Type of registration:
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Initial Amendment Periodic (Continuing) Review
Make sure you accessed this form with a Return Code that you received at your original (initial) submission.
For this Continuing Review, will you make any changes to this form to update it? If No, please scroll all the way down to Submit.
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Yes
No
Make sure you accessed this form with a Return Code that you received at your original (initial) submission. Briefly summarize changes being made.
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Last name
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First name
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College
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Dental Medicine Medicine Health professions Nursing Pharmacy Graduate Studies
Dept/Division
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Office Phone number
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MUSC Email address
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Funding Source(s)
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Check all that apply
Provide Name Funding Source or specify Other:
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Do you have any MUSC co-investigators on this project?
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Yes
No
Co-I Last Name
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Co-I First name
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Co-I MUSC email
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Do you have any more MUSC co-investigators on this project?
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Yes
No
Co-I Last Name
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Co-I First name
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Co-I MUSC email
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List freezer/facilities where hPSCs will be stored (Building(s) and room number(s), separated by ';')
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List facilities where hPSCs will be used (Building(s) and room number(s), separated by ';')
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2A: Activities planned with hPSCs
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If Other, describe
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Provide IBC registration number(s)
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Provide IACUC registration number(s)
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Provide IRB registration number(s)
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2B: Types of cells/tissues to be used.
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2C: Lay summary
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Using lay language, describe the research project goals, rationale , general approach, and benefit to society. For ethically controversial research, provide a detailed justification for the work. Max. 1000 characters
2D: Proposed experiments
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Summarize the proposed experiments and expected outcomes. Max. 5000 characters
2E: Training. All listed personnel and PI need to take the CITI Human Stem Cell Research modules. Log in to http://www.musc.edu/cgi-bin/citi/login.cgi with your NetID. Instructions: http://research.musc.edu/ori/SCRO/Education%20and%20Training
Section 3A: Human embryonic Stem Cells (hES cells)
3A1: Which of the following hES cell lines will be used?
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Please list all stored, actively used, and created hES cell lines in a SCRO inventory spreadsheet (See link in Section 6). Upload this document in Section 6
Clarify N/A
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3A2: Purpose of hES cell line use:
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Check all that apply
Differentiation into other cell type. Specify target tissue/cell type (e.g. neural tissue):
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Creation of human gametes or morulae/blastocysts/embryo. Provide justification:
This will require full SCRO committee review.
Culture of any intact human embryo, regardless of method of creation, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first, is prohibited at MUSC.
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If Other, specify:
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3A3: Provide a rationale for the need to use hES cells as opposed to other human pluripotent stem cells.
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3A4: Provider(s) of hES cells
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Check all that apply
SCRO #
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Name provider/company/institution/contact
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3A5: Donor identifiers
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Section 3B: Human Induced Pluripotent Stem Cells (iPSCs)
3B1a: Will existing human Induced Pluripotent Stem Cells be used?
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Yes
No
3B1b: Will human Induced Pluripotent Stem Cells be generated?
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Yes
No
3B2: Please list all actively used and created human pluripotent stem cell lines in a SCRO inventory spreadsheet (See link in Section 6). Upload this document in Section 6
3B3: Purpose of hIPSC line use:
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Differentiation into other cell type. Specify target tissue/cell type (e.g. neural tissue):
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Creation of human gametes or morulae/blastocysts/embryo. Provide justification:
This will require full SCRO committee review.
Culture of any intact human embryo, regardless of method of creation, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first, is prohibited at MUSC.
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If Other, specify:
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3B4: Provider of hIPSC
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IRB and/or SCRO #
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Name provider/company/institution/contact
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3B5: Donor identifiers
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Section 3C: Human Adult Stem Cells
3C1: What is/are the source(s) of the human adult stem cells?
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Check all that apply
If Other, specify source
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3C2: Please list all actively used and created human adult stem cell lines in a SCRO inventory spreadsheet (See link in Section 6). Upload this document in Section 6.
3C3: Purpose of human adult stem cell line use:
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Check all that apply
Purpose of hIPSC line (derived from adult stem cells) use:
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Check all that apply
Creation of human gametes or morulae/blastocysts/embryo. Provide justification:
This will require full SCRO committee review.
Culture of any intact human embryo, regardless of method of creation, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first, is prohibited at MUSC.
* must provide value
For differentiation into other cell type, specify target tissue/cell type (e.g. neural tissue):
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If other, please explain:
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3C4: Provider of human adult stem cells
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SCRO #
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Name provider/company/institution/contact
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3C5: Donor identifiers
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Section 3D: Human Pre-/Post-implantation Embryos
Note: Experiments that involve 1) transplantation of hPSCs into human blastocysts, or 2) in vitro culture of any intact human embryo, regardless of method of creation, for longer than 14 days or until formation of the primitive streak begins (whichever occurs first), are prohibited at MUSC.
3D1: Provide rationale for the need to use pre-/post-implantation embryos as opposed to other tissue.
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3D2: Purpose of pre-/post-implantation embryo use:
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Check all that apply
Clarify 'Other'
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Provide rationale for the need to each purpose checked in 3D2.
Note: Experiments that involve 1) transplantation of hPSCs into human blastocysts, or 2) in vitro culture of any intact human embryo, regardless of method of creation, for longer than 14 days or until formation of the primitive streak begins (whichever occurs first), are prohibited at MUSC.
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3D3a: Specify the number of embryos needed:
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3D3b: Justify this number of embryos needed and explain why fewer would not be sufficient:
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3D4: Provider(s) of embryos :
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Check all that apply
Name provider/company/institution/contact. Also, read Note 1 below.
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3D5: Donor identifiers
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Section 3E: Human Gametes
3E1a: Indicate gametes to be used:
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Check all that apply
3E1b: Provide rationale for the need to use gametes as opposed to other tissue.
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3E2: Purpose of using gametes:
Note: Experiments that involve 1) transplantation of hPSCs into human blastocysts, or 2) in vitro culture of any intact human embryo, regardless of method of creation, for longer than 14 days or until formation of the primitive streak begins (whichever occurs first), are prohibited at MUSC.
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Check all that apply
Clarify 'Other'
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3E2a: Provide rationale for the need for this/these purpose(s):
Note: Experiments that involve 1) transplantation of hPSCs into human blastocysts, or 2) in vitro culture of any intact human embryo, regardless of method of creation, for longer than 14 days or until formation of the primitive streak begins (whichever occurs first), are prohibited at MUSC.
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3E2b: Duration that embryos will be maintained in vitro:
Note: Experiments that involve 1) transplantation of hPSCs into human blastocysts, or 2) in vitro culture of any intact human embryo, regardless of method of creation, for longer than 14 days or until formation of the primitive streak begins (whichever occurs first), are prohibited at MUSC.
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3E3: Biological source of gametes
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Check all that apply
Clarify "Other" source
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3E4: Provider(s) of gametes (Please read Note 1 below) :
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Check all that apply
Specify "Other" provider
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Name provider/company/institution/contact
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3E5: Donor identifiers
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Section 3F: Human neural progenitor, somatic, or other human cells not listed above
3F1: Specify cells to be used (incl. cell line names, catalog numbers etc):
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3F2: Purpose of using human neural progenitor, somatic, or other human cells not listed above:
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Check all that apply
Purpose of hIPSCs derived from human neural progenitor, somatic or other human cells:
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Specify target tissue/cell type (e.g. germ cells, neural tissue):
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Creation of human gametes or morulae/blastocysts/embryo. Provide justification:
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Clarify 'Other'
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3F3: Provider of human neural progenitor, somatic, or other human cells
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Name provider/company/institution/contact
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Clarify 'Other'
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3F4: Donor identifiers
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Section 4: Animal research
4A: Specify species of animals to be used:
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Clarify 'Other' species
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4B: Maturity level of the animal at the time of administration:
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Check all that apply
Clarify 'Other' maturity level
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4C: Cell types to be injected/transplanted:
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Check all that apply
Specify 'Other' human cells to be administered:
Note: It is prohibited at MUSC to transfer into a non-human uterus any experimentally created human or cybrid (a cell with a human nucleus and the cytoplasm of another species) embryos made by any method.
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4D: Specify planned injection/transplantation site(s):
4E: Rationale for injection/transplant in an animal:
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4F: Describe the most likely pattern and effects of differentiation and integration of the human cells into the non-human animal tissues:
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NOTE: At MUSC it is prohibited to conduct research in which human PSCs are introduced into mammalian (incl. non-human primate) blastocysts, pending further research that will clarify the potential of such introduced cells to contribute to neural tissue or to the germ line.
4G:If applicable, what method to prevent breeding of animals will be used?
Note: Breeding of animals into which hPSCs have been introduced is prohibited at MUSC. The full SCRO Committee will consider exceptions to this prohibition with a strong scientific rationale for breeding.
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4H: Until what developmental stage after injection/transplant will animals be allowed to survive?
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Section 5: Human research
IMPORTANT: Please upload in Section 6, if applicable, the Clinical Protocol, Consent Form, and (if applicable) Investigator's Brochure.
5A: Cell types to be injected/transplanted:
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Check all that apply
Specify 'Other' human cells to be administered:
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5B: Maturity level of the human(s) at the time of administration:
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Define Maturity level 'Other'
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5C: Rationale for performing this injection/transplant in a human:
NOTE: Transplantation of stem cells as part of recognized and accepted medical treatment for a disease or condition will not need SCRO review (e.g. hematopoietic progenitor cells for certain indications).
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5D: Specify planned injection/transplantation method and site(s):
5E: Describe the most likely pattern and effects of differentiation and integration of the human cells into the human tissues:
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Note 1) In Section 6, upload documentation of the provenance of the donated materials. At minimum, this includes a copy of an IRB approval letter from the institution(s) responsible for the derivation of the stem cell line(s). Include specific information about the informed consent process and consent form as used at the time of consent.
Section 6: Uploads
Complete this SCRO inventory spreadsheet and upload below.
Upload here 1) SCRO inventory Spreadsheet
Upload here 2) If applicable, upload provenance documentation (combine all into 1 file):
Upload here 2) If applicable, clinical research protocols, consent forms, IRB approvals etc. here (combine all into 1 file):
Principal Investigator Attestation and Signature.
I, the Principal Investigator:
- certify that I have answered all questions on this document and its attachments truthfully and with appropriate completeness.
- understand that all personnel (researchers and staff) involved with human embryonic/pluripotent stem cell research must complete the CITI Human Stem Cell Research training modules.
- understand that I must file an amendment for any change in human embryonic/pluripotent stem cell research personnel and that all new personnel must complete the CITI Human Stem Cell Research training modules.
- understand that no investigators will conduct human pluripotent stem cell research in locations other than as described in this registration without prior notification to the SCRO Committee.
- understand that I will be required to file an annual continuing review, including an updated SCRO inventory spreadsheet) on the human embryonic stem cell lines in my possession and human pluripotent stem cell lines actively used in my research.
- understand that no investigators will perform experiments with human embryonic/pluripotent stem cells that are prohibited by MUSC, including:
1) Research involving in vitro culture of any intact human embryo, regardless of method of creation, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first.
2) Experiments that involve transplantation of human pluripotent stem cells into human blastocysts.
3) Transfer into a human or non-human uterus of experimentally created human or cybrid (a cell with a human nucleus and the cytoplasm of another species) embryos made by any method.
4) Research in which human pluripotent stem cells are introduced into non-human primate blastocysts, pending further research that will clarify the potential of such introduced cells to contribute to neural tissue or to the germ line.
5) Breeding of animals into which human pluripotent stem cells have been introduced, unless specifically allowed by the MUSC SCRO committee.
6) Engaging in human stem cell research deemed ineligible by the National Institutes of Health.
- understand that I am responsible to notify the SCRO of any amendments to my IRB, IACUC and/or IBC protocols relevant to human pluripotent stem cell research prior to implementation. In addition, I am responsible to notify the IRB, IACUC and/or IBC of any amendments to my human pluripotent stem cell protocols under the jurisdiction of those committees.
- understand that members of the SCRO or Office of Research Integrity at MUSC have the right to perform unannounced audits of laboratories involved with human pluripotent stem cells.
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