91×ÔÅÄ

Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to adversely impact: a) students’ opportunity to learn required educational content, or b) the assessment of educators who provide instruction. Could include (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 is exempted.

Please note: if you work in a school or other educational setting and want to do research for your own work, dissertation, or thesis, this category alone will not cover you. Using a student or teacher population you have access to because of your job or position in order to further your own education does not constitute “normal educational practices” and you will need further permission to do this work. If the research involves minors, it is automatically given Expedited status.

When (a) information recorded cannot be readily linked back to subjects, or (b) any information disclosure would not place subjects at risk of harm, or (c) identifiable information is recorded with limited IRB review for privacy and confidentiality protection.

When Information Collection is Limited to Verbal or Written Responses (including data entry) or Audiovisual Recording, and: (a) information recorded cannot be readily linked back to subjects, or (b) any information disclosure would not place subjects at risk of harm, or (c) identifiable information recorded with limited IRB review for privacy and confidentiality protection.

Consent is not required if: (a) identifiable private information or identifiable biospecimens are publicly available, or (b) information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects or re-identify subjects, or (c) investigator’s use is regulated under HIPAA as “health care operations,” “research,” or “public health,” or (d) research is conducted by, or on behalf of, a Federal agency using data collected or generated by the government for non-research purposes, and the information is protected by federal privacy standards.

Research and demonstration projects which are conducted and/or supported by or subject to the approval of department or agency heads are exempted if they 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.

Taste and food quality evaluation and consumer acceptance studies are exempted if, (i) wholesome foods without additives are consumed; or (ii) 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 FDA or approved by EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Clinical studies of drugs and medical devices only when condition (a) or (b) is met:

1. 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.)
2. 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.

1. 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
2. from other adults and children2, 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.

Examples of collecting biological specimens for research purposes by noninvasive means:

• 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 prophylactic 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

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 subjects 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.

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.

Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects.

Research projects that do not meet the Federal requirements to be called human subjects research but should still be submitted in the same fashion as an IRB application for the sake of 91×ÔÅÄAA-wide recordkeeping. This category includes oral history, archival research, historical scholarship, and journalistic activity among other examples.

Research projects that do not meet the Federal requirements to be called human subjects research but should still be submitted in the same fashion as an IRB application for the sake of 91×ÔÅÄAA-wide recordkeeping. This category includes oral history, archival research, historical scholarship, and journalistic activity among other examples.

Translational research is the systematic effort to convert basic research knowledge into practical applications to enhance human health and well being. In order for the IRB to review your project under the translational research category, it must meet all of the following criteria:

• The activity is intended to improve the process/delivery of care while decreasing inefficiencies within a specific setting
• The activity is intended to evaluate current practice/delivery and/or attempt to improve it based upon existing knowledge
• There is sufficient evidence to support implementing this activity to create practice change
• The activity is conducted by, or under direct supervision of, clinicians and staff who provide care or are responsible for the practice change in the institutions where the activity will take place
• The methods for the activity are flexible and include approaches to evaluate incremental changes
• The activity will involve a sample of the population (patients/participants) ordinarily seen in the site where the activity will take place
• The planned activity will only require consent that is already obtained in clinical practice, and the activity could be considered part of the usual care
• The risk to the patient/participant is no greater than what is involved in the care they are already receiving, OR participating in the activity can be considered acceptable or ordinarily expected when practice changes are implemented within the site’s environment
• You have a letter of permission from the project site (some sites will require you to go through their own IRB or other process, so please do your research)

In general, a Quality Improvement (QI) project uses a specific process, measures, and existing data to improve outcomes in a specific group. In order for the IRB to review your project under the translational research category, it must meet the following criteria (as outlined, for example, by Yale and Duke Universities):

• The activity is intended to improve the process/delivery of care while decreasing inefficiencies within a specific health care setting?
• The activity is intended to evaluate current practice and/or attempt to improve it based upon existing knowledge
• There is sufficient existing evidence to support implementing this activity to create practice change
• The activity is conducted by clinicians and staff who provide care or are responsible for the practice change in the institution where the activity will take place
• The methods of the activity are flexible and include approaches to evaluate rapid and incremental changes
• The activity will involve a sample of the population (patients/participants) ordinarily seen in the institution where the activity will take place
• The planned activity will only require consent that is already obtained in clinical practice, and the activity could be considered part of the usual care
• Future patients/participants at the institution hosting the activity will potentially benefit from the project
• The risk to the patients/participants is no greater than what is involved in the care they are already receiving OR participation in the activity can be considered acceptable or ordinarily expected when practice changes are implemented within a health care environment

A "Limited IRB review" option is required under the 2018 Revised Common Rule for certain Exempt human subjects research categories. Its purpose is to ensure privacy/confidentiality protections are in place with exempt research that involves the collection of sensitive, identifiable data (categories 2(iii) and 3(i)(C)).

The "Limited IRB reviewer" must determine that, per 45 CFR 46.111(a)(7), "When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data."