When conducting Clinical Research it is important for an Investigator to develop and Awareness, Sensitivity and ability to Apply their knowlege of the regulations and ethical considerations to their research. This is especially important to the conduct of Research involving Human Subjects particularly when implementing Interventional procedures or treatments. There are International, Federal, Local, and Institutional Regulations that must be complied with when implementing a research trial. The Investigator should first Identify the respective Code of Federal Regulation (CFR) when developing or initiating research. The key regulations for the protection of Human Subjects are:
Title 45 CFR Part 46 - Protection of Human Subjects"Common Rule" (Department of Health and Human Services - NIH Funded Research)
Sub-Part A - Basic HHS Policy for Protection of Human Research Subjects (IRB membership, function, operation and Informed Consent Requirements)
Sub-Part B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Sub-Part C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Sub-Part D - Additional Protections for Children Involved as Subjects in Research
Title 46 CFR 160 and 164 (Office of Civil Rights) - Health Insurance Portability and Accountability Act
Title 21 CFR Parts 11, 50, 54, 56, 312, and 812 (Food and Drug Administation) - The conduct of research using an FDA regulated products that includes Investigational New Drug (IND's) or Investigational New Device (IDE's).
Part 11: Electronic Records; Electronic Signatures
Part 50: FDA Regulations for the Protection of Human Subjects (Informed Consent)
Part 54: Financial Disclosure by Clinical Investigators
International Guidance for Industry - The objective of this ICH GCP guidance is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
Commonly Referred to at ICH/GCP Guidelines or E6 Good Clinical Practice - Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
to
Expand Menu 
