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Update: November 13, 2009

This page lists recent, upcoming, and ongoing options for meeting ethics training requirements for the San Diego Research Ethics Consortium. Click on this link, Past education options, and see a list of events held prior to this month.


1. Initial Training Requirement

To be approved for any use of human embryonic stem cells, each individual must first complete an "initial training requirement." Topics covered by this introductory training must include the following:
  1. Stem Cell Research: Promise, Controversy, and Scrutiny
  2. Prohibitions on research
  3. Funding limitations
  4. Training requirements
  5. Requirements for review and approval
  6. Some challenging ethical issues
  7. Responsibilities of scientists
  8. Resources
Recent, upcoming, and ongoing options to meet this requirement are listed below:

General Options:
 
  • Online training program:

    An online course titled “Introduction to Stem Cell Ethics” has now been launched.  This course is available at no charge, it can be accessed 24 hours a day, and completion of the course will meet the initial ethics education requirement for stem cell researchers.  If you are a student, staff, or faculty member at UCSD, then you can access the course by signing in to Enrollment Central:

      https://enrollmentcentral.ucsd.edu/sed_course.cfm?cdcrs=SCETHICS

    If you are at the Burnham, Salk, or Scripps, then please contact Shannon Prior <sdrec@ucsd.edu>  to request that you be provided with an affiliate status that will allow you to access the course.

    Completion of this course will typically require no more than a half hour.  A certificate is issued after successful completion of a brief, multiple choice quiz.

  • Individual meetings (contact the SDREC for further information)
  • Any other equivalent experience
Specific Options:
 
  • December 8, 2009- Initial Training @ The Salk Institute, 12pm-1pm in the Parker Conference Room. Parking may be reserved by emailing klemic@salk.edu (at least one week in advance). Register here.


2. First Year Continuing Education Requirement
To be certified for use of human embryonic stem cells in a second year, an additional four hours of stem cell ethics training must have been completed within the preceding two years. Because the primary purpose of this requirement is to promote a culture in which the ethics of this research is a part of what we all do, all researchers are encouraged to take advantage of ongoing opportunities for education and discussion about the ethical dimensions of human embryonic stem cell research. However, individuals who anticipate that their research responsibilities raise minimal ethical concerns may petition their institution’s ESCRO or SCRO Committee to be exempt from this requirement.

Recent, upcoming, and ongoing options to meet this requirement are listed below:

General Options:
 
  • The stem cell ethics components of stem cell research conferences
  • Individual meetings
  • Any other equivalent experience
Specific Options:
 
  • Thur., November 12, 12-2pm UCSD, Early hESCell Clinical Trials, UCSD, Stein Clinical Research Building, Room 148. Please bring a sack lunch. Register here.

    • This workshop focuses on ethical issues in bringing stem cell research from the lab to the clinic. The Geron spinal cord injury trial recently approved by the FDA will serve as a case study.
    • Questions include: How much pre-clinical data is enough? What are the risks and benefits of early hES cell trials? How do investigators balance the need for good scientific data with the ethical obligation to protect human subjects?  With media hype? What role should patient advocates play in decisions about early clinical trials for diseases such as Parkinson's or Alzheimer's? What potential conflicts of interest do stem cell researchers  face and how are such conflicts avoided or managed?
  • Thurs., November 19, 2009 12-2pm UCSD, Ethical Issues in Working with hESCells UCSD, Stein Clinical Research Building, Room 148. Please bring a sack lunch Register here.

    • Stem cell research offers great promise for relieving or resolving many human diseases. Recent progress along a number of fronts suggests that the clinical testing of hESC-derived therapies may not be far off. This workshop focuses on issues of safety, informed consent for patients in Phase I trials, risks and benefits of moving to early trials, and concerns about fair access to eventual therapies.  Discussion will focus on the March 2009 White Paper: Translation Issues for hESC-Derived Therapies by Marie Csete, MD, Ph.D., Chief Scientific Officer at CIRM http://www.cirm.ca.gov/sites/default/files/PDFs/Publications/Translating_Discoveries.pdf
    •  Furthermore, because of the unknowns and calculated risks in translation of hESC-derived  therapies, the patient populations studied should be those with disease or injury that has high  mortality or morbidity and for whom adequate therapies do not currently exist.  [These populations may be especially vulnerable, that is, inherently coercible, because of their disease state.  For this reason again, special attention to staged informed consent is warranted, analogous to the practice in living donor organ donation (Colardyn, 2003)].  This consideration of the appropriate  populations for initial Phase I testing also implies that testing of hESC-derived cell therapies in  normal human volunteers before Phase I tests in diseased subjects is not justifiable since real  benefits of therapy cannot be weighed against risks in normal subjects.   





3. Subsequent Year Continuing Education Requirement
To be certified for use of human embryonic stem cells in each subsequent year, an additional two hours of stem cell ethics training must have been completed within the preceding two years. Because the primary purpose of this requirement is to promote a culture in which the ethics of this research is a part of what we all do, all researchers are encouraged to take advantage of ongoing opportunities for education and discussion about the ethical dimensions of human embryonic stem cell research. However, individuals who anticipate that their research responsibilities raise minimal ethical concerns may petition their institution’s ESCRO or SCRO Committee to be exempt from this requirement.

Recent, upcoming, and ongoing options to meet this requirement are:
  • Any of the options listed for the "first year requirement"
  • The UC San Diego Ethics and Survival Skills in Academia course (COGS/NEUR/PATH 241) (Winter)
  • The UC San Diego Ethics in Scientific Research course (PHAR 219) (Spring)
  • The UC San Diego Scientific Ethics course (SOMI 226) (Spring)
  • The UC San Diego Summer Research Ethics Workshop for medical students (Summer)
  • The TSRI Ethics in Science course (Summer)
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