HRP Program

Protecting Human Research Participants:
Legal, Ethical and Practical Considerations

Program Information Program Description How to Register Agenda

Program Information

April 25 and 26, 2013 The Westin San Diego 400 West Broadway San Diego, CA 92101 USA Hotel Phone: +1 (619) 239-4500 For Hotel Reservations, please contact the hotel or call +1 (888) 627-9033. Please mention SoCRA to receive the hotel room rate of $169 (plus applicable taxes), available until March 25, 2013 or until the SoCRA room block is filled.

The SoCRA program chairpersons for this program are:

• Cheryl I. Jacobs, CCRP
  Translational Research Management
• Carolyn Rugloski, MS, CCRP
  Paragon Biomedical, Inc.

Registration Fees:

• Member Fee- $590
• Non-Member Fee*- $665

* Non-Member Fees include a (non-refundable) one-year membership in SoCRA

Continuing Education Credit Hours:
SoCRA designates this educational activity for a maximum of 12.5 Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity for a maximum of 12.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Accreditation Statements:
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. ANCC/PSNA Provider Reference Number: 205-3-A-09

SoCRA Course Series: 300

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Program Description

SoCRA is proud to announce this conference on Protecting Human Research Participants. The conference is designed to aid the Clinical Research Professional’s understanding of the legal, ethical, and practical considerations in human subjects research.

This two-day conference for Clinical Research Professionals will study, explain and discuss the activities and roles of the FDA and individual states as they affect record keeping, investigator responsibilities, IRB management issues, audits, the informed consent process, and administrative activities falling under the FDA and state regulations. The attendee will understand and be able to convey the responsibilities of these very important functions and the complementary role of the clinical researcher as a fundamental contributor to successful clinical research and the protection of research subjects.

The program will focus on the relationships among clinical trial staff, investigators, IRBs and the FDA. The conference will highlight five areas that present challenges to sponsors and investigational sites: safety reporting, data monitoring, communication, education, and the informed consent process.

Learning Objectives:

Upon completion of the program, the attendee should be able to:

• Discuss the fundamentals, history, ethics, and regulatory aspects of the informed consent process and the informed consent document
• Describe the myriad of challenges associated with successful implementation of informed consent in research
• Discuss statistical methods used in clinical trials to examine accumulating results for early evidence of treatment differences
• Discuss human research protection issues through case study examples
• Discuss specific pediatric regulatory and ethical considerations including recent national and international efforts that impact the conduct of research in children
• Describe the impact of state regulations related to human research protections on study participation and study conduct
• Discuss the operation of the legal system and its impact on research
• Discuss the training and education of health care professionals related to the ethical conduct of human research
• Describe how to best approach training of personnel and developing of standardized procedures to build quality into a translational research network, and how this approach is thought to impact compliance with Good Clinical Practice
• Discuss FDA inspection procedures, informed consent documentation and the impact that significant deviations may have on human subject protection

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How to Register

Click HERE to Register Online* Note: If you experience difficulties, please use the PDF form.

Click Here to view/print the Program Registration Form in Adobe PDF format.*

• Non member fees include a one year membership in SoCRA.
• Membership fees are processed immediately and are not refundable.
  Fees are in U.S. dollars.
• Please make checks payable to “SoCRA”
• Checks must be drawn on a U.S. bank or marked “Pay in U.S. Funds”.
• Written cancellation requests received by SoCRA at least 10 business days prior to start of course may receive a $415 refund.
• We regret that refunds cannot be issued for cancellations on or after 10 business days prior to start of course.
• Taping (audio or video) is prohibited unless SoCRA’s written permission has been acquired.
• ADA - This program is accessible to persons with disabilities. Please list any special needs in the area indicated in the registration form.
• If for any reason this conference cannot be held, SoCRA is not responsible for costs incurred by attendees, such as airfares, or hotel or other reservations.
• SoCRA is an educational non-profit membership organization (corporation) - Federal Tax ID #61 1208981

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Agenda

Click Here to view/print the 2013 Program Agenda in Adobe PDF format.

The 2014 Conference Agenda will be posted once it is available.

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