Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB.
Evaluating if Proposed Activities are No More than Minimal Risk
The expedited review procedure may not be used, for example, when 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, educational advancement, 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. In evaluating the risks, the IRB reviewer should consider only those risks that may result from the research (as distinguished from the risks of therapies subjects would receive even if not participating in the research).
a. Research involving use of “over-the-counter” drugs, when used within their approved indications and dosages, and exempt from the IND requirements of 21 CFR 312.
2. The collection of blood specimens for research purposes using techniques consistent with routine clinical practice to minimize pain and risk of infection and within the following limits: (a) from adults whose health will not be adversely affected by the blood draws who weigh at least 50 kg, the amounts collected should not exceed 550 ml in an 8-week period; or (b) from children2 and other adults whose health will not be adversely affected by the blood draws, the amounts collected should not exceed the lesser of 150 ml or 3 ml per kg in an 8-week period. Examples: Finger stick, heel stick, ear stick, venipuncture, collection of blood from an indwelling peripheral venous catheter (not including a PICC line) placed for research purposes, or collection of blood from an indwelling catheter already in place for clinical purposes.
3. Prospective collection of biological specimens, excluding blood, for research purposes by noninvasive means and not requiring sedation for research purposes.
4. Prospective collection of biological specimens, excluding blood, for research purposes by minimally invasive means and not requiring sedation for research purposes.
5. Collection of additional information or biological specimens, excluding blood, for research purposes during procedures already being performed for clinical purposes, provided the additional collection does not introduce more than a minimal increase in risk, pain or discomfort over that imposed by the underlying procedure. When extension of general anesthesia is required, it must meet the criteria for minimal risk. 3
6. Collection of information for research purposes through noninvasive procedures and interventions routinely employed in clinical practice and not requiring general anesthesia or sedation.
7. Collection of information for research purposes through activities performed by persons in daily life in individuals and groups whose health will not be adversely affected by the activities.
8. Activities at statistical and data coordinating centers or biospecimen repositories that are not responsible for the primary oversight of the primary data collection activities and are not involved in the primary collection of information or specimens, which may be ongoing at other sites.
9. Collection of information from voice, video, digital, or image recordings made for research purposes that are not exempt under §__.104(d).
a. the research remains active only for long-term follow-up of subjects;5 or
1 In research involving the use of investigational devices that require a non-significant risk (NSR) determination, the determination should be made by the convened IRB. Continuing review of research where the FDA or the IRB has determined that a device is NSR may be eligible for continuing review under category 10(c).
2 Children are defined in the HHS [45 CFR 46.402(a)] and FDA [21 CFR 50.3(o)] 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 the jurisdiction in which the research will be conducted."
3 Extension of anesthesia time may be considered minimal risk when: the extension of anesthesia time is limited to no more than 15 minutes; the appropriate level of anesthesia has been achieved and the patient is determined to be clinically stable by an anesthesiologist uninvolved in the research protocol; the method/mode of anesthesia to be used is determined not by the research protocol but is in accordance with current standard clinical practice; the same anesthetic agents are utilized for the extension of time required for research; the same clinical care team responsible for administering and monitoring the anesthesia remain with the subject during the research procedure, and; the same level and frequency of monitoring will be maintained throughout the research procedures.
4 The US Nuclear Regulatory Commission’s allowable annual exposure to individual members of the public is 0.1 rem (1 mSv) per year. 10CFR20.1031(a)(1) https://www.nrc.gov/reading-rm/doc-collections/cfr/part020/part020-1301.html, links to an external website
5 No continuing review is required for research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. (45 CFR 46.109(f)(1)(iii))