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What is informed consent and why is it important in drug development?

Informed consent is the process by which a researcher or investigator explains all aspects of a study, including the risks and benefits, to the participant. Potential participants learn about their rights as study participants and are usually required to sign a written consent form stating that they understand the study and agree to participate. To learn more about informed consent and why it is important for drug development, click on the links below.

• Office for Human Research Protection, HHS: Videos
• Genetic Alliance: Biobank Governance

Testimonials: How we did it

Relevant publications

• Group Health Research Institute: Glad You Asked: Participants' Opinions of Re-Consent for dbGap Data Submission
• Genetic Alliance: Weekly Tips

Related Tools

Informed Consent and Clinical Trials

• FDA: Clinical Trials and Institutional Review Boards
• International Psoriasis Council: Informed Consent
• FDA: A Guide to Informed Consent
• FDA: Regulation on the Protection of Human Subjects