AAHRPP DOCUMENT # 24 THE UNIVERSITY OF ALABAMA HUMAN RESEARCH PROTECTIONS PROGRAM FORM: EXEMPTION ELIGIBILITY CHECKLIST Note: For use by investigators, Research Compliance staff, and IRB proposal. members who question the ruling of “exempt” status for a Investigators are reminded that they must apply for and request exempt status—this decision can be made only by the Research Compliance Office/IRB. Please consult with Research Compliance staff as desired. I. Does the project meet the definition for Human Subject Research? (SEE FORM Human Research Determination Checklist (DHHS and FDA) for Research Compliance Staff and IRB reviewers.) 1. NO. Research Compliance: Notify PI IRB review is not needed. 2. YES. Proceed. II. Is an exemption prohibited? The research involves prisoners as participants The research involves Human Embryonic Stem Cells For categories 1 through 5: The research is subject to FDA regulations YES. Exempt status cannot be granted. NO. Proceed. III. Does the research fall into one or more of these categories? Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
AAHRPP DOCUMENT # 24 THE UNIVERSITY OF ALABAMA HUMAN RESEARCH PROTECTIONS PROGRAM FORM: EXEMPTION ELIGIBILITY CHECKLIST Note: For use by investigators, Research Compliance staff, and IRB members who question the ruling of “exempt” status for a proposal. Investigators are reminded that they must apply for and request exempt status—this decision can be made only by the Research Compliance Office/IRB. Please consult with Research Compliance staff as desired. I. Does the project meet the definition for Human Subject Research? (SEE FORM Human Research Determination Checklist (DHHS and FDA) for Research Compliance Staff and IRB reviewers.) 1. NO. Research Compliance: Notify PI IRB review is not needed. 2. YES. Proceed. II. Is an exemption prohibited? The research involves prisoners as participants The research involves Human Embryonic Stem Cells For categories 1 through 5: The research is subject to FDA regulations YES. Exempt status cannot be granted. NO. Proceed. III. Does the research fall into one or more of these categories? Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: