HIPAA and Consent Forms

A new consent form template has been posted on the IRB web site. The upcoming implementation of the HIPAA privacy regulations will require use of specific patient authorization to release identifiable data as part of research projects. In hopes of minimizing the burden on research participants and investigators, we have decided to add the HIPAA privacy authorization language to the informed consent documents that are reviewed by the IRBs. In addition to incorporating HIPAA language, we took this opportunity to revise the consent document format extensively to improve its readability for participants. The new format includes required paragraph headings and required institutional language.

Effective 3/1/2003, new submissions to the IRBs, protocol amendments that require changes in the consent form, and continuing review applications must include a consent form developed with the new template. The new Combined Informed Consent/Authorization Template and Fill-In Form, (HIPAA IRB Form 2) and instructions may be found at the IRB web site. We are developing training sessions on use of the consent form template and will send out an announcement when the sessions are available.

For existing studies, there is no need to revise the existing consent form using the new template. Protocols with an already approved consent form may use a separate HIPAA privacy authorization form (HIPAA IRB Form 1: Authorization for Use and Disclosure of Health Information for Research), available at the JHM IRB web site.

If you plan to request a waiver of consent/authorization for research, use HIPAA IRB Form 4: Application for Privacy Waiver of Authorization for Research Protocol. It also may be found at the JHM IRB web site.

Please send questions regarding the new format and template to the IRB e-mail addresses at ohsceb@jhmi.edu or ohscbay@jhmi.edu. Questions regarding HIPAA requirements should be sent to the Central HIPAA Office at HIPAA@jhmi.edu. Thank you for your help and cooperation in implementing this change.

Human Subject Protection Course

Register now! The Baltimore Chesapeake Bay Chapter of the Association of Clinical Research Professionals (ACRP) is presenting a one-day course, " How to Face Realities in Research: Human Subject Protection in Today's Environment" on March 14, 2003, from 8:00 am - 5:00 pm. Complete details, including location and how to register, appear below.

Speakers/Topics:

Ernest Prentice, PhD (Associate Vice Chancellor for Regulatory Affairs and Compliance, University of Nebraska) - "The Impact of Lawsuits on Clinical Research and the IRB"

Jeffrey Cooper, MD (Deputy Director of the Association for the Accreditation of Human Research Protection Programs, Inc. [AAHRPP])- "Accreditation, SOP's and GCP's"

Deborah Waltz (Director of Regulatory Compliance Monitoring, University of Pennsylvania, School of Medicine) - "Development of a Regulatory Compliance and Monitoring Program"

John Farley, MD (Director of Center for Clinical Trials, University of Maryland, Baltimore) - "Vulnerable Populations: Research and the Circle of Life"

Gary Yingling, JD (Partner Kirkpatrick & Lockhart LLP, Washington, DC) - "Private Party Disputes"

Objectives:

• List and discuss legal issues in human subjects research.
• Describe components of a comprehensive compliance and monitoring program.
• List guidelines for protection of vulnerable populations.
• Integrate SOP development in accreditation preparation.

Cost:

ACRP & Chapter Member - $100
ACRP & Non-Chapter Member - $150
Non-ACRP/General Public - $200

Location:

University of Maryland, Baltimore
School of Nursing Auditorium
655 West Lombard Street
Baltimore, MD 21201

Six (6) contact hours are pending ACRP approval.

Registration is open to the first 200 individuals. For more details or to register, please click here:

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