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

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.

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.

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.

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. 

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.

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

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 46.404) Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. (45 CFR 46.405) 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 46.406) 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 46.407)

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

IRB Regulations 45 CFR 46.110 Expedited review procedures 45 CFR 46.111 Criteria for IRB Approval of Research 45 CFR 46.116 General Requirements for Informed Consent 45 CFR 46.117 Documentation of Informed Consent

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

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