The IRB committee makes the final determination about the level of review required for any IRB application. However, if you are familiar with the review types, you may include a rationale for a specific review type as part of your application (section III). If you are not familiar with levels of IRB review, you do not need to complete this section of the application; the committee will determine the required review level for you.
Following are the criteria for each review type. These same criteria are found in the Human Subjects Research Review Committee policy
The review process time can take up to 2 months or longer. Please plan for a minimum of 4-6 weeks between submission to the IRB and planned start date for your human subjects research activities.
Under revised federal regulations, many studies now qualify for a exemption of review if one of the following exemptions can be claimed. Many surveys, interviews, and public observation studies will fall in one of these categories, and will, as a result, undergo a process of certification by a member of the HSRRC, rather than review.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- research on regular and special education 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), survey procedures, interview procedures, or observations of public behavior, unless:
- information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- any disclosure of the human subjects' responses outside the research could reasonably place these subjects at risk of criminal or civil liability or be damaging to the subjects' 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 exemption 2 above if:
- the human subjects are elected or appointed public officials or candidates for public office; or
- federal statutes require 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 such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Secondary data that has identifiers falls under exempt.
- 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
- 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 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.
Research activities involving no more than minimal risk, and in which the only involvement of human subjects will be in one or more of the following categories, carried out through standard methods, may be reviewed by the HSRRC through the expedited review process. Proposals which qualify for expedited reviews do not require a convened Committee meeting, but, instead, are mailed to members of the HSRRC and given a written review.
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met:
- 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.)
- 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.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
- 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
- From other adults and children* considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, 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 a week period and collection may not occur more frequently than 2 times per week.
- *Children are defined in the DHHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402 (a). In Oregon, this is 21 years of age.
- Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
- hair and nail clippings in a nondisfiguring manner
- deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
- permanent teeth if routine patient care indicates a need for extraction
- excreta and external secretions (including sweat)
- 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
- placenta removed at delivery
- amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
- supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylatic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
- mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
- sputum collected after saline mist nebulization.
- 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:
- 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;
- weighing or testing sensory acuity;
- magnetic resonance imaging;
- electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
- moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- 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 from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). 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 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.
Full Committee Review
Any research involving greater than minimal risk or which involves a vulnerable subject population will require a full committee review. And, any protocol which does not fall under the categories for an exemption or expedited review will be scheduled for discussion at the next meeting. To this end, the HSRRC meets once a month (3rd Friday). In order to be added to the meeting agenda, proposals must be submitted two weeks in advance. Click here for the Committee's meeting schedule and submission deadlines.