The IRB Review Levels

The following section is based on the Expedited Review Categories (1998) accepted by the Final Rule (2019)

Research activities that

• present no more than minimal risk to human subjects,

• identification of the subjects and/or their responses does not "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" (63 FR 216),

• involve only procedures listed in one or more of the following categories

  1. Clinical studies of drugs and medical devices, if an investigational new drug application is not required or the medical device is cleared/approved for marketing

  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, nonpregnant adults who weigh at least 110 pounds (*)

  3. Collection of biological specimens by noninvasive means, such as hair and nail clippings, excreta and external secretions (including sweat), uncannulated saliva, skin swab, or mouth washings, sputum (*)

  4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves (*)

  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (if not exempt) (*)

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

  7. Research on individual or group characteristics or social behavior or research employing survey, interview, oral history (if not exempt) (*)

  8. Continuing review of research (*)

(*) if interested, check the specifications on the Expedited Review Categories (1998) page.

The following section is based on (45 CFR §46.104. Exempt research.)

Research may be exempt from the review, if

1. is conducted in commonly accepted educational settings and involves normal educational practices (*)

2. only includes interactions involving educational tests, survey, interview, or observation of public behavior if at least one of the following criteria is met

   • the identity of the human subjects cannot readily be ascertained

   • any disclosure of the responses would not reasonably place the subjects at risk

   • the above was determined in a limited IRB review (*)

3. involves benign behavioral interventions in conjunction with the collection of information from an adult subject if the subject agrees to the intervention and information collection and at least one of the three criteria listed under #2 are met and

   • interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, no offensive or embarrassing.

   • no deception is involved (*)

4. it is a secondary research for which consent is not required

   • secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

     • the identifiable private information or identifiable biospecimens are publicly available;

     • the identity of the human subjects cannot readily be ascertained

     • identifiable health information is used for public health activities and purposes (*)

5. is conducted or supported by a Federal department or agency (*)

6. falls under taste and food quality evaluation category (*)

7. involves storage or maintenance of identifiable private information or biospecimens for which broad consent is required (*)

8. involves the use of identifiable private information or identifiable biospecimens for secondary research, if the following criteria are met:

   • broad consent for the storage, maintenance, and secondary research use was obtained

   • documentation of informed consent or its waiver was obtained

   • a limited IRB review determines that the research to be conducted is within the scope of the broad consent (*)

(*) if interested, check the specifications at 45 CFR §46.104. Exempt research

The Final rule mentions limited review with selected exempt categories.

Category 2 (educational tests, survey, interview, or observation of public behavior) and Category 3 (benign behavioral interventions in conjunction with the collection of information from an adult subject) may be exempt if the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination whether adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data were implemented (§46.111(a)(7))

Category 7 (storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research) may be exempt if a limited IRB review and makes the determinations that broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained and appropriately documented (§46.111(a)(8))

Category 8 (secondary research involving the use of identifiable private information or identifiable biospecimens) may be exempt if an IRB conducts a limited review to make the determination whether adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data were implemented (§46.111(a)(7)) and makes the determination that the research to be conducted is within the scope of the broad consent and the investigator does not include returning individual research results to subjects as part of the study plan.