1. IRB Educational Session - IRB Regulations on Expedited Review
May 15, 2018

2. Expedited Review
To qualify for an expedited review, research must fall into one of 9 federally-defined expedited categories. These categories involve collection of samples and data in a manner that involves no more than minimal risk to subjects.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

3. Expedited Review
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.

4. Expedited Review
An IRB may use the expedited review procedure to review either or both of the following:
research appearing on the list of Expedited Review categories and found by the reviewer(s) to involve no more than minimal risk,
minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson, from among members of the IRB, to evaluate and approve specific types of research.
A research activity may be disapproved only after review in accordance with the non-expedited procedures.

5. Expedited Review - Categories
Clinical studies of drugs and medical device
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture 
Prospective collection of biological specimens for research purposes by noninvasive means.
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. 

6. Expedited Review - Categories
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). 
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (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.

7. Expedited Review – Criteria for Approval
Risks to subjects are minimized
Risks to subjects are reasonable in relation to anticipated benefits
Selection of subjects is equitable
Informed consent will be sought from each prospective subject
Informed consent will be appropriately documented
When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects
When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data

8. General Points – Children in Research
Children in Expedited Research
For research that is not exempt, federal regulations identify four categories of research that may be allowable in children. Three of them may be approved by the local IRB; the fourth also needs special federal approval.
Explanations and what's required for IRB approval under each category is provided below:
Research involving no more than minimal risk. (45 CFR )
Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. (45 CFR )
Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. (45 CFR )
Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. (45 CFR )

9. General Points – Consent, Assent, Parental Permission
For non-exempt human subjects research
Signed Consent is required
Unless choosing a waiver of documentation
Assent is required
Parental permission is required
Consent, Assent and Parental permission documents must be written in a language understandable to the participant
Translated documents are required for non-English speakers

10. IRB Regulations 45 CFR 46.110 Expedited review procedures
45 CFR Criteria for IRB Approval of Research
45 CFR General Requirements for Informed Consent
45 CFR Documentation of Informed Consent

11. Both involve the use of secondary data/specimens
Exempt 4 vs Expedited 5
Exempt 4
Expedited 5
Both involve the use of secondary data/specimens
Only retrospective data/specimens collection
Retrospective or Prospective data collection
Recorded without identifiers
Recorded with identifiers
Is publicly available secondary data/specimens
Originally collected for research or non-research puposes

12. Both include surveys, interviews, focus groups
Exempt 2 vs Expedited 7
Exempt 2
Expedited 7
Both include surveys, interviews, focus groups
Cannot include an intervention
Can include an intervention
No involvement with children unless the research is observation of public behavior if the researcher is not participating in the observed activity.
May involve children but subject to Subpart D