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Policies and Procedures

Policies and Procedures
Version date: August 1, 2013
 

PART ONE: GENERAL PROVISIONS; STANDARDS AND PROCEDURES FOR REVIEW

I.Institutional Oversight of Human Pluripotent Stem Cell Research at the Johns Hopkins University
II.Purpose of the JHU ISCRO Committee
III.The Authority of the JHU ISCRO Committee
 A.Initial Approval of Human Stem Cell Research
 B.Continuing Oversight
 C.Monitoring of JHU ISCRO Committee Approved Research
 D.Restrictions, Suspension, and Termination of Research
 E.Review of Research within the Jurisdiction of the JHU ISCRO Committee by Other University Committees or Officials
 F.Principal Investigator Responsibilities
 G.Education and Training
IV.Conflicts of Interest
 A.Disclosure
 B.Abstention from Deliberations and Decision Making
 C.Consultants and Conflict of Interest Disclosure
V.Prohibited Research
 A.Introduction of hPSCs into human blastocysts
 B.Introduction of hPSCs into non-human primate blastocysts
 C.In vitro culture of any intact human embryo for longer than 14 days or until formation of the primitive streak begins, whichever occurs first
 D.Breeding of animals that have had hPSCs introduced into the germ line
VI.Standards for JHU ISCRO Committee Review
 A.Procurement of Gametes, Blastocysts, or Somatic Cells for hPSC Generation
 B.Transfer of Human Materials from Outside Entities
 C.Derivation of hESCs
 D.Transfer of hPSCs into Non-human Primates
 E.Trials with Humans
 F.Privacy
 G.Justice
 H.Collaboration with Other Institutions
VII.Procedures for Research Requiring JHU ISCRO Committee Review
 A.Quorum Requirements
 B.JHU ISCRO Committee Review of Research Proposals
VIII.Process for Protocols Following JHU ISCRO Committee Vote
 A.Protocols Granted Full Approval
 B.Protocols Approved Subject to Concurrence with JHU ISCRO Committee-Directed Changes
 C.Protocols Reconsidered or Not Approved
IX.JHU ISCRO Committee Meetings
 

PART TWO: JHU ISCRO COMMITTEE ORGANIZATION, RESPONSIBILITIES AND MANAGEMENT

I.JHU ISCRO Committee Composition
 A.Number
 B.Standing Membership
 C.Alternate Members
 D.Consultants
 E.Confidentiality
IIJHU ISCRO Committee Appointments and Terms
 A.Appointment of Co-Chairs
 B.Term of the Co-Chairs
 C.Appointment of Members
 D.Term of Members
III.Management and Responsibilities of the JHU ISCRO Committee
 A.General Management
 B.Overall Responsibilities
 C.Responsibilities of the Co-Chairs
 D.Responsibilities of the Members
 E.Resignation or Termination of Chairs and Members
IV.Continuing Education
V.Support for the JHU ISCRO Committee
 A.JHU ISCRO Committee Protocol Files and Record Retention
 B.Database of Submitted Research Protocols and Registry of Human Embryonic Stem Cell Lines
 C.Review of Submitted Materials
   
   
PART ONE: GENERAL PROVISIONS; STANDARDS AND PROCEDURES FOR REVIEW
I.Institutional Oversight of Human Pluripotent Stem Cell Research at the Johns Hopkins University
  

It is the policy of the Johns Hopkins University School of Medicine (JHU) that some types of research involving human pluripotent stem cells (hPSCs) being conducted by JHU faculty, staff or students or involving the use of JHU facilities or resources shall be subject to oversight by the JHU Institutional Stem Cell Research Oversight (ISCRO) Committee. Covered research includes:

 A.

All research using human embryonic stem cells (hESCs);

 B.

All research involving somatic cell nuclear transfer (SCNT) involving human cells;

 C.

Other hPSCs (e.g., human induced pluripotent stem cells [iPSCs], human embryonic germ cells [hEGCs]) where the research involves:

  1.

Introduction of the cells into humans;

  2.

Introduction of the cells into the central nervous system of non-human primates;

  3.

Introduction of the cells into non-human animals and there is a reasonable possibility of the cells giving rise to gametes; or,

  4.

Creation of gametes or embryos.

II.Purpose of the JHU ISCRO Committee
  

The primary purpose of the JHU ISCRO Committee is to provide ethical oversight for all research conducted at JHU using hESCs or SCNT involving human cells, as well as for research with other hPSCs under the limited circumstances identified in Section I.C. above. The JHU ISCRO Committee also requires compliance with other applicable governmental regulations and JHU Institutional policies.

The JHU ISCRO Committee serves as an educational resource for researchers engaged in this research. The JHU ISCRO Committee also serves as a consultative body for researchers working with all types of human adult 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.

III.The Authority of the JHU ISCRO Committee
 A.Initial Approval of Human Stem Cell Research
  

The JHU ISCRO Committee shall have the authority to approve, require modifications of, or withhold approval of all research activities that fall under its jurisdiction, (see Part One, Section I) within the JHU. In addition, other Divisions of the University may refer research protocols to the JHU ISCRO Committee for review. Research already in progress and within the purview of the JHU ISCRO Committee under conditions delineated under I.C. above 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.

 B.Continuing Oversight
  1.Approved research shall be reviewed by the JHU ISCRO Committee every year, or more frequently, as determined by the JHU ISCRO Committee on a case-by-case basis. The investigator is responsible for submitting the renewal application in a timely manner as specified by the JHU ISCRO, but no later than 6 weeks prior to the expiration date. All investigators will be notified in advance of specific renewal requirements. Failure to submit the application by the deadline may result in withdrawal of approval.
  2.Progress Reports and Adverse Event Reports pertaining to JHU ISCRO Committee approved research and submitted to a University IRB, IACUC, and/or IBC must also be submitted to the JHU ISCRO Committee.
  3.No modifications to JHU ISCRO Committee approved research shall be implemented prior to JHU ISCRO Committee approval of the modifications, except when a deviation is necessary to prevent imminent harm. Such deviations should be reported to the JHU ISCRO Committee within 3 business days. The JHU ISCRO Committee has the authority to review and approve, require modifications of, or withhold approval of all proposed modifications to JHU ISCRO Committee approved research prior to the implementation of such modifications.
 C.Monitoring of JHU ISCRO Committee Approved Research
  

The JHU ISCRO Committee or its representatives shall have the authority to observe the conduct of any research activity subject to JHU ISCRO Committee oversight. This function includes the authority to review all records associated with the conduct of the research.

 D.Restrictions, Suspension, and Termination of Research
  1.The JHU ISCRO Committee shall have the authority to place restrictions on research activities that fall under its jurisdiction. The JHU ISCRO Committee will notify other relevant committees (e.g., IRB, IACUC, IBC, and Committee on Conflict of Interest [CCOI], Clinical Radiation Research Committee/Radioactive Drug Research Committee [CRRC/RDRC]) of any such restrictions.
  2.The JHU ISCRO Committee shall have the authority to suspend or terminate its approval of research that falls under its jurisdiction and that is not being performed in compliance with JHU ISCRO Committee requirements, applicable governmental regulations, and/or University policies. 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.
  3.If a JHU sponsor or a JHU researcher [1] participates as a co-investigator in research at a site outside the University that would be subject to JHU ISCRO Committee oversight if it were conducted at JHU, the JHU ISCRO Committee shall have the authority to terminate the participation of JHU researchers in the research if that research is not in compliance with JHU ISCRO Committee requirements. In such cases, the JHU ISCRO Committee will inform the responsible Institutional Official(s) at JHU and the relevant official at each institution other than JHU involved in the research of the termination.
 E.Review of Research within the Jurisdiction of the JHU ISCRO Committee by Other University Committees or Officials
  1.Research requiring JHU ISCRO Committee review ordinarily will be submitted for review and approval by the JHU ISCRO Committee concurrently with submission of the research to any other JHU entity (e.g., IRB, IACUC, IBC, CCOI, CRRC/RDRC) that may have responsibility for oversight of other aspects of the research.
  2.Research activities approved by the JHU ISCRO Committee may be subject to further review, modification of, approval and/or disapproval by all relevant bodies, such as the JHU IRBS; the JHU IBC; the JHU IACUC; and the JHU SOM Vice Dean for Clinical Investigation or Vice Dean for Research. 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.
  3.The JHU ISCRO Committee will make annual informational reports (e.g., number of applications reviewed, number approved, number for which approval was withheld, and number involving human subjects) to the JHU IRBs.
 F.

Principal Investigator Responsibilities

  

The JHU ISCRO requires that the principal investigator (PI) of a JHU ISCRO application must be a faculty member at JHU.  Faculty positions that may serve as a PI are Professor, Associate Professor, Assistant Professor, Instructor, Research Associate, Lecturer or Assistant.  A faculty mentor should submit a protocol application as PI for research awarded (such as a Post Doctoral Fellowship award from the Maryland Stem Cell Research Fund) to a post-doctoral fellow.  In this situation, the post-doctoral fellow should be listed as a co-investigator.  The PI must understand the responsibilities associated with conducting human stem cell research.  PIs and co-investigators must comply with federal regulations, state and local laws, Organization policies, and the determinations of the JHU ISCRO.  PIs are responsible for training staff and for conducting the research at the Organization.

 G.Education and Training
  All study team members engaged in research, subject to oversight by the JHU ISCRO Committee shall complete educational activities related to the ethics of such research, as specified by the JHU ISCRO Committee.
IV.Conflicts of Interest - JHU ISCRO Committee Co-Chairs, Members and Consultants
 A.Disclosure
  JHU ISCRO Committee co-chairs and JHU ISCRO Committee members shall be required to disclose conflicts of interest at the beginning of each JHU ISCRO Committee meeting. Conflicts of interest include being a listed investigator, having a financial interest in the sponsor of the research or the technology being evaluated, as defined by the JHU SOM Policy on Conflict of Interest, or having any other conflict that might reasonably be perceived to inhibit a fair and unbiased review of the research.
 B.Abstention from Deliberations and Decision Making
  

JHU ISCRO Committee members who have conflicts of interest with respect to protocols submitted for JHU ISCRO Committee review will abstain from participation in JHU ISCRO Committee deliberations and decisions relative to those protocols. They will not be present in the room during voting on proposals. However, such members may be consulted on the research prior to voting.

 C.Consultants and Conflict of Interest Disclosure
  Consultants shall be asked, at the time they are contacted to review a research study, if they have a conflict of interest with the study on which they are being asked to consult.
V.Prohibited Research
  In accordance with prevailing ethical and policy guidance and applicable law [2], the following categories of research are currently prohibited at JHU:
 A.Research involving the introduction of hPSCs into human blastocysts;
 B.

Research involving the introduction of hPSCs into non-human primate blastocysts;

 C.Research involving in vitro culture of any intact human embryo for longer than 14 days or until formation of the primitive streak begins, whichever occurs first; and
 D.Breeding of animals that have had hPSCs introduced into the germ line.
  This list may be revised to reflect changes in prevailing ethical and policy guidance and applicable law.
VI.Standards for JHU ISCRO Committee Review
 In conducting review of proposed research, the JHU ISCRO Committee will take into account considerations that include the following:
 A.Procurement of Gametes, Blastocysts, or Somatic Cells for hPSC Generation
  For the purposes of JHU ISCRO Committee review, donors of human materials will be considered human research subjects (per 45 CFR 46), regardless of the context in which the materials are procured. The oversight of the procurement process, including provisions for informed consent, is under the purview of a properly constituted IRB. Nevertheless, information about the process will be considered by the JHU ISCRO in its deliberations.
  

The ethical and legal issues related to hPSC research depend in part on the context in which human materials are procured (e.g., infertility treatment, research, clinical care). The context of procurement will involve established standards of care that will be taken into consideration during JHU ISCRO Committee deliberations. Therefore, protocols must describe:

  1.Ethical considerations for procurement of human materials in the context of clinical care:
   a.

Plans to ensure that an individual's decision about donation will not affect the quality of care s/he receives;

   b.Plans to ensure that infertility treatment teams will not generate more oocytes than clinically necessary;
   c.In the case of hPSCs derived from fetal tissue, plans to ensure that an individual's decision about donation is separate from the decision to terminate the pregnancy.
  2.Voluntariness of Consent
   a.Plans to ensure that undue inducements will not be provided for donation (e.g., financial or special considerations for services);
   b.Plans to ensure that decisions to donate are made free from undue influence (e.g., the investigator and the attending physician responsible for the infertility treatment are not the same person).
   The IRBs may be consulted if either of the above (VI, A, 2.a or 2.b) is in question.
  3.Informed Consent:
   In addition to the required elements of informed consent specified in 45 CFR 46. 116, the informed consent process and document must disclose the following, if applicable:
   a.

That procured human materials will be used to derive hPSCs for research that may include research on human transplantation;

   b.That embryos will be destroyed in the process of deriving hPSCs;
   c.That embryos will not be used to produce a pregnancy and will not be allowed to develop in culture for longer than 14 days from fertilization;
   d.That procured human materials might involve:
    i.The introduction of the cells into humans,
    ii.The introduction of the cells into the central nervous system of non-human primates,
    iii.The introduction of the cells into non-human animals and there is a significant possibility of the cells giving rise to gametes, or
    iv.The creation of gametes or embryos;
   e.That resulting cell lines will be genetically similar or identical to the donor;
   f.That the hPSCs and/or cell lines might be used in research involving genetic manipulation of the cells or the mixing of human and non-human cells in animal models;
   g.That derived hPSCs and/or cell lines might be kept for many years;
   h.Whether the donated material will be coded or deidentified prior to research use
   i.If donors' identities are retained (even if coded), whether donors can elect to be contacted to receive information obtained through studies of the cell lines;
   j.That restricted and/or directed donation (e.g., to individuals or groups) are/is not permitted;
   k.That the results of study of the hPSCs may have commercial potential and that the investigator and institution may benefit; however, the donor will not receive financial or any other benefits from any commercial development;
   l.That the research is not intended to provide direct medical benefit to the donor(s);
   m.That neither consenting nor refusing to donate embryos for research will affect the quality of any care provided to potential donors;
   n.Risks to donors.
 B.Transfer of Human Materials from Outside Entities
  

To determine the scientific and ethical integrity of hPSC research under its purview, the JHU ISCRO Committee must examine the circumstances under which human materials were (or will be) procured for use in such research and the details of the derivation of cell lines. The applications must include documentation of the provenance of all hPSC lines, whether the cell lines were imported into the Institution or derived locally. Such documentation must include evidence of IRB-approval of the procurement process, evidence of and adherence to basic ethical and legal principles of procurement, and compliance with applicable laws.

 C.Derivation of hESCs
  

Protocols must describe:

  1.Appropriate expertise of the research team in the derivation or culture of either human or non-human ESCs;
  2.The scientific rationale for the need to generate new hESCs, as well as the basis for the number of blastocysts used in the derivation process;
  3.Any plans for compliance with an established set of good manufacturing practices (GMPs), and if so, with which GMPs;
  4.How any new hESC lines will be characterized, validated, stored, and distributed.
 D.Transfer of hPSCs into Non-human Primates
  Protocols must describe:
  1.Why hPSCs are required in lieu of stem cells from non-human primates or other animals;
  2.Relevant animal work that precedes the proposed work;
  3.Quality control of the cell lines and their derivatives, (such as genetic stability, freedom from contamination);
  4.

The developmental stage of the non-human animal to which the cells will be transferred;

  5.The procedures that will be used to assess whether the animal may acquire cognitive characteristics that are thought of as distinctly human, as well as how non-human primates will be evaluated (pre- and post-transplant).
 E.Trials with Humans
  Protocols must describe:
  1.Pre-clinical testing with animal models;
  2.Quality control of hPSC lines and their derivatives;
  3.Selection of subjects (e.g., the appropriateness of using healthy volunteers in early human trials);
  4.Risk of infectious disease (e.g., from cells cultured in mouse feeder layers);
  5.Risk of transfer of genetic disorders;
  6.Risks of misdifferentiation, mistargeting, tumor formation, and immune rejection;
  7.Risk of uncontrolled cell growth.
 F.Privacy
  Although IRBs and other bodies have jurisdiction over the confidentiality of the identifying information of human research subjects, there may be cases in which identifying information is transmitted with hPSC lines for research that does not fall under the jurisdiction of any of these groups. Therefore, whenever hPSC research under JHU ISCRO jurisdiction involves the transmission of identifying information on donors of gametes, blastocysts, hPSC lines or somatic cells, protocols must describe the information to be obtained and the steps taken to ensure that the privacy of donors is protected, (e.g., how the requirements of HIPAA will be met).
 G.

Justice

  

Protocols must describe mechanisms established for subject selection. The process for selection among groups and individuals to participate must be equitable.

 H.Collaboration with Other Institutions
  

Where JHU faculty, staff or students acting in their capacity as JHU faculty, staff or students respectively, collaborate with a researcher at another institution, protocols must describe the oversight and review mechanisms at the other institution.

VII.Procedures for Research Requiring JHU ISCRO Committee Review
 

The review process and the records of the JHU ISCRO Committee will be maintained as confidential to the extent permitted by law.

 A.Quorum Requirements
  

The JHU ISCRO Committee shall officially conduct its review of proposed research at convened meetings at which at least fifty percent (50%) of the voting members (i.e., a quorum) of the JHU ISCRO Committee are present, in person or by electronic conferencing. Quorum requirements also include that there be representation of at least two scientific members and one member whose expertise is in ethical issues. The Co-chairs may appoint a designee to act as Chair, in the event neither is available for a convened meeting.

 B.JHU ISCRO Committee Review of Research Proposals
  1.Each research study requiring review and approval by the convened JHU ISCRO Committee shall be addressed separately at JHU ISCRO Committee meetings.
  2.

Submitted protocols will be made available to JHU ISCRO Committee members in advance of JHU ISCRO Committee meetings to allow sufficient time for review.

  3.

The primary reviewers for each protocol shall summarize the proposed research followed by an open discussion of the research by the JHU ISCRO Committee members.

  4.The reviewers may contact the principal investigator with questions about the submitted protocol. In such cases, the principal investigator will have an opportunity to submit revisions before full JHU ISCRO Committee review.
  5.

Reviewers who are absent from a full JHU ISCRO Committee meeting may provide written comments regarding the proposed research, but absent members shall not be counted in the JHU ISCRO Committee vote.

  6.Following open discussion, the JHU ISCRO Committee co-chair or a designee shall call for a vote of the JHU ISCRO Committee to grant:
   a.Full Approval: No changes are required to the proposed research;
   b.Approval Pending Concurrence with JHU ISCRO Committee-directed Changes: The proposed research may be granted full approval by the JHU ISCRO Committee co-chairs pending principal investigator concurrence with specific revisions stipulated by the JHU ISCRO Committee. The research may not receive full approval until such time that the research procedures have been modified to comply with the specific revisions stipulated by the JHU ISCRO Committee and such revisions have been reviewed and approved by the JHU ISCRO Committee co-chair or a designee;
   c.Reconsideration: Approval of the proposed research requires substantive clarifications or modifications of the research design or procedures. The principal investigator must respond to the identified clarifications, modifications, or revisions and resubmit the revised research protocol for re-review by the JHU ISCRO committee; or
   d.Approval withheld: The proposed research has fundamental design problems and/or presents significant ethical, legal or regulatory compliance concerns. The principal investigator must undertake a major revision of the proposed research before it can be resubmitted for re-review by the JHU ISCRO Committee.
  7.The vote of the majority of the JHU ISCRO Committee members present at the meeting shall determine the final determination status (i.e., full approval, approval pending concurrence with JHU ISCRO Committee-directed changes, reconsideration, or approval withheld) of the proposed research. The JHU SOM Vice Dean for Research may impose additional restrictions on approved research, but may not approve research for which approval was withheld by the JHU ISCRO Committee .
  8.Following a JHU ISCRO Committee vote for full approval or approval pending concurrence with JHU ISCRO Committee-directed changes, members voting to reconsider or withhold approval of the research in the face of a majority vote for full approval or approval pending concurrence with JHU ISCRO Committee-directed changes will be asked to summarize the reasons for their contravention.
  9.The JHU ISCRO Committee shall notify the investigators in writing of the Committee's decision to approve, reconsider, or withhold approval of the research, or of the Committee-directed changes required to secure JHU ISCRO Committee approval of the research.
VIII.Process for Protocols Following JHU ISCRO Committee Vote
 A.Protocols Granted Full Approval
  

For research granted full approval by the JHU ISCRO Committee, the principal investigator will be notified. The principal investigator shall be responsible for ensuring that all other applicable institutional requirements are met (e.g., IRB, IACUC, IBC, CCOI, or CRRC/RDRC approval).

  

The principal investigator must notify the JHU ISCRO Committee upon his/her termination of the JHU ISCRO Committee approved research.

 B.

Protocols Approved Subject to Concurrence with JHU ISCRO Committee-Directed Changes

  

If the convened JHU ISCRO Committee decides to approve the proposed research pending concurrence with JHU ISCRO Committee-directed changes, the principal investigator will be provided:

  1.Notification addressing the specific revisions stipulated by the JHU ISCRO Committee in order to obtain full approval of the research;
  2.Notification instructing the investigator to revise the research to concur with the specific revisions stipulated by the JHU ISCRO Committee and to resubmit for full approval; and
  3.Notification specifying that the principal investigator must respond to the JHU ISCRO Committee's request for revisions within six (6) weeks of the date of the notification, and that failure to respond within this six (6) week period may result in termination of the respective research submission.
  For research approved by the JHU ISCRO Committee pending concurrence with JHU ISCRO Committee-directed changes, the revised research submitted in response to the specific revisions stipulated by the JHU ISCRO Committee shall be reviewed by a JHU ISCRO Committee co-chair or his/her designee and, based on an appropriate response, granted full approval. Any problems or concerns related to the principal investigator's response shall be communicated, in writing or by e-mail, to the principal investigator. In the event that the principal investigator does not agree with certain specific revisions stipulated by the JHU ISCRO Committee, the research proposal (to include any JHU ISCRO Committee-directed changes agreed on by the principal investigator) and the investigators justification for not complying with certain of the JHU ISCRO Committee-directed change(s) shall be referred to convened meeting review. The investigator shall be notified that s/he will be afforded an opportunity to appear in person at the JHU ISCRO Committee meeting during which the research will be reconsidered.
 C.Protocols Reconsidered or Not Approved
  

If the JHU ISCRO Committee decides to reconsider or disapprove the proposed research, the principal investigator will be provided:

  1.The primary reason(s) for the JHU ISCRO Committee's decision to reconsider or withhold approval of the research;
  2.A listing of additional problems or deficiencies identified by the JHU ISCRO Committee;
  3.Instructions regarding resubmission of the research for review by the JHU ISCRO Committee including a requirement to address the statements and concerns emanating from the first JHU ISCRO review;
  4.Notification that s/he may appear in person at the meeting of the JHU ISCRO Committee wherein the research will be reconsidered, to address any additional questions or concerns of the JHU ISCRO committee; and
  5.Notification that s/he must respond to the JHU ISCRO Committee's request for revisions within six (6) weeks of the date of the notification, and that failure to respond within this six (6) week period may result in termination of the respective research submission.
IX.JHU ISCRO Committee Meetings
  

The minutes of the JHU ISCRO Committee meetings shall include but not be limited to the following items: record of attendance, declared conflicts of interest, protocols reviewed (including controverted issues), documentation of approval intervals (if applicable), and JHU ISCRO Committee votes.

  Documentation shall include enumeration of the number of JHU ISCRO Committee members voting for and against the action taken by the JHU ISCRO Committee and the number of members abstaining from the vote (e.g., 7-for, 1-against, 1-abstain), including the name(s) of any voting member(s) who abstained from the vote due to conflict-of-interest or other considerations.
  

The minutes shall be reviewed and accepted by the JHU ISCRO Committee co-chairs prior to generating investigator correspondence.

  

The minutes shall be distributed to JHU ISCRO Committee members. At each meeting, a vote of JHU ISCRO Committee members shall be taken to approve the minutes of the previous meeting. The minutes may be modified as necessary to obtain approval of the JHU ISCRO Committee.

   

PART TWO: JHU ISCRO COMMITTEE ORGANIZATION, RESPONSIBILITIES AND MANAGEMENT

   
I.JHU ISCRO Committee Composition
 A.Number
  

The JHU ISCRO Committee shall comprise at least nine (9) voting members, who shall collectively have adequate training and experience to promote the appropriate review of research activities pertaining to hPSCs and SCNT conducted at JHU and/or by JHU faculty, staff or students acting in their capacity as JHU faculty, staff or students respectively.

 B.Standing Membership
  The JHU ISCRO Committee shall include both men and women, with representation of more than one profession. The JHU ISCRO Committee shall include the following voting members:
  1.Scientists (3);
  2.Ethicists/legal scholars (2);
  3.

An individual with expertise in clinical transplantation (1);

  4.Co-chairs (2), one with expertise in science and one with expertise in ethics;
  5.

A non-institutional member (i.e., an individual who has, or whose immediate family members have no direct occupational affiliation with the University);

  6.Representative of the University's Office of General Counsel, ex-officio; and
  7.Representative of the JHU SOM Office of Research Administration (ORA), ex-officio.
 C.Alternate Members
  

The JHU ISCRO Committee may include standing alternate voting members to serve in the absence of regular voting members. Each alternate voting member shall have expertise similar to that of the regular voting member for whom s/he is serving as a replacement. The alternate voting member shall assume all of the responsibilities of the voting member for whom s/he is serving as a replacement. Alternate voting members may attend JHU ISCRO Committee meetings without serving as replacements for a regular voting member; however, in this capacity, alternate members may not vote. The Co-chairs may appoint a designee to act as Chair, in the event neither is available for a convened meeting.

 D.Consultants
  The JHU ISCRO Committee may consult individuals with special expertise in human stem cell research or with a specific community perspective.
 E.Confidentiality
  

All Standing Members, Alternate Members, Consultants, Guests and Staff shall execute a Confidentiality Agreement prior to participating in any JHU ISCRO meeetings or review of research documents.

II.

JHU ISCRO Committee Appointments and Terms

 A.Appointment of Co-Chairs
  The co-chairs of the JHU ISCRO Committee shall be appointed by and report to the Vice Dean for Research.
 B.Term of the Co-Chairs
  The term of the JHU ISCRO Committee co-chair shall be two years with the option of appointment renewal for additional two year terms.
 C.Appointment of Members
  

The JHU ISCRO Committee co-chairs shall recommend potential members of the JHU ISCRO Committee to the Vice Dean for Research.

  

The members of the JHU ISCRO Committee shall be appointed by the Vice Dean for Research in consultation with the Vice Provost for Research.

 D.Term of Members
  

Members will be appointed to a two-year term on the JHU ISCRO Committee, with approximately one-half of the member terms expiring each year. Initial appointments may be made for one or two years. Voting members may be reappointed to subsequent two-year terms, depending on the member's interest and the needs of the JHU ISCRO Committee. The term of a member appointed to fill a vacancy created by a resignation will end at the time that the former member's term would have ended.

III.Management and Responsibilities of the JHU ISCRO Committee
 A.General Management
  

The JHU ISCRO Committee shall be managed as determined by the JHU SOM Vice Dean for Research and the Vice Dean for Clinical Investigation. The Vice Deans shall ensure that adequate facilities, equipment, and resources are available to support the JHU ISCRO Committee. The Vice Deans shall be responsible for providing an appropriate level of administrative support to the co-chairs of the JHU ISCRO Committee and the JHU ISCRO Committee members. Management on a day-to-day basis shall be carried out under the direction of the JHU ISCRO Committee co-chairs and administrative / management staff.

 B.Overall Responsibilities
  The JHU ISCRO Committee shall be responsible for:
  1.Providing oversight of JHU faculty, students or staff or involving JHU facilities, regardless of the source of funding, who conduct research involving the derivation and/or research use of hPSC lines and/or SCNT as described in Part One Section I;
  2.Providing consultation to researchers working with all types of human stem cells;
  3.Maintaining a database of research protocols reviewed;
  4.Maintaining a registry of all hESC lines that are imported into or maintained at, the JHU SOM;
  5.Auditing JHU ISCRO approved research, and suspending or terminating JHU ISCRO Committee approval of research determined not to be conducted in compliance with applicable federal and state regulations and/or University policies;
  6.Reviewing, on a routine basis, current JHU ISCRO Committee policies, and assuring appropriate revisions to these policies as new, applicable federal and/or state regulations are implemented; and
  7.Developing and disseminating pertinent education and training programs for JHU SOM researchers involved in the conduct of research that falls under the JHU ISCRO Committee's jurisdiction.
 C.Responsibilities of the Co-Chairs
  The JHU ISCRO Committee co-chairs shall lead JHU ISCRO Committee review of research. In addition, the JHU ISCRO Committee co-chairs shall:
  

1.

Oversee recruitment, training, continuing education and retention of JHU ISCRO Committee members;
  2.Recommend appointment and dismissal of Committee members to the Vice Dean for Research;
  3.Oversee the JHU ISCRO Committee's development and implementation of appropriate policies, procedures and guidelines for the conduct of research pertaining to hPSC and/or SCNT;
  4.Preside over JHU ISCRO Committee meetings and communicate JHU ISCRO Committee decisions and directives to researchers working in area(s) that fall under the JHU ISCRO Committee's jurisdiction;
  5.Have authority to request audits of research projects that fall under the JHU ISCRO Committee's jurisdiction and will notify Institutional Official(s) in the event of suspension;
  6.

Represent the University at national and local meetings related to JHU ISCRO Committee activities and the ethical conduct of hPSC research.

 D.Responsibilities of the Members
   JHU ISCRO Committee members shall:
  1.Review and evaluate proposed research in a manner that is consistent with the Policies and Procedures of the JHU ISCRO Committee; and
  2.Attend convened meetings, participate in deliberations, and vote. Members are expected to attend all meetings and membership may be revoked if a member is unable to attend a sufficient number of meetings.
 E. Resignation or Termination of Chairs and Members
  1.Co-Chairs
   

The Vice Dean for Research shall have the authority to terminate the appointment of the JHU ISCRO Committee co-chairs.

  2.

Members

   

JHU ISCRO Committee members may be dismissed by the Vice Dean for Research due to a failure of the JHU ISCRO Committee member to attend a sufficient number of meetings and/or otherwise actively participate in JHU ISCRO Committee functions.

   

Resignation of JHU ISCRO Committee membership shall be submitted, in writing, to the Vice Dean for Research and the co-chairs.

IV.Continuing Education
 A.

The JHU ISCRO Committee shall maintain a Web site that includes JHU ISCRO Committee Policies and Procedures, JHU ISCRO approved hESC lines, JHU ISCRO application forms, and a training module for researchers.

 B.JHU ISCRO Committee members shall be provided education related to the ethical, legal, scientific, and policy issues associated with human stem cell research.
V.Support for the JHU ISCRO Committee
 A.JHU ISCRO Committee Protocol Files and Record Retention
  

All research submitted for JHU ISCRO Committee review shall indicate the date of receipt, and be assigned a unique JHU ISCRO Committee number.

  

JHU ISCRO Committee staff shall maintain records of research submitted for JHU ISCRO Committee review. The files shall be maintained for at least seven years following the termination of JHU ISCRO Committee approved research.

  JHU ISCRO Committee staff shall also maintain JHU ISCRO Committee meeting minutes, a roster of all current JHU ISCRO Committee members, biographical sketches of current JHU ISCRO Committee members, and a record of inquiries submitted to the JHU ISCRO Committee.
 B.Database of Submitted Research Protocols and Registry of Human Embryonic Stem Cell Lines
  

JHU ISCRO Committee staff shall maintain a secure computer database of research submissions.

  

JHU ISCRO Committee staff shall maintain a registry of all hESC lines maintained at or imported into the University.

 C.Review of Submitted Materials
  Applications submitted for JHU ISCRO Committee review shall be screened by JHU ISCRO Committee staff to verify that the submission is complete, and complete applications shall be assigned to a meeting of the JHU ISCRO Committee in as timely a manner as practicable.
   
Portions of this document were derived from the University of Pittsburgh Policies and Procedures of the Human Stem Cell Research Oversight (hSCRO) Committee (http://www.rcco.pitt.edu/hscro/hSCROPolicy.pdf) and from the National Academy of Sciences Guidelines for Human Embryonic Stem Cell Research (http://books.nap.edu/openbook.php?isbn=0309096537).

 


[1] JHU researchers are JHU faculty, staff or students acting in their capacity as JHU faculty, staff, or students.

[2] Pursuant to Maryland State law, a person may not conduct or attempt to conduct human cloning.

 

 

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