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 have been adopted by the University of Houston-Downtown:
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, or
(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, interview procedures or observation of public behavior, unless:
(i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
(ii) any disclosure of the human 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; or
(iii) the research involves the use of children as subjects (legal age of consent in the State of Texas is 18 years old).
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if:
(i) The human subjects are elected or appointed public officials or candidates for public office; or
(ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research, involving 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. 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.
FREQUENTLY ASKED QUESTIONS ABOUT EXEMPTION
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." It is up to your IRB to decide.
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. Your IRB will need to determine whether the questions you will ask and the bank you will use meet the requirements for an Exemption.