Application for Irb Reliance

Application for Irb Reliance

FO 306-B

APPLICATION FOR IRB RELIANCE

INSTITUTIONAL RESEARCH REVIEW COMMITTEE

REVIEW OF A PROJECT INVOLVING HUMAN SUBJECTS

Institutional Research Review Committee (IRRC)

The IRRC requires all researchers bringing projects before this Committee to access the Human Subjects Training Tutorial prior to beginning their research. Present verification of completion of human subjects training along with the application packet. Links provided below:

Scope of the IRB Reliance Program:

The Edward W. Sparrow Hospital Association has entered into an agreement with Michigan State University under which the Sparrow IRRC may rely on MSU’s review of certain projects otherwise under its jurisdiction when the MSU BIRB or SIRB has reviewed and approved the projects. The categories of projects for which a “Reliance” would apply are as follows:

  1. Projects proposed to be initiated or continued by investigators employed by MSU.
  2. Projects proposed to be initiated or continued by any investigator approved by MSU to conduct a protocol approved by BIRB or SIRB on behalf of the same or another investigator.

  1. TITLE OF PROPOSAL:

  1. Responsible Project Investigator: (Professional Staff, Faculty or Staff Supervisor)

Name:
Address:
Phone:
Fax:
Email:
Primary Employer:
  1. Co-Investigator (if applicable): (MSU Students Must Provide Student ID#)

Attach a separate sheet for additional co-investigators.

Name:
Student ID # (if applicable):
Address:
Phone:
Fax:
Email:
Primary Employer:
  1. Do you have any related projects that were approved by the IRRC?

YES / { } / NO / { } / If yes, please list title and IRRC protocol numbers below.

5. When enrolling patients from Sparrow Hospital locations, you must provide the subject with the appropriate Sparrow Health System HIPAA Use and Disclosure Authorization Form.

6. The principal investigator is responsible for identifying any departments (e.g., Medical Records, Pharmacy, Laboratories, Nursing, etc.) of Sparrow Health System that will be affected by this research and obtaining the Department Manager/Director’s approval.

Examples: Investigator(s) collecting blood samples

Providing pathology specimens

Performing the informed consent

Discussion/obtaining informed consent

Administration of an investigational agent

Conducting an interview/survey

Administering a questionnaire

If appropriate, be sure to have an agreement in place with the department manager/director on reimbursement of expenses. Be aware that without this departmental approval you may not be able to conduct your study at Sparrow Health System facilities even if the IRB has approved the research project.

Please identify below any departments within Sparrow Health System which will be affected by this research and obtain the Department Managers approval.
YOUR APPLICATION WILL NOT BE CONSIDERED IF THIS SECTION IS NOT COMPLETED
Medical Records / Not Applicable / { } / Yes / { } / or / No / { }
Laboratories / Not Applicable / { } / Yes / { } / or / No / { }
Nursing / Not Applicable / { } / Yes / { } / or / No / { }
Pharmacy / Not Applicable / { } / Yes / { } / or / No / { }
Other (specify) / Not Applicable / { } / Yes / { } / or / No / { }
Be sure to explain to the Director/Manager what your needs will be.
Consider:
1. / staff time (pull records, collect data, prepare or administer medication, etc.)
2. / additional supplies
3. / equipment
4. / training of staff or physicians
5. / any other resource needs
6. / be in agreement regarding departmental reimbursement of expenses, if applicable

By submitting this application, the principal investigator affirms that the protocol for this research project has been reviewed and approved by the Michigan State University, Biomedical and Health Institutional Review Board (BIRB) or Social Sciences Institutional Review Board (SIRB). I accept responsibility for conducting the proposed research in accordance with the protections of human subjects as specified by Sparrow IRRC, including the supervision of professional staff and any student(s) investigator(s), and attest to the accuracy of the information contained in this document.

NAME:
Principal Investigator
electronic signature verified via IRB’s online submission system

CHECKLIST:

Please submit the following items along with this application:

  • The BIRB/SIRB application along with the complete research protocol and any amendments;
  • The Sparrow HIPAA Use and Disclosure Authorization Form, if applicable;
  • Protocol Impact statement, if necessary.

**********

George S. Abela, MD, IRRC Chair

Sparrow Health System

IRRC/Office of Research Oversight and Compliance

1215 East Michigan Avenue PO Box 30480

Lansing MI 48909-7980

PHONE 517.364.2150FAX 517.364.2763 E-mail:

Office Hours: Monday - Friday (8:00 am – 5:00pm)

PROTOCOL IMPACT STATEMENT

Please read the following information carefully, and return this completed statement with your application.

Researcher: Identify any departments (e.g., Medical Records, Pharmacy, Laboratory, Nuring, etc.) at Sparrow that will be affected by this research and obtain the Department Manager/Director’s approval.

Department Manager/Director: Be sure you have a clear understanding of the role your department plays in this research project, have an agreement with the researcher on reimbursement of expenses, and approve the project for implementation.

Project Title:

Investigator:

I have had the opportunity to discuss the impact above protocol will have on my department with the Investigator.

______

Name and DateDepartment

______

Name and DateDepartment

______

Name and DateDepartment

______

Name and DateDepartment

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