UHD CPHS Aug/2007
Expedited Review categories (bolded categories 6, 7, and 8 are typical at UHD)
The following types of research may be reviewed under an expedited review : 1) present no more than minimal risk to human subjects, and 2) involve only procedures listed. [Note: The activities listed should not be deemed to be of minimal risk simply because they are included on this list. =]
CATEGORY 1 - Clinical studies of drugs and/or devices
CATEGORY 2 - Collection of blood samples
CATEGORY 3 - Prospective collection of biological specimens.
CATEGORY 4 - The collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
CATEGORY 5 - Research involving materials (data, documents, records, or specimens) that have been, or will be, collected solely for non-research purposes such as medical treatment or diagnosis.
CATEGORY 6 - Collection of data from voice, video, digital, or image recordings made for research purposes.
CATEGORY 7 - Research on individual or group characteristics or behavior. For example,
a) perception,b) cognition,
c) motivation,
d) identity,
e) language,
f) communication,
g) cultural beliefs or practices, and
h) social behavior, / OR / Research employing -
I) survey
j) interview
k) oral history
l) focus group
m) program evaluation
n) human factors evaluation, or
o) quality assurance methodologies
CATEGORY 8 - Continuing review of research previously approved
Exempt
EXEMPTIONS (updated on Dec 2004)
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.
Categories:
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: