EXEMPTED IRB: If the research does involve living human subjects and yet qualifies for an exemption from an IRB review, complete the exemption checklist in the course. Possible reasons for exemption are identified Title 45 Code of Federal Regulations Part 46 (45 CFR 46). Reasons for exemption currently include the following:
• Specific educational practices and setting involving normal educational practices such as instructional strategies, effectiveness, and instructional techniques, curricula, or classroom methods and the and the research is not FDA-regulated or involving special populations such as prisoners (not likely to be used in strategic security studies)
• Anonymous educational tests, surveys, interviews or observations unless information obtained by recording, discloses the responses, involves special populations such as children and prisoners or is FDA regulated (not likely to be used in strategic security studies)
• Special circumstances of educational tests, practices, and settings not addressed above if the human subjects are elected or appointed for public office or the federal state(s) require without exception confidentiality of personally identifiable information and the research is not FDA-regulated or involving prisoners (not likely to be used in strategic security studies)
• Collection or study using existing data, documents, records, pathological specimens, or diagnostic specimens if those sources are publicly available or if the information was recorded in such a way that the subjects cannot be identified, directly, or through identifiers linked to the subject and the research is not FDA- regulated or involving prisoners (most likely exemption for strategic security studies)
• Public benefit or service program which is conducted by and subject to the approval of a federal department or agency head and are designed to study, evaluate, or otherwise examine federal public benefit or service programs, procedures for obtaining those benefits, alternatives or changes of those benefits, or methods of payments or levels of payments for those benefits. Additionally, they must be conducted under federal statutory authority, have no statutory requirement for an IRB, do not involve significant physical invasions upon privacy, have federal funding, are not FDA-regulated or involving prisoners
• Taste and food evaluations as approved by the FDA but not involving prisoners
EXPEDITED IRB: If the study proposed involves living human subjects but does not fall into one of the federally specified exemption categories, it must meet one of the nine expedited review categories or have a full IRB approval. Expedited and full reviews require the candidate to take the CITI training. Expedited review may be used if the study falls into one of the following nine categories and is found to be of minimal risk (low probability and magnitude of harm and discomfort anticipated are no greater in and of themselves than those ordinarily encountered in daily life):
Continuing review of research previously approved by the convened IRB where the research is permanently closed to the enrollment of new subjects, all subjects have completed the intervention, and the research remains active for long-term follow- up or where no subjects have been enrolled and no additional risks are identified or where the remaining research activities are limited to data analysis (not likely to be applicable to H-PSSS dissertation candidates).
Continuing review of research where categories 2-8 above do not apply but the IRB has determined and documented at a convenes meeting that the research involves no greater than minimal risks and no additional risks have been identified (such as a candidate needs more time than the original full IRB granted)
FULL IRB: A full IRB must be conducted if data is collected on any special or vulnerable population, including children and minors 17 years of age or younger, adults 65 years of age or older, medically or psychologically vulnerable persons, institutionalized persons, prisoners, parolees, probationers, economically vulnerable populations, military or veteran persons, non-English speakers, international persons, pregnant women, or any other special population covered by the law.
The IRB determines if the criteria for IRB approval have been met and may take one of the following actions: