Type of registration: * must provide value
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. * must provide value
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. * must provide value
Last name* must provide value
First name* must provide value
Middle initial
College* must provide value
Dental Medicine Medicine Health professions Nursing Pharmacy Graduate Studies
Dept/Division* must provide value
Office Phone number* must provide value
MUSC Email address* must provide value
Funding Source(s)* must provide value
Start-up funds
Private industry
Federal Grant
Other
Check all that apply
Provide Name Funding Source or specify Other: * must provide value
Do you have any MUSC co-investigators on this project? * must provide value
Yes
No
Co-I Last Name* must provide value
Co-I First name* must provide value
Co-I MUSC email* must provide value
Do you have any more MUSC co-investigators on this project? * must provide value
Yes
No
Co-I Last Name* must provide value
Co-I First name* must provide value
Co-I MUSC email* must provide value
List freezer/facilities where hPSCs will be stored (Building(s) and room number(s), separated by ';')* must provide value
List facilities where hPSCs will be used (Building(s) and room number(s), separated by ';')* must provide value
2A: Activities planned with hPSCs* must provide value
In vitro work
Recombinant DNA or viral vectors
Administration to non-human animals, at any stage of embryonic, fetal, or post-natal development
Administration to humans, at any stage of embryonic, fetal, or post-natal development (incl. clinical trials)
Other
Storage (No activities planned)
If Other, describe* must provide value
Provide IBC registration number(s)* must provide value
Provide IACUC registration number(s)* must provide value
Provide IRB registration number(s)* must provide value
2B: Types of cells/tissues to be used. * must provide value
Human Embryonic Stem Cells
Human Pre-/Post-implantation Embryos
Human Gametes
Human Somatic cells
Human Induced Pluripotent Stem Cells
Human Adult Stem Cells (incl. fetal and cord blood derived)
Human Neural Progenitor Cells
Other
2C: Lay summary * must provide value
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* must provide value
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? * must provide value
Cell line(s) on the NIH registry
Cell lines NOT on the NIH registry, but previously approved by the MUSC SCRO.
Cell lines NOT on the NIH registry, and NOT previously approved by the MUSC SCRO. Please read Note 1 below.
N/A
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* must provide value
3A2: Purpose of hES cell line use:* must provide value
Differentiation into other cell type. Specify target tissue/cell type (e.g. germ cells, neural tissue):
Use as a control or standard for other cell line development
Creation of human gametes or morulae/blastocysts/embryo.
Storage (No activities planned)
Other
Check all that apply
Differentiation into other cell type. Specify target tissue/cell type (e.g. neural tissue): * must provide value
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
If Other, specify: * must provide value
3A3: Provide a rationale for the need to use hES cells as opposed to other human pluripotent stem cells. * must provide value
3A4: Provider(s) of hES cells* must provide value
MUSC researcher with approved protocol. Provide SCRO # below
Self-derived with approved protocol. Provide SCRO # below
Other research institution. Name institution and contact below
Purchased. Name Company below
Other. Specify below
Check all that apply
SCRO #* must provide value
Name provider/company/institution/contact* must provide value
3A5: Donor identifiers * must provide value
Cells are completely de-identified.
Cells are linked to one or more identifiers by code. MUSC researchers cannot trace cells back to donor per written agreement or policy. However, the provider of the hESCs can.
Cells are identifiable.
Section 3B: Human Induced Pluripotent Stem Cells (iPSCs) 3B1a: Will existing human Induced Pluripotent Stem Cells be used? * must provide value
Yes
No
3B1b: Will human Induced Pluripotent Stem Cells be generated? * must provide value
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:* must provide value
Differentiation into other cell type. Specify target tissue/cell type (e.g. germ cells, neural tissue):
Use as a control or standard for other cell line development
Creation of human gametes or morulae/blastocysts/embryo.
Storage (No activities planned)
Other
Differentiation into other cell type. Specify target tissue/cell type (e.g. neural tissue): * must provide value
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
If Other, specify: * must provide value
3B4: Provider of hIPSC* must provide value
MUSC researcher with approved protocol. Provide IRB # and/or SCRO # below
Self-derived with approved protocol. Provide IRB and/or SCRO # below. (If marked, also fill out section 3F). Please read Note 1 below.
Other research institution. Name institution and contact below
Purchased. Name Company below
Other. Specify below
IRB and/or SCRO #* must provide value
Name provider/company/institution/contact* must provide value
3B5: Donor identifiers * must provide value
Cells are completely de-identified.
Cells are linked to one or more identifiers by code. MUSC researchers cannot trace cells back to donor per written agreement or policy. However, the provider of the hIPSCs can.
Cells are identifiable.
Section 3C: Human Adult Stem Cells 3C1: What is/are the source(s) of the human adult stem cells?* must provide value
Cord blood
Fetus
Hematopoietic
Mesenchymal
Placental
Amniotic
Progenitor (does not include germ cells)
Other. Specify below
Check all that apply
If Other, specify source* must provide value
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:* must provide value
Induction of pluripotency. Describe induction process in Section 2B (Proposed experiments) above.
Differentiation into other cell type. Specify target tissue/cell type (e.g. germ cells, neural tissue) below.
Storage (No activities planned)
Other
Check all that apply
Purpose of hIPSC line (derived from adult stem cells) use:* must provide value
Differentiation into other cell type. Specify target tissue/cell type (e.g. germ cells, neural tissue):
Use as a control or standard for other cell line development
Creation of human gametes or morulae/blastocysts/embryo.
Storage (No activities planned)
Other
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):* must provide value
If other, please explain: * must provide value
3C4: Provider of human adult stem cells* must provide value
MUSC researcher with approved protocol. Provide IRB and/or SCRO # below
Self-derived with approved protocol. Provide IRB and/or SCRO # below. Also read Note 1 below.
Other research institution. Name institution and contact below
Purchased. Name Company below
Other. Specify below
SCRO #* must provide value
Name provider/company/institution/contact* must provide value
3C5: Donor identifiers * must provide value
Cells are completely de-identified.
Cells are linked to one or more identifiers by code. MUSC researchers cannot trace cells back to donor per written agreement or policy. However, the provider of the human adult stem cells can.
Cells are identifiable.
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. * must provide value
3D2: Purpose of pre-/post-implantation embryo use:* must provide value
Derivation of new hESC lines
Somatic Cell Nuclear Transfer
Other
Storage (No activities planned)
Check all that apply
Clarify 'Other' * must provide value
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. * must provide value
3D3a: Specify the number of embryos needed: * must provide value
3D3b: Justify this number of embryos needed and explain why fewer would not be sufficient: * must provide value
3D4: Provider(s) of embryos :* must provide value
IVF clinic. Provide name below
Other research institution. Provide name of institution and contact below.
Purchased. Provide name company below
Other. Specify below.
Check all that apply
Name provider/company/institution/contact. Also, read Note 1 below. * must provide value
3D5: Donor identifiers * must provide value
Completely de-identified.
Linked to one or more identifiers by code. MUSC researchers cannot trace morulae/embryos back to donor per written agreement or policy. However, the provider of the morulae/embryos can.
Morulae/embryos are identifiable.
Section 3E: Human Gametes 3E1a: Indicate gametes to be used: * must provide value
oocytes
Sperm
Check all that apply
3E1b: Provide rationale for the need to use gametes as opposed to other tissue. * must provide value
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. * must provide value
Derivation of new pluripotent stem cell lines
Somatic Cell Nuclear Transfer
Parthenogenesis
Other
Check all that apply
Clarify 'Other'
* must provide value
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. * must provide value
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. * must provide value
3E3: Biological source of gametes * must provide value
Procured as part of assisted reproductive treatment cycle.
Donated specifically for research purposes.
Discarded material and not useable/suitable for reproduction.
Procured as part of assisted reproductive treatment cycle, but donated separately for research.
Other
Check all that apply
Clarify "Other" source* must provide value
3E4: Provider(s) of gametes (Please read Note 1 below) :* must provide value
IVF clinic. Provide name below.
Other research institution. Provide name of institution and contact below. below.
Purchased. Provide name company below.
Other. Specify below.
Check all that apply
Specify "Other" provider* must provide value
Name provider/company/institution/contact* must provide value
3E5: Donor identifiers * must provide value
Completely de-identified.
Linked to one or more identifiers by code. MUSC researchers cannot trace gametes back to donor per written agreement or policy. However, the provider of the gametes can.
Gametes are identifiable.
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): * must provide value
3F2: Purpose of using human neural progenitor, somatic, or other human cells not listed above:* must provide value
Induction of pluripotency. If checked, describe induction process in Section 2D (Proposed experiments) above.
Other. Specify below.
Storage (No activities planned)
Check all that apply
Purpose of hIPSCs derived from human neural progenitor, somatic or other human cells: * must provide value
Differentiation into other cell type. Specify target tissue/cell type (e.g. germ cells, neural tissue) below.
Use as a control or standard for other cell line development
Creation of human morulae/blastocysts/embryo. Provide justification below.
Other. Specify below.
Storage (No activities planned)
Specify target tissue/cell type (e.g. germ cells, neural tissue): * must provide value
Creation of human gametes or morulae/blastocysts/embryo. Provide justification: * must provide value
Clarify 'Other' * must provide value
3F3: Provider of human neural progenitor, somatic, or other human cells* must provide value
MUSC researcher with approved protocol Provide IRB and/or SCRO # below. Read Note 1 below.
Harvested as described in this application. Describe in section 2C. Provide IRB and/or SCRO # below. Read Note 1 below.
Other research institution. Name institution and contact below
Purchased. Name Company below
Other. Specify below
SCRO # and/or IRB #
Name provider/company/institution/contact* must provide value
Clarify 'Other' * must provide value
3F4: Donor identifiers * must provide value
Completely de-identified.
Linked to one or more identifiers by code. MUSC researchers cannot trace cells back to donor per written agreement or policy. However, the provider of the gametes can.
Cells are identifiable.
Section 4: Animal research 4A: Specify species of animals to be used: * must provide value
Mouse
Rat
Other
Clarify 'Other' species* must provide value
4B: Maturity level of the animal at the time of administration: * must provide value
Morulae
Blastocyst
Fetus
Neonate
Adult
Other
Check all that apply
Clarify 'Other' maturity level* must provide value
4C: Cell types to be injected/transplanted:* must provide value
Human embryonic stem cells (hESC)
Human induced pluripotent stem cells (iPS)
Human adult stem cells
Other human cells. Specify below.
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. * must provide value
4D: Specify planned injection/transplantation site(s):
4E: Rationale for injection/transplant in an animal: * must provide value
4F: Describe the most likely pattern and effects of differentiation and integration of the human cells into the non-human animal tissues: * must provide value
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. * must provide value
4H: Until what developmental stage after injection/transplant will animals be allowed to survive? * must provide value
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:* must provide value
Human embryonic stem cells (hESC)
Human induced pluripotent stem cells (iPS)
Human adult stem cells
Other human cells. Specify below.
Check all that apply
Specify 'Other' human cells to be administered: * must provide value
5B: Maturity level of the human(s) at the time of administration: * must provide value
Morulae
Blastocyst
Fetus
Neonate
Children
Adult
Other
Define Maturity level 'Other'* must provide value
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).* must provide value
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: * must provide value
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. * must provide value
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