Stem Cell Research Oversight (SCRO) Protocol Management

Layout for printing
Policy Number:
UW-4026
Responsible Office:
Office of Research Compliance

University Policy

Rationale/​Purpose:

This policy outlines protocol management for the Stem Cell Research Oversight (SCRO) Committee. This includes principal investigator (PI) status, types of SCRO applications, and SCRO review.

Note: UW-4026 was previously "PI status Policy Principal Investigator Status for UW–Madison Stem Cell Research Oversight Protocols." The following prior published policies have all been retired and consolidated into this updated version (as of August 2024):

  • UW-4026 PI status Policy Principal Investigator Status for UW–Madison Stem Cell Research Oversight Protocols
  • UW-4027 UW–Madison Stem Cell Research Oversight Initial Review, Continuing Review, and Changes of Protocol
  • UW-4028 Stem Cell Research Oversight Full and Expedited Review
  • UW-4029 UW–Madison Stem Cell Research Oversight Multisite Research
Definitions:
Expedited Panel Review
The review is carried out by the Stem Cell Research Oversight Committee chair or by one or more committee members designated by the chair. In reviewing the research, the expedited reviewer(s) may exercise all of the authorities of the committee except that the reviewer(s) may not disapprove the research. The expedited reviewer(s) may also bring the application to the full committee for review when they determine that full committee review is appropriate.
Full Stem Cell Research Oversight Committee Review
The application is reviewed at a Stem Cell Research Oversight Committee meeting with a quorum, defined as half the committee plus one member present, and any action taken on the application is done via a majority vote of members present.
Human Embryonic Stem Cells (hESCs)
Cells derived from very early in development, usually the inner cell mass of a developing blastocyst. These cells are self-renewing (can replace themselves) and pluripotent (can form all cell types found in the body.)
Human Pluripotent Stem Cells (hPSCs)
Stem cells that can become all of the cell types that are found in implanted embryo, fetus, or developed organisms. Embryonic stem cells are pluripotent stem cells.
Repository
A facility designed to collect, store, and broadly distribute cells, and data or information about those cells, on an ongoing basis. It might also store and distribute DNA or other biomaterials.
Policy:
  1. Principal Investigator (PI) Status
    1. To qualify as PI on a human embryonic stem cell (hESC) research protocol reviewed by the UW-Madison Stem Cell Research Oversight (SCRO) committee, individuals must:
      1. Have a UW-Madison appointment and will be working within the scope of that appointment in performing the research, and at least one of the following:
        1. Hold a UW-Madison tenure-track faculty appointment (generally, a 50% or more appointment). This includes faculty with a full-time UW-Madison position but who hold a $0 UW-Madison appointment only because their position is funded by the federal government.
        2. Hold a UW-Madison Clinical/Health Sciences (CHS) appointment.
        3. Hold a UW-Madison Research Professor track appointment.
        4. UW-Madison unclassified staff (academic staff and limited appointees) who have obtained approval of their Chair/Director using the form “Request for Principal Investigator Status Form” (This includes Emeritus professors).
        5. Individuals with Permanent PI Status for Academic Staff through the Vice Chancellor for Research.
      2. Or, meet one of the following exceptions to the requirement of a UW-Madison appointment (subject to SCRO committee approval):
        1. UW Hospital and Clinics’ (UWHC) employees with the approval of their supervising UWHC Vice President.
        2. Employees of the Morgridge Institute for Research with approval of the Executive Director or their designee.
        3. Employees of WiCell with approval of the Executive Director or their designee.
    2. Individuals who do not meet the above requirements may qualify as coinvestigators or key personnel if an individual as described above is listed as PI on the protocol.
    3. Exception: When approved by the UW-Madison SCRO committee, a UW-Madison faculty member who leaves the university but maintains a 0% or other small percentage appointment with UW-Madison may remain as PI on a hESC protocol for one year to complete the research or transition the research to a new PI.
    4. The SCRO committee has authority to determine that an individual cannot serve as PI on a hESC protocol, even though the individual meets the criteria in this policy, if the committee determines that the individual does not possess the appropriate expertise to execute the research as described in the protocol or the individual has failed to abide by applicable laws, regulations, UW-Madison policy or SCRO committee decisions.
  2. Conflicts of Interest
    1. The SCRO Committee follows UW-1075 Conflict of Commitment, UW-4001 Conflicts of Interest, and UW-4002 Institutional Conflicts of Interest adhering to the definitions associated with these policies, including financial thresholds.
    2. An SCRO member has a conflict of interest with respect to a protocol when the SCRO member, or an immediate family member of the SCRO member, is serving as a principal investigator or co-investigator in the protocol.
    3. An SCRO member has a potential conflict of interest with respect to a protocol when:
      1. An SCRO member, or an immediate family member of an SCRO member, has a personal relationship that may cause bias or creates the appearance of bias by the member in the review of the protocol.
      2. An SCRO member, or an immediate family member of an SCRO member, has a financial interest or leadership position in a business entity that:
        1. Sponsors the study; or
        2. Owns or licenses a technology tested in the study
    4. An SCRO member may not participate in the review of any research protocol in which the member has a conflict of interest, except to provide information at the SCRO’s request.
    5. Any SCRO member with a conflict of interest or potential conflict of interest in a research protocol under review by the SCRO, or in any SCRO business, must:
      1. Disclose the conflict of interest or potential conflict of interest to the SCRO Chair upon receipt and review of meeting materials and in advance of the next scheduled meeting
      2. Leave the room during the discussion of the protocol and the related vote, except:
        1. If the member is providing information at the SCRO’s request
        2. If the SCRO by majority vote determines that the individual does not have a conflict
    6. When a disclosure of a conflict of interest or potential conflict of interest occurs, the minutes of the SCRO meeting will reflect:
      1. The disclosure which was made
      2. The nature of the conflict of interest
      3. Any action taken to determine whether a conflict of interest was present
      4. The committee’s decision as to the disposition of the matter
      5. The names of the members present for the discussion and vote
      6. The final determination of the matter
  3. Multisite Research

    If a non-UW–Madison site has its own Stem Cell Research Oversight Committee, then both UW–Madison’s committee and the other site’s committee must review and approve the research.

  4. Types of SCRO Applications
    1. SCRO Applications are hosted in AAROW (Application Review for Research Oversight at Wisconsin)
    2. Transplantation of human pluripotent stem cells (hPSCs) into Non-Human Animals
      1. The full committee will review transplantation research that involves the integration of human pluripotent stem cells or their derivatives into non-human animals at any embryonic, fetal, or postnatal stage into the central nervous system, testes, or ovaries of the animal.
      2. New protocols that involve transplantation will be initially reviewed by the Stem Cell Research Oversight Committee chair or by one or more committee members designated by the chair. In reviewing the research, these reviewer(s) may deem that the research does not meet the criteria for full review and review may be expedited.
      3. Teratoma experiments to test pluripotency of human pluripotent stem cells may qualify for expedited review.
    3. Expedited Review
      1. Initial and continuing review applications that qualify for expedited review include:
        1. In vitro studies using National Institutes of Health (NIH) approved cell line(s)
        2. In vitro studies using a cell line(s) previously approved by the Stem Cell Research Oversight Committee and listed on UW–Madison's hESC Registry.
        3. Teratoma assay transplantation research. Teratoma experiments to test pluripotency of human pluripotent stem cells may qualify for expedited review.
      2. Changes of protocol that qualify for expedited review include:
        1. Changes in personnel
        2. Changes in funding source
        3. Other changes that do not affect the research type, research design, or research question
    4. Initial Review
      1. In accordance with UW-4025 Human Embryo and Human Pluripotent Stem Cell Research, all research on campus involving campus faculty or staff that involves areas of SCRO oversight must be submitted to the Stem Cell Research Oversight Committee for review and approval.
      2. Investigators must submit an Application for Initial Review of Research Projects Involving Human Embryo and or Human Pluripotent Stem Cells.
      3. Stem Cell Research Oversight Records on Initial Review
        1. 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.
        2. 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.
        3. 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.
    5. Continuing Review
      1. UW–Madison's SCRO Expedited Review Committee 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.
      2. Continuing review of human pluripotent stem cell research is conducted by the full committee, except protocols that qualify for expedited initial review may undergo expedited continuing review.
      3. Protocols that initially qualified for full committee review may qualify for expedited continuing review when there have been no changes and no problems reported.
    6. Changes of Protocol

      A change of protocol application must be submitted before a change is made for the following actions:

      1. 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.
      2. A change in the principal investigator.
      3. A change in funding source.
      4. 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.
  5. SCRO Committee Review
    1. All applications submitted to the Stem Cell Research Oversight Committee for initial or continuing review of research involving human embryo and or human pluripotent stem cells will be reviewed by the full committee, except for those applications that qualify for expedited review as outlined in this policy.
    2. Applications for changes of protocol will be reviewed by the full committee, except for those applications that qualify for expedited review as outlined in this policy.
Related UW-Madison Policies:
Related UW–Madison Documents, Web Pages, or Other Resources:

AAROW (Application Review for Research Oversight at Wisconsin)

Request for Principal Investigator Status Form

UW–Madison hESC Registry

External References:

National Institutes of Health (NIH) Embryonic Stem Cell Registry

Policy Administration

Approval Authority:
Vice Chancellor for Research
Policy Manager:
Office of Research Compliance
Contact:
Office of Research Compliance -- Heather Mc Fadden, HEATHER.MCFADDEN@WISC.EDU, (608) 890-2468
Effective Date:
06-21-2024
Date Issued:
06-21-2024
Revised Dates:

05-21-2024

Retrieved:
10-05-2024 15:13:44