The Department of Research is charged with the
oversight, facilitation, and support of all research activity occurring
within LifeBridge Health. The Department serves as a resource for
faculty, physicians, residents, fellows, and administrators, providing support
services and guidance in fulfilling the obligation to plan and conduct all
experimental procedures with the highest scientific, humane, and ethical
principles.
The department�s Institutional Review Board, whose primary
responsibility is to ensure respect and protect the rights, welfare and privacy
of all individuals who participate in a research study, is guided by principles
set forth in the Code of Federal Regulations, 45 CFR 46, 21 CFR 50, and 21 CFR
56.
Similarly, the Department�s Institutional Animal Care and Use
Committee (IACUC) oversees the animal laboratory facility and all laboratory
procedures ensuring the appropriate care, use and humane treatment of all
animals maintained for the purpose of research or training. The Department
provides individual and group educational opportunities for all LifeBridge
Health employees designed to aid in the maintenance of these standards.
The department also maintains an
Administrative Review Board to review the impact on ancillary departments
required to support research endeavors.
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Contacts: |
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Arthur N. Freed, PhD
LifeBridge Director of Research
(410) 601-8742
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Patty Lohinski, CIM
Research Coordinator
(410) 601-9272
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Hours of Operation: |
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Monday through Thursday 6:00 am- 4:45 pm
Friday:7:00 am- 4:45
pm
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Main Phone Numbers: |
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(410) 601-9021 (Office) |
(410) 601-8282 (Fax) |
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Mailing Address: |
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Sinai Hospital of Baltimore
Schapiro Building, Suite 203
2401 W. Belvedere Ave.
Baltimore, MD 21215
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The LifeBridge Health Institutional Review Board (IRB) ensures that the rights and welfare of human subjects participating in research are adequately protected, the risks to subjects are outweighed by the potential benefits of the research, the selection of subjects is not coercive or biased, informed consent will be obtained and documented where appropriate, and there is scientific merit to the proposal.
IRB Information
Standard Operating Procedures
LBH Conflict of Interest Policy
Membership Rosters
Meeting Schedules
Deadlines and Meeting Dates for IRB A
Deadlines and Meeting
Dates for IRB B
Initial Submission Forms
Application
Checklist
Application for New Research
NCI CIRB Application Checklist
Instructions for Initial Application Submissions
NCI CIRB Facilitated
Application for New Research
Co-Investigator Signature Form
Investigator Delegation Form
Informed Consent Exception Request
De-Identified Data Form
Consent Form Template
HIPAA
Authorization Form- Investigator Sponsored Research
HIPAA Authorization Form- Outside Sponsored Research
HIPAA Text for Use in Consent Form
Adverse Events
Claim of Exemption Form
Financial Interest Disclosure
SAE & SRs Annual Report
Guidelines
Adverse Events
Case Reports and Chart
Reviews
De-Identified Data
Humanitarian Use Devices
NCI
CIRB
LBH Conflict of Interest Guidelines
Outreach
Guidelines
Renewal Submission Forms
Renewal Application
Protocol Review Form
Financial Interest Disclosure
IRB Fees
$2,000 Single Protocol
$1,000 Expedited
Review
$500 Exempt Status
Payable
to : LifeBridge Health IRB
HIPAA Policy
LifeBridge Health HIPAA Policy #4 - Use of Protected Health Information for Research(PDF)
Education
Requirements
You have the following options for completing the required training requirements:
CITI Course: The Protecton of Human Research Subjects -www.citiprogram.org or comparable education from another institution
HIPAA Appendices
Instructions for Individual Authorization Form for Use
or Disclosure of Protected Health Information (PHI) for Research
Purposes (Word format)
Application for Waiver of
Individual Authorization for Use or Disclosure of Protected Health Information
(PHI) in a Research Study (Word
format)
Request for Use or
Disclosure of Protected Health Information (PHI) Preparatory to Research (Word format)
Request for Use or
Disclosure of Protected Health Information (PHI) of Decedents (Word
format)
Guidance and
Regulatory Links
The Belmont Report
IRB Guidebook
45 CFR 46: DHHS-Protection of Human Subjects
FDA 21 CFR 50 Protection of Human Subjects
FDA 21 CFR 56 Institutional Review Boards
FDA Information Sheets: Guidance for IRBs and Clinical
Investigators
US Department of Health and Human Services
Federal Drug Administration
National
Institutes of Health
The LifeBridge Health Administrative Review Board (ARB) ensures that the facilities under LifeBridge Health obtain reimbursement of overhead and direct expenses when research is conducted on LifeBridge properties or patients. To develop a system whereby research costs, direct and indirect, are appropriately accounted and reimbursed. To ensure that ancillary departments required to support research endeavors are aware of demands on personnel, equipment, and supplies and that these resources are available and accessible when required by the research protocol. To further ensure that the patient�s third party payors will not be billed for services provided associated with clinical research over and above routine care provided in the absence of research.
ARB
Information
Policy and Procedures
Finance Policy Manual
LBH Conflict
of Interest Policy
Meeting Dates
and Deadlines
Membership
Rosters
Submission Forms
Application Checklist
Application for New
Research
Expedited Review
Form
Nursing Allocation
Sinai Hospital�s Institutional Animal
Care and Use Committee (IACUC) oversees the facility and procedures insuring the
appropriate care, use and humane treatment of all animals maintained for the
purpose of research or training. The IACUC serves as a resource for the
physicians, residents, fellows, and administrators, providing guidance in
fulfilling the obligation to plan and conduct all animal use procedures with the
highest scientific, humane, and ethical principles. Sinai Hospital�s IACUC
policies for animal care and use incorporate federal and local policies and
guidelines and principles of the United States Public Health Service policy. It
is the IACUC�s responsibility to monitor and uphold the compliance of these
policies.
IACUC
Information
- Policy
and Procedures
- Membership Rosters - IACUC Committee Members
- Guidelines
IACAU
Animal Research Training Program
Handling Animals on
an Expired Protocol: Animal Holding Protocol
Policy on Isolation of
Sick Animals
- Training Requirements
Federal Animal Welfare
Act regulations and regulations of the Department of Health and Human Services
require training and continuing education of all scientists, research
technicians, animal care technicians and other personnel involved with animal
care and treatment. LifeBridge Health (LBH) is required to provide training in
the following areas:
1. Humane practice of animal
maintenance and experimentation.
2. Research or testing
methods that minimize or eliminate the use of animals or limit pain or
distress.
3. Utilization of the information service of the
National Agricultural Library.
4. Methods whereby deficiencies
in animal care and treatment should be reported.
The regulations
require that each research facility establish a program of adequate veterinary
care that includes: appropriate facilities, personnel and equipment; methods
to control, diagnose and treat diseases; daily observation and provision of
care; guidance to personnel on the use of anesthetic, analgesic and euthanasia
procedures and pre- and post-procedural care. Specific requirements for
maintaining records and filing annual reports are included in the regulations
along with a miscellaneous section containing a variety of requirements to
which a research facility must adhere.
To fulfill these requirements the
LBH Department of Research and the Sinai Hospital Animal Care Facility
provides a three (3) tier training program. All personnel directly
involved in animal research must complete this training program prior to the
initiation of any new animal research protocol. Please note that an
animal research protocol can not be initiated until all key personnel listed
on the research protocol application satisfactorily complete all three (3)
levels of training as described under Guidelines
Submission
Forms
Application for
New Research
