San Diego Research Ethics Consortium
Ethics Education Requirements

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Background
Based on guidelines from the National Academy of Sciences, regulations from the California Institute of Regenerative Medicine, and guidelines of the participating institutions of the San Diego Consortium for Regenerative Medicine, the institutional Stem Cell Research Oversight Committees are charged with overseeing a requirement for ethics training.

The focus of this requirement is on individuals, rather than on protocols submitted for review. Protocols can be approved, but individuals are not authorized to work on those protocols unless they have completed the appropriate training requirements. Also, although training requirements will be fulfilled by individuals, the purpose of the requirement is to foster a community environment in which the ethical, legal, and social dimensions of human embryonic stem cell research are widely discussed and understood.
Requirement
Effective December 15, 2007, the Burnham Institute for Medical Research, the Salk Institute, The Scripps Research Institute, and the University of California San Diego have jointly adopted the following training requirements for approval of human embryonic stem cell research projects by their respective Embryonic Stem Cell Research Oversight (ESCRO) or Stem Cell Research Oversight (SCRO) committees:
  1. Initial Training Requirement
    No individual is approved to work on embryonic stem cell research oversight projects until he or she has completed a basic training requirement; however, approvals for those research projects can be issued independently by the ESCRO or SCRO Committees before all personnel have had ethics training. Individuals or research groups can contact their institutional ESCRO or SCRO Committee about options available for meeting this requirement. Completion of this requirement is sufficient for the individual to conduct embryonic stem cell research for one year from the date of initial authorization by the ESCRO or SCRO Committee.

  2. First Year Continuing Education Requirement
    Each individual conducting human embryonic stem cell research at an institution of the San Diego Consortium for Regenerative Medicine is expected to complete an additional four hours of stem cell ethics training to be approved for the first annual renewal. This training must be completed before the ESCRO or SCRO Committee can authorize that individual to conduct human embryonic stem cell research in the second year. Options for such training are numerous and can include appropriate stem cell ethics courses, seminars, workshops, conferences, or research group meetings. Options will be publicized by the San Diego Research Ethics Consortium (http://sdrec.ucsd.edu), but individuals are encouraged to contact the Committee with any questions. Completion of this requirement is sufficient for that individual to continue conducting embryonic stem cell research for a second year following the date of initial authorization by the ESCRO or SCRO Committee.

    Exemptions from First Year Continuing Education Requirement:
    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 for a reduced continuing education requirement or to be exempt from this "First Year Continuing Education Requirement."

  3. Subsequent Year Continuing Education Requirement
    Each individual conducting human embryonic stem cell research at an institution of the San Diego Consortium for Regenerative Medicine is expected to complete an additional two hours of stem cell ethics training during each year of authorization by the ESCRO or SCRO Committee. This training must be completed before the ESCRO or SCRO Committee can authorize that individual to conduct human embryonic stem cell research in each subsequent year. Options for such training are numerous and can include appropriate stem cell ethics or research ethics courses, seminars, workshops, conferences, or research group meetings. Options will be publicized by the San Diego Research Ethics Consortium (http://sdrec.ucsd.edu), but individuals are encouraged to contact the Committee with any questions. Completion of this requirement is sufficient for that individual to continue conducting embryonic stem cell research at UCSD for each subsequent year following the date of initial authorization by the ESCRO or SCRO Committee.

    Exemptions from Subsequent Year Continuing Education Requirement:
    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 the ESCRO Committee for a reduced continuing education requirement or to be exempt from this "Subsequent Year Continuing Education Requirement."

  4. Special Requirements
    Because particular projects or individual situations may raise unusual ethical or regulatory concerns, the ESCRO or SCRO Committees may on rare occasions require and/or provide additional training.