¹ú²úAV

¹ú²úAV IRB Definition of Research:  ¹ú²úAV defines research as a systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge. (45 CFR §46.102)

Conditions for IRB Oversight: The following conditions may not meet the definition of “research” as provided above, but may require IRB review/oversight:

• • • Intent to produce results that will be submitted for peer-reviewed publication or presentation
    • Include minors (e.g. those under the age of 18)
    • Target potentially vulnerable individuals
    • May place pregnant women and/or fetuses at risk of physical harm
    • Deal with a topic of sensitive nature in a way which anonymity cannot be sustained
    • Involve any activity that places the participants at more than minimal risk

“Intervention” includes both physical procedures by which data are gathered (e.g. measurement of heart rate of venipuncture)

“Interaction” includes communication or interpersonal contact between the investigator and participant (e.g. surveying or interviewing)

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or video recording is taking place.

Identifiable means that the identity of the participant maybe ascertained by the investigator.

(a) the research is on drugs for which an investigational new drug application (21 CFR 312) is not required or

(b) the research is on medical devices for which

(i)  an investigational device exemption application (21 CFR 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.

(a) healthy, non-pregnant adults who weigh at least 110 pounds for whom

(i) the amounts drawn do not exceed 550 ml in an 8 week period and

(ii) collection does not occur more frequently than 2 times per week or

(b) other adults and children, for whom, considering the age, weight, and health of the participants, and the collection procedures,

(i) the amount of blood to be collected does not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and

(ii) collection does not occur more frequently than 2 times per week.

(NOTE: Children are defined 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.")

(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; and

(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 participant or an invasion of the participant'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; and

(e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

(NOTE: Where medical devices are employed, they must be cleared/approved for marketing.)

(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.

Describe how you will implement the informed consent process. If English is not the participants’ first language, describe how you will communicate with the participants and how you will provide an understandable written consent document. If appropriate, a Child Assent Form written at an age-appropriate level should also be developed.

In lay terms, describe the specific procedures that relate to the participants’ participation. What will the participants do and/or what will be done to them? Provide enough detail so that a lay reader will understand exactly what is going to occur in the study.