HRP Program
Legal, Ethical and Practical Considerations in Protecting Human Research Participants
April 14 and 15, 2011
Westin San Diego
400 West Broadway
San Diego, CA 92101 U.S.A.
Hotel Phone: +1 (619) 239-4500
Please mention SoCRA to receive the hotel room rate of $159 (plus applicable taxes), available until March 31, 2011 or until the SoCRA room block is filled. |
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The SoCRA program chairpersons for this program are:
- Cheryl I. Jacobs, CCRP
Breastlink Medical Group, Inc.
- Carolyn Rugloski, MS, CCRP
UCSF ITN
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 12.3 Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this educational activity for a maximum of 12.3 AMA PRA Category 1 Credit(s)™. Physicians should claim 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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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 the psychological and biological underpinnings of how subjects process information delivered or shared during the informed consent process and by the informed consent document
- Discuss the operation of the legal system and its impact on research
- Discuss specific pediatric regulatory and ethical considerations including recent national and international efforts that impact the conduct of research in children
- Discuss the training and education of health care professionals related to the ethical conduct of human research.
- Discuss the critical evaluation and decision-making roles played by the members of the DMC team
- Discuss what constitutes a conflict of interest and how conflicts may be managed
- Discuss FDA inspection findings and case studies to highlight the impact of inspection failures on subject protection and the quality and integrity of data generated by a clinical trial
- Discuss how the use of stored biological samples and data prompts ethical questions about privacy and confidentiality.
- Discuss human research protection issues through case study examples.
SoCRA is proud to announce this meeting on Legal, Ethical and Practical Considerations in Protecting Human Research Participants - designed to aid the Clinical Research Professional's
understanding of the mission, responsibilities and authority of the FDA and OHRP
Department of Health and Human Services.
This two-day program for Clinical Research Professionals will study,
explain, and discuss the activities and roles of the FDA and OHRP as they affect
record keeping, investigator responsibilities, IRB management issues, audits,
the informed consent process, and administrative activities falling under the
FDA and OHRP guidelines. 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, the FDA and the OHRP. The program will highlight three
areas that present challenges to sponsors and investigational sites: policies
and procedures, communication, education, and the informed consent process.
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Click HERE to register online!
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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Click Here to view/print the 2010 Program Agenda in Adobe PDF format.
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