Consent Process Best Practices for Special Populations to Reduce Perceived Pressure to Participate in Clinical Trials

Clinical Researcher—July 2021 (Volume 35, Issue 5) SPECIAL FEATURE Sean Horkheimer, JD, CIP   When recruiting participants for a clinical trial, the U.S. Department of Health and Human Services (HHS) regulations require that “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether […]

The Vital and Ongoing Process of Modernizing Informed Consent

Clinical Researcher—July 2021 (Volume 35, Issue 5) SPECIAL INTERVIEW Gary W. Cramer with Alison Holland and Pamela Tenaerts, MD, MBA   In this special interview with thought leaders on clinical research processes from Medable, we concentrate on how clinical trials team members and technology trends are catching up to each other in the pursuit of […]

Five Considerations for Sites When Selecting an eConsent Solution

Clinical Researcher—July 2021 (Volume 35, Issue 5) SITES & SPONSORS Bree Burks, RN, MSN   How can research site staff manage patient consent efficiently if they are required to use a different system for each study? Learning and using multiple consenting solutions is difficult and adds complexity to research operations, leading sites to rely on […]

Two Birds, One Stone: Informed Consent and GDPR

Clinical Researcher—July 2021 (Volume 35, Issue 5) SCIENCE & SOCIETY Al O. Pacino; Matthew Chandler   With the successful expediting of clinical research for COVID-19, many have questions about the future of clinical research compliance. The challenges of adhering to U.S. Food and Drug Administration (FDA) requirements and new regulations regarding the protection of personal […]

Patient-First Strategy vs. “Pharma Strategy Expertise” for Building Clinical Research Success in Rare and Orphan Disease Treatment

Clinical Researcher—July 2021 (Volume 35, Issue 5) PRESCRIPTIONS FOR BUSINESS Donvan Quill   Rare diseases affect 1% or less of the global population, with the geographic spread and small number of those impacted making the cost of research and development (R&D) prohibitive and leaving patients without treatments. Of the 7,000 known rare diseases, 95% […]