DEPARTMENTOFRESEARCH

LBH IRB Form #1a LBH Application Form New Research Page 1 of 3

Version date 14-10-22

Institutional Review Board

Application for New Research - Instructions

The LifeBridge Health, Inc. Institutional Review Board (IRB) must review and approve all activities which, in whole or in part involve research with human subjects if:

  1. the research is sponsored by this institution, or
  2. the research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or
  3. the research is conducted by or under the direction of an employee or agent of this institution using any property or facility of this institution, or
  4. the research involves the use of this institution’s non-public information to identify or contact human research subjects or prospective subjects.

PROCEDURE

  1. The Collaborative IRB Training Initiative (CITI) located at must be up-to-date for all research investigators, research coordinators, and research nurses in order to participate in research activities. For more information look on our website.
  2. Complete the IRB application forms for all research conducted at LBH IRB except those studies which have been reviewed by the NCI CIRB. For those studies the NCI CIRB Application must be completed.
  3. Attach your proposed informed consent form documents for review with the first page on LifeBridge Health or institution letterhead including a footer that includes page numbers, space for patient initials, a protocol identifier, and Consent Form version date. A copy of the LifeBridge Health Informed Consent Template is available which includes the required HIPAA language. A separate HIPAA Authorization Form may also be used. The Templates for the Informed Consent Form and the HIPAA Authorization Form may be found on the web at LifeBridge Health Research Department.

If there is an outside research sponsor consent document template, please

(i) include a reference copy for review, and

(ii) indicate in the review copy where the changes are that you have made in your document.

  1. Include a brief (1page) lay summaryof the study.
  2. Send two separate packets to the IRB office. The first should contain the original and four (4) collated and stapled copies in the order indicated below:
  • Signed and dated application checklist
  • Completed application form with all appropriate signatures
  • Signed Co-Investigator form(s) (if applicable)
  • Investigator Delegation of Responsibility Form
  • Lay summaryof the study
  • Consent and assent form(s)*, including HIPAA language or separate HIPAA Authorization Form(s)
  • Complete protocol
  • Investigator Brochure and/or package insert(s) (drugs and biologics), or Report of Prior Investigation, or FDA Summary of Data, or Safety or Patient Information sheet, or booklets prepared by sponsor (required for HUD)
  • A copy of the sponsor’s statement of Medical Device Risk determination, indicating the FDA regulatory classification and providing justification if a claim of Non-Significant Risk (NSR) is made
  • Investigator CVs (if not currently on file in the Department of Research office)

The second packet will contain two (2) copies for either IRB (A) or IRB (B) collated and stapled in the order indicted below:

  • Signed and dated application checklist
  • Completed application form with all appropriate signatures
  • Signed Co-Investigator form(s) (if applicable)
  • Investigator Delegation of Responsibility Form
  • Lay summaryof the study
  • Consent and assent form(s)*, including HIPAA language or separate HIPAA Authorization Form(s)
  • Complete protocol

*If you are requesting an exception to the standard informed consent requirements, please complete the “Request for Exception to Informed Consent Requirements for Research” form and attach to your application.

ELECTRONIC SUBMISSIONS

The LBH IRB requires that an electronic version of all documents be submitted at the same time as the paper packets. For those documents that require signature, please submit both the original unsigned document along with the scanned version with all required signatures.

NOTE:All applications involving a clinical department must include the signature of the Department Chief.

  1. Third party payers will not cover research procedures, laboratory tests, or other patient expenses that are not standard of care. If the project involves such costs, please state the source of the funding and include cost information for board review. Attach separate sheets as necessary.
  2. All research conducted at a LifeBridge Health facility requires budgets to be reviewed and approved by the LifeBridge Health Administrative Review Board (ARB)
  3. All applications sponsored by a researcher from an outside institution must include a copy of the approval from that institution’s IRB.
  4. All applications that are both
  1. sponsored by a researcher from an outside institution and
  2. involve in-house patient contact

must have an in-house sponsor. Please include a letter verifying person’s willingness to be a sponsor.

  1. A fee of $2,000 is required for the Full Board review of the IRB protocol regardless of approval. NIH Grants will be negotiated separately. A fee of $1,000 is required for Expedited reviews, a fee of $500 is required for Exempt reviews, and there is no fee for NIH cooperative research protocols. The fee for LBH-sponsored and resident-driven research will be waived. The receipt of the appropriate fee is required prior to full approval.
  2. IRB-A and IRB-B meet on the second and fourth Wednesdays of each month. Applications from Obstetrics and Gynecology, Oncology, Orthopedic Surgery, Pediatrics, Perinatology, Radiation Oncology, Radiology, Rehabilitation Medicine, and Women’s and Children’s Services should be submitted to IRB-A. Applications from Anesthesiology, General Surgery and subspecialties, Infection Control, Internal Medicine and subspecialties, Patient Care Services, Ophthalmology, Pathology, Pharmacy, Psychiatry, and Social Work, should be submitted to IRB-B. Protocols to be considered are to be submitted no later than 16 calendar days prior to the meeting date to permit distribution and review by committee members.
  3. Mail or deliver the completed application with supporting documentation to:

LifeBridge Health Institutional Review Board

SinaiHospital of Baltimore

2401 W. Belvedere Avenue

SchapiroBuilding, Suite 203

Baltimore, Maryland 21215

  1. Incomplete applications will not be accepted for review.

PLEASE NOTE:All Active Clinical Trials will be listed on the Department of Research web

site, which is available to the public.

Thank you for your cooperation

LBH IRB Form #1a LBH Application Form New Research Page 1 of 3

Version date 14-10-22