Human Subjects Decision Tree

Does your project involve direct interaction with participants or use identifiable data or specimens?

Will your project generate information that is broadly applicable to settings outside of KUMC?

Do any of these federal funding characteristics apply to your project? (check all that apply)

Does your project potentially involve physical, emotional, financial or social risks?

If yes, what are the sources of the potential risks to participants?

If other, please explain.

Do you plan to use KUMC as the IRB for this project?

If no, please clarify which IRB will be reviewing this project?

Does your project fit into one of these categories?

Does your project fit into any of these other categories?

Please confirm your project meets all the requirements for this category listed below.

Research conducted in established or commonly accepted educational settings, involving normal educational practices. This category includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instruction techniques, curricula or classroom management methods.

Research approved under this category must meet the following criteria:

• The research must not adversely impact students' opportunity to learn required education content.
• The research must not adversely impact the assessment of educators who provide instruction.
• Participants must prospectively agree to be included and be informed as described in Section III.

This category allows participation by pregnant women and children and incidental inclusion of prisoners

Please confirm your project meets all the requirements for this category listed below.

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording).

One or more of the following criteria must apply to the research:

• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
• Any disclosure of the human subjects' responses outside the research must not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation;
• The information obtained is be recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.*

*Specific identifiers must be included on the data collection sheet. The IRB will conduct a limited IRB review to evaluate privacy and data security issues.
This category applies only to interactions and data collection. It may include visual or auditory recordings. It may not include any interventions.

Participants must prospectively agree to be included and be informed as described below in Section III.

This category allows participation of pregnant women and incidental inclusion of prisoners. Children may be enrolled when relates to educational tests or observations in which the investigators don't participate in the activities being observed, and no identifiable data about the children will be recorded.

Please confirm your project meets all the requirements for this category listed below.

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection. Participants may include pregnant women or a prison population if prisoners are not specifically targeted as participants. [Investigators are encouraged to consult the KUMC IRB's guidance document that provides examples of projects that qualify for this category]

At least one of the following criteria must be met:

• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

• 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, educational advancement, or reputation;

• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.*


*Specific identifiers must be included on the data collection sheet. The IRB will conduct a limited IRB review to evaluate privacy and data security issues.
This category is limited to behavioral interventions, not medical interventions. In order to be considered benign, the research must meet all of the additional criteria:
• Participants must be adults who are able to prospectively agree to the research. Subjects who require a surrogate decision-maker may not be enrolled.
• The overall duration of the study must be brief. It should occur in a single day and not exceed more than a few hours.
• The research interventions must be behavioral in nature; they cannot include medical interventions, even if those interventions are low risk. The interventions must be harmless, painless, not physically invasive, not likely to have significant adverse lasting impact and not potentially offensive or embarrassing.
• Data collection must only be through verbal and written responses by the subject, data entry by the subject or observation of the subject which may include audiovisual recordings. Data from electronic sensors or devices would not be approvable in this exemption category.
• Changes to the subject's physical environment are allowed, provided they do not involve extremes of heat, cold, noise or light.
• Deception is allowed only if the subject prospectively agrees to the deception and is fully informed after participation about the nature and purpose of the research. Explanation of the planned deception must be addressed in the consent script.

Please confirm your project meets all the requirements for this category listed below.

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including 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. These projects must be published on a Federal website before involvement of human subjects begins. Investigators are asked to consult with the KUMC IRB office if this category applies.
This category allows participation by pregnant women and children and incidental inclusion of prisoners

Please confirm your project meets all the requirements for this category listed below.

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.

Please confirm your project meets all the requirements for this category listed below.

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

(a) from healthy, non-pregnant 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.

Please confirm your project meets all the requirements for this category listed below.

Prospective collection of biological specimens for research purposes by noninvasive means.

(a) hair and nail clippings in a non-disfiguring 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.

Please confirm your project meets all the requirements for this category listed below.

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.)

(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

Please confirm your project meets all the requirements for this category listed below.

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. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt).