TO:  The University of Maryland Baltimore Research Community,

Effective December 4th, 2023, the University of Maryland Baltimore Human Research Protections Program (HRPO) will adopt a revised version of the informed consent document (ICF) template. 

This announcement applies to new studies only that submit their application in CICERO after December 4^th, 2023.

The revised version can be found at the UMB HRPO website: https://www.umaryland.edu/media/umb/oaa/hrp/documents/consent-forms/HRP-502a---TEMPLATE---Consent-and-HIPAA-Document(Post12-4-2023).docx

Key revisions to the ICD were made to address institutional requirements regarding the corporate clinical trial pre-award process. The ICF sections Costs to Subjects and Study-Related Injury were updated to align with these requirements. Please note that, when applicable to your study, you must follow the Office for Research and Development Center for Clinical Trials (CCT) ICF guidelines.

Additional changes to the document can be found in the following sections:

1. Concise Summary – Instructions revised
2. Procedures - Instructions revised to include addressing drug interactions and genetic testing
3. Risks- Instructions revised to address drug washout period, non-clinical risks, device malfunctions, and device removal risks
4. Alternatives to Participation- Instructions revised to simplify the section
5. Confidentiality and Access to Records – language added regarding the Genetic Information Nondiscriminatory Act (GINA)
6. University Statement - Added instructions for external sites
7. Signature Page – Revisions to page name, instructions, and signature lines

We appreciate the continuous input from the community during the ICF overhaul process. Upcoming updates to the consent form will address Social Behavioral and International studies.