Introduction: Background and Foundations

Kesselheim AS - Specimen Science: Ethics and Policy Implications

  • Regulation and Clinical Evidence

Summary:

This introductory book chapter frames the legal and ethical challenges surrounding the use of biospecimens in research, synthesizing contributions on privacy law, the Common Rule, property rights in biological materials, and the legacy of cases like Henrietta Lacks. The author argues that the field’s piecemeal oversight may benefit from more centralized governance to ensure consistent protections, patient engagement, and public trust.

VIEW SOURCE

Recent Work from PORTAL

Talk bubble graphics representing commentary and opinion.

How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Regulation and Clinical Evidence
Simple graphic of magnifying glass examining papers to signify reviewing research publications.

International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway

Mulsant SS, Kesselheim AS, Naci H - Journal of Cancer Policy

  • Price, Value, and Access
  • Regulation and Clinical Evidence
An icon of a bill representing government policy.

Comments on FDA Discussion Paper, “Considerations for the Regulation of Generative AI-Enabled Medical Devices”

Jaiswal N, Gorijavolu R, Thomas S, Hwang TJ, Celi LA, Kesselheim AS - Food and Drug Administration (FDA)

  • Regulation and Clinical Evidence