Procedure for Transfer/Waiver of IRB Authority to CIRB

Procedure for Transfer/Waiver of IRB Authority to CIRB

(Central Institutional Review Board)

The Bronson IRB may rely on the review of another IRB in cases where use of a single central IRB would improve efficiency of the IRB review and/or to avoid duplication of efforts, delays, and increased expenses in the conduct of research.

1. Initial Submission:

The following documents should be submitted by the PI/designee to the Bronson IRB Office for a request to transfer/waiver of IRB review to a CIRB:

___ Cover Letter requesting transfer to the CIRB http://www.bronsonhealth.com/research/cirb-transfers

___ Investigator Brochure or Device Information

___ Informed Consent with Flesh-Kincaid reading level ≤8 grade reading level.

Contact if you would like assistance in lowering the reading level.

___ Required HIPAA Authorization language, if applicable (below)

___ Bronson Specific wording for CIRB transfer ICF’s (below)

___ Signed Investigator agreement form or 1572 Form

___ Signed Conflict of Interest/Financial Disclosure for PI and all Co-investigators (may use form required by the CIRB)

___ Recruitment materials

___ Research Team member list

The Bronson IRB office will notify the study coordinator if updated CVs or current evidence of education is required for research team members.

2. Review and Approval of Transfer

The submission materials will be reviewed by the Bronson IRB chair and/or designee. If approved, the PI/designee will be provided with IRB approval documents for the CIRB transfer. The Bronson IRB Office will ensure that written Authorization Agreements have been executed with the CIRB.

3. CIRB Submission & Approval

The PI/designee will submit the required documents for transfer and approval to the CIRB.

The Bronson IRB office will request that the CIRB issue approval documents to the Bronson IRB in addition to the PI/designee.

HIPAA Authorization Language

(Please note that this is part of the Bronson IRB Informed Consent Template)

Release of Protected Health Information for Research Purposes:

This section explains how we may use your personal health information that is collected for this study. The law lets us use and share health information for research, if you agree to let us do this. The law requires us to protect the health information that you agree to let us use and share.

What information are you asking me to release?

The health information that may be used or released for this study includes

[Complete as appropriate; provide a description of information to be used or disclosed for the research project. This may include, for example, all information in a medical record, results of physical examinations, medical history, lab tests, or certain health information indicating or relating to a particular condition]

What will be done with this information?

Your information may be used and shared with others:

§  To do the study and evaluate the results

§  To make sure the study is correctly performed

§  To meet the reporting requirements of government agencies or for legal actions

Who may use or share your protected health information for this research study?

If you sign this document you are giving permission to [covered entity] to use and share your health information for this research.

This information may be shared with: [complete as appropriate-see examples below]:

§  The Research team including the Principal Investigator, study coordinator, research nurses, and all other research staff; Do not list names because they may change over the course of the study; instead list them by title or category only]

§  Research teams at other institutions (if a collaborative project)

§  Sponsor of the study and/or its agents

§  Contract Research Organization

§  Outside Laboratories

§  Data Analysis, Data Coordinating Centers

§  Study Safety Monitors

§  Drug Safety Monitoring Board

§  The medical staff who are taking care of you

Others who may see your health information during this study include:

§  The Bronson Methodist Hospital Institutional Review Board and its staff;

§ Agencies of the federal, state, or local government. This includes the Food and Drug Administration (FDA), Department of Health and Human Services (DHHS) and the Office for Human Research Protection.

If the information is shared with others and leaves [Institution], we cannot promise that others will keep it private. The information will be shared only if necessary.

If the results of this study are published, or presented at medical meetings, you will not be identified in any way.

How long will this authorization last?

[List a specific time period, at the completion of the research project, or state that you do not know when the information will no longer be used therefore the information will be kept for an indefinite length of time]

What happens if you do not give authorization or want to stop a past authorization?

You can refuse to release your personal health information for this study. If you decide not to permit the release of your information:

§  You will not be able to take part in the study

§  Your medical care outside of this study will not change

§  Your medical care benefits will not change

You can change your mind and decide to withdraw your consent for the release of this information. You can stop collection of the information for the study by contacting [PIs name, phone number, and address]. If you decide to withdraw your consent for the release of this information:

§  We will stop collecting your medical information, and

§  Any information that was collected before you withdrew your consent will be used and seen as described above.

Bronson Specific wording for inclusion in Informed Consents of Protocols transferred to a Central IRB

Bronson Methodist Hospital, a subsidiary of Bronson Healthcare Group, has an agreement with ______and has deferred to this Institutional Review Board for the approval of this research study. If you have questions regarding your rights as a research subject, you may contact Bronson IRB at 269-341-7898.

There may be risks to you that the researchers did not expect. You will receive emergency care if you are injured during the study. You will not be paid for the additional treatment unless it is covered in this consent form.

An injury is study-related if it is caused by study activities. The activities must be different from procedures or treatment you would receive if you were not in the study. Your insurance company may be billed.

Bronson Healthcare Group, and its subsidiaries, will not pay for the medical treatment of other injuries or illnesses, or pay any other type of compensation. You will not receive money if you are injured. You will not receive any money for wages lost because you were:

·  Hospitalized

·  In physical therapy

·  Getting other recovery services.

You will not receive any money for pain, suffering, or for any other loss of income.

Revised 7/22/14