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Stem Cell Information

Stem Cell Policy Questions and Answers

Questions and Answers on Submitting a New Cell Line

Restrictive Language in Informed Consents

Why Has NIH Proposed to Change the Wording of the Guidelines?

NIH Guidelines and FDA Donor Eligibility Rule

Research and Policy Questions

Cell Line Availability and the Registry

Subclones and Modified hESC Lines


Q: What materials should I consider including in my submission?

A: Relevant materials may include, for example, the consent for donation of embryos for research purposes, the consent for reproductive treatment (including the consent for cryopreservation of embryos, if applicable), and the research protocol or other document(s) demonstrating the relative timing of reproductive treatment and the donation of embryos for research purposes. The materials should be those that were in effect at the time of the embryo donation.

Q: I am an investigator using one of the human embryonic stem cell lines that I received from the NIH stem cell bank. Should I submit a "Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research"?

A: Unless your organization has the authority and/or rights pertaining to the human embryonic stem cell line (e.g., your organization is the owner, deriver or licensee or have written permission of the same to submit), you should not submit the request. You can see if a request has been submitted for the line you are using by checking http://grants.nih.gov/stem_cells/registry/pending.htm. (Draft requests can also be seen at http://grants.nih.gov/stem_cells/registry/draft_intent.htm.)

Q: What organization should submit the "Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research"?

A: The submitting entity should have the authority and/or rights pertaining to the human embryonic stem cell line (e.g., be the owner, deriver or licensee or have written permission of the same to submit). If you are not sure whether your organization should submit a request, seek appropriate advice from within your organization, such as from your organization's legal counsel.

Q: Who is the Signing Official in my organization?

A: The Signing Official should be an individual with direct or delegated authority to sign on behalf of the organization /submitting entity and verify that the information submitted on Form 2890 is correct. In some cases, this may be an individual who serves as a Signing Official for purposes of submitting grant applications to NIH. Please note that there are Assurance, Certification, and Authority boxes in NIH Form 2890 that should be checked by the Signing Official if he/she is submitting the form. If you are not a Signing Official, do not check the boxes, but provide, as one of the attached supporting documents, a letter signed by the Signing Official that provides the required certifications (see the sample letter in Form 2890).

Restrictive Language in Informed Consents

 

Q: Do the NIH Guidelines for Human Stem Cell Research differ from the human subject regulations at 45 CFR 46 (the Common Rule)?

A: Yes. The July 7, 2009, NIH Guidelines for Human Stem Cell Research require written informed consent in all cases from the individuals donating the embryos. Per OHRP "Guidance on Research Involving Coded Private Information or Biological Specimens" http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm, consent is not generally required if the cells cannot be linked to specific living individuals by the investigators, either directly or indirectly through coding systems. In addition, NIH made a policy decision to honor any restrictive language in the informed consent signed by individuals donating human embryos for research, such as statements limiting research using the cells to studies on a particular disease or aspect of development.

Why Has NIH Proposed to Change the Wording of the Guidelines?

 

Q: What exactly do the current Guidelines say and what are you proposing to change?

A:The Final Guidelines, issued on 7/7/2009, state the following:

"For the purpose of these guidelines, “human embryonic stem cells” are cells that are derived from the inner cell mass of the blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers."

The proposed revision states:

"For the purpose of these Guidelines, ‘human embryonic stem cells (hESCs)’ are pluripotent cells that are derived from early stage human embryos, up to and including the blastocyst stage, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers."

Q: Why is NIH revising the Guidelines now?

A: NIH recently learned from the scientific community that there are scientifically important sources of human embryonic stem cells (hESCs) that may otherwise meet the strict ethical requirements of the Guidelines, but do not meet the precise definition of hESCs in the current Guidelines. NIH is proposing to make a technical change to the wording of the Guidelines so that they can consider the eligibility of hESCs that have been derived earlier in the development of the embryo. This change would not allow for lines that are derived from embryos that have developed beyond the blastocyst stage. It is important to note that the proposed change to the definition would not alter the rigorous ethical standards in the Guidelines for donation of embryos for hESC research.

Q: Is NIH proposing to revise other aspects of the Guidelines?

A: No. NIH is only proposing this technical change to the definition of hESCs. At some point in the future, the NIH may consider other changes to the Guidelines, per the Executive Order from President Obama.

Q: Why were three hESC lines from Children's Hospital Boston on the Registry put "on hold"?

A: When NIH was asked by a deriver to consider the eligibility of hESCs that do not meet the current definition, the Agency realized that it had inadvertently listed several lines on the Registry that were derived from early stage embryos that had not reached the blastocyst stage. These three lines are temporarily on “hold” and should not be used in NIH-funded research until NIH reviews the public comments on the proposed change to the Guidelines and makes a final decision about a change in the definition of hESCs. At that time, depending on the outcome of the proposed change to the Guidelines, NIH will either take the lines off “hold” status so that they can be used in NIH funded research or remove them from the Registry. It is important to note that these lines met all of the ethical requirements under the Guidelines.

NIH Guidelines and FDA Donor Eligibility Rule

 

A: No. NIH does not require that lines listed on the Registry meet the FDA requirements of 21 CFR 1271 Part C. To be listed on the NIH Human Embryonic Stem Cell Registry, lines must meet the NIH Guidelines for Human Stem Cell Research, which focus on ethical requirements pertaining to the embryo donation process. Thus, the embryo donor screening and testing requirements for relevant communicable diseases agents or diseases in 21 CFR 1271 Part C are not incorporated in the NIH Guidelines. Researchers interested in developing a clinical product, which would be regulated by the FDA, should contact the FDA for more information, ideally prior to donation of the embryo.

See:

Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products and

References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies

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Research and Policy Questions

  • Can a scientist use federal funds to conduct research using derivatives of human embryonic stem cell lines that are not listed on the NIH Human Embryonic Stem Cell Registry?

    No federal funds may be used, either by an awardee or a sub-recipient, to support research using derivatives of human embryonic stem cell lines (hESCs) that are not listed on the NIH Human Embryonic Stem Cell Registry, with the exceptions described below. Derivatives include, but are not limited to, subclones of hESC lines, modified hESC lines (such as a line expressing green fluorescent protein), differentiated cells developed from hESC lines (such as muscle progenitor cells), and cellular materials (such as DNA, RNA, and proteins). Thus, no federal funds may be used for the generation of new data from unapproved hESC lines or derivatives. However, publicly accessible data from unapproved lines or derivatives may be used and analyzed with federal funds.

                                                                                                                                                                                    

    Ongoing NIH-supported research involving derivatives of hESC lines that were listed on the NIH Registry before April 17, 2009, is subject to the same policy explained in NIH Guide Notice NOT-OD-09-123 for hESC lines.


  • Which research is best to pursue?
    The development of stem cell lines that can produce many tissues of the human body is an important scientific breakthrough. This research has the potential to revulutionize the practice of medicine and improve the quality and length of life. Given the enormous promise of stem cell therapies for so many devastating diseases, NIH believes that it is important to simultaneously pursue all lines of research and search for the very best sources of these cells.

  • Why not use adult stem cells instead of using human embryonic stem cells in research?
    Human embryonic stem cells are thought to have much greater developmental potential than adult stem cells. This means that embryonic stem cells may be pluripotent—that is, able to give rise to cells found in all tissues of the embryo except for germ cells rather than being merely multipotent—restricted to specific subpopulations of cell types, as adult stem cells are thought to be. However, a newer type of reprogrammed adult cells, called induced pluripotent stem cells, has proven to be pluripotent. Please refer to Basic Questions FAQ #3, above.

     

  • May individual states pass laws to permit human embryonic stem cell research?
    Individual states have the authority to pass laws to permit human embryonic stem cell research using state funds. Unless Congress passes a law that bans it, states may pay for research using human embryonic stem cell lines that are not eligible for federal funding.

     

  • Where can I find information about patents obtained for stem cells?
    The U.S. Patent and Trademark Office offers a full-text search of issued patents and published applications. Try searching for "stem cell" or "stem cells."

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Cell Line Availability and the Registry

  • I am a scientist funded by the NIH. How many cell lines are available to me, and how do I get them?
    The NIH has developed the NIH Human Embryonic Stem Cell Registry. This Registry lists all cell lines that are eligible for use in NIH funded research.

    The number of lines available for use in NIH funded research continues to expand, as we continue to review new lines that have been submitted for NIH's consideration. Please check the current NIH Human Embryonic Stem Cell Registry page for the most up-to-date list.

    To obtain these cells, please fullow the "see details" link, which is found under the Cell Line name, within the NIH Human Embryonic Stem Cell Registry. This link includes more information about the selected cell line, as provided to the NIH. Some of this information may include: whether or not the cell line is available for distribution, the provider's name, telephone number, email address, and URL.

  • Who owns the cells?
    The stem cell lines remain the property of the individual stem cell providers, as listed on the NIH Human Embryonic Stem Cell Registry. Researchers may negotiate a material transfer agreement (MTA) with the cell providers in order to specify their rights and responsibilities concerning resulting data, publications, and potential patents.

  • Are there any restrictions on the use of lines listed on the NIH Human Embryonic Stem Cell Registry?
    The "see details" link on the NIH Human Embryonic Stem Cell Registry includes information on two categories of possible use restrictions: Provider Restrictions and NIH Restrictions. Provider Restrictions include things such as experiments that are prohibited with the cell line, or requirements that proposed research be approved by an ESCRO or other type of ethical review committee. NIH Restrictions are imposed on the use of a line based on the usage of the cells as agreed to by the donors in their informed consent process.

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Subclones and Modified hESC Lines

  • Once a human embryonic stem cell line is listed on the NIH Human Embryonic Stem Cell Registry, are lines derived from it also eligible?
    The NIH Guidelines on Human Stem Cell Research focus on the requirements for donation of the embryo that was used for derivation. Once that determination has been made for a particular line, it applies to all subclones or modifications. For example, now that WA01 (H1) is eligible for NIH funding, WA01 lines that express GFP are also eligible.

  • Should scientists list the name of the subclone in their NIH grant application?
    Yes, scientists should refer to the parent hESC line and list the cell line name of the modified line or subclone in the research plan of their application.

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