Meriter's Clinical Research - IRB
Federal Regulations for IRBs and Human Subject Research

Food and Drug Administration Regulations

21 CFR 50    Protection of Human Subjects

Subpart A – General Provisions

Subpart B – Informed Consent

Subpart D – Additional Safeguards for Children in Clinical Research

21 CFR 56    Institutional Review Boards

Subpart A – General Provisions

Subpart B – Organization and Personnel

Subpart C – IRB Functions and Operations

Subpart D – Records and Reports

Subpart E – Administrative Actions for Noncompliance

FDA Information Sheets

Department of Health & Human Services Regulations

45 CFR 46    Protection of Human Subjects

Subpart A – Basic HHS Policy for Protection of Human Research Subjects

Subpart B – Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

Subpart D – Additional Protections for Children Involved as Subjects in Research

Expedited Review Categories

2/11/2008

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