Rules and Regulation Overview

Human Subjects Research

Regulations, Rules, and Research Oversight

Knowing the requirements of your funding source dictates the protocol and regulations.

 

Funding Source

US Department of Health and Human Services (DHHS), National Institutes of Health (NIH) Office of the Assistant Secretary for Health (ASH), NIH Institutes and Centers, Office for Human Subject Protection (OHRP)

-45 CFR 46 subpart A: Basic HHS Policy for Protection of Human Research Subjects (The Common Rule)

-45 CFR 46 subpart B: Protection for Pregnant Women, Human Fetuses & Neonates

-45 CFR 46 subpart C: Protection for Prisoners

-45 CFR 46 subpart D: Protection for Children

-45 CFR 46 subpart E: Registration of IRBs

 

Food and Drug Administration (FDA)

-21 Code of Federal Regulations (CFR)

-21 CFR 50: Protection of Human Subjects

-21 CFR 54: Financial Disclosure

-21 CFR 56: Institutional Review Boards

-21 CFR 312: Investigational New Drug Application (IND)

-21 CFR 803, 812: Devices

 

Per International Conference on Harmonization (ICH) E6, Good Clinical Practice is defined as an “…ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects”.

 

7 key principles of ICH E6

-Data Quality and Integrity

-Ethics

-Informed Consent

-Investigational Products

-Protocol and Science

-Responsibilities

-Quality Control Quality Assurance

 

Good Clinical Practices Forms

Sponsor responsibilities

21 CFR 312 & 812

 

Investigator responsibilities

21 CFR 312 & 812 (IND & IDE)

FDA information sheets

Financial Disclosure – 21 CFR 54

 

Drug/Device quality standards

Drugs – 21 CFR 210 & 211

Biologics – 21 CFR 600 & 606

Tissue – 21 CFR 1271

Devices – 21 CFR 820

 

Protocol standards & requirements

Standards – 21 CFR 312 & 812

IRB review requirements – 21 CFR 56

 

Participant

Informed Consent – 21 CFR 50

Medical care – 21 CFR 312

Protection of human subjects 21

CFR 50; 45 CFR 46

 

Documentation

Essential & source documents – 21 CFR 312 & 812

Electronic records & signatures – 21 CFR 11

 

Safety reporting

To IRB – 21 CFR 56 & 812

To Sponsor – 21 CFR 312 & 812

To FDA – 21 CFR 312, 812, & 803

To manufacturer – 21 CFR 803

 

Monitoring (Quality Assurance & Quality Control)

21 CFR 312 & 812

 

*Content adapted from Training Elements of Human Subjects Research Coordination CTSA Research Coordinator Taskforce Overview of the Regulatory Environment in Academic Health Centers Version 5/31/12