Webster University: IRB: Categories of Research

The IRB Process

Design Issues

Categories of Research

Following submission, the application is reviewed by the IRB Chair/Expediter based on the IRB guidelines. The Chair/Expediter then determines whether the IRB application is complete and appropriate for review. Proposals must be submitted using the most current forms. Incomplete or poorly prepared proposals will be returned unreviewed. A reviewed application is assigned to one of the following categories:

Level I – No risk to human subjects
Level II – Minimal risk to human subjects
Level III – Possible risk to human subjects, a sensitive topic is being researched, or subjects include special populations (including children under 18, mentally handicapped, or legally incompetent)

The following lists of Level I, Level II, and Level III research are provided as examples and are not meant to be inclusive. The activities listed should not be deemed to be Level I, II, or III simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review in that specific category. For additional clarification or guidance contact the IRB expeditor/chair.

Per the HHS definition: RISK is defined as the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk."

LEVEL I (No risk to human subjects):

The following types of research may be classified as Level I and exempt from full board review. Level I status and exemption from full board review must be granted by the IRB Chair/Expediter:

Educational Settings: 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.

Educational Tests: Research involving the use of educational tests if

information taken from these sources is recorded in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects and
any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing employability, or reputation.
Educational tests includes cognitive, diagnostic, aptitude, and achievement tests. Test administration must be appropriate to the test administrator's qualifications and licensing.

Surveys, Interviews, and Observation: Research involving survey or interview procedures, or observation of public behavior, provided

The responses are recorded in such a manner that the human subjects cannot be identified directly or through identifiers linked to the subjects.
Level I status for Survey/Interview research is not applicable to children.
In observational research involving children, investigators cannot participate in the activities being observed.

Public Officials and Federal Statutes: Research involving the use of eductional tests, survey procedures, interview procedures, or observation of public behavior that is not exempt under category #3, if:

The human subjects 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.

Existing Data: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if:

These sources are publicly available; or
The information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Service Programs: Research and demonstration projects which are: Conducted by or subject to the approval of department or agency heads; and designed to study, evaluate, or otherwise examine:

Public benefit or service programs; or
Procedures for obtaining benefits or sevices under those programs; or
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.

Other: Research involving the use of non-research informants (elite interviewing) or testimony from identified individuals in a journalistic format.

Why surveys and interviews involving children are never Level I: The Department of Health and Human Services assumes that adults have the capability to determine whether or not to participate in survey or interview research. However, the Department of Health and Human Services believes that children being surveyed or interviewed by an investigator may not be capable of recognizing that their responses to questions on sensitive issues could be potentially damaging to themselves or others. Therefore, it is appropriate that the IRB at least review such research to determine whether the rights and welfare of children participating as subjects are adequately protected and when the requirements of permission or assent can be waived.

Why observational research involving children with investigator participation is never Level I: The department of Health and Human Services believes that children involved in observational research, with the investigator(s) also participating in the activities being observed, may not have the capability to determine whether or not to participate and therefore, IRB review of such research is appropriate.

LEVEL II (minimal risk to human subjects):

The following types of research may be classified as Level II if the research is no more than minimal risk. Level II status must be granted by the IRB Chair/Expediter.

Existing Data: 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).

Behavior: 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. In these cases the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.

Exercise: Moderate exercise by healthy volunteers.

Drugs: Clinical studies of drugs and medical devices only when either of the following conditions are 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:
- An investigational device exemption application (21 CFR Part 812) is not required
- The medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Voice Recordings: Collection of data from voice, video, digital, or image recordings made for research purposes.

Blood Samples: 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

Noninvasive Procedures: Collection of data from subjects 18 years of age and older 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.

Biological Specimens: 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 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.

The IRB can approve research with children as Level II (minimal risk) only if adequate provisions are made for soliciting assent of the children and the permission of their parents or guardians.

LEVEL III (possible risk to human subjects):

The following types of research may be classified as Level III if the research involves possible risk to human subjects. Level III status must be granted by the IRB Chair/Expediter. For example:

Confidentiality: Subjects may be identifiable to anyone other than the researcher.

Risk of Liability: Subjects could be at risk for criminal or civil liability, damage to employability or to finacial standing, or undue embarrassment, if responses became known outside this research project.

Sensitve Aspects of Behavior: The research deals with sensitive aspects of subjects' behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.

Private Records: The research involves the collection or study of existing data from sources not publicly available.

Deception: The research includes deception of subjects.

Children: The research deals with subjects who are children under eighteen years of age.

Special Populations: The research deals with subjects who are not-legally competent adults, prisoners, mentally disabled, pregnant women, physically challenged, or other special population.

Medical Procedures: The research involves administering drugs, invasive tissue samples, administering nutritional supplements, giving injections, or other medical procedures.