II. What Research is Exempt from UCSC IRB Oversight

To determine if your proposed research is exempt from full UCSC IRB review you must make a Declaration of Exemption. The Declaration of Exemption Form takes you through the process of determining whether or not your human subjects research is exempt. If the UCSC IRB determines that your Declaration is valid, then UCSC IRB will not further review your project other than confirming that the request for the exemption is granted.

If a researcher proposes to request an exemption from full review by the UCSC IRB, please contact the UCSC IRB Office to obtain the appropriate Declaration of Exemption Form or download them from the OSP Web site (http://www.ucsc.edu/osp/forms.html).

A. Exemptions:

Research in which the only involvement of human subjects is in one of the following categories is exempt from full review by the UCSC IRB, provided that the researcher submits and obtains Committee approval of a Declaration of Exemption. No research is exempt if any of the targeted populations for this research consists of persons who are:

• legally incompetent;
• significantly mentally ill or impaired; or
• vulnerable to extraordinary institutional coercion, such as prisoners, residents of 24-hour skilled nursing facilities, or anyone who is involuntarily confined.

B. Categories:

1. Educational Practices: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.
   This exemption does not apply to the school records of identifiable students or interviewing instructors about them.
   
2. Educational Tests: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) is exempt, if:
   1. in the researcher's private data (including field notes) as well as in any published material, information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects; or
   2. the information, if disclosed outside the research, could not reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.
      
3. Surveying or Interviewing:
   
   1. Research involving survey or interview procedures is exempt if:
      1. in the researcher's private data (including field notes) as well as in any published material, responses are recorded anonymously and in such a manner that the human subjects cannot be identified, directly or through identifiers linked to the subjects; or
      2. the responses, if disclosed outside the research, could not reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.
         
         Except in unusual political circumstances, surveys or interviews concerning attitudes on public issues are within section (a)(ii) of this exemption.
         
   2. This exemption does not apply if the subjects are minor children. "Minor children" are persons who have not attained the legal age for consent under the applicable jurisdiction in which the research will be conducted. In the United States, this age is 18 years.
      
4. Public Observations: Research involving the observation of public behavior, including observation by participants, is exempt if:
   
   1. in the researcher's private data (including field notes) as well as in any published material, observations are recorded in such a manner that individual human subjects cannot be identified, directly or through identifiers linked to the subjects; or
   2. the observations, even if disclosed outside the research, could not reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.

   This exemption applies to research involving minor children only when the investigator does not participate in the activities being observed. "Minor children" are persons who have not attained the legal age for consent under the applicable jurisdiction in which the research will be conducted. In the United States, this age is 18 years.

5. Public Officials: All research involving educational tests, survey or interview procedures, or public observations is exempt without exception when the respondents are elected or appointed public officials or candidates for public office.
   
6. Existing Data: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens is exempt, (a) if these sources are publicly available, or (b) if in both the researcher's private data (including field notes) and in any published material, the information is recorded by the researcher in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

   NOTE: all procedures for all subjects in a project must be exempt in order for the project to be exempt from full Committee review.

DRAFT (January 2000)

 

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This page modified April 6, 2000 by dmriggs@cats.ucsc.edu