Policies and Procedures
Version date: April 17, 2009
| PART ONE: GENERAL PROVISIONS; STANDARDS AND PROCEDURES FOR REVIEW | ||||
| I. | Institutional Oversight of Human Embryonic Stem Cell and Related Research at the Johns Hopkins University School of Medicine | |||
It is the policy of the Johns Hopkins University (JHU) School of Medicine (SOM) that all research using human embryonic stem cells (hESCs) or somatic cell nuclear transfer (SCNT) involving human cells being conducted by JHU SOM faculty, staff or students or involving the use of JHU SOM facilities or resources shall be subject to oversight by the JHU SOM Embryonic Stem Cell Research Oversight (ESCRO) committee. All such research must be approved in advance by the JHU SOM ESCRO committee. | ||||
| II. | Purpose of the JHU SOM ESCRO Committee | |||
The primary purpose of the JHU SOM ESCRO committee is to provide ethical oversight for all research conducted at the JHU SOM using hESCs or SCNT involving human cells. The JHU SOM ESCRO committee reviews protocols [1] to determine if they are ethically and scientifically sound. The JHU SOM ESCRO committee also considers compliance with applicable governmental regulations and institutional policies related to stem cells and research. The JHU SOM ESCRO committee serves as an educational resource for researchers engaged in this research. The JHU SOM ESCRO 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 JHU SOM ESCRO committee review. | ||||
| III. | The Authority of the JHU SOM ESCRO Committee | |||
| A. | Initial Approval of Human Stem Cell Research | |||
The JHU SOM ESCRO committee shall have the authority to approve, require modifications of, or withhold approval of all research activities that fall under its jurisdiction within the JHU SOM, (see Part One, Section I). In addition, other Divisions of the University may refer research protocols to the JHU SOM ESCRO committee for review. 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 within one year of the launch of the JHU SOM ESCRO committee. | ||||
| B. | Continuing Oversight | |||
| 1. | Approved research shall be reviewed by the JHU SOM ESCRO committee every three years, or more frequently, as determined by the JHU SOM ESCRO committee on a case-by-case basis. The investigator is responsible for submitting the renewal application in a timely manner. Failure to submit the application by the deadline will result in withdrawal of approval. | |||
| 2. | Progress Reports and Adverse Event Reports pertaining to JHU SOM ESCRO committee approved research and submitted to a University IRB, IACUC, and/or IBC must also be submitted to the JHU SOM ESCRO committee. | |||
| 3. | No modifications to JHU SOM ESCRO committee approved research shall be implemented prior to JHU SOM ESCRO committee approval of the modifications, except when a deviation is necessary to prevent imminent harm. Such deviations should be reported to the JHU SOM ESCRO committee within 3 business days. The JHU SOM ESCRO committee has the authority to review and approve, require modifications of, or withhold approval of all proposed modifications to JHU SOM ESCRO committee approved research prior to the implementation of such modifications by the investigator. | |||
| C. | Monitoring of JHU SOM ESCRO Committee Approved Research | |||
The JHU SOM ESCRO committee or its representatives shall have the authority to observe the conduct of any research activity subject to JHU SOM ESCRO 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 SOM ESCRO committee shall have the authority to place restrictions on research activities that fall under its jurisdiction. The JHU SOM ESCRO 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 SOM ESCRO 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 SOM ESCRO committee requirements, applicable governmental regulations, and/or University policies. 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. | |||
| 3. | If the JHU SOM sponsors or an JHU SOM researcher [2] participates as a co-investigator in research at a site outside the University, the JHU SOM ESCRO committee shall have the authority to terminate the participation of JHU SOM researchers in the research. In such cases the JHU SOM ESCRO committee will inform the responsible Institutional Official(s) at JHU SOM 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 SOM ESCRO Committee by Other University Committees or Officials | |||
| 1. | Research requiring JHU SOM ESCRO committee review ordinarily will be submitted for review and approval by the JHU SOM ESCRO committee concurrently with submission of the research to any other JHU SOM 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 SOM ESCRO committee may be subject to further review, modification of, approval and/or disapproval by all relevant bodies, such as the JHU SOM IRBS; the JHU SOM IBC; the JHU SOM 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 SOM ESCRO committee’s jurisdiction if approval was previously withheld by the JHU SOM ESCRO committee. | |||
| 3. | The JHU SOM ESCRO 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 SOM IRBs. | |||
| F. | Education and Training | |||
| All study team members engaged in research, subject to oversight by the JHU SOM ESCRO committee shall complete educational activities related to the ethics of such research, as specified by the JHU SOM ESCRO committee. | ||||
| IV. | Conflicts of Interest – JHU SOM ESCRO Committee Co-Chairs, Members and Consultants | |||
| A. | Disclosure | |||
| JHU SOM ESCRO committee co-chairs and JHU SOM ESCRO committee members shall be required to disclose conflicts of interest at the beginning of each JHU SOM ESCRO 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 SOM ESCRO committee members who have conflicts of interest with respect to protocols submitted for JHU SOM ESCRO committee review will abstain from participation in JHU SOM ESCRO 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. | Research Requiring Review and Approval by the JHU SOM ESCRO Committee | |||
| All research under the jurisdiction of the JHU SOM ESCRO committee shall be subject to review by the JHU SOM ESCRO committee, in addition to all other relevant bodies with oversight, such as the IRBs and the IACUC. | ||||
| VI. | Prohibited Research | |||
| In accordance with prevailing ethical and policy guidance and applicable law [3], the following categories of research are currently prohibited at JHU SOM: | ||||
| A. | Research involving the introduction of ESCs into human blastocysts; | |||
| B. | Research involving the introduction of hESCs 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; | |||
| D. | Breeding of animals that have had hESCs introduced into the germ line. | |||
| This list may be revised to reflect changes in prevailing ethical and policy guidance and applicable law. | ||||
| VII. | Standards for JHU SOM ESCRO Committee Review | |||
| In conducting review of proposed research, the JHU SOM ESCRO committee will take into account considerations that include the following. | ||||
| A. | Procurement of Gametes, Blastocysts, or Somatic Cells for hESC Generation | |||
| For the purposes of JHU SOM ESCRO 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 ethical and legal issues related to hESC research will depend in part on the context in which human materials are procured (for example, infertility treatment, research, clinical care). The context of procurement will involve established standards of care that will be taken into consideration during JHU SOM ESCRO 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. | |||
| 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 (VII, 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: | ||||
| a. | That blastocysts or gametes will be used to derive hESCs for research that may include research on human transplantation; | |||
| b. | That embryos will be destroyed in the process of deriving hESCs; | |||
| 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 resulting cell lines will be genetically similar or identical to the donor; | |||
| e. | That restricted and/or directed donation (e.g., to individuals or groups) are/is not permitted; | |||
| f. | Whether the donors’ identities will be ascertainable; | |||
| g. | If the donors’ identities are retained (even if coded), whether donors can elect to be contacted to receive information obtained through studies of the cell lines; | |||
| h. | That derived hESCs and/or cell lines might be kept for many years; | |||
| i. | That the hESCs 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; | |||
| j. | That the results of study of the hESCs 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; | |||
| k. | That the research is not intended to provide direct medical benefit to the donors; | |||
| l. | That neither consenting nor refusing to donate embryos for research will affect the quality of any care provided to potential donors; | |||
| m. | Risks to donors. | |||
| B. | Transfer of Human Materials from Outside Entities | |||
To determine the scientific and ethical integrity of hESC research the JHU SOM ESCRO committee must examine the circumstances under which human materials were (or will be) procured for use in hESC research and the details of the derivation of hESC lines. The applications must include documentation of the provenance of all hESC 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 hESCs into Non-human Animals | |||
| Protocols must describe: | ||||
| 1. | Why hESCs are required in lieu of ESCs from primates or other animals; | |||
| 2. | Relevant animal work that precedes the proposed work involving hESCs; | |||
| 3. | Quality control of ESC lines and their derivatives, (such as genetic stability, freedom from contamination); | |||
| 4. | The part of the non-human animal’s body to which the cells will be transferred; | |||
| 5. | The developmental stage of the non-human animal to which the cells will be transferred; | |||
| 6. | When the proposed research involves potential for neural grafting, 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 ESC 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 hESC lines for research that does not fall under the jurisdiction of any of these groups. Therefore, whenever hESC research involves the transmission of identifying information on donors of gametes, blastocysts, hESC 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 SOM faculty, staff or students acting in their capacity as faculty, staff or students respectively, collaborate with a researcher at another institution, protocols must describe the oversight and review mechanisms at the other institution. | ||||
| VIII. | Procedures for Research Requiring JHU SOM ESCRO Committee Review | |||
The review process and the records of the JHU SOM ESCRO committee will be maintained as confidential to the extent permitted by law. | ||||
| A. | Quorum Requirements | |||
The JHU SOM ESCRO 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 SOM ESCRO 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. | ||||
| B. | JHU SOM ESCRO Committee Review of Research Proposals | |||
| 1. | Each research study requiring review and approval by the convened JHU SOM ESCRO committee shall be addressed separately at JHU SOM ESCRO committee meetings. | |||
| 2. | Submitted protocols will be made available to JHU SOM ESCRO committee members in advance of JHU SOM ESCRO 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 SOM ESCRO 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 SOM ESCRO committee review. | |||
| 5. | Reviewers who are absent from a full JHU SOM ESCRO committee meeting may provide written comments regarding the proposed research, but absent members shall not be counted in the JHU SOM ESCRO committee vote. | |||
| 6. | Following open discussion, the JHU SOM ESCRO committee co-chairs shall call for a vote of the JHU SOM ESCRO committee to grant: | |||
| a. | Full Approval: No changes are required to the proposed research; | |||
| b. | Approval Pending Concurrence with JHU SOM ESCRO committee-directed Changes: The proposed research may be granted full approval by the JHU SOM ESCRO committee co-chairs pending principal investigator concurrence with specific revisions stipulated by the JHU SOM ESCRO 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 SOM ESCRO committee and such revisions have been reviewed and approved by the JHU SOM ESCRO committee co-chairs or their 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 SOM ESCRO 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 SOM ESCRO committee. | |||
| 7. | The vote of the majority of the JHU SOM ESCRO committee members present at the meeting shall determine the final determination status (i.e., full approval, approval pending concurrence with JHU SOM ESCRO 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 SOM ESCRO committee. | |||
| 8. | Following an JHU SOM ESCRO committee vote for full approval or approval pending concurrence with JHU SOM ESCRO committee directed changes: | |||
| a. | JHU SOM ESCRO committee 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 SOM ESCRO committee-directed changes shall be requested to summarize the reasons for their contravention. | |||
| 9. | The JHU SOM ESCRO 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 SOM ESCRO committee approval of the research. | |||
| IX. | Process for Protocols Following JHU SOM ESCRO Committee Vote | |||
| A. | Protocols Granted Full Approval | |||
For research granted full approval by the JHU SOM ESCRO 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 SOM ESCRO committee upon his/her termination of the JHU SOM ESCRO committee approved research. | ||||
| B. | Protocols Approved Subject to Concurrence with JHU SOM ESCRO Committee-Directed Changes | |||
If the convened JHU SOM ESCRO committee decides to approve the proposed research pending concurrence with JHU SOM ESCRO committee-directed changes, the principal investigator will be provided: | ||||
| 1. | Notification addressing the specific revisions stipulated by the JHU SOM ESCRO 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 SOM ESCRO committee and to resubmit for full approval; and | |||
| 3. | Notification specifying that the principal investigator must respond to the JHU SOM ESCRO 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 SOM ESCRO committee pending concurrence with JHU SOM ESCRO committee-directed changes, the revised research submitted in response to the specific revisions stipulated by the JHU SOM ESCRO committee shall be reviewed by a JHU SOM ESCRO 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 SOM ESCRO committee, the research proposal (to include any JHU SOM ESCRO committee-directed changes agreed on by the principal investigator) and the investigators justification for not complying with certain of the JHU SOM ESCRO 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 SOM ESCRO committee meeting during which the research will be reconsidered. | ||||
| C. | Protocols Reconsidered or Not Approved | |||
If the JHU SOM ESCRO committee decides to reconsider or disapprove the proposed research, the principal investigator will be provided: | ||||
| 1. | The primary reason(s) for the JHU SOM ESCRO committee’s decision to reconsider or withhold approval of the research; | |||
| 2. | A listing of additional problems or deficiencies identified by the JHU SOM ESCRO committee; | |||
| 3. | Instructions regarding resubmission of the research for review by the JHU SOM ESCRO committee including a requirement to address the statements and concerns emanating from the first JHU SOM ESCRO review; | |||
| 4. | Notification that s/he may appear in person at the meeting of the JHU SOM ESCRO committee wherein the research will be reconsidered, to address any additional questions or concerns of the JHU SOM ESCRO committee; and | |||
| 5. | Notification that s/he must respond to the JHU SOM ESCRO 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. | |||
| X. | JHU SOM ESCRO Committee Meetings | |||
The minutes of the JHU SOM ESCRO 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 SOM ESCRO committee votes. | ||||
| Documentation shall include JHU SOM ESCRO committee members voting for and against the action taken by the JHU SOM ESCRO 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 SOM ESCRO committee co-chairs prior to generating investigator correspondence. | ||||
The minutes shall be distributed to JHU SOM ESCRO committee members. At each meeting, a vote of JHU SOM ESCRO 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 SOM ESCRO committee. | ||||
PART TWO: JHU SOM ESCRO COMMITTEE ORGANIZATION, RESPONSIBILITIES AND MANAGEMENT | ||||
| I. | JHU SOM ESCRO Committee Composition | |||
| A. | Number | |||
The JHU SOM ESCRO committee shall comprise at least 9 voting members, who shall collectively have adequate training and experience to promote the appropriate review of research activities pertaining to hESC and SCNT conducted at the JHU SOM and/or by JHU SOM faculty, staff or students acting in their capacity as faculty, staff or students respectively. | ||||
| B. | Standing Membership | |||
| The JHU SOM ESCRO committee shall include both men and women with representation of more than one profession. The JHU SOM ESCRO committee shall include: | ||||
| 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. | Consultants | |||
The JHU SOM ESCRO committee may consult individuals with special expertise in human stem cell research or with a specific community perspective. | ||||
| D. | Alternate Members | |||
The JHU SOM ESCRO 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 SOM ESCRO committee meetings without serving as replacements for a regular voting member; however, in this capacity, alternate members may not vote. | ||||
| E. | Ex-officio Members | |||
Representatives of the JHU SOM Office of General Counsel and of the JHU SOM Office of Research Administration (ORA) shall serve as voting, ex-officio members of the JHU SOM ESCRO committee. | ||||
| II. | JHU SOM ESCRO Committee Appointments and Terms | |||
| A. | Appointment of Co-Chairs | |||
| The co-chairs of the JHU SOM ESCRO committee shall be appointed by and report to the Vice Dean for Research. | ||||
| B. | Term of the Co-Chairs | |||
| The term of the JHU SOM ESCRO committee co-chair shall be two years with the option of appointment renewal for additional two year terms. | ||||
| C. | Appointment of Members | |||
Committee co-chairs shall recommend, potential members of the JHU SOM ESCRO committee to the Vice Dean for Research. | ||||
The members of the JHU SOM ESCRO 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 SOM ESCRO 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 SOM ESCRO 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 SOM ESCRO Committee | |||
| A. | General Management | |||
The JHU SOM ESCRO committee shall be managed as determined by the 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 SOM ESCRO committee. The Vice Deans shall be responsible for providing an appropriate level of administrative support to the co-chairs of the JHU SOM ESCRO committee and the JHU SOM ESCRO committee members. Management on a day-to-day basis shall be carried out under the direction of the JHU SOM ESCRO committee co-chairs and administrative/management staff. | ||||
| B. | Overall Responsibilities | |||
| The JHU SOM ESCRO committee shall be responsible for: | ||||
| 1. | Providing oversight of JHU SOM faculty, students or staff or involving JHU SOM facilities, regardless of the source of funding, who conduct research involving the derivation and/or research use of hESC lines and/or SCNT; | |||
| 2. | Providing consultation to 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; | |||
| 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 SOM ESCRO approved research, and suspending or terminating JHU SOM ESCRO 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 SOM ESCRO 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 SOM ESCRO committee’s jurisdiction. | |||
| C. | Responsibilities of the Co-Chairs | |||
| The JHU SOM ESCRO committee co-chairs shall lead JHU SOM ESCRO committee review of research. In addition, the JHU SOM ESCRO committee co-chairs shall: | ||||
1. | Oversee recruitment, training, continuing education and retention of JHU SOM ESCRO committee members; | |||
| 2. | Recommend appointment and dismissal of committee members to the Vice Dean for Research; | |||
| 3. | Oversee the JHU SOM ESCRO committee’s development and implementation of appropriate policies, procedures and guidelines for the conduct of research pertaining to hESC and/or SCNT; | |||
| 4. | Preside over JHU SOM ESCRO committee meetings and communicate JHU SOM ESCRO committee decisions and directives to researchers working in area(s) that fall under the JHU SOM ESCRO committee’s jurisdiction; | |||
| 5. | Have authority to request audits of research projects that fall under the JHU SOM ESCRO 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 SOM ESCRO committee activities and the ethical conduct of hESC research. | |||
| D. | Responsibilities of the Members | |||
| JHU SOM ESCRO committee members shall: | ||||
| 1. | Review and evaluate proposed research in a manner that is consistent with the Policies and Procedures of the JHU SOM ESCRO 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 SOM ESCRO committee co-chairs. | ||||
| 2. | Members | |||
JHU SOM ESCRO committee members may be dismissed by the Vice Dean for Research due to a failure of the JHU SOM ESCRO committee member to attend a sufficient number of meetings and/or otherwise actively participate in JHU SOM ESCRO committee functions. | ||||
Resignation of JHU SOM ESCRO committee membership shall be submitted, in writing, to the Vice Dean for Research and the co-chairs. | ||||
| IV. | Continuing Education | |||
JHU SOM ESCRO 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 SOM ESCRO Committee | |||
| A. | JHU SOM ESCRO Committee Protocol Files and Record Retention | |||
All research submitted for JHU SOM ESCRO committee review shall indicate the date of receipt, and be assigned a unique JHU SOM ESCRO committee number. | ||||
JHU SOM ESCRO committee staff shall maintain records of research submitted for JHU SOM ESCRO committee review. The files shall be maintained for at least seven years following the termination of JHU SOM ESCRO committee approved research. | ||||
| JHU SOM ESCRO committee staff shall also maintain JHU SOM ESCRO committee meeting minutes, a roster of all current JHU SOM ESCRO committee members, biographical sketches of current JHU SOM ESCRO committee members, and a record of inquiries submitted to the JHU SOM ESCRO committee. | ||||
| B. | Database of Submitted Research Protocols and Registry of Human Embryonic Stem Cell Lines | |||
JHU SOM ESCRO committee staff shall maintain a secure computer database of research submissions. | ||||
JHU SOM ESCRO 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 SOM ESCRO committee review shall be screened by JHU SOM ESCRO committee staff to verify that the submission is complete, and complete applications shall be assigned to a meeting of the JHU SOM ESCRO committee. | ||||
| 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). | ||||
