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IRB-HSR > Protocol Review Process > Levels of Review > Exempt Criteria

 

 

 

 

 

 

Exempt Criteria

Unless otherwise required by the IRB, research activities designated in 45 CFR 46 or 21 CFR 56.104(ad), in which the only involvement of human subjects will be in one or more of the following categories, may be considered by exempt review by the IRB:

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Educational research proposals are exempt providing all of the following are met:
    1. All of the research is conducted in a commonly accepted educational setting (e.g., a private or public school).
    2. The research involves normal educational practices (e.g., comparison of instructional techniques).
    3. The study procedures do not entail a significant deviation in time or effort from those educational practices already existent in the study site.
    4. The study procedures do not involve an increase in the level of risk or discomfort beyond
    5. normal, routine educational practices, including physical education.
    6. The study procedures do not involve deception or withholding of information.
    7. The study procedures do not involve sensitive topics, such as sexual behavior of individual
    8. subjects. A sensitive survey is one that deals with socially questionable or highly personal issues or alcohol and/or drug abuse.
    9. Provisions are made to ensure the existence of a non-coercive environment for all students, including those who choose not to participate.
    10. The school or other agency grants written approval for the research to be conducted.
    11. Educational tests of (i) knowledge, (ii) mastery, or (iii) skills.
  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.
  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) (b) of this section, if: (a) the human subjects are elected or appointed public officials or candidates for public office or (b) Federal statue(s) require(s) without exception that the confidentiality of the personally identifiable information be maintained throughout the research and thereafter. Copies of the informed consent form and questionnaire or survey instrument(s) to be used must be forwarded to the IRB for review.
  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 which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs. This category may also be applied to service/program evaluations of State, city or county programs providing: (a) the program being studies delivers public benefits or services; (b) there is specific statutory authority over the program; (c) there is no statutory requirement that the program evaluation plan be reviewed by an IRB; and (d) there is no significant intrusion or invasion of the privacy of the participant.
  6. Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed; (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe by the Food and Drug Administration (FDA) or approved by the Environmental Protection Agency or the Food Safety and Inspection Services of the U.S. Department of Agriculture. The following categories of clinical investigations regulated by the FDA (21 CFR 56) are exempt from the requirements of this part for IRB review:
    1. Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981.
    2. Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date.
    3. Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.
    4. Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed; (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe by the Food and Drug Administration (FDA) or approved by the Environmental Protection Agency or the Food Safety and Inspection Services of the U.S. Department of Agriculture.

Breach of Confidentiality

Additional consideration for exemption includes whether there is a risk associated with a possible breach of confidentiality (i.e., accidental disclosure of drug use to law enforcement personnel). In surveys with potential psychological risk, review of exemption includes risks associated with surveys about sensitive topics as well as those resulting from a breach of confidentiality. When confidentiality is an issue, the presence or absence of subject identifiers may be a decisive factor in determining if a study may be considered exempt.

Questionnaires/Surveys/Interviews

Questionnaires or surveys covering sensitive topics may qualify for a Claim of Exemption if they fulfill the following:

  • anonymity of the subject is guaranteed,
  • potential subjects are fully informed of the sensitive nature of the topics prior to their participation,
  • the study does not exceed minimal risk; and
  • children are not involved as subjects.

Existing Data, Documents, and Human Biological Specimens

Research involving existing data, documents and/or specimens is typically exempt under Exempt Category 4 as long the following conditions pertain:

  • The data, documents and/or specimens exist prior to the conceptualization of the research project. OHRP indicates that the term "existing" refers to data, documents, biological material and/or tissue "archived" or "on the shelf" prior to the conceptualization of the research project and prior to review by the IRB.
  • The data, documents and/or specimens are publicly available. Data, documents and/or specimens whose access is restricted to select groups are not publicly available.
  • The information from the data, documents and/or specimens must be recorded in such a manner that subjects cannot be identified directly, or through identifiers linked to the subjects.
  • The researcher must provide written confirmation to the IRB that permission for the use of data, documents and/or specimens has been granted by the gatekeeper and that the information is publicly available.

Determination of Non-Human Subject Research

Some research on archived data / pathology or diagnostic specimens may be considered to be non- human subject research and do not require IRB approval.

Use of Private Information

Please note that research, which includes review of private records involving access to and recording of identifiable information, requires IRB /Privacy Board review. Records considered private based on federal and state statutes, include medical records, insurance records, and educational records.

Protocols Not Eligible for Exemption

Specimen Protocols

The following types of studies would not meet an exempted from review by the IRB:

  • Material or tissue that has not been archived prior to the submission of the research protocol to the IRB
  • Research with residual material where the investigator intends to identify the subject/subject donor with the acquired sample, either for future purposes or with the intent that the research results may have implications for diagnostic or clinical decisions
  • Requests for additional material, i.e., blood, tissue, bodily fluid, from a subject or subject who is scheduled for a diagnostic or clinical procedure.. IRB review is required regardless of the amount of extra material requested and regardless of the purpose for which it is procured.
  • Specimens received as extra material or extra specimens requested from a physician conducting a clinical procedure are not pre-existing or "archived".

Certain Research Involving Children

Research that involves children and falls into categories 1 - 6 described above under Exempt Criteria may be found to be exempt by the IRB.

However, the exemption category 2 at 45 CFR 46.101(b)(2), pertaining to survey or interview procedures or observations of public behavior, does not apply to research involving children, except for research involving public behavior when the Investigator does not participate in the activities being observed.

Research Involving Prisoners

Research under Exempt Criteria categories 1-3, 5 & 6 is not exempt if it involves prisoners. These applications must be submitted for IRB review. However, certain epidemiological research under category 4 may qualify for exemption.

Observational Research

Observational research involving sensitive aspects of subjects' behavior, or in settings where subjects have a reasonable expectation of privacy, is not exempt.

In addition, observation of children is not exempt from IRB review if the researcher participates in or influences the observed activities.

Sensitive Research

Sensitive survey research is seldom exempt from IRB review (see below for exceptions). A sensitive survey includes questions about illegal activities, or highly personal aspects of the subject's behavior, life experiences, or attitudes.

Examples include chemical or substance abuse, sexual activity or attitudes, sexual abuse, criminal behavior, sensitive demographic data, detailed health history, etc.

The potential for provoking a negative emotional reaction from subjects is a principal determining factor in sensitive survey research.

Projects involving classified research cannot be completed by exempt review.

IRB Oversight of Exempt Studies

The IRB retains the right to require oversight and continuing review when warranted by the nature of the research and/or inclusion of vulnerable subject populations even though it may not be required by federal regulation.

This right may be exercised in situations when the IRB:

  1. Has sufficient reason, through anonymous reports, to suspect that the research is not being conducted as described in the submitted protocol and no modifications to the protocol have been received noting changes in the protocol,
  2. Receives a complaint from a subject about the conduct of the research,
  3. Receives a complaint from another investigator or associate of the researcher,
  4. Believes that the research, while meeting the exempt research criteria, could unfairly embarrass individuals, the University or the University's research affiliates,
  5. Has other reasons yet to be determined.

Modifications to Exempt Studies

If the researcher wishes to modify the procedures in a project approved under Exempt review, they must submit the modification to the IRB so that the IRB can determine if the project still meets Exempt criteria.  The modification may not be implemented until the IRB has reviewed the change.

Quality Assurance

Many agencies and/or departments routinely collect data or information as part of an ongoing quality-control or quality assurance process. In most situations, the collection of such information does not constitute research and is, therefore, not reviewable by the IRB. In addition, educational agencies may collect information related to student progress or to assess the effectiveness of new programs or projects. As with quality control or quality assurance information, the data collected by educational agencies is usually not reviewed by the IRB. The IRB becomes involved when researchers wish to access this information for research purposes.

Submission Process

Proceed to Protocol Builder.  Answer the questions appropriately.  When you get to the question- "Does this study meet exempt approval criteria?  Answer the question  YES.  Protocol Builder will then provide you with the appropriate documents to complete.

 

*Taken from UVa IRB-HSR Research Guidance