A. General Information

There are six categories of research activities involving human subjects that may be exempt from the requirements of the Federal Policy for the Protection of Human Subjects (45 CFR 46). If research is found to be exempt, it need not receive full or subcommittee (expedited) review. However, individual investigators do not have the authority to determine that their own research qualifies for exempt status; this determination must be made by the Office for Protection of Human Subjects (OPHS) staff, upon review of a Request for Determination of Exempt Status application submitted by the investigator. The research may not begin until the investigator has received notification that the research qualified for exemption. In order to be eligible for exempt status, all of the proposed research activities of a study must fit in one or more of the six exemption categories listed below; OPHS cannot exempt parts of the research project. In addition, the OPHS staff, in consultation with the OPHS Director and/or CPHS Chair/ Designee, may forward an exempt application to the Chair or full committee for non-exempt review on a case-by-case basis.

Although research that qualifies for exempt status is not governed by federal requirements for research involving human subjects, investigators still have a responsibility to protect the rights and welfare of their subjects, and are expected to conduct their research in accordance with the ethical principles of Justice, Beneficence and Respect for Persons described in the Belmont Report. See also Part D, Respect for Persons and Informed Consent, below.

Note: Before applying for exempt status, investigators should confirm that their study is, in fact, considered research on human subjects. For example, some research involving the use of coded private information or specimens does not require CPHS or OPHS review at all. See CPHS Guidelines on Activities that Require CPHS/OPHS Review for more information.

B.  Research That Is Not Exempt

Research that involves greater than minimal risk: Research eligible for exemption usually involves negligible risks to subjects. When reviewing an application for exempt status, OPHS staff apply the “minimal risk” standard. As defined in the federal regulations, minimal risk means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Research that involves greater than minimal risk will not qualify for exempt status.

Research with vulnerable populations: Certain research activities are not eligible for exempt status because additional protection has been granted by federal regulations for vulnerable populations. Specifically, the following do not qualify for exempt status: (1) survey or interview of children; (2) observation of the public behavior of children when investigators interact with the children; and (3) research involving prisoners.

Research regulated by the Food and Drug Administration (FDA): With the exception of Category 6, FDA-regulated research does not qualify for exempt status. In addition, research will not qualify for exempt status under Category 6 if there have been food and color additives incorporated into the food product and these additives are used in research with the intent to apply to the FDA for marketing of the additive.

Research using UC Berkeley protected health information (PHI): Research involving protected health information from the UCB Tang Health Center, the Optometry Clinic, or the Psychology Clinic does not qualify for exempt status. See HIPAA and Human Subjects Research for more information.

C. Exemption Categories (per 45 CFR 46.101(b)) and Examples

1. Educational Practices: 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.

As noted above, research must be conducted in “established or commonly accepted educational settings” and involve “normal educational practices” to be exempt under this category.

Commonly accepted educational settings include but are not limited to K-12 schools and college classrooms. They may also include after-school programs, preschools, vocational schools, alternative education programs, and other sites where educational activities regularly occur.

Normal educational practices include established teaching methods, curriculum content and commonly accepted classroom management techniques that are planned and implemented by the classroom teacher. Normal educational practices are activities that would occur regardless of whether the research is conducted. Thus, a study that evaluates a radically new instructional strategy or curriculum, or that randomly assigns students to different instructional strategies/curricula for comparison, would probably not be exempt, since these are not “normal educational practices.” Studies that involve surveys and interviews with minors that are outside of “normal education practices” also do not qualify for exemption.

Examples of Research Exempt under Category 1:

• A study evaluating the effectiveness of a commonly accepted science curriculum. For the study, researchers will observe classroom instruction and collect quizzes and class evaluations that are part of the curriculum and classroom practices.
• A study comparing two curricula that are currently being implemented in a school. Researchers will observe classrooms as well as interview instructors about their experiences implementing the instructional materials (but not about specific students).
• A study comparing driver’s education curricula offered by area driving schools. The researcher will observe classes and compare driving test scores at the end of the courses.

2. Educational Tests (Cognitive, Diagnostic, Aptitude, Achievement), Survey Procedures, Interview Procedures, or Observation of Public Behavior: Research involving these procedures is exempt if: (a) the information obtained is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects; or (b) any disclosure of the subject’s responses outside of 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 exempt category applies only to the activities listed above. Public behavior refers to behavior taking place in a publicly accessible location in which the subject does not have an expectation of privacy (e.g., a public plaza or park, a street, a building lobby, a government building). If subjects have a reasonable expectation of privacy at the location where the researcher is conducting the observation, the project may not be considered exempt.

Note: Research involving surveys or interviews with children or observation of public behavior when investigators interact with the children does not qualify for exemption.

The research must meet either of the following two conditions to qualify under Category 2:

(1) The data is collected anonymously (which means that no identifiers can be connected to the data, either directly or through a coding system). In addition to videotapes and photographs, audio recordings are considered to be identifiable; therefore any data collection that involves audio recordings, video recordings, or photographs of subjects would not be considered anonymous. It is also possible that multiple pieces of information, none of which are identifiable on their own, may uniquely identify a person when brought together; in this case, the data would be identifiable and would not be considered anonymous.

(2) The information collected is not anonymous (because, for example, the researcher has a key linking respondents’ names to coded identifiers), but the information is so innocuous that, in the event of disclosure outside of the research, there would be no significant detrimental consequences to the subject. The significance of “detrimental consequences” depends in part on context. For example, including a question about sexual identity in an interview study that investigates adults’ plans to change careers could be non-controversial – and exempt – in some locales, but highly sensitive – and non-exempt – in other places.

Examples of Research Exempt under Category 2:

• A study involving an anonymous survey regarding workplace satisfaction at area firms.
• An observational study of pedestrians crossing a street; the researcher takes notes of what occurs, recording sex, race, and type of clothing of pedestrians, but does not interact with subjects.
• A study involving interviews with college seniors (age 18 and older) about their plans after graduation. The answers to questions asked would present no risks to subjects if divulged outside the research.
• A study involving focus groups with expectant mothers regarding their perceptions of parenting education.

3. Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public Behavior: Research involving these procedures that is NOT exempt under Category 2 can be exempt only 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 confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Part (a) includes the research procedures previously described in Category 2, but holds public servants (i.e., public officials and candidates for public office) to a different privacy standard by not requiring that the data be collected anonymously, and is not concerned with any risks that may result from disclosure of the data. This category does not apply to public employees such as managers and staff in public agencies/offices.

Part (b) of this category applies only to research on specific programs conducted or supported by the Department of Justice or the National Center for Education Statistics. These agencies have specific programs that create databases which are protected by law from being accessed by anyone other than those agencies. The data collected for these programs is immune from legal process and cannot be revealed or furnished for any purpose other than that for which it was collected.

Examples of Research Exempt under Category 3:

• A study that includes interviewing town mayors about their religious beliefs and views on the separation of church and state.
• A study of candidates for the State Legislature that includes intelligence tests and interview questions about their finances, past employment, and drug use.

4. Existing Data: Research involving collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens: (i) if these sources are publicly available; or (ii) 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.

In order to qualify for this exemption, the materials to be used in the research must be existing or “on the shelf” at the time that the research is proposed. This category does not apply to the prospective collection of data or specimens. Note: Many projects involving the use of existing data/specimens do not meet the threshold definition of “human subjects” research. See CPHS Guidelines on Activities that Require CPHS/OPHS Review for more information.

Research can be exempted if the data is publicly available (the general public can obtain the data/biological specimens and they are available to anyone regardless of occupation, purpose, or affiliation). Research can also be exempted if the investigators initially have access to identifiable private information but abstract the data needed for the research in such a way that the information can no longer be connected to the identity of the subjects. This means that the abstracted data set does not include direct identifiers (names, social security numbers, addresses, phone numbers, etc.) or indirect identifiers (codes or pseudonyms that are linked to the subject’s identity).

Examples of Research Exempt under Category 4:

• A research study of treatment outcomes for a certain drug that involves the review of patient charts at a non-UCB medical facility. The researcher records patient age, sex, diagnosis, and treatment outcome in such a way that the information cannot be linked back to the patient.
• A graduate student has access to coded data from a study previously conducted by her faculty advisor and records the information she needs for her research without the code, so that the data being analyzed for the research can in no way be traced back to individual subjects.

5. Research and Demonstration Projects Conducted by or Subject to the Approval of Department or Agency Heads: This research is exempt if it is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in methods or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
          
Exemption Category 5 only applies to research on public benefit programs (such as Social Security) conducted by the federal government and therefore is rarely, if ever, applied to research at UC Berkeley. Research and demonstration projects in general (e.g., state or city funded public service programs) do not fit under this exempt category.

6. Taste and Food Quality Evaluation and Consumer Acceptance Studies: This research is exempt, if: (i) wholesome foods without additives are consumed; (ii) 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 (EPA) or the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA); or (iii) a food is consumed that contains an agricultural chemical or environmental contaminant at or below the level found to be safe by the FDA or approved by the EPA or the FSIS of the USDA.

Taste and food quality evaluation studies conducted under this exemption may not involve the consumption of any type or volume of food that would present any risk to the subjects and should fall into what would be considered reasonable eating behaviors by the subject.

The food must be “wholesome” (no additives), or if it involves plants or animals raised for food products, the level of chemical additives or environmental contaminants must be at or below the levels approved by the FDA, EPA, or USDA. Studies involving the consumption of alcohol, vitamins, and other supplements do not qualify for exempt status.

Examples of Research Exempt under Category 6:

• A taste-test on different varieties of a fruit to determine consumer preference, when the fruits do not have any additives and subjects are asked to indicate which fruit they prefer.
• A study that involves taste-testing of various beef products from cattle that have been given feed with a chemical additive. If the researcher can document that the amount of the additive was at or below the levels approved by the USDA, the research may qualify for an exemption.

D. Respect for Persons and Informed Consent

The Belmont Principle of Respect for Persons generally requires that subjects be given the opportunity to choose whether or not to participate in research. For this reason, voluntary informed consent should be obtained from participants for any exempt research where the investigator will be collecting data through interaction with the participant. OPHS does not review consent materials for exempt research but recommends that researchers provide participants with, at a minimum, the information listed below during the consent process and before any data collection begins. In some cases, researchers may find it necessary or appropriate to provide more information.

Minimum Consent Information:

1. The identity/affiliation of the researcher

2. A clear description of the study procedures

3. A statement that participation in the research is voluntary

E. Change/Modifications to Exempt Research

An exempt determination is not subject to annual continuation/ renewal review, as long as the research remains the same. However, all modifications to a project previously deemed exempt must be submitted to OPHS for review and certification of exemption prior to implementation. In some circumstances, proposed changes to the protocol may disqualify the project from exempt status, in which case either expedited or full committee review will be required as appropriate.