedited review procedure for research activities that present no more than minimal risk to human subjects and involve only procedures in one or more of the categories listed below.

1. Clinical studies of drugs and medical devices only when:
   
   1. research on drugs for which an investigational new drug application is not required

      or

   2. research on medical devices for which:
      
      1. an investigational device exemption application is not required

         or

      2. 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 as follows:
   
   1. not more than 550 ml in an eight-week period from healthy, nonpregnant adults who weigh at least 110 pounds; collection may not occur more frequently than two times per week

      or

   2. not more than the lesser of 50 ml or 3 ml per kg in an eight-week period from other adults and children considering 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; collection may not occur more frequently than two times per week.

3. Prospective collection of biological specimens for research purposes by noninvasive means including:
   
   1. hair and nail clippings in a nondisfiguring manner
   2. deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
   3. permanent teeth if routine patient care indicates a need for extraction
   4. excreta and external secretions including sweat
   5. uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue
   6. placenta removed at delivery
   7. amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
   8. supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
   9. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings

      or

   10. sputum collected after saline mist nebulization.

4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications. Examples include:
   
   1. 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
   2. weighing or testing sensory acuity
   3. magnetic resonance imaging
   4. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography

      or

   5. moderated 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. Some research in this category may be exempt; this category refers only to research that is not exempt.
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. Some research in this category may be exempt; this category refers only to research that is not exempt.
8. Continuing review of research previously approved by the convened IRB where:
   
   1. the research is permanently closed to the enrollment of new subjects
   2. all subjects have completed all research-related interventions

      and

   3. the research remains active only for long-term follow-up of subjects

   or where

9. 1. no subjects have been enrolled and no additional risks have been identified

      or

   2. the remaining research activities are limited to data analysis.

9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two through eight above do not apply but 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.

The standard requirements for informed consent apply to projects approved by the use of expedited review.

For additional specific information, see:

1. RSP 201–01, “Human Subjects in Research—General”
2. RSP 201–02, “Human Subjects in Research—Application and Consent”
3. RSP 201–04, “Human Subjects in Research—Project Monitoring”

   and

4. RSP 201–05, “Human Subjects in Research—Assurance of Compliance.”

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