Applicability and Exemptions

I. Applicability of Review Requirements

  A. Federal Regulations 56 FR 28012-28018 and 45 CFR Part 46, both as revised 6/18/91 effective 8/19/91, require that:

    1. All research involving human subjects conducted, funded or otherwise subject to regulation by any federal department or agency, unless exempt (see heading III), be reviewed and approved by an IRB prior to any involvement of human subjects.

    2. Each institution that receives grant or contract funds from any federal department or agency governed by 56 FR 28012-28018 for research involving human subjects assure the protection of the human subjects of research, regardless of source of funding, conducted at or sponsored by the institution.

  B. University of California Policy—Revised University Policy on Protection of Human Subjects in Research states that:

    1. Federal regulations set forth in 56 FR 28012-28018 and 45 CFR Part 46, are applicable to all research involving human subjects for which the University is responsible, regardless of the source of funding, where the research is conducted or whether the research is funded.

    2. Each campus is to develop a process for determining

      a. whether an activity constitutes research under the regulations (see heading 'Definitions' for the definition of research);

      b. whether the research activity is exempt from formal review.

II. Implementing Procedures for Exemptions

  A. The UCSB Policy on the Use of Human Subjects (Research Circular No. D.2., formerly 22-72, revised August 1991) specifies the following exemption procedures, put into place in July 1983 and revised in August 1991.

    1. The investigator claiming exemption of a research project involving human subjects from the requirement for HSC review will submit a completed UCSB/OR Form 112X to the Head of the Investigator's Department or ORU.

    2. The Department/ORU Head will, if concurring with the exemption claim, sign the completed Form 112X and forward it to the Office of Research for the signature of the HSC Chairperson or other designee.

    3. If the project does not appear to meet the criteria for exemption, the investigator will be contacted by a representative of the HSC.

    4. When the completed Form 112X has been signed by both the Department/ORU Head and the HSC Chairperson, a copy will be returned to the Department/ORU head, and the original will be filed in the Office of Research.

    5. If an exemption claim is not confirmed, the project must be modified and the exemption request resubmitted. Or the full HSC protocol form (UCSB/OR Form 112f) must be completed for the proposed project.

II. Implementing Procedures for Exemptions

The UCSB Policy on the Use of Human Subjects (Research Circular No. 22-72, revised July 1983) specifies the following exemption procedures, put into place in July 1983.

 BEFORE RUNNING *ANY* SUBJECTS:

  A. The investigator claiming exemption of a research project involving human /subjects from the requirement for HSC review will submit a completed UCSB/ORDA Form 112X (Claim of Exemption from Requirement for Review of Use of Human Subjects) to the Head of the Investigator's department or ORU.

  B. The Department/ORU Head will, if concurring in the exemption claim, sign the completed Form 112X and forward to to the Office of Research for approval by the HSC.

  C. If the project does not appear to meet the criteria for exemption, the investigator will be contacted by a representative of the HSC.

  D. When the completed Form 112x has been signed by both the Department/ORU Head and the HSC Chairperson, a copy will be returned to the Department/ORU Head, and the original will be filed in the Office of Research.

  E. If an exemption claim is not confirmed, the standard application (UCSB/ORDA Form 112f must be submitted to the HSC.

III. Exemption Criteria

  A. Projects which involve no element of research do not require review by the Human Subjects Committee.

  B. Unless otherwise required by Federal Department or Agency head(s), research activities in which the only involvement of human subjects will be in one or more of the following require only an Exemption form (112X) unless the project involves research that includes a subject population, such as prisoners, pregnant women, fetuses, or in vitro fertilization, 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

      a. research on regular and special education instructional strategies;

      b. 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, achievement),

 survey procedures (using adults only),

 interview procedures (using adults only), or

 observation of public behavior (children allowable if investigator does not participate in the activity observed), unless:

        a. information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects; and

          (i) ANY disclosure of the 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, (using adults only),

 interview procedures, (using adults only) or

 observation of public behavior, (children allowable if investigator does not participate in the activity observed) that is not exempt under paragraph 2, if:

    a. the subjects are elected or appointed public officials or candidates for public office; or

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

  4. The Research involves 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. The Research and demonstration projects are conducted by or subject to the approval of Federal Department or Agency heads, and are designed to study, evaluate or otherwise examine:

    a. Public benefit or service programs;

    b. procedures for obtaining benefits or services under these programs.

    c. possible changes in or alternatives to these programs or procedures

    d. possible changes in methods or levels of payment for benefits or services under these programs.

    6. Taste and food quality evaluation and consumer acceptance studies, if:

      a. wholesome foods without additives are consumed, or

      b. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the Food Safety and Inspection Service of the USDA.

  C. Federal Department or Agency heads retain final judgment on whether specific research or classes of research subject to regulation by the Department or Agency can be exempted from review.

  D. Compliance with this policy does not affect any Federal, state, local or foreign laws or regulations that provide additional protections for human subjects.