The following types of research may be reviewed by the HRPO (IRB) under an expedited review procedure (45 CFR 46.110 and 21 CFR 56.110). These research activities 1) present no more than minimal risk to human subjects, and 2) involve only procedures listed in one or more of the following categories. [Note: The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.]

CATEGORY 1           Drugs and/or Devices
Clinical studies of drugs and/or devices only when
a) Research on drugs for which an investigational new drug [IND] application is not required (21 CFR Part 312). (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.) or
b) Research on medical devices for which
     i) an investigational device exemption application [IDE] is not required (21 CFR Part 812); or
     ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its      cleared/approved labeling.  

Information Required for Justification
1. State the name of the commercially available drug to be used as described in the above requirements, or
    State the name of the approved device and confirm its use as described above.
2. Confirm that the research does not increase the risks or decrease the acceptability of the risks associated with the use of the      product.

CATEGORY 2      Blood Samples
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
a) 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
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.

Information Required for Justification
    1. State how the blood sample(s) will be collected.
    2. Provide the health status of the research population and state whether pregnant women are eligible to participate.
         (a) For healthy, nonpregnant adults who weigh at least 110 pounds -
         Confirm that the amounts of blood to be drawn will not exceed 550 ml in an 8 week period and will not occur more          frequently than 2 times per week.
         (b) For other adults (e.g., with an illness) or children*
         Confirm that the amount of blood to be collected will not exceed the lesser of 50 ml or 3 ml p/kg in an 8 week period          and not occur more frequently than 2 times per week.

        *Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or          procedures involved in the research, under the applicable law of jurisdiction in which the research will be conducted." 45          CFR 46.402(a).

CATEGORY 3        Prospective Specimen Collections
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.

Information Required for Justification
    1. State the biological specimen(s) to be collected.
    2. Describe the noninvasive method by which the specimens will be collected.

CATEGORY 4        Routine Noninvasive Procedures
The 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 of such procedures:
a) physical sensors applied 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 (MRI) with or without contrast;
d) electrocardiography (ECG or EEG);
e) thermography;
f) detection of naturally occurring radioactivity;
g) electroretinography;
h) ultrasound;
i) diagnostic infrared imaging;
j) doppler blood flow;
k) echocardiography;
l)  moderate exercise. . . where appropriate, given age, weight, and health of the individual.

*The HRPO classifies MRI with contrast as a minimal risk procedure (12/29/03).

Information Required for Justification
    1. State the type of data to be collected.
    2 State the source of the data and the procedure that will be used to collect the data.

CATEGORY 5        Data Collected
It is OHRP's interpretation that expedited review category 5 includes research involving materials (data, documents, records, or specimens) that: (1) will be prospectively collected solely for non-research purposes such as medical treatment or diagnosis, or (2) have already been collected for either non-research or research purposes, provided the materials were not collected for the currently proposed research. (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

Information Required for Justification
1. State the type of materials and the purpose for which it was, or will be, collected. (Material collected for non-research purposes includes but is not limited to information collected as part of routine practice.)
2. State the source of the material and whether it is currently existing (i.e. on the shelf at the present time refers to material that was collected prior to the protocol submission) or will be collected prospectively. Give dates of inclusion including month and year, e.g. June 1999 to November 2000.



CATEGORY 6        Voice, Video, Digital, Image Recordings
Collection of data from voice, video, digital, or image recordings made for research purposes -

Information Required for Justification
    1. State the type of data and its original (clinical or research) purpose(s); how data will be stored; and who will have access.
    2. State whether there will be identifiable information on the tapes and when the tapes will be destroyed.

CATEGORY 7        Group or Behavior Characteristics
Research on individual or group characteristics or behavior including, but not limited to, research on:

a) perception,
b) cognition,                                    
c) motivation,
d) identity,
e) language,
f) communication,
g) cultural beliefs or practices, and
h) social behavior,

or

Research employing -  
I) survey
j) interview
k) oral history
l) focus group
m) program evaluation
n) human factors evaluation, or
o) 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.)

Information Required for Justification
     1. State whether this is research on individual or group characteristics or behavior.
     2. State the method to be used to gather the data.

CATEGORY 8             Previously Approved Research
Continuing review of research previously approved by the convened IRB (has undergone full board review)
a.) where (i) the research is permanently closed to enrollment of new subjects; (ii) all subjects have completed
all research- related interventions; and (iii) the research remains active only for long-term follow-up of subjects
b.) where no subjects have been enrolled and no additional risks have been identified
c.) where the remaining research activities are limited to data analysis.

Information Required for Justification
1. For 8a and 8c, indicate the date of the last completed research related intervention.
2. For 8b, explain the delay in accrual and provide an estimated date that accrual will begin.

CATEGORY 9             Previously Approved Research not using an IND or IDE
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Your research is renewed, usually annually, with an expedited review allowable under Expedited Category 9. At renewal please submit information to the HRPO (IRB) on a Form 7a.

Applicability
Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

The categories in this list apply regardless of the age of subjects, except as noted.

The expedited review procedure may not be used where 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, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

The expedited review procedure may not be used for classified research involving human subjects.

The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened IRB.

Categories one (1) through seven (7) pertain to both initial and continuing HRPO review.