Frequently Asked Questions (FAQs)
| Who is required to complete the online training module "Ethical Oversight of hESC Research", and where is it located? |
General Questions
The National Academies of Sciences publication, “Guidelines for Human Embryonic Stem Cell Research” (2005) http://www.nap.edu/catalog/11278.html#toc recommended that institutions conducting human embryonic stem cell (hESC) research should establish an Embryonic Stem Cell Research Oversight (ESCRO) committee, in order to ensure that all applicable regulatory requirements are met, and that hESC research is conducted in accordance with the guidelines set forth in the report. ESCRO committees are intended to provide local oversight of all issues related to derivation and research use of hESC lines, and to facilitate education of investigators involved in hESC research.
The Johns Hopkins University School of Medicine (JHU SOM) has established an ESCRO committee, which will provide an additional level of review and scrutiny warranted by the complex issues raised by hESC research. It does not take the place of other types of review that might be required, such as review by an Institutional Review Board (IRB) or the Institutional Animal Care and Use Committee (IACUC). The ESCRO committee has nine members: 2 co-chairs, one with expertise in science and one with expertise in ethics; 3 scientists; 2 ethicists/legal scholars; an individual with expertise in clinical transplantation; and a non-institutionally affiliated member. Membership also includes a representative of the University’s Office of General Counsel, ex-officio and a representative of the JHU SOM Office of Research Administration (ORA), ex-officio. In addition to determining whether protocols are ethically and scientifically sound, the JHU SOM ESCRO committee considers compliance with applicable governmental regulations and institutional policies related to stem cell research.
JHU SOM ESCRO Review
What type of research is reviewed by the JHU SOM ESCRO committee?
The JHU SOM ESCRO committee currently reviews all research using human embryonic stem cells (hESCs) or somatic cell nuclear transfer (SCNT) involving human cells at JHU SOM.
The committee also serves as a consultative body for researchers working with human embryonic germ (EG) cells, human adult stem (AS) cells, human induced pluripotent stem cells (iPS), human umbilical cord blood (UCB) stem cells, and/or human/non-human chimeras. Upon referral by the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), or an Institutional Review Board (IRB), the JHU SOM ESCRO committee reviews research protocols that the referring committee believes would benefit from ESCRO committee review.
How is the JHU SOM ESCRO committee review coordinated with reviews by other oversight committees?
Research requiring JHU SOM ESCRO committee review should be submitted concurrently with submission of the research to any other University entity (e.g., IRB, IACUC, IBC, CCOI, CRRC/RDRC) that may have responsibility for oversight of other aspects of the research. Research activities approved by the JHU SOM ESCRO committee may be subject to further review, modification of, approval and/or disapproval by all relevant bodies; however, those committees and officials may not approve the conduct of research within the JHU SOM ESCRO committee’s jurisdiction if approval was previously withheld by the JHU SOM ESCRO committee.
Must JHU SOM ESCRO committee review research that began prior to establishment of the JHU SOM ESCRO committee?
Research already in progress and within the purview of the JHU SOM ESCRO committee must be submitted to the JHU SOM ESCRO committee for review by December 31, 2007.
How frequently is JHU SOM ESCRO committee review required for a research project?
Approved research shall be reviewed by the JHU SOM ESCRO committee every three years, or more frequently, as determined by the committee on a case-by-case basis. The investigator will be notified of expiration and is responsible for submitting the renewal application in a timely manner.
Actions likely to be considered a change in scope requiring prior approval from the ESCRO committee include, but are not limited to the following:
- change in the specific aims;
- change in source or type of human embryonic stem cells;
- any change from the approved use of animals or human subjects, including the substitution of one animal model for another;
- shift of the research emphasis from one disease area to another;
- a clinical hold by the FDA under a study inolving an IND or IDE;
- application of a new technology;
- transfer of the performance of substantive programmatic work to a third party through a consortium agreement, by contract, or any other means; (where JHU SOM faculty, staff or students acting in their capacity as faculty, staff, or students respectively, collaborate with a researcher at a foreign institution, protocols must describe protections afforded and procedures prescribed by the foreign institution);
- change in investigators listed on the approved ESCRO application, including change in PI and removal of members;and a
- change in funding source to the lab or to the project.
When does the JHU SOM ESCRO committee meet?
The JHU SOM ESCRO committee meets the second Monday of each month.
JHU SOM ESCRO Application
Where can I get a JHU SOM ESCRO committee application?
The JHU SOM ESCRO committee application is located on the JHU SOM ESCRO website, at http://www.hopkinsmedicine.org/Research/ESCRO/Forms/forms.html
Training
Who is required to complete the online training module "Ethical Oversight of hESC Research", and where is it located?
All study team members participating in research under ESCRO purview are required to complete the online training module "Ethical Oversight of hESC Research". The course may be accessed at http://www.hopkinsinteractive.org/ with Internet Explorer.
Compliance
What are the consequences for conducting research covered by the JHU SOM ESCRO committee without the committee’s approval?
The JHU SOM ESCRO committee shall have the authority to suspend or terminate research that falls under its jurisdiction and that has not been approved by the JHU SOM ESCRO committee. The JHU SOM ESCRO committee will notify the JHU SOM Institutional Official(s), as well as other relevant committees (e.g., IRB, IACUC, IBC, CCOI, CRRC/RDRC) of any suspension or termination.
The JHU SOM ESCRO committee also has the authority to terminate the participation of JHU SOM researchers in research conducted at a site outside the University. In such cases, the JHU SOM ESCRO committee co-chairs will inform the responsible institutional officials at each institution involved in the research of the termination.
What happens if the continuing review application is not submitted by the expiration of approval date?
Failure to submit the application by the deadline will result in withdrawal of approval.
Funding and Sample Identifiers
Why is information about funding for all study team members and research facilities required by the JHU SOM ESCRO Committee?
On August 9, 2001 President George W. Bush outlined constraints on federal funding of stem cell research that served to establish federal policy in this area. Under this policy, federal funds may be used for hESC research only when the following criteria are met: the hESC line was, 1) created prior to August 9, 2001; 2) derived from an embryo that was created for reproductive purposes and no longer needed; and 3) derived from a embryo donated with informed consent, where the donation did not involve financial inducements. A list of stem cell lines currently eligible for federal funding (“registered” or “presidential” lines) may be found at http://stemcells.nih.gov/research/registry/eligibilitycriteria.asp .
In laboratories where there is both federal and non-federal funding, investigators and their staffs must separate allowable and unallowable activities in such a way that permits the costs incurred in the research to be charged consistently to the appropriate funding source. Additional information about stem cell research and federal funding may be found at http://stemcells.nih.gov/info/faqs.asp .
What constitutes sample identifiers?
Sample identifiers, such as NIH Code WA09, Provider's Code H9 provide reference for detailed information, such as characterization about a cell line. Go to http://www.wicell.org/index.php?option=com_oscommerce&Itemid=130 for information about the National Stem Cell Bank.
Policies Relevant for Collaboration
Will approval by the JHU SOM ESCRO committee ensure that stem cell lines created and approved at Hopkins will be compliant with other international, state and local policies?
Policies vary greatly across jurisdictions, and because they are continually changing, the JHU SOM ESCRO committee recommends that investigators contact the JHU Office of the Vice President and General Counsel prior to beginning any stem cell research that might be governed by the policies of other jurisdictions.
