Research Exempt from Full Review

(effective 21 JAN 2019)

Although the category is called "exempt," this type of research does require the principle investigator to submit a CUHSR application. Only CUSHR can make the determination if a human subject research protocol is exempt from a full review and thus exempt from all the federal regulations regarding human subjects in research. The exempt review process is less rigorous than an expedited or full-committee review. To qualify, research must fall into one of eight (8) federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous, publicly-available or de-identified data, or the conduction of very benign behavioral research experiments. The exempt human subjects research must still be conducted in a manner that meets general ethical guidelines such as:

1. The research has no or very little risk (many minimal risk studies may be considered under expedited review)
2. The selection of participants is equitable
3. Adequate provision are made to maintain the confidentiality of the data
4. If there are interaction with participants, a consent process should be in place that discloses such information as:
1. The activity involves research
2. A description of the procedures and the nature of the information collected
3. Participation is voluntary
4. Adequate provisions to maintain the privacy of the participants
5. Name and contact information for the researcher
   
   (See the consent template of exempt studies)

Some of the following factors that may raise questions in the review whether a protocol is exempt or not:

1. The protocol does not clearly fit into one of the exempt categories. The application should be written so that it is clear to the reviewer which category the research falls under.
2. The data is not collected anonymously. Data is considered anonymous if there is not a link between participant identifiers and the data. The application should be very clear as to how the data is managed to be considered anonymous.
3. Demographics information collected is so extensive such that individuals could be identified. The application should be clear whether demographics information is used to only describe the subject pool and not linked to the primary data, or if the (or which) demographics are variables of interest and linked to the data.
4. The data collected is sensitive and if identified would put an individual at risk.
5. The questions asked could be disturbing to the individual.
6. If there were potential violations in collecting protected health information (HIPAA Privacy rule) or protected student information (FERPA).
7. Vulnerable populations as subjects. Involving children, adults with impaired decision-making capacity, pregnant women and prisoners in research will in all likelihood required an expedited or full CUHSR review process.

The following are the eight categories exempt research specified by the Department of Health and Human services 45 CFR 46.104

Category 1 Exemption: Normal Educational Practices and Settings
Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2 Exemption: Anonymous Education tests, Surveys, Interviews or Observations
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7) [When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data]. (For item iii CUHSR is likely to ask that these types of studies undergo expedited review).

Category 3 Exemption: Benign behavioral interventions

1. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7) [When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data]. (For item iii CUHSR is likely to ask that these types of studies undergo expedited review).
2. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
3. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Category 4 Exemption: Secondary Research for which consent is not required
Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

1. The identifiable private information or identifiable biospecimens are publicly available;
2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Category 5 Exemption: Public Benefit or Service Program
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

Category 6 Exemption: Taste and Food Evaluation and Acceptance Studies
Taste and food quality evaluation and consumer acceptance studies:

1. If wholesome foods without additives are consumed, or
2. 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 Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Category 7 Exemption: Storage or maintenance for secondary research for which broad consent is required
Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).

Category 8 Exemption: Secondary research for which broad consent is required
Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
2. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
3. An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.