Review of Research Using Human Specimens

 

 

Level of Review

Eligibility

Examples

“Not human subjects research”

 

[Review by an IRB Chair]

Both of the following conditions are satisfied: 

 

a) the material, in its entirety, was collected for standard practice or for submission to a repository that follows the OHRP guidance (11/7/97);

 

and

 

b) the material is not identifiable or is released from a repository that follows the OHRP guidance (11/7/97) without any identifiable private data or information.

a) the material was collected solely for clinical purposes, or for legitimate but unrelated research purposes, with no "extra" material collected for submission to the Repository;

 

b) no codes or linkers of any sort may be maintained, either by the Submitter or by the Repository, that would permit access to identifiable private data or information about the living individual from whom the material was obtained.

Exemption, category 4

 

[Review by an IRB Chair]

45CFR46.101(b)(4)

Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Specimen is obtained that is labeled with a code number.  The researcher who receives the specimen does not have ready access to the identifiable information, but identifiers are maintained at the site from which the specimen was obtained.

Expedited review, category 2

 

[Review by an IRB Chair or experienced member of the Board]

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 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.

The research activity may present no more than minimal risk to subjects.

 

Expedited review, category 3

 

[Review by an IRB Chair or experienced member of the Board]

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

The research activity may present no more than minimal risk to subjects.

(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.

 

Expedited review, category 5

 

[Review by an IRB Chair or experienced member of the Board

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).

 

The research activity may present no more than minimal risk to subjects.

 

(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.)

Research utilizing retrospectively or prospectively collected, leftover specimens collected at the time of clinical care, if the information is not considered sensitive and any potential breach of confidentiality would not be damaging to the subject. 

Full Board review

 

[Review by the convened IRB]

Research that does not qualify for exemption or expedited review. 

Research using identifiable specimens that is greater than minimal risk, e.g., certain HIV-related or genetic research.

                                                                       

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                                                                                                                                                                                March 9, 2004