Office of Research Compliance, the University of Connecticut
Phone: (860) 486-1725 Fax: (860) 486-1044, email:
Please note that all research projects in the following categories are required to complete this application form and receive SCRO approval before acquiring cells or cell lines and commencing research:
· All stem cell research projects funded by the State of Connecticut, including those that do not use human embryonic stem cells;
· All stem cell research involving human embryonic stem cells and their derivatives;
· All stem cell research involving human gametes and human embryos;
· in vitro human induced pluripotent stem cell research involving the generation of gametes, embryos, or other types of totipotent cells;
· in vivo human induced pluripotent stem cell research involving implantation of human cells into prenatal animals or into the central nervous system of post-natal animals. /
SCRO office use only
SCRO #:
Date Rec’d:
Approval Date:
Expiration Date:
SCRO Protocol Application Form
Send a signed and completed electronic copy of this form AND 1 electronic copy of the grant application to the above address. If you do not have an electronic signature, you may fax the signature page to the SCRO Office.
I. Investigator Information
Date of this application:*If this is a revised submission, please be sure to change the date to reflect the current date. Also sign and date the back page again. / * / Is this an original submission?
Is this a revised submission?
Principal Investigator (name):
Department:
Study Title:
Duration of Project / Project Start Date:
Role* / Name / Email** / Phone / Fax
Principal Investigator
Contact Person
* PI and Contact Person are required; list all other study personnel as well, one line per person.
*Mailing address
*This is the address where you would like signed materials delivered.
Co-Investigator(s) at the University of Connecticut / Name / Email / Phone / Fax
Non-University of Connecticut Investigator(s) / Name / Institution / Email* / Phone
II. Scientific Review
1. Has this project been reviewed by an expert scientific panel Yes No
(e.g. a NIH study group or other form of peer review)?
If yes, please identify the review panel(s).
III. Conflict of Interest
Does the principal investigator, any co-investigator, or research coordinator involved with this study (or in aggregate with his/her spouse, dependents, or member of his/her household) have a financial relationship with the source of funding that requires filing a University of Connecticut financial disclosure form?*Yes No
* If Yes, SCRO will not approve the protocol until the relevant Conflict of Interest Committee (either at Storrs or UCHC) has completed its review.
IV. Approvals from other Committees/Offices within the University of Connecticut
Submit applications to SCRO after or at the same time as application to the IBC, IACUC, or IRB. SCRO will not approve protocols until documentation of all other necessary approvals has been received. The PI is responsible for submitting approval documents to the SCRO.
Check all that apply:
Other Committees/Offices / Pending Approval / Approved / Protocol Number*Institutional Biosafety Committee
Institutional Animal Care and Use (IACUC)
**Institutional Review Board
* For use of recombinant DNA, any potentially hazardous biological materials, or any biological toxins.
** IRB approval is required for donation of human gametes, somatic cells, embryos, and human biological materials for which the donor can be identified.
*** Must be completed prior to release of funds by all PIs and staff working on the project. Contact the SCRO office for the Tutorial.
V. Stem Cell Research Activities
Check all that apply:
1. Research using human fetal tissue or human embryos at any stage.2. In vitro research using pre-existing anonymous human embryonic stem cells (hESCs) or their derivatives.
Uses federally eligible lines (i.e. lines on the NIH registry http://grants.nih.gov/stem_cells/registry/curren...)
Uses federally ineligible lines (i.e. lines not on the NIH registry (http://grants.nih.gov/stem_cells/registry/curren...)
3. Research using human ESCs, human iPS cells, or other human cells that is funded by the Connecticut Stem Cell Research Program.
4. Production of human gametes from hESCs or human iPS cells.
5. Introduction of human ES cells or derivatives into animals.
6. Introduction of hESCs and/or human iPS cells into the central nervous system of animals.
7. Derivation of hESC from donated excess embryos from fertility treatments.*
8. Use of hESCs or human iPS cells to contribute to a human embryo.
9. Creation of human embryos intended for research purposes using SCNT. ***
10. Creation of human embryos from donated human gametes, or from gametes derived from hESC or human iPS lines.**
* Requires IRB approval for embryo donation.
** Requires IRB approval for gamete donation and written procedures and practices to protect human oocyte donors.
***Requires refined SCNT techniques that reduce the quantity of required oocytes and requires stringent written policies and practices to ensure that derived embryos are used only for the intended research purpose.
VI. Source(s) of Funding
What is the source of funding for this project? Check all that apply.
Connecticut Stem Cell Research Program
Other Connecticut State Funds
Federal Funds
Private Research Foundation Funds
Private Industry
Laboratory Start Up Funds
Other (indicate source______)
VII. Location of Research Activities and Equipment Use
Laboratory space, office space, shared equipment rooms, equipment, and any object that is supported with federal funds may not be used for stem cell research activities that are not eligible for Federal support.
Federally eligible stem cell research includes research that is restricted to: (a) the use of nonhuman stem cells; (b) human adult, fetal, or umbilical cord stem cells, (c) or NIH-registered hESC lines and their derivatives.
http://stemcells.nih.gov/research/registry/
Federally ineligible stem cell research includes research that: (a) involves non-NIH-registered human embryonic stem cell lines or their derivatives (b) creates human embryos for stem cell research (c) combines hESC with human embryos.
Locations of federally eligible research activities and equipment use:
Building Name or Service Center / Room Number / Approximate Start Date / Duration of Use for ProjectLocations of federally ineligible research activities and equipment use:
Building Name or Service Center / Room Number / Approximate Start Date / Duration of Use for Project(Documentation: An equipment inventory for all listed rooms is required. Please contact Robin Hoagland for the Storrs campus at 486-3780 or . For UCHC contact Julie Schwager at 679-7649 or .)
Does all equipment to be used reside in the locations(s) listed above? Yes *No
*If No, please attach list of other equipment to be used along with the location of the equipment. Research Finance must approve and tag all equipment in the space before work on this project may begin and funding released. This process may take 30 days.
Other Institutions: List all other collaborating institutions where the research will be conducted. (If you are using human embryonic stem cells at any of these locations, you will need SCRO approval from that institution.)
Building Name or Service Center / Room Number / Approximate Start Date / Duration of Use for ProjectVIII. Human Biological Materials
Does the research involve human cells/tissues? *Yes *No
*If No, you have completed all relevant sections of this application form. If Yes, continue with Section 1.
1. Complete the following table for all human cells/tissues involved with the research:
Material / Source(Provide identifying information for all hESC lines, e.g. WiCell H-9) / Quantity / MTA/SLA #
(If applicable attach copy of MTA)
human iPS or other Non-Embryonic Derived Human Pluripotent Stem Cells for uses described in section IV. / Source/ Provenance
1.
2.
3. / 1.
2.
3. / 1.
2.
3.
Human Somatic Cells to be used for iPS for uses described in section IV / Source/ Provenance
1.
2.
3. / 1.
2.
3. / 1.
2.
3.
Multipotent Human Neural Stem Cells (if there is the potential that they may contribute to central nervous system of chimeric animals) / Source/ Provenance
1.
2.
3. / 1.
2.
3. / 1.
2.
3.
NIH-Registered hESC lines / 1.
2.
3. / 1.
2.
3. / 1.
2.
3.
Non-NIH-Registered hESC lines / 1.
2.
3. / 1.
2.
3. / 1.
2.
3.
frozen embryos / 1.
2. / 1.
2. / N/A – Requires IRB
approval for donation
process.
fresh embryos / 1.
2. / 1.
2. / N/A – Requires IRB
approval of donation
process.
frozen sperm for uses described in section IV. / 1.
2. / 1.
2. / N/A – Requires IRB
approval of donation
process.
fresh sperm for uses described in section IV. / 1.
2. / 1.
2. / N/A – Requires IRB
approval of donation
process.
frozen oocytes for uses described in section IV. / 1.
2. / 1.
2. / N/A – Requires IRB
approval of donation
process.
fresh oocytes for uses described in section IV. / 1.
2. / 1.
2. / N/A – Requires IRB
approval of donation
process.
2. Informed Consent for Human Somantic Cell, Gamete, Embryo, and hESC Donors
2a. Does the research involve hESC lines from sources other than the University of Connecticut Stem Cell Core and which are not listed on the SCRO website as “approved”? (Materials banked in the UConn Stem Cell Core have been reviewed previously for informed consent).
*Yes No
*If Yes, attach documentation of IRB approval from the institution(s) responsible for the derivation of the stem cell lines. Include specific information about the informed consent process and form. Informed consent is required from the donors of the embryo and all gamete donors.
2b. Do any human somatic cells, gametes, or embryos come from sources other than the University of Connecticut Stem Cell Core? (Materials banked in the UConn Stem Cell Core have been reviewed previously for informed consent).
*Yes No
*If Yes, attach documentation of IRB approval from the responsible institution(s). Include specific information about the informed consent process and form. Donor informed consent must be in accordance with NAS Guidelines.
3. Donor Confidentiality (IRB approval is needed for protocols using materials with direct or coded donor identifiers that may be accessible to investigators.)
3a. Do any of the materials listed in #1 or #2 have direct donor personal identifiers accessible to investigators or laboratory personnel? (These samples are supplied to investigators from identified specimens with a personal identifier (such as a name, patient number, or HIPAA defined PHI) that would allow the researcher to link the biological information derived from the research directly to the individual from whom the material was obtained).
*Yes No
*If Yes, indicate the direct identifiers provided with the material and provide justification for retaining the direct identifiers with the material. Describe procedures for maintaining confidentiality. IRB approval is required.
3b. Do any of the materials listed in #1 or #2 have coded donor identifiers accessible to investigators or staff? (Also called “linked” or “identifiable”, these samples are supplied to investigators from identifiable specimens with a code such as “A001” that could be linked back to direct identifiers of the donors).
*Yes No
*If Yes, describe (a) the process for coding the samples, (b) where the link is stored and its security, (c) the personnel who have access to the links and their training in confidentiality procedures, and (d) what becomes of the coded data and samples when the study is completed.
IRB approval is required.
IX. Research Plan
Summarize your study : To the extent possible, the summary should be written in language intelligible to a layperson. Provide clear and concise statements of research objectives, research hypotheses, study rationale and methodology, and expected results. The length should be at least one half of a page and no more than one page.
Benefits: Explain the scientific significance of the expected results.
Background: State the background information and recent work that support the plan for this project. If hESC lines are used, discuss relevant supporting work already done with animals. If the research involves ethically controversial methods (e.g. creation or destruction of human embryos; research involving human gametes; experiments with the potential for integration of human and nonhuman cells or DNA in animal brains, germ lines, or new pluripotent cells), discuss relevant supporting work that has been done with ethically less controversial methods. Provide references to peer-reviewed scientific publications and data.
Proposed experiments: Outline the proposed experiments and their scientific rationale. Clearly present the sequence and projected timeline for the experiments. Chart format is helpful. Special attention should be given to specifying activities for the first year of the study and clearly describing the timeline and scientific rationale for ethically controversial areas of research (e.g. creation or destruction of human embryos; research involving human gametes; experiments with the potential for the integration of human and nonhuman cells or DNA in animal brains, germ lines, or new pluripotent cell lines).
X. Justification for Use of Pre-existing hESC Lines or Derivatives
1. If the research involves pre-existing hES cells or derivatives, justify the use of hESC lines or hESC derivatives rather than an alternative methodology that uses human adult, human fetal or nonhuman stem cells. Cite supporting peer reviewed scientific journal articles or data.
2. Does the research involve the generation of human gametes or embryos from hESC?
*Yes No
*If Yes, describe what further work will be done with the gametes or embryos as part of the proposed project and state whether they will be maintained or disposed of when the project is completed. If the generated gametes will be tested through embryo genesis answer section XI.
X. Justification for Derivation of New hESC Lines Using Excess Embryos from IVF Fertility Treatments
1. Justify the derivation of new hESC lines by this method. (Why are new lines needed? What will be distinctive about the proposed lines? Are there valid alternatives to creating new hESC lines in achieving the benefits of the research?) Cite supporting peer reviewed scientific journal articles or data.
2. Identify and justify the requested numbers of embryos, showing that the requested number is the smallest necessary to achieve research objectives. Cite supporting peer reviewed scientific journal articles or data.