ESCRO (Stem Cell Research Oversight)

Research Oversight

Per UMass Chan’s Policy for Human Embryo and Human Pluripotent Stem Cell Research (available for review HERE), all research on campus involving campus faculty or staff that involves the following must be submitted to the Stem Cell Research Oversight Committee for review and approval:

• • The use of human embryonic stem cells or their derivatives.
  • The introduction of human pluripotent stem cells or their derivatives, obtained from a non-embryonic source, into non-human animals at any embryonic, fetal, or postnatal stage, if an expected effect is that human cells will be integrated into the central nervous system, testes, or ovaries of the animal.
  • All research that:
    • Involves preimplantation stages of human development, human embryos, or embryo-derived cells; or
    • Entails the production of human gametes in vitro when such gametes are tested by fertilization or used for the creation of embryos. 
  • The storage or disposition of human embryos or gametes obtained for the purposes of stem cell research.
  • The storage and distribution of human embryonic stem cells through a repository.

SCRO review occurs as the last review in the process of working with other oversight committees.

Biosafety (IBC): All SCRO protocols require IBC review and approval. Approval must be in place before submitting your protocol for review to SCRO.

Animal Care and Use (IACUC): If your research involves introduction of hPSCs, or their derivatives, obtained from a non-embryonic source, into non-human animals at any embryonic, fetal, or postnatal stage, and if an expected effect is that human cells will be integrated into the central nervous system, testes, or ovaries of the animal, IACUC review and approval is required. You must have IACUC approval before submitting a protocol for SCRO review.

Human Subjects (IRB): If your research involves human subjects, IRB review and approval is required. You must have IRB approval before submitting a protocol for SCRO review.

Initial SCRO Review

If your research falls under the purview of SCRO Committee review, you need to submit a protocol for review to the UMass Center for Clinical and Translational Science at ccts@umassmed.edu The SCRO form is available HERE.  The financial certification form is available HERE.  Depending on the nature of the research the protocol will be assigned for full committee or expedited review. Studies qualifying for expedited review include:

1. 1. In vitro studies using an NIH approved cell line(s); and ​
   2. In vitro studies using a cell line(s) previously approved by the SCRO Committee and listed on UMass Chan’s hESC Registry. ​

Continuing Review

A continuing review application is due to the committee one year minus a day from the initial protocol or last continuing review. PIs and Points of Contact will receive emails from the UMCCTS as a reminder to complete the continuing review. Reminders will begin to be sent 30 days before the continuing review is due. Once a protocol expires, an investigator has 30 days to respond before a new initial review application must be started. The continuing amendment form is available HERE.

Change of Protocol

Investigators must submit a change of protocol for the following reason:

1. 1. Addition of a new cell line not listed on the NIH or UMass Chan hESC Registries.
   2. Change of PI
   3. Change in funding
   4. Significant change in research type, study design, or research question

Study Completion

If your research has ended, you must submit a protocol completion report, available here.

Training Requirements & Classes

Stem Cell Ethics and Policy training is required for principal investigators, co-investigators, points of contact, key personnel, and other study team members listed. Training requirements and information on training classes is available HERE.