The University has adopted six categories of research as exempt from continuing CPHS review based upon DHHS regulations published in the Federal Register on January 26, 1981 and March 4, 1983 . In order to establish an individual research project as exempt an investigator must complete and submit a CPHS application for review and approval. On the CPHS application the investigator should indicate the number of the category under which an exemption is claimed. Final determination as to whether a research project is exempt rests with the CPHS.
If a research project is certified as exempt by the CPHS, the investigator need not resubmit the project for annual CPHS review as long as there are no modifications in the exempted procedures.
The use of the term "exempt" refers to the requirement for annual CPHS review, but not the general requirements for informed consent and protection of subjects
Thus, even if your project is determined to be exempt you still must inform potential subjects of the proposed procedures and their rights as subjects.
The following categories of exemption (based on 45 CRR 46.104) have been adopted by the University of Houston-Downtown:
1. 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
2. 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:
(i) 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;
(ii) 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
(iii) 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).
3.(i) 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:
(A) 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;
(B) 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
(C) 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).
(ii) 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.
(iii) 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.
4. 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:
(i) The identifiable private information or identifiable biospecimens are publicly available;
(ii) 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;
(iii) 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.
5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are 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 or alternatives to those programs or procedures; or
(iv) possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies:
(i) if wholesome foods without additives are consumed; or
(ii) 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.
What is meant by "existing" data?
The term "existing data" applies to retrospective studies involving already collected data where data must be "on the shelf" when the protocol is initiated. For research supported on NIH grants or contracts, the data should be in place when the application or proposal is submitted for IRB review.
Some researchers mistakenly believe that secondary data analyses using existing data to address new research questions are always exempt. Exemption #4 does not apply to existing data as long as participants can be identified. A status of "No Human Subjects" applies when data are given to a researcher by others after being permanently and completely delinked from the identity of living subjects. Check with your IRB to see if approval is necessary, especially if any data may be linked to research participants.
What is meant by "identifiers linked to the subjects"?
Identifiers such as names, Social Security numbers, medical record numbers, and code numbers permit data to be linked to individual people and perhaps also to associated medical, financial, or employment information. Exemption # 4 applies most clearly to behavioral and social sciences research (BSSR) data where such personal identifiers do not accompany the data provided to or utilized by the researcher. Your IRB will determine whether Exemption #4 applies when you receive coded BSSR data from a collaborator or other source.
What is meant by "publicly available sources"?
This refers to public sources of data, such as telephone books and public records. Although there are organizations that make data sets broadly accessible at reasonable cost to the research community, these materials are not usually available to the public at large. If you obtain data from any of these sources, you should not assume that the source meets the definition of "publicly available." The determination is up to CPHS based on information provided.
What about behavioral and social sciences research (BSSR) data obtained from a data bank or archive?
BSSR data obtained from a data bank or archive may be exempt depending on the policies and procedures to prevent the release of personal identifiers. There are many kinds of data banks that operate in different ways. CPHS will need to determine whether the questions you will ask and the bank you will use meet the requirements for an Exemption.