Type of Research Review - Policy Statement Part Two
Determining the Type of Research Review
The type of review that a research project undergoes is determined by the level of risks to the participants and the types of participants involved in the research. There are three types of initial reviews for research, exempt, expedited, and full. The researcher must evaluate risk and type of participants to determine which type of review may be appropriate for the project. If the risk and participant type is appropriate for exempt or expedited review, the researcher must determine if the research falls in one of the categories under that type of review. Most of the research conducted at MSSU is expected to fall in the exempt or expedited categories. Approval of research under these policies is for a one year period, unless the IRB determines the risk is sufficiently high to require more frequent review. Any research project that lasts for more than one year must petition the IRB for continuing approval.
Level of Risk
Researchers should make every effort to minimize the amount of risk involved in the research design. The IRB will evaluate the risk and determine if the risks are reasonable in relationship to the anticipated benefits of the research to the subjects, if any, or the knowledge that may reasonably be expected to result.
is research in which there is no known physical, emotional, psychological, or economic risk. This research can qualify as exempt if it does not involve a vulnerable population and falls in an exempt category.
is research that presents only the kind of risks encountered in daily life by most people (e.g., moderate exercise testing, minor stress from psychological tests, or surveys involving sensitive topics). This research can qualify as expedited if it does not involve a vulnerable population and falls in an expedited category.
is research procedures that may include risk beyond that ordinarily encountered by subjects (e.g., maximal exercise testing, stressful psychological testing, questions about illegal activities). This type of research requires a full review.
Type of Participants
Vulnerable populations require a higher level of protection, thus a higher level of scrutiny for the research procedures. Prisoners, mentally disabled persons, and children are considered vulnerable because their ability to give truly voluntary and informed consent may be limited. Pregnant women are considered vulnerable in the case of research procedures that pose any hazard to the fetus. Research considered to be less-than-minimal-risk for nonvulnerable adults is considered as minimal-risk for vulnerable populations, thus only research on nonvulnerable adults qualifies for the exempt category.
Qualifications for Exempt Status
Exempt review is used for studies presenting less than minimal risk to nonvulnerable subjects
- Even research that you believe to be exempt must be reviewed under the exempt process to assure that it really is exempt from further review. The categories of research that qualify for exempt review are listed below. Note that even if research falls into one of the general categories that is normally exempt, it is not exempt if it involves sensitive topics (e.g., recreational drug use, sexual practices, use of alcohol by minors, criminal behavior) or vulnerable participants (e.g., children, victims, persons with mental retardation). Exempt protocols are reviewed by a Departmental Review Panel or reviewer selected by the IRB manager (see the section on Research Review Procedures). The researcher must not begin contacting research participants or collecting data until written approval is received from the IRB. This usually requires three working days for processing after the exempt projects are submitted.
- Research activities in which the only involvement of human subjects is in one or more of the following categories qualify for review under the exempt category:
- 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.
- Research involving the use of educational tests (e.g., cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) data obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects' 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.
- Note: When videotaping and/or photography is used for data collection, the research no longer meets the exempt requirements. This is because information is recorded in such a manner that participants can be identified. Audio taping may fit under this same category, depending upon how the recording is made and its intended use. If the recording is to facilitate accurate record keeping and will be erased following transcription, it may go in the exempt category. If it is to be used for purposes that would make the recording part of the reporting process it would not be exempt.
- 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 category (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.
- Research involving the collection or study of existing information, 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.
- Research and demonstration projects that are conducted by or subject to the approval of supporting agencies, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed or (b) 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 and approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Qualifications for Expedited Status
Expedited reviews are used for research presenting minimal risk to nonvulnerable participants or less-than-minimal risk to vulnerable participants
Expedited reviews do not require a convened meeting of the IRB. Two reviewers, one from the Departmental Review Panel and one IRB member outside the department review the protocol. The reviewers will send the completed review to the IRB manager, who will notify the principal investigator or supervisor of the results of the review. This may require up to one week for review after it is received by the IRB.
Research involving no more than minimal risk and in which the involvement of (nonvulnerable) participants is in one or more of the following categories may be reviewed through the expedited review procedure. The categories in this list are exempt regardless of the age of the subject, except as noted.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt. This listing refers only to research that is not exempt.)
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt. This listing refers only to research that is not exempt.)
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/ approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
(b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
Qualifications for Full Review
Any research that does not meet the qualifications listed under exempt or expedited review will be reviewed by the IRB at a regular meeting