Clinical Trials

Jackson Health System’s Office of Research is established to carry out the organization’s goal of providing a high standard of quality care for its patients, while facilitating clinical research studies which may improve overall healthcare for all patients at Jackson facilities.

Overview

As a Research Center of Excellence, the Office of Research & Grants will provide oversight, central support and guidance to staff physicians participating in clinical trials.

What the Office of Research can do for you:

  • Centralize negotiation and budgeting
  • Central IRB review
  • Provide training and education for research investigators and coordinators
  • Provide education and training on billing for research studies
  • Financial competitiveness
  • Regulatory training and/or assistance (as required)
  • Compliance for Medicare billing
  • Access to large and diverse patient population for studies

Overview

As a Research Center of Excellence, the Office of Research & Grants will provide oversight, central support and guidance to staff physicians participating in clinical trials.

What the Office of Research can do for you:

  • Centralize negotiation and budgeting
  • Central IRB review
  • Provide training and education for research investigators and coordinators
  • Provide education and training on billing for research studies
  • Financial competitiveness
  • Regulatory training and/or assistance (as required)
  • Compliance for Medicare billing
  • Access to large and diverse patient population for studies

Location

Office of Research & Grants

Jackson Medical Towers
1500 NW 12th Avenue
Miami, Florida 33136
305-585-7226 (office)
305-585-6144 (fax)

Support Groups

Location

Office of Research & Grants

Jackson Medical Towers
1500 NW 12th Avenue
Miami, Florida 33136
305-585-7226 (office)
305-585-6144 (fax)

Agreements & Contracts

The Clinical Trials Agreement contains legal and financial terms as related to performing a clinical research study at Jackson Health Systems (JHS). As an Academic Medical Center, agreements may be by and between JHS, the sponsor and associated University. All Clinical Trials Agreements are negotiated by the JHS Office of Research and signed by an authorized signatory.

During contract negotiations, the JHS clinical trials staff will work with the sponsor until a final draft is reached and agreeable to all involved parties. In light of the growing complexity of clinical trials, JHS clinical trials may include and/or consult other departments, such as Risk Management, IT Security and HIPAA Compliance, in order to achieve a comprehensive agreement.

The following areas most commonly negotiated by Jackson Health System are:

  • Data ownership and use
  • Governing law
  • Indemnification and insurance
  • Site responsibility
  • Confidentiality
  • Compensation and payment schedule

The length of time necessary to negotiate and reach a final draft of a contract varies. However, the JHS Office of Research encourages that all agreements/contracts and site budgets be submitted as they become available so to avoid any unnecessary delay.

Agreements & Contracts

The Clinical Trials Agreement contains legal and financial terms as related to performing a clinical research study at Jackson Health Systems (JHS). As an Academic Medical Center, agreements may be by and between JHS, the sponsor and associated University. All Clinical Trials Agreements are negotiated by the JHS Office of Research and signed by an authorized signatory.

During contract negotiations, the JHS clinical trials staff will work with the sponsor until a final draft is reached and agreeable to all involved parties. In light of the growing complexity of clinical trials, JHS clinical trials may include and/or consult other departments, such as Risk Management, IT Security and HIPAA Compliance, in order to achieve a comprehensive agreement.

The following areas most commonly negotiated by Jackson Health System are:

  • Data ownership and use
  • Governing law
  • Indemnification and insurance
  • Site responsibility
  • Confidentiality
  • Compensation and payment schedule

The length of time necessary to negotiate and reach a final draft of a contract varies. However, the JHS Office of Research encourages that all agreements/contracts and site budgets be submitted as they become available so to avoid any unnecessary delay.

Coverage Analysis

The coverage analyst is responsible for conducting the coverage analysis for all research studies (device and drug) before submission to the JHS Clinical Trials Research Review Committee and Institutional Review Board. A coverage analysis is a review to determine if a research study is a deemed and qualifying clinical trial pursuant to Medicare’s National Coverage Decision and will outline what items and services pertaining to a research study can be billed to Medicare.

Coverage Analysis

The coverage analyst is responsible for conducting the coverage analysis for all research studies (device and drug) before submission to the JHS Clinical Trials Research Review Committee and Institutional Review Board. A coverage analysis is a review to determine if a research study is a deemed and qualifying clinical trial pursuant to Medicare’s National Coverage Decision and will outline what items and services pertaining to a research study can be billed to Medicare.

The coverage analysis consists of three components

  • The billing plan completed by the principal investigator.
  • The study calendar also completed by the principal investigator, which includes all items and services required to conduct the study
  • The summary incorporating the first two components to reach a billing guide for the research study.

The coverage analyst will identify which are the items and services for a research study

  • Paid for by the sponsor
  • Billable to Medicare as “routine” care
  • Not billable to Medicare as “routine” care without documentation as to medical necessity
  • Non-reimbursable
  • Patient/research subject’s responsibility (costs incurred for participating in clinical trial)

The coverage analysis process provides

  • Assist investigator in determining feasibility of a clinical trial
  • Assist investigator in developing a study budget
  • Provide awareness to patients/research subjects as to their potential financial liability
  • Provide a billing process template to verify that research study items and services are billed to the appropriate party

Forms

Department Studies

The National Institute of Health defines clinical trials as biomedical or health-related research studies in human beings that follow a pre-defined protocol. Clinical trials involve human beings that have a disease, but may also involve healthy volunteers. An investigational item is usually being studied. Clinical Trials can be Phase 1, 2, 3 or 4 depending on the stage of experimentation on the investigational item (i.e. device or drug).

Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available. Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.

Department Studies

The National Institute of Health defines clinical trials as biomedical or health-related research studies in human beings that follow a pre-defined protocol. Clinical trials involve human beings that have a disease, but may also involve healthy volunteers. An investigational item is usually being studied. Clinical Trials can be Phase 1, 2, 3 or 4 depending on the stage of experimentation on the investigational item (i.e. device or drug).

Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available. Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.

HIPAA & Research

The Jackson Health System Office of Research & Grants encourages and facilitates high-quality clinical research in order to improve the healthcare quality of the entire health system. The Office of Research & Grants supports research for investigators and staff engaged in the entire spectrum of clinical research.

Office of Research & Grants resources include:

  • Staff Resources
  • Research Billing Compliance
  • Clinical Research Associate Support Services
  • Training and Educational Programs
  • Representation and Advocacy for Clinical Research throughout Jackson
  • HIPAA & Research
  • Research Subject Information

HIPAA & Research

The Jackson Health System Office of Research & Grants encourages and facilitates high-quality clinical research in order to improve the healthcare quality of the entire health system. The Office of Research & Grants supports research for investigators and staff engaged in the entire spectrum of clinical research.

Office of Research & Grants resources include:

  • Staff Resources
  • Research Billing Compliance
  • Clinical Research Associate Support Services
  • Training and Educational Programs
  • Representation and Advocacy for Clinical Research throughout Jackson
  • HIPAA & Research
  • Research Subject Information

HIPAA and research

The conservation of patients’ Protected Health Information (PHI) is always a priority for Jackson Health System even in clinical trials. The process of consenting a patient is deeply monitored, whereby the informed consent template, sponsor contract, study budget and protocol must be harmonious. In addition, the informed consent must be approved by the Institutional Review Board (IRB).

However, in certain instances an informed consent is not required and therefore an alteration or waiver is requested by the investigator and issued by the IRB. Clearly, HIPAA can be of concern in a clinical trial, whether it be resolved via an informed consent template, alteration of informed consent, waiver of informed consent or waiver of authorization.

For additional information on the criteria for requesting a waiver and/ or alteration of informed consent, please visit: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.23

In many studies investigators run statistical models and analysis off of their assessments made during study and house information in a database. It is imperative that these databases also remain HIPAA compliant in that they must not contain any patient Protected Health Information (PHI) or any patient identifiers. In addition, these databases must meet the stringent IT Security guidelines as to physical security of the data including, but not limited to, where the PC is located, whether the PC password protected, who has access to the PC, etc. With the evolution of technology and information transmission, IT Security, as well as the Privacy Officer are often consulted. At times, Business Associate Agreements are negotiated specifically when a sponsor, reporting and/ or repositories are involved.

Copying Medical Records & Case Report Authentication by Sponsors

Jackson Health System (JHS) as the custodian of the medical records of JHS patients does not release or allow copies to be made of patient’s medical records. If the patient has consented to his medical record being reviewed by the study-staff including the sponsor, Jackson will arrange to have the monitor review only those documents required to authenticate the Case Report Forms of a JHS Clinical Research Review Committee (CRRC) approved study.

If the patient consents to have copies made of their medical record, the sponsor or the PI must submit the request for copies to the Jackson Health System Office of Research & Grants on the authorization form. The JHS Office of Research & Grants will submit the request to Healthport, the company in contract with JHS, to facilitate this process. There is a charge to the study of 12 cents per page for copies of documents requested from the medical record.

Copying medical records and case report authentication by sponsors

Jackson Health System (JHS) as the custodian of the medical records of JHS patients does not release or allow copies to be made of patient’s medical records. If the patient has consented to his medical record being reviewed by the study-staff including the sponsor, Jackson will arrange to have the monitor review only those documents required to authenticate the Case Report Forms of a JHS Clinical Research Review Committee (CRRC) approved study.

If the patient consents to have copies made of their medical record, the sponsor or the PI must submit the request for copies to the Jackson Health System Office of Research & Grants on the authorization form. The JHS Office of Research & Grants will submit the request to Healthport, the company in contract with JHS, to facilitate this process. There is a charge to the study of 12 cents per page for copies of documents requested from the medical record.

Forms

Research subject information

Jackson Health System assumes responsibility for ensuring that important functions are executed promptly and documented in accordance with federal regulatory and JHS policy requirements.

If you are a research subject who has a complaint about a research project you are involved in or if you have questions about your “rights” as a research subject, you may contact the Office of Research & Grants at 305-585-7226 for assistance.

You may also file an anonymous complaint of non-compliance using the Jackson Health System hotline, 1-800-684-6457. This is a secure service provided to the JHS community that allows the reporter to remain anonymous while reporting possible non-compliance to relevant institutional officials, we will then provide feedback.

Please remember every research subject:

  • Has the right to be treated with respect, including respect for their decision whether or not he/she continues involvement in the study.
  • Is free to choose to stop being in the study at any time.
  • Must read the consent form and have the research study explained to them.
  • Must be given time to ask questions, and must be told who to contact if they have any more questions.
  • Must be given a copy of the consent form after they have signed it.

Institutional Review Board

Jackson Health System’s Office of Research & Grants has certain Institutional Review Boards of record which investigators may submit new research studies for board review and approval.

Institutional Review Board

Jackson Health System’s Office of Research & Grants has certain Institutional Review Boards of record which investigators may submit new research studies for board review and approval.

University of Miami

Human Research Subjects Office
Jackson Medical Towers
1500 NW 12th Ave., #1002
Miami, FL 33136

Western Institutional Review Board

3535 Seventh Ave. SW
Olympia, WA 98502-5010
and
P.O. Box 12029
Olympia, WA 98508-2029

Sterling Institutional Review Board

6300 Powers Ferry Rd.
Suite 600-351
Atlanta, GA 30339

Policies

Policies

New policies

To schedule training, please contact Marjorie Patterson at 305-585-7226.

Procurement policy

Jackson Health System’s procurement department, specifically the Value Analysis Team (VAT), will review all “new technology,” such as clinical trial research, prior to receiving approval from the Clinical Research Review Committee. This review should not cause any delay on the review and approval of the clinical trial.

Pursuant to JHS policy and procedure as it relates to procurement, if a device or product is brought and used without a purchase order it is considered a donation to JHS.

Procurement is firm in that a vendor is not to approach employees, including physicians on JHS grounds unless they are a registered lobbyist. Vendors do not need to be registered lobbyists if they are on grounds to provide support for an existing product. In addition, if a sponsor of an investigational device is providing the device free of charge, JHS does not require that the sponsor be an approved vendor. However, the sponsor’s device description/package insert and contract must be provided for JHS procurement for review. Once JHS decides to move forward with a device for procurement, the lobbyist is not required, but the JHS vendor registration is. This includes Humanitarian Use Devices sponsors whom must apply to JHS as an approved vendor prior to JHS purchasing the device.

Additional resources

Submission

The Office of Research & Grants requires a complete submission of all required documents for the study to be accepted and reviewed by the JHS Clinical Research Review Committee:

Submission

The Office of Research & Grants requires a complete submission of all required documents for the study to be accepted and reviewed by the JHS Clinical Research Review Committee:

I. Drug studies

  • Complete JHS Office of Research & Grants Study Application & Study Calendar
  • Study Protocol
  • Electronic Modifiable Version of the Contract or Grant Award/Sub-award agreement
  • Form 1572
  • FDA letter re: IND or IND Exemption
  • IRB Application and Approval Letter (may submit Pre-IRB)
  • Questionnaires and/or Assessments
  • JHS HIPAA or Waiver of Authorization
  • Informed Consent Draft
  • Clinical Trials set up fee

II. Device studies

  • Complete JHS Office of Research & Grants Study Application & Study Calendar
  • Study Protocol
  • Electronic Modifiable Version of the Contract or Grant Award/ Sub-award agreement
  • Sponsor Device Description
  • FDA letter re: IDE or IDE Exemption
  • Determination of Local Fiscal Intermediary
  • IRB Application and Approval Letter (may submit Pre-IRB)
  • Questionnaires and/or Assessments
  • JHS HIPAA or Waiver of Authorization
  • Informed Consent Draft
  • Clinical Trials set up fee

III. Chart review/repository studies

  • Complete JHS Office of Research & Grants Study Application
  • Study Protocol
  • Electronic Modifiable Version of the Contract or Grant Award/Sub-award agreement
  • IRB Application and Approval Letter (may submit Pre-IRB)
  • JHS HIPAA or Waiver of Authorization
  • Informed Consent Draft
  • Clinical Trials set up fee

Forms

Flowsheets

Contact Us

Contact Us

Katuska Barbery, MD, MBA

Director of Clinical Research
Katuska.Barbery@jhsmiami.org

Gabriel Blaschke Polania, M.D.

Clinical Trials Coverage Analyst
305-585-7226 ext. 5
Gabriel.BlaschkePola@jhsmiami.org

Marjorie Paterson, M.B.A.

Clinical Trials Auditor Coordinator
305-585-7226
Marjorie.Paterson@jhsmiami.org

Elena Castillo, B.S., C.P.C.

Sr. Research Billing Code Analyst
ECastillo@jhsmiami.org

Fanny Dalal

Compliance Auditor
305-585-2901
fdalal@jhsmiami.org

Melissa Orbegoso

Research Billing Code Analyst
Melissa.Orbegoso@jhsmiami.org