Short Course Details
Informed Consent and Beyond: Challenges, Implementation Issues and Strategies in the Collection and Use of Specimens for Research
Instructors: Nicole Sieffert, Program Director, Biorepository Regulatory Support, MD Anderson Cancer Center
Marianna J. Bledsoe, Individual Consultant, Former Senior Program Manager, Department of Veterans Affairs, Office of Research and Development
With the explosion of new technology and the need for high quality specimens for research towards the development of targeted therapies, there is an increased level of interest in obtaining “front door” consent for the future use of specimens during the course of routine care. In this three hour workshop, faculty will:
• Discuss when front-door mechanisms are feasible and what makes this approach to consent work.
• Address the ethical and regulatory responsibilities of an institution and its researchers.
• Review the challenges and benefits of an institution-wide biospecimen banking initiative and explore a practical approach to evaluating barriers, risks, and benefits in implementing “front door” consent.
Nicole Sieffert is the Program Director of Biorepository Regulatory Support at MD Anderson Cancer Center where she’s been involved with clinical research and human biospecimen repository management for 14 years. Mrs. Sieffert was instrumental in the development of MD Anderson’s Institutional and Satellite Banking System as well as the management of the institutional biorepository, and the “front door” consent mechanism. Current responsibilities include strategic planning, QA/QC, educational program and policy development, and biospecimen-related compliance for the MD Anderson Central Campus and its Sister Institutions. After her daughter was diagnosed with breast cancer at the age of 22, Mrs. Sieffert became a spokesperson for the Houston Affiliate of the Susan G. Komen Race for the Cure. This combination of personal and professional experience continues to provide a valuable opportunity to share information with patients as well as the scientific community, which she feels is her greatest contribution. An active member of ISBER, the International Society for Biological and Environmental Repositories, Mrs. Sieffert Co-Chairs the Science Policy Committee as well as the Education and Training Committee. She is also a member of the Informed Consent Working Group, the Specimen Rights & Ownership Working Group, and is an Ex-officio member of the ISBER Board of Directors. She received the ISBER Special Service Award in 2012.
, MA, is an independent research professional who teaches, writes and consults on biomedical research policy matters including the ethical, legal and social issues related to tissue banking and the use of human specimens in research. Marianna has been involved in human specimen research and tissue banking for nearly 20 years. She provided strategic oversight and direction for a variety of different tissue banks at the National Cancer Institute and the Department of Veterans Affairs. As Deputy Associate Director of the Clinical Research Policy Analysis and Coordination Program in the Office of Science Policy, Office of the Director, NIH, she led an interagency effort to streamline and harmonize federal policies related to human specimen research. In addition, she was heavily involved in the development of policies related to genetic and genomic data sharing, privacy and confidentiality, and electronic health records.She has presented and participated in research policy development efforts at both the national and international levels. Marianna serves as Associate Editor for the journal, Biopreservation and Biobanking. She was President of the International Society for Biological and Environmental Repositories (ISBER) from 2007 – 2008 and is a current member of the ISBER Board of Directors and ISBER Science Policy Committee. She received the 2012 ISBER Distinguished Leadership and Service Award, and the 2013 ISBER Special Act or Service Award.