The NIH and other federal agencies have developed guidelines and policies for safe, ethical, and high quality clinical research.

NIH Human Subjects Policy and Guidance
Policies and Guidelines for Monitoring Clinical Research
Education and Training for Investigators Conducting Clinical Research
Protecting Confidentiality
Office for Human Research Protections and General Human Subjects Guidelines
U.S. Food and Drug Administration (FDA) Guidelines for Conduct of Clinical Trials
Gene Therapy, Stem Cells and Fetal Tissue

NIH Human Subjects Policy and Guidance

Review the guidelines for human subject research and policies for inclusion of women, children, and people from minority populations in studies when appropriate.

Policies and Guidelines for Monitoring Clinical Research

Review the NIH and other federal agency policies for data and safety monitoring in the conduct of clinical trials to ensure the safety of participants.

Education and Training for Investigators Conducting Clinical Research

Participate in training to become aware of the ethical issues involved in human subjects research and the role of the principal investigator in clinical research.

Protecting Confidentiality

Learn the policies and guidance for ensuring the confidentiality of people who participant in clinical research studies.

Office for Human Research Protections (OHRP) and General Human Subjects Guidelines

Learn the procedures investigators must follow in order to protect human subjects who are part of clinical research studies.

U.S. Food and Drug Administration (FDA) Guidelines for Conduct of Clinical Trials

Understand the FDA’s policies and guidance for the conduct of clinical trials as they relate to drugs, devices, and biologics.

Gene Therapy, Stem Cells, and Fetal Tissue

Learn the policies for conducting clinical research studies that involve gene therapy, stem cells, or fetal tissue.

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