SHERLEY et al v. SEBELIUS et al
Filing
66
ADMINISTRATIVE RECORD by FRANCIS S. COLLINS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, NATIONAL INSTITUTES OF HEALTH, KATHLEEN SEBELIUS. (Attachments: # 1 Part 1 of 41, # 2 Part 2 of 41, # 3 Part 3 of 41, # 4 Part 4 of 41, # 5 Part 5 of 41, # 6 Part 6 of 41, # 7 Part 7 of 41, # 8 Part 8 of 41, # 9 Part 9 of 41, # 10 Part 10 of 41, # 11 Part 11 of 41, # 12 Part 12 of 41, # 13 Part 13 of 41, # 14 Part 14 of 41, # 15 Part 15 of 41, # 16 Part 16 of 41, # 17 Part 17 of 41, # 18 Part 18 of 41, # 19 Part 19 of 41, # 20 Part 20 of 41, # 21 Part 21 of 41, # 22 Part 22 of 41, # 23 Part 23 of 41, # 24 Part 24 of 41, # 25 Part 25 of 41, # 26 Part 26 of 41, # 27 Part 27 of 41, # 28 Part 28 of 41, # 29 Part 29 of 41, # 30 Part 30 of 41, # 31 Part 31 of 41, # 32 Part 32 of 41, # 33 Part 33 of 41, # 34 Part 34 of 41, # 35 Part 35 of 41, # 36 Part 36 of 41, # 37 Part 37 of 41, # 38 Part 38 of 41, # 39 Part 39 of 41, # 40 Part 40 of 41, # 41 Part 41 of 41)(Moore, Tamra)
SHERLEY et al v. SEBELIUS et al
Doc. 66 Att. 3
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Adopt 17 Cal. Code of Regs. section I00 1 I0 to read:
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6 1001 10. Fairness and Diversitv in Research.
ClRM grantees shall comply with the California Health Research Fairness Act, California Health and Safety Code, sections 439.900-439.906. and Inclusion of Women and Minorities in Clinical Research Act. Health and Safety Code, sections 100237-100239. Note: Authority cited: Article XXXV. California Constitution; Section 125290.40(i), Health and
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Safetv Code. Reference: Sections 439.900-439.906, 100237-100239, 125290.40, 125290.55, Health and Safetv Code.
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Adopt 17 Cal. Code of Regs. section 100120 to read:
tj 100120. Record Keeping,
(a) In addition to any other reporting or record retention obligations required by the CIRM, each grantee's institution shall also maintain records documenting: (1) Review or notification requirements as described in Title 17, California Code of Rewlations. section 100070; (2) The final disposition of gametes, embryos and, somatic cells donated for CIRMfunded research or products of SCNT. For donated materials used to derive a covered stem cell line this record must demonstrate compliance with section 100080, subdivision (a). Jb) Such records shall be made available at CIRM7srequest. Note: Authority cited: California Constitution, article XXXV; Section 125290.40(i), Health and Safety Code. Reference: Sections 125290.35, 125290.40 and 124290.55, Health and Safety Code.
Eff. 08/13/08
100 120 OAL Approved
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DEPARTMENT O HEALTH & HUMAN SERVICES F
office of the (kwelly
The Genenl Counsel !y r. I , : :
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Washington, D.C. 20201
TO:
FROM:
Harold Varmus, M.D.
Dhector, NIH Harriet S. Rab
.
SUBJECT:
Federal Funding for Research Involving Humm Pluripotmt Stem Cells
The Office of the General Counsel of the U.S. Department of Health and H m n Smices (HHS) ua has prepared the following in response to your request for a legal opinion on whether federal funds may be used for research conducted with human pluripotent stem cells derived from embryos created by in vibo fertilization or from primordial germ cells isolated from the tissue of non-living fetuses. This inquiry arises f o the recently reparted msarch of; (1) D .James A. rm r Thornson of the University of Wisconsin-Madison, who isolated pluripotent stem cells h m embryos donated for research by persons undergoing fertility treatment1;and (2) D .Michxl r Shamblott of thc Johns Hopkins University School of Medicine, who dcrivcd pluripotent stem cells from primordial germ cells from non-living fetuses.' The research described in these two published reports was not funded by H S H.
S m a r v Answer
The statutory prohibition on the use of funds appropriated to HI-IS for human mbryci research would not apply to research utilizing human pluripotent stem cells because such cclls arc not a human embryo within the statutory definition, To the extent human pluripotent stem cells are considered human fetal tissue by law, they are subject to the statutory prohibition on sale for valuable consideration, the restrictions on fetal tissue transplantation research that is conducted o funded by HHS, a well as t the federal criminal prohibition on the directed donation of fetal r s o
James A. Thornson et a]., Embryonic Stem Cell Lines Derived fiom .Human Blastocvsts, Science, vol. 282, November 6, 1998, pp. 1 145- 1147.
Michael J. Shamblott et al., Derivation of Plurimtent Stem Celh from Cultured Human Primordial Germ Cells, 95 Proc. Nat'l. Acad. Sci. USA 13726 (Nov. 1998).
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tissue. Rescarch involving human pluripotent stem cells excised f o a non-living fetus may be rm conducted only in accordance with any applicable state or local law. Finally, the Presidential Directive banning federal finding of human cloning would apply to plwipotent stem cclls, only if they were to be used for that purpose.
Analvsis
I. ,Prohibition on Federal Funding for Human Enbws .Research
In the appropriations provision for the Departments of Labor, Health and Human Services, and Education,and Related Agencies in the Omnibus Consolidated and Emergency Supplmmtal Appropriations Act, F s a Ycar 1999, Public Law 105-277, sectiod 51 1 provides that none of thc icl h d s made available in that appropriation may be used for:
(1) the creation of a human embryo or embryos for research. purposes; or (2) research in which a human embtyo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero undcr 45 CFR 46.208(a)(2) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g (b)).
The term "human embryo or embryosnis defrned in the statute to include "any organism,not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is
derived by fertilization, parthenogenesis, cloning, or any ofher means from one or more human gametes or human diploid cells."
Pluripotent stem cells are not a human "organism"as that t r is used in the definition of human em embryo provided by statute. The term "urganism"is not itself defined by law, and the question of what is an organism calls for a science-based answer. According to the McGraw-Hill Dictionary of Scientific and Technical T m s (hereinafter Mchw-Hill), an organism is "an [] individual constituted to carry out aU life fk~ctions."~ Pluripotent stem cells are not organisms
McGraw-Hill Dictionary of Scientific and Technical Terms 1408 ( 5" edition 1994). See also N.Campbell, Bialo?~, edition 1996) pp. 8-9, which defines o g n s as follows: (4b raim
While cells are the units of organisms, it is organisms that are the units of life. It's an important distinctioa h c q t for unicelIular life, 'cell' does not equal 'organism.' A single-cellcd organism such as an amoeba is analogous not t one o of your cells, but to your whole body. What the amoeba accomplishes with a single cell the uptake and processing of nutrients, excretion of wastes, response to environmental stimuli, reproduction, and other functions a human or ather rnulticellulnr organism accomplishes with a division of labor among specialized tissues, organs, and organ systems. Unlike the amoeba, none of your cells could Live for long on i s own. Ihe organism we recognize as an animal or plant is not a t
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a d do not have the capacity to develop into an organism that could perhrm all the Life functions n of a human being i this stnsc they arc not cvcn precursors t hufnan organisms4 Thcy art, n o rather, human cells that have the potential to evolve into different types of cells such as blood cells or insulin producing cells.
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Moreover, a human embryo, as that term is virtually universally understad, has the potentid to develop in the normal come of events into a living human b e k . .Thescientific definition of embryo, as described in M e w - H i l l , is "[tlhe product o f canccption up b the third month of human pregna~cy."~ Pluripotent stem cells do not have the capacity tii develop into a human being, even if transferred to a uterus." Therefore, in addition to falling outside of tht legal definition provided by statute, pluripotent stem cells cannot be considered human embryos consistent with the commonly accepted or scientific understanding of that tcnn. Thus, based on
collection of unicells, but a multicellular cooperative with the emergent properties of 'whole organism.'
At a December 2,1998, stem cell research hearing before the Subcommittee on Labor, Health and Human Services, E,ducationand Related Agencies of the Senate Appropriations Committee, Senator Tom Harkin asked five scientists, two biocthicists, and a thcolopian testifiing before the wmmittcc if, in their view, stem cells wnc or&ukms. h of the experts l who responded concluded that human pluripotent stem cells are not organisms. Use of Fetal Tissue in Brain Stem Cell Research: Hearin9 Before the Subcomm. on Labor. Health and Human Services. and Education of the Scnatc A~propriations o m , 105th Cong. (December 2, f 998) C available in LEGI-SLATE, Transcript No. 983360015 pereinafter Stem Cell Hearing] (statement of Dr. h o l d Varmus, Director, National Institutes of Health; D .John Gearhart, r Johns Hopkins University School of Medicine; Dr. James Thomsgn,,Wisconsin Primate Research Center, University of Wisconsin; D .Michael Wwt, Advanood Ccll Technology; Dr. r Thomas Okamza, G-eron Corporation; Dr.Arthur Caplan, Center for B i d c s , University of Pennsylvania Health System; and M .Richard Doerflinger, Associate Director for Policy r Development, Secretariat of Pro-Life Activities, Na;tional Confmencc of Cablio Bishops). One expert, Dr, Eric Meslin, Executive Director of the National Bides Advisory Commission, stated that he could not speak on behalf' of the Commission because it had not considered the question. Stem Cell Hearing, supra (statement of Dr. Exit Meslin). McGm-Hill Dictionary,a note 3, at 673.
Set Letter h r n thc Chair of the National Bioethics Advisory Commission, to the Prcsidcnt of thc Unitcd Statcs, rcspnsc to qucstion no.2, November 20, 1998; National Institutes of Hedth, Report ofthe Human Embryo Research Panel, Sept 1994, p. 26. See also Stem Cell Heatinq, sunra noto 4, (statements of Dr. Michael West, Advanced Cell Technology; Dr. Thomas Okarma, Geron Corporation; and Dr. Arthur Caplan, Center for Bioethics, University of Peunsylvania Health System).
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an analysis of the relevant law and scientific h t s , federally W c d research that utilkcs human pluripotent stem cells would not be prohibited by the HI-IS appropriations law prohibiting human embryo research, because such stem cells arc not human embryos.
II. Restrictions on the Use of Hwnan Fetal T i s m
There are a number ofpotential sources of human pluripotent stem cells; some of these stan cells may fall within te legal definition of hwzan fetal tissue and would, therefom, be subject to h federal regulations. Section 498A of the Public H d t h Service Act specifics that f b d tissue "means tissue or cells obtained fiom a dead human embryo or fetus after a spontaneous or induced abortion, or aAer a stillbktk" 42 U.S.C.289g-1(g). Some s e cells, for example those tm derived from the primordial germ cells of non-living fetuses, would be considered human fetal tissue for purposes of Section 498A.
The Public Health Service Act (hereinaRer "The Act") c o n w three relevant provisions
governing the use and transfer of human fetal tissue: (1) a criminal prohibition against the sale of human fetal tissue for valuable consideration;(2) restrictions on fetal tissue transplantation research supported by federal funds; and (3) a prohibition on the directed donation of f d tissue for transplantation. We explore cach of these restrictions in turn
Section 498B(a) of the Act states that it is unlawful for any person to knowingly acquire, receive, or otherwise transfer any h m a n fetal tissue for valuable consideration,' if the transfer affects interstate 42 U.S.C. 28%-2(a). It is common prS:ctice for scientists throughout the United States to share research materials through transactions that result in such materials crossing state boundaries, Such exchanges, as well as transactions within the Disbict of Columbia, or exchanges within a state that "affect i t r t t arrnmerce"would meet the statutory nesae criterion of affecting inttrstatt commerce, but wodd not fall within the scope ofthe criminal
' The term "valuable~nsideration" encompasses both m n t r and non-monetary oeay
payments, Section 498B (dX3) provides that the term docs not include "reasonablepayments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue."
Food, Drug, and Cosmetic Act, 2 1 U.S.C. 321@): ". . . commer& Ixtween any State or Territory and any place outside tbereof, and , . commerce within the District of Columbia or within any other Territory not organized with a legislative body." The statute does not define what "affects" interstate commerce, but, in interpreting similar language in another crimiaal statute the Supreme Court found that "affectinginterstate commerce" is an expression of Cbngress' intent t broadly o exercise its Commerce Clause power under the Constitution. Scarbornugh v United States, 43 1 . U.S. 563,571-72 (1977).
' 'The statute adopts the definition of interstate commerce i.ti section 201@) of the Federal
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prohibition unless the scientist providing the materials sought payment i excess of the expenses n included in the statutory definition of "valuablcconsideration"
I addition, the: law places some restrictions on W e d support for research on the transplantation n of fetal tissue, Section 49814 of the Act provides that the Secretary may conduct or support &search on thc "transplantationof fctd tissue for therapeutic purposes," only if certain statutory requirements are met. 42 U.S.C. 289g-1. Thesc requirements include obtaining: (1) the informed consent of the woman donating the tissue; (2) a statement by the atteding physician regarding the woman's consent and the m t o of obtaining the tissue; (3) a statement by the ehd researcher regarding his or her understanding of the source of the tissue, that such information has been conveyed to the donee, and that the researcher has not participated in any decision regarding termination of the pregnancy.
Finally, section 498B(b) of the Act provides that it shall be unlawful for any person to soIicit or knowingly acquire, receivt, or accept a damtion of human fetal tissue for the purpose of transplantation into another person if the tissue will be or is obtained pursuant to an induced abortion, and there is a promise to the donor: (1) to transplant the tissue into a person specified by the donor; (2) the tissue will be transplanted into a relative of the donor; or (3) the donee of the tissue has provided valuablc consideration for the costs associated with the abortion. 42 U.S.C. 289g-2(b). The Act provides criminal penalties for violation of the prohibition on directed donations,
111. Federal Restrictions on Fetal Research
Federal regulation provides that activities involving cells, tissues, or organs excised h m a nonliving fetus shall be conducted only in accordance with any applicable state or local law. 45 ClFR 46.210, Subpart B. T i regulation would apply to certain human pluripotent s e cells, hs tm including those derived from the primodial germ cells of non-living fetuses.
IV. Prohibition on F e d d Funding for Cloning of Human Bcinns
In a March 4, 1997, memmdum to the heads of executive departments and agencies, the President directed that no federal h d s will be used for the cloning of human beings and that The* are myriad uses fa human federal funds shall not be allocated for that plwipotent stem cells that are compIetely unrelated to cloning. However,to the extent such stem cells were to be used for human cloning, the prohibition on tho urn df federal finds for that purpose would apply. ..
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' Memorandum fiom the President ofthe United States to Heads of Executive
Departments and Agcncics (March 4,1997).
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This sample document may not conform to the standards ofyour local Research Ethics Board
ISSCR SAMPLE RESEARCH CONSENT FORM Egg Procurement for Stem Cell Research (Eggs Provided Directly and Solely for Stem Cell Research)
Project Title: Principal Investigator: Participating Institution(s):
PROJECT INFORMATION
You are being asked to provide eggs for a human embryonic stem cell research project led by [name of principal investigator] at [name(s) of institution(s)]. Embryonic stem cells can be found in embryos around the fifth day of development. These stem cells have the unique ability to turn into any kind of specialized human cell, such as liver cells, heart cells, pancreatic cells, or nerve cells. For this reason, embryonic stem cells can be used to study, and possibly one day help treat, diseases or injuries that have caused patients' specialized cells to die or become damaged - diseases and injuries such as Parkinson's disease, heart disease, diabetes, and spinal cord injury.
[Name of principal investigator] wants to collect new human embryonic stem cells from embryos that have been created by [as applicable: nuclear transfer; parthenogenesis; the union of sperm and egg.] [As applicable: "Nuclear transfer" is the process by which researchers place donated adult body cells into unfertilized eggs that have had their DNA removed. If successful, this technique can create embryos that contain stem cells which are genetically matched to the body cell donors.] [As applicable: "Parthenogenesis" is the process by which an unfertilized egg is stimulated to begin going through the very early stages of human development. Stem cells that arise from parthenogenesis would be genetically matched to the person who provided the unfertilized egg.] [Insert additional information about this project using very simple language.] VOLUNTARY CHOICE
Providing your eggs for this research project is completely voluntary. You have the right to agree or to refuse to provide your eggs for this project. The quality of your current or future medical care and your relationship with [name(s) of institution(s)] will NOT
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change in any way whether you agree or refuse to provide any eggs for this research project.
WHAT IS THE PURPOSE OF THIS CONSENT FORM?
[Name of person obtaining consent] is authorized to give you information and to answer your questions about this research project. It is very important that you have a detailed conversation with this person so that you can make a careful, voluntary decision about whether or not you want to provide your eggs for this research project.
Your signature on the last page of this consent form is meant to show that you have had this conversation and that you freely agree to provide your eggs for this research project. This consent form must not replace actually having this conversation, so be certain you have this conversation. Please take as much time as you need to ask questions and to talk about this project with your family or friends before you decide whether or not to sign this consent form. You may take this form home with you before you decide what to do. Do not sign this form if you feel pressured in any way by any person to provide your eggs for this project. This must be your own decision, not someone else's.
WHAT WILL HAPPEN TO MY EGGS?
None of the eggs you provide for this research project will be used to produce a baby or a pregnancy. And no embryos created from your eggs will be allowed to develop for more than a total of 14 days after they have been [as applicable: created through nuclear transfer; created through parthenogenesis]. If any of the resulting embryos are frozen, then the time that they are frozen is not counted as part of the 14 day limit. Researchers will only use your eggs to create embryos from which they will attempt to get stem cells before the 14 day limit. The resulting embryos will be destroyed during the stem cell collection process. There is no guarantee that embryos will be successfully created fiom your eggs. And there is no guarantee that researchers will be able to get stem cells fiom any resulting embryos. Researchers will routinely discard as medical waste any eggs which are not used for this research project, as well as any embryos from which they are unable to get stem cells.
WHAT WILL HAPPEN TO THE COLLECTED STEM CELLS?
It is likely that the retrieved stem cells will be stored for many years. Embryonic stem cells have the ability to self-renew indefinitely, and they are likely to be used by researchers at other institutions and for many other research purposes.
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One possible research use of these stored stem cells might involve changing some of their genes. Another possible research use might be to study some of the stem cells by placing them into laboratory animals. In addition, the stored stem cells might be used in the future for new research related to human stem cell transplantation. These are just three common examples of what might happen to the stored stem cells. But there are many other future possible research uses that are simply unknown at this time. You will have no say as to which institutions or researchers may share the stem cells made from the embryos that were created using your eggs. If stem cell transplantation studies are developed in the future, you will have no say as to who may be a transplant recipient of the collected stem cells [as applicable: except in the case of autologous transplantation after parthenogenesis]. Future uses of stored stem cells must be approved by local ethical and scientific review committees to make sure that they are used in scientifically, ethically, and legally appropriate ways. Please contact the individuals listed on the last page of this form if you have any questions or concerns about the future possible uses of the stem cells collected through this research project.
WHAT IS THE EGG RETRIEVAL PROCEDURE?
If you decide to provide your eggs for this research project, you will have to undergo several steps. First you will meet with fertility physicians and nurses to discuss in detail the medical procedures involved in egg retrieval. These individuals are qualified to discuss with you in much more detail the procedures and the risks of hormonal stimulation and egg retrieval. You will be asked to sign another consent form for these medical procedures specifically. It is important to emphasize that the consent form you now hold in your hands is not a substitute for these medical consent forms. [As applicable: The person authorized to give you information about this stem cell research project is not authorized to lead you through an informative conversation about hormonal stimulation and egg retrieval.] You will undergo medical testing to screen you for genetic and infectious diseases. [Specify which tests will be conducted and whether the volunteer will have access to these test results.] After your medical tests, you will have to give yourself hormonal injections daily for up to three weeks in order to stimulate your ovaries to produce mature eggs. If you are unwilling to give yourself these shots, you may have another person do this for you.
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This sample document r n q not conform to the standarch ofyour local Research Ethics Board.
When your ovaries are ready, doctors will retrieve your eggs by inserting a needle through your vagina and into one or both of your ovaries. Anesthesia and/or sedatives will be used during this process, which will take about thirty minutes.
WHAT ARE THE POTENTIAL RISKS OF PROVIDING EGGS FOR THIS RESEARCH PROJECT?
There are several risks associated with hormonal stimulation and egg retrieval. [As applicable: A fertility physician who is not a member of the research team will discuss these risks with you in far more detail.] Hormonal stimulation poses a possible risk of severe ovarian hyperstimulation syndrome. This is a serious medical condition that, if left untreated, may lead to kidney failure, infertility, and in extremely rare cases, death. These risks can be greatly reduced if doctors use low doses of hormonal stimulation drugs and if your response to these drugs is monitored daily by health professionals. [As applicable: Therefore, these safety measures will be followed for your care.] Other possible risks include bleeding, discomfort, infection, cramping, mood swings, unintended pregnancy, and complications associated with anesthesia. Hormonal stimulation may also pose some unknown long-term health risks. At this time, scientists do not know for certain what kinds of long-term negative effects, if any, these drugs may have on your fertility or your risk for developing cancer. You should discuss any concerns you may have about these uncertainties with a physician. The egg retrieval procedure carries some risk that the needle used to retrieve your eggs fiom your ovaries might accidentally puncture one of your organs or blood vessels. There are some psychological risks involved in providing your eggs for this project. Some women who provide eggs for stem cell research might experience feelings of anxiety or regret, especially when considering the possibility that their eggs may result in the creation of embryos that will be destroyed during the stem cell collection process. Some may also feel vulnerable and anxious during the consent process. All egg providers will be asked to undergo medical screening tests for genetic and infectious diseases. While these medical tests involve minimal physical risk, such as from a blood draw, some women may feel anxious about their test results Due care will be taken to help minimize these psychological risks. [Specify how this will be done, e.g. whether counseling services will be provided upon request.] Providing eggs for this project involves some risk to your privacy. Efforts to protect you against this risk are discussed in the section entitled HOW WILL MY PRIVACY BE PROTECTED?
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WHAT WILL HAPPEN IF I GET A RESEARCH RELATED INJURY?
We are obligated to inform you about [name of institution(s)'] policy in the event that injury occurs resulting from your participation. [Insert description of the institution's policy addressing provision of healthcare and/or compensation related to injury resulting from participation.]
WHAT ARE THE POTENTIAL BENEFITS OF PROVIDING EGGS FOR THIS PROJECT?
This research project is not intended to provide any direct medical benefit to you or anyone else. You would be providing your eggs solely for the advancement of this research project and stem cell research in general. [As applicable: The stem cells that are collected from the resulting embryos may have significant commercial potential in the future. However, by signing this form you understand that there are no plans for you to receive any direct financial benefits from any future commercial development and scientific patents of discoveries made through the use of these stem cells.]
WHAT IF I CHANGE MY MIND?
You may withdraw your consent for whatever reason at any time before or during the egg retrieval process. Similarly, you may also withdraw your consent after your eggs have been retrieved, but before they are used in research. However, once the resulting embryos are destroyed in the stem cell collection process, you will not be able to change your mind or request that any of the collected stem cells be removed from this research project. If you decide to withdraw your consent after you have signed this form, please contact any of the individuals listed at the end of this document immediately.
WHAT ARE THE ALTERNATIVES TO PROVIDING MY EGGS FOR THIS PROJECT?
One of your alternatives is to refuse to participate at all in this research project. You may decide to do nothing, or you may decide to undergo hormonal induction specifically to donate your eggs for fertility treatment or another research project. The study staff would be happy to talk with you about other possible alternatives outside of this research project. In the case that your eggs are retrieved but you decide not to participate any longer in this research project, you may (1) have them discarded according to the routine practice of [name of institution], (2) donate your eggs to another research project, (3) donate your eggs to other individuals for fertility treatment, or (4) use them for your own fertility treatment, if necessary. Please note that your retrieved eggs will no longer be suitable for
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reproductive use once they are transferred to Dr. (principal investigator)'^ laboratory and prepared for research. Also, if you decide to use your eggs for your own or others' fertility treatment, you may have to undergo additional screening tests.
HOW WILL MY PRNACY BE PROTECTED?
The records of your involvement with this research project will be kept confidential. Identification codes will be used instead of names, and all records will be kept in a private database that can only be accessed by (person). The results of your medical screen tests will also be confidentially handled through the use of identification codes instead of names. [Specify how this information will be protected and whether the identification code will be linked to the egg providers and under what circumstances these providers will be identified.]
[As applicable: If your eggs undergo parthenogenesis, then the resulting stem cells and any new stem cells that they produce will be a complete genetic match to you. To protect your genetic privacy, only your identification code, not your name, will be discoverable to the researchers who collect these stem cells and the researchers who may later work with the resulting stored stem cells.] [As applicable: Some stem cell researchers working with genetic diseases may want to see genetic information about the egg donors. If you agree to allow these researchers to see this coded information, please check yes. yes no ] [As applicable: Research on the collected stem cells may reveal information that could be important to your health. If you wish to be contacted in the future about any such information, please check yes. yes no ] [As applicable: If you answered "yes" to this question, (name of institution) will, to the extent possible, pass to you any information that it is given from other researchers o r other institutions regarding important information received through research on the collected stem cells.]
Local and other regulatory agencies, and project sponsors and funding agencies may review the research project records to ensure that your rights as an egg provider were adequately protected. However, your identity will not be readily discoverable to these individuals. Any report that the researchers publish will not include any information that will make it possible for readers to identify you as an egg provider.
WILL I RECEIVE PAYMENT?
You will not receive any cash or payment with goods or services for the number or the quality of the eggs you provide for this research project.
Eggs Provided Directly for Research Purposes Only
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[As applicable: Any reimbursements for money you had to spend to participate in the consent process will be decided by local and other relevant review committees.] [As applicable: You will receive a compensation amount of $ in recognition of your time, effort, and inconvenience. This amount has been decided by local and other relevant review committees based on local community standards for paying other healthy research volunteers for their time, effort, and inconvenience.] DISCLOSURE O F RESEARCHERS' POTENTIAL FINANCIAL INTERESTS In addition to their scientific interests in this research project, the individuals conducting this stem cell study might profit financially from the research. There may be current or potential financial benefits to the Principal Investigator, [name], the participating institution(s), [names], and other research institutions or researchers arising from discoveries made through this research pro-ject and the stem cells collected from your donated embryos. [Disclose using plain language the researchers' and the institution(s)' financial interests in the research.] If you have any questions or concerns about these matters, please contact the persons listed below. [As applicable: If you are undergoing fertility treatment, it is important that your physician inform you of any personal benefits he or she may gain by your agreement to provide eggs for this research project. (Disclose here any potential personal benefits the treating physician may receive through this research protocol.)] The person who has been authorized to provide you with information may also have a personal vested interest in this research project. [Disclose here any potential personal benefits this person may have in this research protocol.] CONTACT INFORMATION If you have any questions about this research project, contact:
(Principal Investigator)
(phone) [List any toll-free or reverse-charge line.]
(Research Administrator)
(phone) [List any toll-free or reverse-charge line.]
If you have any questions about your rights as an egg provider, contact:
(Review Board Member)
(phone) [List any toll-free or reverse-charge line.]
Eggs Provided Directly for Research Purposes Only
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This sample document may not conform to the standards ofyour local Research Ethics Board.
If you have any questions about the egg retrieval process, contact:
(Physician)
(phone) [List any toll-free or reverse-charge line.]
CONSENT AND SIGNATURE
Please read the statements below, think about your choice, and sign if and when you are ready to agree, or 'take this form home and discuss it with anyone you wish to and then return it to us later if you wish to participate in this research:
[Name of person obtaining consent] has fully explained to me the nature and purpose of this research project in a way that I have understood. [Helshe] has encouraged me to be actively involved during the information interview and has responded to all of my questions and concerns in a satisfactory and respectful way. [Helshe] has offered me opportunities to consult with an independent person whom I trust, including a counselor or a physician, prior to my making my decision and has given me adequate time to decide.
I hereby give my voluntary consent to provide up to (insert number) eggs for the research project entitled [Project Title] conducted by [Principal Investigator] at [Participating Institution(s)].
Date: Signature of Egg Provider Printed Name
Date: Signature of Person Obtaining Consent
Printed Name
Copy given to egg provider:
Yes
Eggs Provided Directly for Research Purposes Only
NIH AR 000323
This sample document may not conform to the standards ofyour local Research Ethics Board.
ISSCR SAMPLE RESEARCH CONSENT FORM Egg Donation for Stem Cell Research (Eggs Collected During the Course of Fertility Treatment and In Excess of Clinical Need)
Project Title: Principal Investigator: Participating Institution(s):
PROJECT INFORMATION [Name of principal investigator] is conducting a human embryonic stem cell research project at [name(s) of institution(s)]. Helshe hopes you will donate any eggs you decide not to use in the course of your own or others' fertility treatment. [Specify whether the eggs to be used are normal or failed-to-fertilize eggs.]
Embryonic stem cells can be found in embryos around the fifth day of development. These stem cells have the unique ability to turn into any kind of specialized human cell, such as liver cells, heart cells, pancreatic cells, or nerve cells. For this reason, embryonic stem cells can be used to study, and possibly one day help treat, diseases or injuries that have caused patients' specialized cells to die or become damaged - diseases and injuries such as Parkinson's disease, heart disease, diabetes, and spinal cord injury.
[Name of principal investigator] wants to collect new human embryonic stem cells from embryos that have been created by [as applicable: nuclear transfer; parthenogenesis; the union of sperm and egg]. [As applicable: "Nuclear transfer" is the process by which researchers place donated body cells into unfertilized eggs that have had their DNA removed. If successful, this technique can create embryos that contain stem cells which are genetically matched to the body cell donors.] [As applicable: "Parthenogenesis" is the process by which an unfertilized egg is stimulated to begin going through the very early stages of human development. Stem cells that arise from parthenogenesis would be genetically matched to the person who provided the unfertilized egg.] [Insert additional information about this project using very simple language.] VOLUNTARY CHOICE
Donating your eggs for this research project is completely voluntary. You have the right to agree or to rehse to donate your eggs for this project. The quality of your current or
Eggs in Excess of Clinical Need
NIH AR 000324
This sample documenf mqv not conform to the standards ofyour local Research Ethics Board
future medical care and your relationship with [namets) of institution(s)] will NOT change in any way whether you agree or refuse to donate any eggs for this project.
WHAT IS THE PURPOSE OF THIS CONSENT FORM?
[Name of person obtaining consent] is authorized to give you information and to answer your questions about this research project. It is very important that you have a detailed conversation with this person so that you can make a careful, voluntary decision about whether or not you want to donate your eggs for this research project.
Your signature on the last page of this consent form is meant to show that you have had this conversation and that you freely agree to donate your eggs for this research project. This consent form must not replace actually having this conversation, so be certain you have this conversation. Please take as much time as you need to ask questions and to talk about this project with your family or friends before you decide whether or not to sign this consent form. You may take this form home with you before you decide what to do. Do not sign this form if you feel pressured in any way by any person to donate your eggs for this project. This must be your own decision, not someone else's.
WHAT WILL HAPPEN TO MY EGGS?
None of the eggs you donate for this research project will be used to produce a baby or a pregnancy. And no embryos created from your eggs will be allowed to develop for more than a total of 14 days after they have been [as applicable: created through nuclear transfer; created through parthenogenesis]. If any of the resulting embryos are frozen, then the time that they are frozen is not counted as part of the 14 day limit. Researchers will only use your eggs to create embryos from which they will attempt to get stem cells before the 14 day limit. The resulting embryos will be destroyed during the stem cell collection process. There is no guarantee that embryos will be successfully created from your eggs. And there is no guarantee that researchers will be able to get stem cells from any resulting embryos. Researchers will routinely discard as medical waste any eggs which are not used for this research project, as well as any embryos from which they are unable to get stem cells.
WHAT WILL HAPPEN TO THE COLLECTED STEM CELLS?
It is likely that the retrieved stem cells will be stored for many years. Embryonic stem cells have the ability to self-renew indefinitely, and they are likely to be used by researchers at other institutions and for many other research purposes.
Eggs in Excess of Clinical Need
NIH AR 000325
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