Embryonic Stem Cell Research Oversight
NYU School of Medicine’s embryonic stem cell research oversight (ESCRO) committee is responsible for approving and registering all research protocols involving the use of human embryonic stem cells or human pluripotent stem cells.
Our committee consists of a diverse group of faculty and staff with expertise in human embryonic stem cell research. We evaluate research protocols to ensure their compliance with institutional, state, and federal regulations—including those of the National Institutes of Health, National Academy of Sciences, Empire State Stem Cell Board, International Society for Stem Cell Research, and NYU School of Medicine.
Prior to beginning of research, all investigators and study personnel must complete required training and review our policy. If you intend to submit a research protocol involving human embryonic stem cells or human pluripotent stem cells, you may learn more about the following steps below:
- Required Training
- How to Apply for Embryonic Stem Cell Research Protocol Approval
- Embryonic Stem Cell Research Review Process
You may contact the ESCRO committee by email at firstname.lastname@example.org. To contact us by phone, please call 212-263-4110, and press “0” when prompted.
All study personnel at NYU School of Medicine performing research involving the use of human embryonic stem cells or human pluripotent stem cells must complete the Collaborative IRB Training Initiative (CITI) Program’s stem cell research training courses and the ESCRO supplemental stem cell research training. Study personnel include the principal investigator and any staff member directly involved with participants or the informed consent process.
To complete the CITI program’s Stem Cell Research Oversight Part I and Part II modules, you must register a profile with CITI or login to an existing one. Instructions for CITI Program login and registration may be found on the NYU School of Medicine Institutional Review Board’s required training page. After registration and login, select “Add a Course” on the main menu. To enroll in the necessary courses, be sure to select the “Stem Cell Research Oversight” box on Question 1 while completing and submitting the course enrollment form.
ESCRO Supplemental Training
The supplemental stem cell research training includes guidance on NYU School of Medicine ESCRO and New York State-funded stem cell research requirements. For more information regarding the supplemental training, please contact Royell Sullivan, senior institutional review board education specialist, at email@example.com.
It is the principal investigator’s responsibility to ensure that all study personnel complete the training. Conducting any study involving human embryonic stem cells or human pluripotent stem cells is also contingent upon research protocol approval by our committee.
In addition, all personnel must review NYU School of Medicine’s embryonic stem cell research oversight committee’s policy before starting research.
Researchers looking to conduct experiments involving the use of human embryonic stem cells or human pluripotent stem cells at NYU School of Medicine submit a research protocol to our ESCRO committee. To apply, all principal investigators and study personnel first complete required training.
If you are a researcher initiating a study, complete the ESCRO Application Form and submit it to firstname.lastname@example.org. Provide a study number, if one has been assigned, and attach a detailed description of your proposed research protocol.
Modifications, Continuing Review, and Closures
Research protocols involving the use of human embryonic stem cells or human pluripotent stem cells must be approved annually by our oversight committee. If you wish to submit a request for renewal of your study or closure of the study, submit the ESCRO Continuation/Closure Application Form to email@example.com.
Continuing review forms must be sent four to six weeks prior to your study’s expiration date to allow sufficient time for review. The continuing review form includes an annual progress report to ensure effective review. Alongside a detailed explanation of study progress within the past 12 months, be sure to describe the following in your report:
- any modifications to your approved research protocol that occurred within the past 12 months
- any events that have occurred during the approval period that may have changed the original category of review
- enrollment details if human subjects are involved
- any additional cell lines that have been procured
- any changes to storage or lab locations
- details on lines that have been registered with the National Institutes of Health (NIH)
If you wish to submit a modification to your study, please submit an ESCRO Modification Form. Alongside a brief description of changes being made, please be sure to indicate the following information relevant to your proposed changes:
- changes in experimental protocols using human embryonic stem cells or derivatives, human gametes, or embryos
- request for additional types of resources of human embryonic stem cell lines or other human biological materials
- changes in research personnel, including postdoctoral fellows and graduate students
- increase in the number of subjects to be enrolled
- addition or deletion of a site
- changes that impact originally approved category of review; if selected, indicate the new category
- changes that increase risk to human subjects or animals
- changes that require re-consenting of human subjects
Depending on the nature of your study, your research protocol may require one or more types of review in addition to ESCRO committee review. For example, your protocol may require additional review by any of the following review boards:
- Protocol Review and Monitoring Committee
- Research Conflicts of Interest Committee
- Radiation Safety Office
- Institutional Biosafety Committee
- Clinical and Translational Science Institute
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, 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.
Reviewer’s Final Assessment
For the types of review your submission may require, including which categories of research fall under full review or registration only, please refer to the ESCRO Application Form. For a breakdown of a review’s approval decision, please refer to the table below.
No changes needed: the protocol is accepted as submitted.
The ESCRO committee may approve research with conditions if, given the scope and nature of the conditions, we are able to make all of the determinations required for approval (i.e., approval criteria and any applicable special determinations).
Substantive issues regarding the protocol and/or consent form must be addressed. This action is taken if substantial modification or clarification is required, or insufficient information is provided to judge the protocol application adequately. Any of the following factors are involved:
Questions and issues are of such a magnitude that the ESCRO committee determines approval of the study is unwarranted. The following factors are involved: