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* * * * * * * * * * * * * * * * * * * * * * * * * * * * Subpart D: Research Involving Children — Assent of Child Required Developmentally Appropriate as Determined by IRB Documentation as Determined by IRB Unless the Research Holds the Prospect of Direct Benefit Available Only in the Research Or Unless Waived by IRB per criteria at 45 CFR 46.116(d) 45 CFR 46.408 * What happens if a child reaches the legal age of consent? Subject is a child enrolled in research Subject reaches the age of majority IRB can: waive informed consent if can meet 4 regulatory requirements otherwise, investigators have to re-consent the individuals * Conflicts of Interest * Types of Conflict of Interest Individual Clinical investigators Study coordinators Research technicians Research officials IRB members Institutional Financial holdings of the institution Decisions regarding research funding or allocation of resources for research Financial Consulting fees Stock ownership Honoraria Salary Intellectual property rights Enrollment bonuses Spouse / dependent finances Professional Pressure to publish Professional rivalries Career advancement * Questions? * * * * * * * * * * * * * * * * * * * * * * * * * * * * FDA Regulations Drugs and Biologics Investigational New Drug Application (IND) 21 CFR Part 312 Devices Investigational Device Exemption (IDE) 21 CFR Part 812 * FDA Regulations: When is an IND Needed? Any use in which a marketed or un-marketed drug is administered or dispensed to, or used involving, one or more human subjects, except for: Use of a marketed drug in course of medical practice, or Investigation of a marketed drug where there is: No intent to support a new indication for use or other significant change in labeling; No intent to support a significant change in advertising; No factor such as route of administration, dosage, or patient population that increases or decreases the acceptability of risks associated with the product; Compliance with FDA Informed Consent and
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