3.4
Payment and Reimbursement

3.4 (a) No payments, cash or in-kind, may be provided for donating blastocysts and/or morulae in excess of clinical need for research purposes. People who elect to donate stored blastocysts and/or morulae for research should not be reimbursed for the costs of storage prior to the decision to donate.


3.4(b) Women who undergo hormonal induction to generate oocytes specifically for research purposes (such as for NT) should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an IRB. Direct expenses may include costs associated with travel, housing, child care, medical care, health insurance, and actual lost wages. No payments beyond reimbursements, cash or in-kind, should be provided for donating oocytes for research purposes. Similarly, no payments beyond reimbursements should be made for donations of sperm for research purposes or of somatic cells for use in NT.


3.5 To facilitate autonomous choice, decisions related to the creation of embryos for infertility treatment should be free of the influence of investigators who propose to derive or use hES cells in research. Whenever it is practicable, the attending physician responsible for the infertility treatment and the investigator deriving or proposing to use hES cells should not be the same person.


3.6 In the context of donation of gametes, morulae, blastocysts, or somatic cells for hES cell research or for hPS cell research that requires human subjects review, the informed consent process, should, at a minimum, provide the following information.9

  1. A statement that the blastocysts, gametes, morulae, blastocysts, or somatic cells will be used to derive hES or hPS cells for research that may include research on human transplantation.

  2. A statement that the donation is made without any restriction or direction regarding who may be the recipient of transplants of the cells derived, except in the case of autologous donation.

  3. A statement as to whether the identities of the donors will be readily ascertainable to those who derive or work with the resulting hES or hPS cell lines.

9

To be eligible for use in federally-funded research, the NIH guidelines specify specific elements for informed consent that may differ from the elements listed below.



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