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 storage and distribution of human embryonic stem cells through a repository.
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.
All new protocols that are not determined to be eligible for expedited review are reviewed by the full Stem Cell Research Oversight Committee. See Full and Expedited Review policy.
To apply for a review of a new protocol, the investigator must submit an Application for Initial Review of Research Projects Involving Human Embryo and or Human Pluripotent Stem Cells.
The Stem Cell Research Oversight Committee staff conduct a preliminary review of each protocol to determine whether the materials provided by the investigator are complete and contact the investigator to obtain missing documents. Incomplete submissions may be returned to the investigator.
Once all requested information is received, the staff determine whether the protocol will be reviewed by the full committee or is eligible for expedited review. If the protocol is eligible for expedited review, the Stem Cell Research Oversight Committee staff will follow UW–Madison's expedited review procedures. See Full and Expedited Review policy.
On initial review of a protocol, the Stem Cell Research Oversight Committee or expedited reviewer may:
To approve a protocol pending resolution of requested modifications:
If a protocol is approved pending resolution of requested modifications, the Stem Cell Research Oversight Committee staff will notify the investigator of those modifications and instruct the investigator that they must respond to these requests as directed.
Upon receipt of the investigator's response to requested modifications, the staff will forward the response to the Stem Cell Research Oversight Committee chair (if the full committee approved the protocol pending requested modifications) or the expedited reviewer. When appropriate, the investigator's response may also be forwarded to the full committee. Upon review, the chair, expedited reviewer, or committee will determine that:
The protocol may be approved; or
The investigator's response is not consistent with the requested modifications. In this case, the investigator may be asked for further modifications.
At intervals of three months, two months, one month, two weeks, and one week from the date the modification request was first sent to the investigator, the electronic protocol management system automatically sends a reminder to the investigator of the need to respond to modification requests and obtain stem cell research oversight approval of the research before research can begin. If a response is not received from the investigator within six months of the first request for modifications, the electronic protocol management system automatically sends a notice to the investigator that the protocol has been closed and will need to be re-submitted for reconsideration before the research may proceed.
To defer a protocol until additional information is obtained:
The Stem Cell Research Oversight Committee or expedited reviewer must defer approval of a protocol if, to approve the protocol, the committee or expedited reviewer requires substantive clarifications or modifications.
The Stem Cell Research Oversight Committee staff will notify the investigator of the substantive clarifications or modifications needed to allow approval of the research.
The investigator may supply the substantive clarifications or modifications or provide a rationale for not doing so. The protocol will then be re-reviewed by the full committee or expedited reviewer.
At intervals of two months, one month, two weeks, and one week from the date of the notice requesting additional information was first sent to the investigator, the electronic protocol management system automatically sends a reminder to the investigator of the need to respond to information requests and obtain stem cell research oversight approval of the research before research can begin. If a response is not received from the investigator within 180 days of the first request for additional information, the electronic protocol management system automatically sends a notice to the investigator that the protocol has been closed and that a new application will need to be submitted and approved before the research may proceed.
The full Stem Cell Research Oversight Committee's discussion, action, and vote on each application for initial review are documented in the minutes for each meeting.
Votes for and against approval of each application for initial review and the name of any committee member abstaining from the vote on each protocol or leaving the room before the vote due to a conflict of interest are recorded in the meeting minutes.
Expedited review is documented by using the Stem Cell Research Oversight (SCRO) Expedited Review Form. This form is filled out by the staff reviewer and forwarded to the expedited reviewer to complete. The completed form is maintained in the paper file.
UW–Madison's SCRO Expedited Review Form conducts continuing review of human pluripotent stem cell research protocols once every year. Depending upon the nature of the proposed research, the committee may determine that the protocol requires more frequent continuing review.
Continuing review of human pluripotent stem cell research is conducted by the full committee, except that those protocols that qualify for expedited initial review may undergo expedited continuing review. Additionally, protocols that initially qualified for full committee review may qualify for expedited continuing review when there have been no changes and no problems reported. See Full and Expedited Review policy.
At 90 days, 60 days, and 30 days before the expiration date of a protocol approval period, the electronic protocol management system automatically sends an email to the principal investigator, co-investigator(s), and point of contact noting that, if the research is continuing, an application for continuing review of research must be submitted and approved by the SCRO Expedited Review Form before the existing approval period expires.
"Expiration date" refers to the last date that the protocol is approved and the last date on which research can be conducted.
The "expiration date" is calculated in the following manner:
For protocols reviewed by the full Stem Cell Research Oversight Committee, the expiration date is one year minus one day from the committee meeting date at which the protocol was approved or approved pending modifications unless the committee has required a shorter approval period.
For protocols reviewed under the expedited procedure, the expiration date is one year minus one day from the date the approval was granted by the expedited reviewer.
To apply for continuing review of a protocol, the investigator must submit an online Application for Continuing Review form. If the investigator is also making changes to the protocol at the time of the continuing review, the investigator must indicate on the continuing review form that a change is being proposed.
On application for continuing review, the Stem Cell Research Oversight Committee or expedited reviewer may:
Approve the application;
Require modifications in the application for continuing review;
Defer the application until additional information is obtained; or
Reject the application. Note however that only the full committee may reject a continuing review application.
In each case, the Stem Cell Research Oversight Office notifies the investigator of the action taken and, except in the case of an approval, the reasons for that action.
If an application for continuing review is not reapproved by the expiration date, the protocol will be closed and no further research activities may be conducted.
Most changes in an approved human pluripotent stem cell research protocol may be submitted at the time of continuing review. However, a change of protocol application must be submitted before a change is made for the following actions:
Addition of a new cell line not listed on the National Institutes of Health (NIH) Embryonic Stem Cell Registry or on the UW–Madison hESC Registry.
A change in the principal investigator.
A change in funding source.
A significant change in research type, study design, or research question. An investigator may modify their list of personnel or add NIH-approved human embryonic stem cell lines through a change of protocol or at the time of continuing review.
Applications for change of protocol are reviewed by the full Stem Cell Research Oversight Committee, except for those changes that qualify for expedited review. See Full and Expedited Review policy.
To apply for a review of a change in a protocol, the investigator must submit an online Application for Change of Protocol. Once submitted, the Stem Cell Research Oversight Committee staff will determine whether the application will be reviewed by the full committee, or whether it is eligible for expedited review.
On application for change of protocol, the committee or expedited reviewer may:
Approve the application;
Require modifications in the application;
Defer the application until additional information is obtained; or
Reject the application. Note however that only the full committee may reject an application for a change of protocol.
In each case, Stem Cell Research Oversight Committee staff must notify the investigator of the action taken and, except in the case of an approval, the reasons for that action.
05-10-2017, 10-06-2021
