To UCSB Site Back to Office of Research Main Page To Office of Research Main Page
ToolboxResearcher's Toolbox Seminar CalendarSeminar Calendar Print PreviewPrint Version

Content

Applicability and Exemptions

  1. Applicability of Review Requirements
    1. Federal Regulation - 45 CFR Part 46 requires that:
      1. All research involving human subjects conducted or funded by the Department of Health and Human Services, unless exempt (see III.A), is to be reviewed and approved by an IRB prior to any involvement of human subjects.
      2. Each institution that receives grant or contract funds from the DHHS for research involving human subjects is to assure the protection of the human subjects of research, regardless of source of funding, conducted at or sponsored by the institution.
    2. University of California Policy - Revised University Policy on Protection of Human Subjects in Research states that:
      1. The regulations of the Department of Health and Human Services, set forth in 45 CFR Part 46, are applicable to all research involving human subjects for which the University is responsible, regardless of the source if funding or whether the research is funded.
      2. Each campus is to develop a process for determining:
        1. whether an activity constitutes research under the regulations (see Definitions for the definition of research);
        2. whether the research activity is exempt from formal review.
  2. Implementing Procedures for Exemptions
    1. The UCSB Policy on the Use of Human Subjects (Research Circular D.2) specifies the following exemption procedures, put into place in July 1983.
      1. The investigator claiming exemption of a research project involving human /subjects from the requirement for HSC review will submit a request for exemption through the Office of Research Application for the use of Human Subjects (ORahs.)
      2. After provisional approval, the investigator will print out the signature page from ORahs, have appropriate signatures collected and submit to the Office of Research.
      3. If the project does not appear to meet the criteria for exemption, ORahs will exit the exemption wizard and return to the beginning of a full protocol.
      4. If an exemption claim is not confirmed, the full protocol must be completed in ORahs.
  3. Exemption Criteria
    1. Projects which involve no element of research do not require review by the HSC.
    2. Projects in which the only involvement of human subjects will be in one or more of the following do not require review by the Human Subjects Committee unless the project involves research which includes a subject population, such as prisoners, for which a Subpart of Part 46, Title 45 of the Code of Federal Regulations provides special protection.
      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;
        2. research on the effectiveness of or the comparison among instructional techniques, curricula, or class room management methods.
      2. Research involving survey or interview procedures, except where
        1. the subject population includes children.
        2. responses are recorded in such a manner that subjects can be identified and
          1. if the subject's responses became known, they could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability or reputation, or
          2. the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
      3. Research involving survey or interview procedures when the respondents are elected or appointed public officials or candidates for public office.
      4. Research involving the observation of public behavior except where responses are recorded in a manner that subjects can be identified, and
        1. if the subject's responses became known, they could place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability or reputation, or
        2. the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior , or use of alcohol.
        3. if the subject population includes children and the investigator participates in the activities being observed.
      5. Research involving 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 in such a manner that subject cannot be identified.
      6. Research and demonstration projects which are conducted by or subject to the approval of DHHS and which are designed to study, evaluate or otherwise examine:
        1. programs under the Social Security Act, or other public benefit or service programs.
        2. procedures for obtaining benefits or services under these programs.
        3. possible changes in those programs, procedures, methods or level of payment of benefits.
Office of Research, UC Santa Barbara | Report Site Problems | Accessibility | Terms of Use
Copyright © 2010-2011 The Regents of the University of California, All Rights Reserved. | UCSB website
Updated: July 18, 2013.