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J47WVFmsJPYmwFCBpzQin2ZIIcCKBEuYpCGTmDtJSrdMGFtaDriYiuh

MUSC SCRO Registration form

Returning?

MUSC leadership has charged the Stem Cell Research Oversight (SCRO) committee with oversight responsibilities for all research projects that fall under the Research Using Human Stem Cells Policy.

To initiate review of a protocol by the SCRO Committee, Principal Investigators (PIs) must submit an MUSC SCRO Registration form to the Committee. Please fill out the form below.

For more information:	http://research.musc.edu/ori/SCRO/
For questions:	Dr. Michael E. Smith, SCRO Program Manager (smitmic@musc.edu or 792-6535)

MUSC prohibits the following categories of research:

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. The SCRO Committee will not approve any of the following categories of research unless there is strong scientific rationale and ethical basis for the proposal:

a. research in which human pluripotent stem cells are introduced into mammalian (including non-human primate) blastocysts;

b. breeding of animals into which human pluripotent stem cells have been introduced;

c. human stem cell research deemed ineligible by the National Institutes of Health.

Yes

reset

Start-up funds

Private industry

Federal Grant

Other

Yes

reset

Yes

reset

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)

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

Expand

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)

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

Expand

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

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

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)

Yes

reset

Yes

reset

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

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

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

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

Cord blood

Fetus

Hematopoietic

Mesenchymal

Placental

Amniotic

Progenitor (does not include germ cells)

Other. Specify below

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.

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

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

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

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.

Derivation of new hESC lines

Somatic Cell Nuclear Transfer

Other

Storage (No activities planned)

IVF clinic. Provide name below

Other research institution. Provide name of institution and contact below.

Purchased. Provide name company below

Other. Specify below.

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

oocytes

Sperm

Derivation of new pluripotent stem cell lines

Somatic Cell Nuclear Transfer

Parthenogenesis

Other

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

IVF clinic. Provide name below.

Other research institution. Provide name of institution and contact below. below.

Purchased. Provide name company below.

Other. Specify below.

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

Induction of pluripotency. If checked, describe induction process in Section 2D (Proposed experiments) above.

Other. Specify below.

Storage (No activities planned)

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)

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

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

Mouse

Rat

Other

Morulae

Blastocyst

Fetus

Neonate

Adult

Other

Human embryonic stem cells (hESC)

Human induced pluripotent stem cells (iPS)

Human adult stem cells

Other human cells. Specify below.

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.

Section 5: Human research

IMPORTANT: Please upload in Section 6, if applicable, the Clinical Protocol, Consent Form, and (if applicable) Investigator's Brochure.

Human embryonic stem cells (hESC)

Human induced pluripotent stem cells (iPS)

Human adult stem cells

Other human cells. Specify below.

Morulae

Blastocyst

Fetus

Neonate

Children

Adult

Other

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.

Attachment:

SCRO inventory spreadsheet July 2017.xlsx

Upload 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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