Embryonic Stem Cell Research Review Process

Embryonic Stem Cell Research Oversight Embryonic Stem Cell Research Review Process
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Embryonic Stem Cell Research Oversight Embryonic Stem Cell Research Review Process

Depending on the nature of your study, your research protocol may require one or more types of review by NYU School of Medicine’s embryonic stem cell research oversight (ESCRO) committee. Your protocol may require review by additional review boards if, for example, your study is related to cancer research.

At this stage of your research, you may also find it helpful to review human stem cell research guidelines issued by the National Institutes of Health (NIH), the National Academy of Sciences, the Empire State Stem Cell Board, and the International Society for Stem Cell Research. NYU School of Medicine complies with the research and ethics standards set by all of these governing bodies.

Types of Review Your Submission May Require

The following types of research require ESCRO committee registration (an expedited review):

  • in vitro research using NIH-registered human embryonic stem cell lines
  • in vitro research using human embryonic stem cell or human pluripotent stem cell lines that have been preapproved for such use by NYU School of Medicine’s ESCRO committee
  • in vitro research using human stem cells obtained by using an Institutional Review Board–approved process and the cell lines have been deidentified, such that the identity will never be released to the investigator
  • research involving the creation of a new human pluripotent stem cell line by any means
  • research involving transplantation into human subjects of autologous or allogeneic adult stem cells derived from human somatic tissue
  • research involving human stem cells being transplanted into animals, except transplantation into an animal embryo or an animal’s germline or brain

Research involving the following requires full review by our ESCRO committee:

  • the creation of a new human embryonic stem cell line, or derived line, by any means, including through the use of somatic cell nuclear transfer, human zygotes, spindle transfer, or a human embryo furnished by an in vitro fertilization clinic or other lawful source
  • payment to a donor for the sole purpose of creating a human embryo to be used in human embryonic stem cell research
  • research in which personally identifiable information about the donor of the blastocysts, gametes, or somatic cells from which the human embryonic stem cells or human pluripotent stem cells were derived is readily ascertainable or might become known to the investigator
  • research utilizing NIH-ineligible human embryonic stem cell lines that have not been preapproved for such use by NYU School of Medicine’s ESCRO committee
  • human pluripotent stem cell research that includes experiments designed or expected to yield neural or gametic cells and tissues
  • mixing human totipotent stem cells or human pluripotent stem cells with preimplantation human embryos—though in no case shall such experiments be allowed to progress for more than 14 days of development in vitro or past the point of primitive streak formation, whichever is first
  • clinical research in which cells of human totipotent stem cells or human pluripotent stem cells are transplanted into living human subjects
  • in vitro culture of an intact human embryo
  • research that generates chimeras using human cells, including but not limited to introducing new human embryonic stem cells, human totipotent stem cells, or human pluripotent stem cells into nonhuman animals at any stage of embryonic, fetal, or postnatal development

Reviewer’s Final Assessment: Decision Letters

Decision Rationale

Approved

No changes needed: the protocol is accepted as submitted

Conditionally Approved

Minor changes needed: clarifications and/or additional information requested from investigator

Deferred

Any of the following factors are involved:

  • Protocol is poorly written, lacking significant amount of information regarding scientific justification, research procedures, etc.
  • Researcher has not adequately considered alternative methods
  • There are ethical concerns, which can be addressed by obtaining more information or requiring changes in research design

Not Approved

The following factors are involved:

  • Ethical risks significantly outweigh the benefit or value of the knowledge to be gained
  • There are significant ethical concerns or questions that deem the study unacceptable