- What research must be reviewed?
Research or teaching activities involving the use of human embryonic or pluripotent stem cells, regardless of source, require the review and approval of the SCRO Committee prior to initiation of the activities.
- What other relevant committees must review and approve human embryonic or pluripotent stem cell research?
The Institutional Biosafety Committee (IBC).
Research with human pluripotent stem cells involving animal subjects must also be reviewed and approved by WesternU’s IACUC prior to initiation of the study.
Research involving human subjects that seek to derive pluripotent cell lines must also be reviewed and approved by WesternU’s IRB prior to initiation of the study.
- What if my proposal requires approval from another oversight committee but I have not yet received their approval?SCRO Committee review can occur simultaneously with other oversight committee reviews.
- When do I need IRB approval?
When the research involves human subjects, defined as living people, human specimens (such as embryos) or data in which the subject’s identity is known or can be readily ascertained. Examples of human subjects research include:
a) Interactions with living individuals such as discussions with potential gamete donors or transplantation of human cells or test articles such as differentiated cells derived from human embryos or human fetal tissue into human recipients;
b) Clinical research involving use of cells or test articles regulated by the Food and Drug Administration, such as drugs, devices, and biological products;
c) Human cell lines where the donor(s) may be identified, including cells that retain links to the donor(s) by a code.
- What other reviews are required for stem cell research?
Depending on the source of materials and funding, a Material Transfer Agreement (MTA) may be required.
Is adult or tissue-specific human stem cell research exempt from requirements for ESCRO Committee review?
Yes, unless the project includes stem cells as defined in the Guidelines cited above: “…culture-derived, human pluripotent stem cell population that is capable of: 1) sustained propagation in culture; and 2) self-renewal to produce daughter cells with equivalent developmental potential. ‘Pluripotent’ means capable of differentiation into mesoderm, ectoderm, and endoderm. This definition includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin.”
Example: research on human hematopoietic stem cells would not normally be subject to SCRO Committee review although it is still subject to review by the IRB.
- What procedures are necessary for transferring hESCs to or from other institutions for the purpose of stem cell research?
Receipt of hESC materials will require a Material Transfer Agreement (MTA) or other written acknowledgement or by purchase.
Any transfer of WesternU-generated or modified human embryonic or pluripotent stem cell material off campus will normally require an MTA or license agreement. For these requirements, contact the Office of Technology Transfer and Intellectual Property at firstname.lastname@example.org or TraciM@westernu.edu.
- Who must complete hESC training?The PI and all other study personnel who will be handling hESCs or iPSCs.
The PI and all other study personnel who will be handling hESCs or iPSCs.
Federal Restrictions and Stem Cell Lines
- Where can I find a list of federally-approved stem cell lines?
The National Institutes of Health maintains the NIH Human Embryonic Stem Cell Registry at http://stemcells.nih.gov/research/registry. A table for converting provider codes to NIH codes can be found at: http://escro.ucsd.edu/NIH_codes.html
- May I use federal funds (e.g., NIH) to study cells or molecules that are derived from stem cell lines that are not federally approved?
It is prohibited to use federal funds for research involving stem cell lines that are not included on the NIH registry of federally approved stem cell lines. If your research project includes or will include any use of biological products of human embryonic stem cell lines that are not on the federal registry, you must consult with WesternU’s SCRO Committee to determine whether or not federal funds can be used for your project
- What are the steps for research project review by the SCRO Committee?
Submit a completed application to the Chair of the SCRO Committee along with documentation of ethics training.
- What is the deadline for submitting a research or teaching project for review by the SCRO Committee?
The Committee meets on an ad hoc basis and, therefore, proposals may be submitted at any time. New applications should be submitted at least two months in advance of when the research is to begin. Protocols up for renewal should be submitted at least two months in advance of the protocol expiration date.
- What if I need to amend my protocol?
Submit an email to the SCRO Committee Chair stating exactly what you want to change and why.
Examples of protocol changes that require prior SCRO Committee approval include, but may not be limited to:
- Change in PI;
- Request for additional cell lines;
- Request to modify the scientific experiments in a significant way (see below);
- Request to change the source, procurement procedure, or privacy protections for the donation of embryos or gametes.
Changes that do not require prior SCRO Committee approval include, but may not be limited to:
- Change in contact information;
- Change in source information;
- Change in location of study.
- What constitutes a significant change to scientific experiments?
Examples include, but may not be limited to:
- Employing new methods for the derivation of hESC lines from gametes, embryos, or fetal tissue;
- Implementing distinct transplantation or analysis protocols when introducing hESC or hESC-like lines into humans or animals;
- Altering the proposed methods for generating human embryos from hESC or hESC-like lines;
- Changes that require oversight of other UW compliance committees or offices.
- What is the purpose of SCRO Committee review?
To ensure that research and teaching involving embryonic or pluripotent stem cells is conducted in an ethical and scientifically justified manner and to protect human and animal subjects.
- What does the SCRO Committee look for in its review?The SCRO Committee typically considers the following questions in reviewing protocols:
- What is the central question or hypothesis to be addressed?
- Why is this important?
- Why can’t this question be reasonably addressed in another way (e.g., with non-human cells)?
- If existing stem cell lines will be used, what is the rationale for using those particular lines?
- If new stem cell lines are to be derived, what is the rationale for doing so?
- Has this work been done previously? And, if so, why is it important that it be repeated?
- Does this research team have experience (years or publications) with the necessary methods?
- If members of the research team do not yet have the necessary expertise, how will they be trained?
- Why am I asked to justify the use of human stem cells, embryos or oocytes in the proposed research?
To provide sufficient information to address potential public concerns and to gain public trust which depends on the judicious use of these tissues. Include in your response:
a) Why other approaches have weaknesses and how your proposed method avoids or mitigates against these problems.
b) The advantages and disadvantages of using hESC for this project compared to other models.
c) Supporting data and research in peer-reviewed scientific journals.
- What types of activities are prohibited?
- Implanting a chimeric embryo containing non-human cells, including ESCs, into the uterus of a human;
- Implanting a chimeric embryo containing hESCs into a uterus of a nonhuman primate and allowing the resulting pregnancy to progress to the point of independent viability;
- Breeding of a chimeric animal having hESCs that were introduced during any stage of the animal’s embryonic or fetal development;
- Breeding of a chimerical animal having hESCs where there is a reasonable possibility that human genetic material could be incorporated into the animal’s germ cells.
- What types of iPSC research require SCRO Committee review and approval?
- Transplantation of iPSCs into research animals;
- Transplantation of iPSCs into humans;
- Use of iPSCs to create an embryo.
- When do I need to renew my protocol approval?
Protocol approvals are for one year from the date of review. To avoid a lapse in approval, a renewal application must be submitted two months prior to expiration of the current approval.
- What if I do not renew my protocol approval before it expires?
If a protocol expires before a renewal application has been submitted, all activities covered by the protocol must stop until a a new protocol has been submitted, reviewed and approved by the SCRO Committee.
- What if I make changes to my project before I renew it?
Any changes to the research plan or in project personnel, funding source or space since the last approval must be submitted for review and approval by the SCRO Committee prior to implementing the changes.
Storage of Stem Cells
- What additional requirements must be met for storing stem cells in a location different from the one in which they are to be used?
-Prior to storing or moving cells to any other location, investigators should check the provisions of any Material Transfer Agreements (MTA), purchase agreements or other documents that govern their responsibilities for control of the stem cells. In all cases, the storage location(s) must be noted in the SCRO Committee Application Form. If the cells are proposed to be stored at any location other than on WesternU property, the storage location will be approvable only if the space is explicitly rented by and under the control of the investigator. All storage arrangements are approvable only if no funding restrictions are violated. Any proposed exceptions to these requirements should be addressed for review by the Office of the Vice President for Research and Biotechnology.
- What additional requirements must be met for storing stem cells at UCSD on behalf of another institution or an investigator at another institution?
-Before storing or moving cells to any other location, non-WesternU investigators should check, or ask his/her institution to check, the provisions of any Material Transfer Agreements (MTA), purchase agreements or other documents that govern their responsibilities for control of the stem cells. Typically, these agreements require the investigator to ensure that the cells will remain under her or his control. If a non-WesternU investigator or another institution then wishes WesternU or a WesternU investigator to store stem cells, both WesternU and the other institution must determine whether or not it is appropriate to enter into an inter-institutional agreement outlining the extent of mutual responsibility. Also, a new or amendment protocol must be submitted by the WesternU investigator for review and approval by the WesternU SCRO Committee. The protocol should indicate that the purpose of the request is for storage of cells only, but the provenance of the stem cell lines should also be documented sufficiently so that the SCRO Committee can ensure that the cells meet the standards expected for any stem cell research project at Western.
- Where can I find more information about stem cells and stem cell research?
- Where can I find more information about possible ethics training options?
- Universityof Pittsburgh
- University of California San Francisco