Scientific Review Committee
The role of the Scientific Review Committee (SRC) is to provide local review of research activities for their scientific merit and operational impact to University of Maryland St. Joseph Medical Center. It operates within the framework of national and local guidelines. Committee independence and the avoidance of conflict of interest are maintained by excluding any member with a direct interest in a proposal from participating in its review. All biomedical or behavioral research proposals involving human research subjects will be reviewed and approved by the SRC prior to submission to the Institutional Review Board (IRB).
The Scientific Review Committee is charged with maintaining ethical and scientific standards of the institution throughout the duration of a research project.
All clinical studies, including exempt studies, are subject to audit by the Scientific Review Committee.
The SRC Chair will provide an overview / summary of the clinical research activity at St. Joseph and major actions of the SRC to the Medical Executive Committee on a quarterly-basis
Study information intended for the Scientific Review Committee must be submitted at least 16 business days prior to the desired review date to guarantee a timely response. Principal Investigators are encouraged to present their protocol at the SRC meeting for which they have submitted study documents. No meetings will be held on institutional holidays; meetings may need to be rescheduled in the absence of a quorum.
Members of the Scientific Review Committee are appointed by the Chairperson. Terms of appointment are for two years and members may be reappointed to consecutive terms. In addition to the voting members, others (including St. Joseph employees and representatives from the research areas) may be invited to attend the meetings and provide their input in a productive manner, as non-voting (ex-officio) members.
University of Maryland St. Joseph Scientific Review Committee
Linda Barr, MD
Internal Medicine/Critical Care,
Respiratory and Pulmonary Diseases
Steven Crawford, MD
Asst Head Psychiatry
Assoc Dir. Center for Eating Disorders, Sheppard Pratt
Gail Cunningham, MD, FACEP
Chairperson, Scientific Review Committee
VP Medical Affairs and
Chief Medical Officer
Susanne DeCrane, PhD
Vice President, Mission Integration
Director, Office of Clinical Research,
Interim Chair, Scientific Review Committee
Lisa Ruppel, PharmD
Grace Serafini, RN
Director, Nursing Services
Richard Schraeder, MD
Interim Chief, Dept of Hematology/Oncology
The following information is required by the Scientific Review Committee for consideration of a study to be conducted at University of Maryland St. Joseph Medical Center:
- Financial Conflict of Interest Disclosure
- Study Protocol
- Lay summary of the protocol (easily understood by non MD or non scientific reader; one page or less)
- Informed consent form
- All supporting documents such as
- Investigators brochure
- Ads, etc.
- Clinical Trial Agreement from sponsor (or outside institution/research organization)
- A copy of completed grant must accompany the application documents if clinical trial is grant funded.
- CITI certification or re-certification of Human Subjects Training education obtained within the past 36 months must accompany each new application to the Scientific Review Committee before the protocol will be reviewed
- Access the CITI course
- To register, UOMSJMC Investigators and Coordinators should select:
- Western IRB as the Participating Institution
- Fill in a unique login and password and complete the registration screen
- Choose Group I Biomedical Research for Investigators and Key Personnel for the quiz
- Please email a copy of certification to firstname.lastname@example.org or fax to 410-427-2137.
- Clinical Trial Approval Form
- Western Institutional Review Board application
How to Submit Materials for Initial Review
Please submit the study information described above at least two weeks prior to the desired review date to guarantee a timely response:
- One electronic copy on disk or email of all submitted documents, including the Clinical Trial Agreement to: email@example.com
- PLUS, two paper copies of the study information should be sent or delivered not less than 2 weeks in advance of preferred meeting date to:
Office of Clinical Research
University of Maryland St. Joseph Medical Center
St. Clare Building, Second Floor
7601 Osler Drive
Towson, MD 21204-7582
Requests for SRC review exceptions may be submitted to the SRC Chair through the Office of Clinical Research.
- The principal investigator of a study will be asked to give a five minute presentation of the study and answer questions at the meeting for which it was submitted.
- A SRC member designated to be the primary reviewer for the protocol will then summarize and present the study to the SRC, suggest changes, if needed, as well as make a recommendation for consideration by the SRC.
- The protocol is discussed in open forum by all members not involved with the study and concludes with a call to vote by the SRC chair for:
- Approval - the study is approved as submitted to the SRC.
- Approval with Clarifications - the protocol and/or consent form are approved provided that clarification(s) are submitted in writing to the satisfaction of the SRC chair and/or Committee. The SRC chair may approve the study upon receipt of the clarification(s) without going before the convened SRC.
- Disapproval – study issues stated by the Committee outweigh the merit and safety of conducting the study at St. Joseph.
- Deferral – issues with the protocol and/or consent form would negatively impact the conduct of the study at St. Joseph and must be addressed by the investigator. The investigator's written response will be brought before the convened SRC to reassess the study.
- The SRC chair will notify the investigator in writing of the Committee's decision.
The Committee has the authority to seek outside review of a protocol if none of the members has expertise in the protocol subject matter. This will be done so that the protocol can receive thorough and appropriate review.
Approved protocols will be reviewed by the Scientific Review Committee annually, or more often if required by the IRB. Terms of approval will be concurrent with those of the IRB.
Research that has been approved by the SRC may be reviewed and disapproved for conduct at St. Joseph by the members of the IRB, however, members of the SRC may not approve research that has been disapproved by the IRB.
A list of on-going protocols will be provided to SRC members noting any significant changes or events that occurred since the previous review. Examples of items that will be included for ongoing review of protocols include:
- Significant number of adverse events with the trial as a whole or at St. Joseph.
- Significant protocol deviations or Good Clinical Practice (GCP) violations
- Major changes to the protocol (excluding administrative changes)
- Changes to the investigator's or research teams financial conflict of interest status
- FDA, IRB and/or sponsor monitoring reports that cite significant GCP and/or regulatory violations
The SRC Chair will review the protocol list and notes describing significant changes. If there are no objections, a Committee vote will be called for continued approval of the protocol. A letter of notification will be sent by the Chair to the principal investigator.
This page contains password-protected links used by members of the SRC in conducting their reviews. Work in progress.