- Research on regular and/or special instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), voluntary survey procedures, voluntary interview procedures or observation of public behavior, unless:
- information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participant; and
- any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation.
- 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 (2) above if:
- the human participants are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- 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 a manner that participants cannot be identified, directly or through identifiers linked to the participants.
- Research and demonstration projects which are conducted by or subject to the approval of State or Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
- Public benefit or service programs;
- 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.
- Taste and food quality evaluation and consumer acceptance studies,
- if wholesome foods without additives are consumed or
- if a food is consumed that contains a food ingredient at or below the level 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.
The principal investigator shall submit an Application for Approval of Investigations Involving Use of Human Subjects. Research activities involving no more than "minimal risk" to subjects and in which the only involvement of human subjects will be in one or more of the following categories may be reviewed by the IRB and/or a designated IRB Expedited Review Subcommittee:
- Collection (in a non-disfiguring manner) of hair, nail clippings, deciduous teeth, and permanent teeth if patient care indicates a need for extraction.
- Collection for analysis of excreta and eternal secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
- Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also include such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays and microwaves).
- Collection of blood samples by fingerstick or venipuncture, in amounts not exceeding 450 milliliters in an eight-week period, and no more often than two times per week, from subjects 18 years of age or older who are in good health and not pregnant.
- Voice recordings made for research purposes such as investigations of speech defects.
- Moderate exercise by healthy volunteers.
- The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
- Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigation does not manipulate subject's behavior and the research will not involve stress to subjects.
Reference: 7 categories of expedited (even though it had 9 numbers) http://www.hhs.gov/ohrp/policy/expedited98.html
- data through intervention or interaction with the individual or
- identifiable private information. (CFR 46:102f)
No study procedures may be performed on you until you sign an informed consent document. If all of your questions have not been answered in that document, the study staff is required to answer any other questions you may have. If you sign an informed consent document, you can decide to withdraw your decision to participate at any time, for any reason, with no penalty to you or your care.
This is a person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence. (CFR 116:21, CFR 50.20 and 50:25)
Secondary research means the researcher can access these data from publications, reports, newspapers, etc.
Secondary data, on the other hand, is basically primary data collected by someone else. Researchers reuse and repurpose information as secondary data because it is easier and less expensive to collect.