Current through Register 2024 Notice Reg. No. 12, March 22, 2024
(a) All CIRM-funded human subjects research
shall be performed in accordance with Title 45 Code of Federal Regulations,
Part 46 (Protection of Human Subjects), revised June 23, 2005, and California
Health and Safety Code section
24173.
In accordance with existing law, California Health and Safety Code section
24173
does not apply to a person who is conducting research as an investigator within
an institution that holds an assurance with the United States Department of
Health and Human Services pursuant to Title 45 Code of Federal Regulations Part
46, revised June 23, 2005, and who obtains informed consent in the method and
manner required by those regulations.
(b) In addition to the requirements of Code
of California Regulations, title 17, section
100080, subdivision (a)(2), the
following provisions apply when CIRM funded research involves donation of human
gametes, embryos, somatic cells or tissue for derivation of new covered stem
cell lines:
(1) CIRM-funds may not be used for
research that violates the documented preferences of donors with regard to the
use of donated materials. The SCRO committee or IRB must confirm that donors
have given voluntary and informed consent in accordance with this section. To
ensure that donors are fully informed of the potential uses of donated
materials in addition to the general requirements for obtaining informed
consent identified in subdivision (a) of this regulation, researchers shall
disclose all of the following, unless a specific item has been determined by
the SCRO committee or IRB to be inapplicable:
(A) Derived cells or cell products may be
kept for many years.
(B) Whether or
not the identity(ies) of the donor will be ascertainable by those who work with
the resulting cells or cell products. If the identity of the donor is to remain
associated with the cell or cell products, then the investigator must inform
the donor of any plan for recontact whether for the purpose of providing
information about research findings to donors, or for the purpose of requesting
additional health information. After donation, an investigator may recontact a
donor only if the donor consents at the time of donation.
(C) Cell lines may be used in future studies
which are not now foreseeable.
(D)
Derived cells or cell products may be used in research involving genetic
manipulation.
(E) Derived cells or
cell products may be transplanted into humans or animals.
(F) Derived cells or cell products are not
intended to provide direct medical benefit to the donor, except in the case of
autologous donation.
(G) The
donation is being made without restriction on the recipient of transplanted
cells, except in the case where donation is intended for autologous
transplantion.
(H) Neither consent
nor refusal to donate materials for research will affect the quality of any
care provided to a potential donor.
(I) Although the results of research
including donated materials may be patentable or have commercial value, the
donor will have no legal or financial interest in any commercial development
resulting from the research.
(2) A donor must be given the opportunity to
impose restrictions on future uses of donated materials. Researchers may choose
to use materials only from donors who agree to all future uses without
restriction.
(3) For CIRM-funded
research involving the donation of oocytes, an IRB finding that potential risks
of donation are reasonable even if there is no anticipated benefit to the donor
shall be documented and made available to the donor, SCRO and the CIRM. In
addition, the following requirements apply:
(A) The description of foreseeable risk
required in subdivision (a) of this regulation shall include but not be limited
to information regarding the risks of ovarian hyperstimulation syndrome,
bleeding, infection, anesthesia and pregnancy.
(B) Any relationship between the attending
physician and the research or researcher(s) must be disclosed to an egg
donor.
(C) Prospective donors shall
be informed of their option to deliberate before deciding whether or not to
give consent. If a deliberation period is chosen, the donor shall be informed
of her right to determine the method of recontact. The donor must be informed
that she has the option to initiate recontact. Investigators shall not initiate
recontact unless the donor has consented, and this consent is documented in the
research record.
(D) The researcher
shall ascertain that the donor understands the essential aspects of the
research involving donated materials, following a process approved by the
designated IRB or SCRO committee. Understanding the essential aspects of the
research includes understanding at least that:
(i) Eggs will not be used for reproductive
purposes.
(ii) There are medical
risks in oocyte donation, including the risks of ovarian hyperstimulation
syndrome, bleeding, infection, anesthesia, and pregnancy.
(iii) The research is not intended to
directly benefit the donor or any other individual.
(iv) Whether stem cell lines will be derived
from her oocytes through fertilization, SCNT, parthenogenesis, or some other
method.
(v) Stem cell lines
developed from her oocytes will be grown in the lab and shared with other
researchers for studies in the future.
(vi) If stem cells derived from her donation
are to be transplanted into patients, researchers might recontact the donor to
get additional health information.
(vii) Donors receive no payment beyond
reimbursement for permissible expenses.
(viii) Stem cell lines derived as a result of
her oocyte donation may be patented or commercialized, but donors will not
share in patent rights or in any revenue or profit from the
patents.
(4)
For funded research involving the donation and destruction of human embryos for
stem cell research, the informed consent process shall include a disclosure
that embryos will be destroyed in the process of deriving embryonic stem
cells.
(5) Research that uses human
umbilical cord, cord blood or placenta, consent shall be obtained from the
birth mother.
(6) For research
involving the donation of somatic cells for SCNT, the informed consent process
shall include disclosure as to whether the donated cells may be available for
autologous treatment in the future.
1. New section
filed 10-10-2006; operative 11-22-2006 (Register 2006, No. 41).
2.
Amendment filed 5-30-2008; operative 6-29-2008 (Register 2008, No.
22).
Note: Authority cited: Article XXXV, California
Constitution; and Section
125290.40(j),
Health and Safety Code. Reference: Sections
24173,
125290.35,
125290.40,
125290.55
and
125315,
Health and Safety Code.