There are three levels of review for research projects involving human subjects, each with its own application form: Exempt, Expedited, and Full. It is the researcher's responsibility to determine the category under which their research falls and fill out the appropriate form. Even those conducting "Exempt" research must fill out a form, which allows an IRB member to independently ascertain that the research is Exempt. Researchers may contact the IRB chair for help in determining which category their research falls under, but only after carefully reviewing the information below.
*note: the goal of IRB review is not to prevent research that involves risk, but to ensure that proper efforts are made to mitigate risk (including risk management, informed consent, and assurance of privacy).
- Exempt from Review: such research poses "No more than minimal risk," which means that "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." There are six sub-categories research that are Exempt (see below). Exempt research will be reviewed by the IRB chair and the Provost’s representative on the IRB within two weeks of proposal submission. If the IRB reviews the proposal and determines that the research is not Exempt, the board will ask the researcher to resubmit with the appropriate form. See below for the specific categories of research that can be Exempt.
- Expedited Review such research poses “no more than minimal risk” (see above, under Exempt), or it poses some risk to the research subject, in the sense that identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing. However, the researcher has implemented reasonable and appropriate protections so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. There are seven sub-categories of research that can undergo Expedited review (see below). Research that undergoes expedited review will be read by two members of the IRB within two weeks of proposal submission, unless they refer the proposal to the full committee for review. See below for the specific categories of research that can undergo Expedited Review.
- Full Review: such research poses a risk to the research subject, in the sense that identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing. The researcher should assess the risk level to his/her research subjects and submit a proposal for full review whenever they feel that risk is “more than minimal.” Certain types of research will always require full review (see below). Finally, any proposal submitted as Expedited may be referred to the full board if a reviewer who believes it warrants more careful consideration, or if the two reviewers doing the Expedited review disagree on the outcome. Research that undergoes Full review will be read by all members of the IRB and discussed at the next monthly meeting (in the third week of the month). See below for a list of specific types of research that must undergo Full Review.
Does your project involve interviews, ethnographic work, and oral histories?
As of October 2003, most oral histories have been excluded by the U.S. Office for Human Research Protection (OHRP) from oversight by Institutional Review Boards because, in OHRP's opinion, this methodology does not meet the federal regulatory definition of research. Note, however, that the IRB does make a distinction between an oral history, viewed as an open-ended account of an individual’s life, and an unstructured interview, in which the researcher guides an individual to discuss certain aspects of their life in order to explore a specific theme. If any researcher is unsure as to whether the IRB needs to review the protocol, s/he should contact the chair of the IRB.
Specific Categories of Research that Require Exempt, Expedited, or Full Review
Exempt from Review (View Application Form)
In addition to meeting the criteria spelled out above, research that is Exempt must fall into one of the following categories:
Category 1: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category 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.
Category 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 category 2, 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.
Category 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.
Category 5: Research and demonstration projects which are conducted by or subject to the approval of [federal] 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.
Category 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.
Expedited Review (View Application Form)
In addition to meeting the criteria spelled out above, research that can undergo Expedited review must fall into one of the following categories:
Category 1: 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 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 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.
Category 2: 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, 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.
Category 3: 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.
Category 4: 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.
Category 5: 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).
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 (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 Review (View Application Form)
Any research that poses “more than minimal risk” (see above) to research subjects should undergo Full Review. While the researcher is responsible for assessing whether there is any risk, the IRB considers certain types of research to be indisputably deserving of Full Review, including research on the following populations and topics:
- Pregnant women
- Children (individuals under the age of eighteen)
- Cognitively impaired persons
- Seriously ill individuals
- Refugees, if targeted or questioned about their experiences as refugees
- Victims of domestic abuse, if targeted and if questioned about their experiences as victims of abuse.
- Stigmatized populations, if targeted or if questioned about bias, discrimination, or harassment
- Individuals involved in illegal activities, if targeted for such behaviors or questioned about them
- Undocumented immigrants, if targeted or questioned about their status or experience as undocumented immigrants
- The research involves the collection of information regarding sensitive aspects of the subjects' behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior)
- The research involves requests for information that might be considered offensive, threatening, or degrading by the respondents.