Human Subjects Protection for Clinical Research Staff

What Every Site Team Member Needs Before a Study Starts

For research site staff at study start-up: coordinators, research nurses, investigators and assistants. Why human subjects protection exists (Nuremberg, Helsinki, Belmont), who protects participants (IRBs, investigators, sponsors, regulators), what counts as human subjects research and the levels of IRB review, informed consent from key information to documentation and re-consent, vulnerable populations and undue influence, privacy and confidentiality (HIPAA in research and certificates of confidentiality), risks and unanticipated problems, and doing it right at your site. Version 1.1, 2026-10-27. Eight modules, each with an assessment graded at 80 percent, plus a final assessment. It reflects US federal regulations and ICH E6(R3): ICH E6(R3) is the international baseline, US regulations are taught as the detailed worked example, and outside the United States national law and ethics committee requirements govern. Local rules may add requirements. Sites, sponsors and IRBs decide which human subjects protection training they accept; check your institution's requirement.

24 lessons, about 123 minutes. Free, in your language.

Why Human Subjects Protection Exists

Who Protects Participants

What Counts as Human Subjects Research

Informed Consent

Vulnerable Populations and Undue Influence

Privacy and Confidentiality

Risks, Adverse Events and Unanticipated Problems

Doing It Right at Your Site