Frequently Asked Questions (FAQs)
In 2007, The Johns Hopkins University School of Medicine (JHU) established an Embryonic Stem Cell Research Oversight (ESCRO) Committee to provide an additional level of review and scrutiny warranted by the complex issues raised by human embryonic stem cell (hESC) research. This was consistent with the National Academies of Sciences publication, "Guidelines for Human Embryonic Stem Cell Research " (2005) http://books.nap.edu/openbook.php?isbn=0309096537 .
Committed to ongoing review of the current research trends, JHU leadership updated the JHM ESCRO Policies & Procedures in March 2010, to include oversight of additional types of human pluripotent stem cell research. As such, the name of the Committee changed from "ESCRO" to "ISCRO" (Institutional Stem Cell Research Oversight), based upon evolving science, policy trends, and the desire for consistency with the International Society for Stem Cell Research (ISSCR) term of "SCRO". The revision in committee name and purview does not mean, however, that oversight extends to all stem cell research, nor does ISCRO oversight substitute for 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 JHU ISCRO Committee is comprised of a minimum of 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 ISCRO Committee considers compliance with applicable governmental regulations and institutional policies related to stem cell research.
JHU ISCRO Review
In addition to all research using human embryonic stem (hES) cells and/or somatic cell nuclear transfer (SCNT) involving human cells being conducted by JHU faculty, staff or students or involving the use of JHU facilities, the following is also subject to oversight by the JHU ISCRO Committee:
Other hPSCs (e.g., human induced pluripotent stem cells [iPSCs], human embryonic germ cells [hEGCs]) where the research involves:
- Introduction of the cells into humans;
- Introductionof the cells into the central nervous system of non-human primates;
- Introduction of the cells into non-human animals and there is a reasonable possibility of the cells giving rise to gametes; or,
- Creation of gametes or embryos.
The JHU ISCRO Committee also serves as an educational resource for researchers engaged in this research, as well as a consultative body for researchers working with all types of human stem cells. Upon referral by the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), or an Institutional Review Board (IRB), the JHU ISCRO Committee reviews research protocols that the referring committee believes would benefit from such review.
Should use of hESC lines as controls be submitted to the JHU ISCRO Committee for review?
All research using human embryonic stem (hES) cells, including use of such cells as controls by JHU faculty, staff or students or involving the use of JHU facilities should be submitted to the JHU ISCRO Committee for review.
How is the JHU ISCRO Committee review coordinated with reviews by other overisight committees?
Research requiring JHU ISCRO 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 ISCRO 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 ISCRO Committee's jurisdiction if approval was previously withheld by the JHU ISCRO Committee.
Must JHU ISCRO Committee review research that began prior to establishment of the JHU ISCRO Committee?
Research already in progress and within the purview of the JHU ISCRO Committee under conditions delineated in the Policies and Procedures Part One, Section I.C. must be submitted to the JHU ISCRO Committee for review by June 30, 2010; otherwise, all other research within the purview of the JHU ISCRO Committee must be submitted and approved prior to being initiated.
Approved research shall be reviewed by the JHU ISCRO Committee every year, or more frequently, as determined by the Committee on a case-by-case basis. The investigator will be reminded of expiration date(s), and s/he is responsible for submitting renewal applications in a timely manner. Annual updates are also requested.
What kind of change to an approved JHU ISCRO application should be submitted for review by the ISCRO Committee prior to implementation?
Actions likely to be considered a change requiring prior approval from the ISCRO Committee include, but are not limited to the following:
- Change in the specific aims
- Change in source or type of human pluripotent 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 involving 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 faculty, staff or students acting in their capacity as JHU 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 ISCRO 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 ISCRO Committee meet?
The JHU ISCRO Committee meets the second Monday of each month; review materials are circulated to Committee members a week in advance of the meeting.
JHU ISCRO Application
The JHU ISCRO Committee applications have been replaced by an online application, "eISCRO", which may be accessed at http://eiscro.jhu.edu . You may login with your JHED ID and password to create an application.
Who is required to complete the online training module "Ethical Oversight of hSC Research 2010", and where is it located?
All study team members participating in research under JHU ISCRO purview are required to complete the online training module "Ethical Oversight of hSC Research 2010". The course may be accessed at http://www.hopkinsmedicine.org/interactive_learning/index.html with Internet Explorer.
What are the consequences for conducting research covered by the JHU ISCRO Committee without the Committee's approval?
The JHU ISCRO Committee shall have the authority to suspend or terminate research that falls under its jurisdiction and that has not been approved by the JHU ISCRO Committee. The JHU ISCRO Committee will notify the JHU Institutional Official(s), as well as other relevant committees (e.g., IRB, IACUC, IBC, CCOI, CRRC/RDRC) of any suspension or termination.
The JHU ISCRO Committee also has the authority to terminate the participation of JHU researchers in research conducted at a site outside the University. In such cases, the JHU ISCRO Committee co-chairs will inform the responsible institutional officials at each institution involved in the research of the termination.
Failure to submit the application by the deadline will result in withdrawal of approval.
Funding and Sample Identifiers
The ISCRO Committee assists investigators and their staff by reviewing nuances of funding requirements.
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. On March 9, 2009, in response to Executive Order 13505, the NIH issued new guidelines to establish policy and procedures under which NIH will fund research in the area of human stem cells, and to help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. These Guidelines, (posted at http://stemcells.nih.gov/policy/2009guidelines.htm) went into effect on July 7, 2009.
Scientists may determine whether a particular hESC line is eligible for use in NIH-supported research under the new Guidelines by referring to the NIH Human Embryonic Stem Cell Registry, posted at http://grants.nih.gov/stem_cells/registry/current.htm.
The funded/JIT grant must be submitted for JHU ISCRO review to determine whether the new project is consistent with current application since the JHU ISCRO Committee is charged with reviewing each use of pluripotent stem cells under its purview. Procedures described in the grant should also be included in the protocol application.
If the newly funded project is closely related to a current JHU ISCRO application, an addendum/change may be submitted to include the new funding and related project. If the funded/JIT grant is a new project, a new JHU ISCRO application should be submitted. In either situation, JHU ISCRO approval must be obtained prior to use of the funds.
You should submit an application describing the research covered by your MSCRF grant to the Institutional Review Board (IRB), regardless of whether or not the protocol involves human subjects research. In order for the Johns Hopkins University (JHU) Office of Research Administration (ORA) to expedite approval for your contract, you must submit appropriate approval documents to your sponsored projects specialist.
All MSCRF grant awards must have Institutional Review Board (IRB) approval before the funds are released, regardless of whether or not the proposal involves human subjects. There are no exceptions to this State regulation. Application forms are located on the following Web sites:
- http://www.hopkinsmedicine.org/institutional_review_board/ (JHM IRBs)
- http://web.jhu.edu/Homewood-IRB/applications.html/ (JH Homewood IRB)
- http://www.jhsph.edu/irb/Applications_and_Other_Forms.html/ (JH Bloomberg School of Public Health IRB)
If your award is a post-doctoral fellowship award, your faculty mentor will need to submit the protocol application(s) as the principal investigator and include you as a co-investigator. Depending on the research activities, other approvals including Biosafety, ISCRO, and IACUC might be required. More information and application forms are located at the following Web sites:
- http://www.hopkinsmedicine.org/hse/biosafety/index.html/ (Biosafety);
- http://www.hopkinsmedicine.org/Research/iscro/ (ISCRO);
- http://web.jhu.edu/animalcare/forms.html/ (IACUC).
REMEMBER: The State of Maryland will not release the funds until all protocols are approved by the IRB, along with any other required approvals. http://www.mscrf.org/content/aboutus/actof2006.cfm/
What constitutes sample identifiers?
Sample identifiers or cell line name, such as NIH Code WA09, Provider's Code H9 provide a reference for the product description, which often includes a Certificate of Analysis. Starting February 2, 2010, cells previously ordered from National Stem Cell Bank (NSCB) may now be obtained from the Wisconsin International Stem Cell Bank (the "WISC Bank"). Go to http://www.nationalstemcellbank.org/ for more information.
Policies Relevant for Collaboration
Will approval by the JHU ISCRO Committee ensure that stem cell lines created and approved at Johns Hopkins University will be compliant with other international, state and local policies?
Policies vary greatly across jurisdictions, and because they are continually changing, the JHU ISCRO 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.
You may contact Suzanne Damaré (at 410-955-3008 or firstname.lastname@example.org ) if you have other questions about JHU ISCRO.