Office of Research

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.

Institutional Review Board

The Public Health Trust of Miami-Dade County Jackson Health System is a participating institution to the SMART IRB, through which other IRBs serve as an IRB of record to Jackson Health System. Jackson Health System also serves as an “Ancillary Reviewer” to the University of Miami IRB (HSRO).

Institutional Review Board

The Public Health Trust of Miami-Dade County Jackson Health System is a participating institution to the SMART IRB, through which other IRBs serve as an IRB of record to Jackson Health System. Jackson Health System also serves as an “Ancillary Reviewer” to the University of Miami IRB (HSRO).

Informed Consent

Informed consent in research is a cornerstone of ethical practice and legal requirement that ensures participants are fully aware and agree to their involvement in a study, understanding its scope, risks, benefits and their rights. The ability of participants to give consent is essential. For more information on Informed Consent you can visit the Code of Federal Regulations Title 45, Part 46.

Informed Consent

Informed consent in research is a cornerstone of ethical practice and legal requirement that ensures participants are fully aware and agree to their involvement in a study, understanding its scope, risks, benefits and their rights. The ability of participants to give consent is essential. For more information on Informed Consent you can visit the Code of Federal Regulations Title 45, Part 46.

HIPAA Authorization in Research

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

What the Office of Research can do for you:

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

HIPAA Authorization in Research

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

What the Office of Research can do for you:

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

HIPAA and research

HIPAA consent refers to the voluntary agreement of a patient to allow a covered entity to use and disclose their protected health information for treatment, payment, and health care operations. HIPAA is a federal law that protects the privacy and security of sensitive patient health information from being disclosed without the patient’s consent or knowledge. In signing the consent and HIPAA form, subjects authorize auditors from funding agencies, sponsors, and regulatory agencies to access participants’ study files to verify study-related data. Investigators must ensure that only the data described in the protocol and the access agreed to by participants in the informed consent and HIPAA authorization forms is available to external auditors. Researchers can find the combined consent; which includes the HIPAA authorization within the UM IBIS system.

Guidelines to release of Medical Records:

If the research participant has signed a consent and HIPAA authorization with a JHS footer, copies will be available only for research purposes while maintaining regulatory standards.

If the study is recruitment only, the investigator will have the research participant sign an “Authorization for Release of Confidential Medical Records” and work directly with the Health Information Management (HIM) department to obtain the records at the stipulated cost.

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 at 786-466-2630 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.
  • 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/HIPAA authorization after they have signed it.
  • Must read the consent form and have the research study explained to them.
  • Is free to choose to stop being in the study at any time.

Submission

The Office of Research requires a complete submission of all required documents for the study to be accepted and reviewed by the JHS Office of Research.

Submission

The Office of Research requires a complete submission of all required documents for the study to be accepted and reviewed by the JHS Office of Research.

I. Drug studies

  • Complete JHS Office of Research Study Application & Study Calendar
  • Study Protocol
  • Investigator Brochure
  • 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 Authorization or Waiver of Authorization
  • Informed Consent Draft

II. Device studies

  • Complete JHS Office of Research Study Application & Study Calendar
  • Study Protocol
  • Electronic Modifiable Version of the Contract or Grant Award/ Sub-award agreement
  • Instructions For Use
  • FDA letter re: IDE or IDE Exemption
  • Determination of Local Fiscal Intermediary (if applicable)
  • IRB Application and Approval Letter (may submit Pre-IRB)
  • Questionnaires and/or Assessments
  • JHS HIPAA Authorization or Waiver of Authorization
  • Informed Consent Draft

III. Chart review/repository studies

  • Complete JHS Office of Research 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 Authorization or Waiver of Authorization
  • Informed Consent Draft

Forms

Agreements & Contracts

The Research Agreements contains legal and financial terms as related to performing a research study at Jackson Health Systems (JHS). As an Academic Medical Center, agreements may be by and between JHS, the sponsor, and the associated University. Under the Master Research Collaboration Agreement with the University of Miami (UM), UM investigators can conduct sponsored research at Jackson Health System. In the event the research study is non-sponsored, a Service Agreement will apply. For more information, please contact the office inbox at [email protected].

For externally funded studies: The UM Office of Research Administration has published guidelines through the University of Miami – Research Administration website and the JHS Work Order process when working with JHS.

During contract negotiations, our staff will work with the sponsor or University until a final draft is reached and agreeable to all parties involved.

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

  • Compensation & Payment Schedule
  • Indemnification & Insurance
  • Data Ownership & Use
  • Site Responsibility
  • Governing Law
  • Confidentiality

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 to avoid any unnecessary delay.

Agreements & Contracts

The Research Agreements contains legal and financial terms as related to performing a research study at Jackson Health Systems (JHS). As an Academic Medical Center, agreements may be by and between JHS, the sponsor, and the associated University. Under the Master Research Collaboration Agreement with the University of Miami (UM), UM investigators can conduct sponsored research at Jackson Health System. In the event the research study is non-sponsored, a Service Agreement will apply. For more information, please contact the office inbox at [email protected].

For externally funded studies: The UM Office of Research Administration has published guidelines through the University of Miami – Research Administration website and the JHS Work Order process when working with JHS.

During contract negotiations, our staff will work with the sponsor or University until a final draft is reached and agreeable to all parties involved.

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

  • Compensation & Payment Schedule
  • Indemnification & Insurance
  • Data Ownership & Use
  • Site Responsibility
  • Governing Law
  • Confidentiality

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 to avoid any unnecessary delay.

Coverage Analysis

A coverage analysis is a review to determine if a research study is deemed a qualifying clinical trial pursuant to Medicare’s National Coverage Decision 310.1. The financial analyst is responsible for conducting the coverage analysis for all research studies including but not limited to device & drug studies before JHS can move forward with approval.

Requirements to perform a coverage analysis

  • The study calendar completed by the principal investigator, highlighting the items and services required for the study.
  • Sponsors proposed budget (what the sponsor is willing to pay)
  • Medicare coverage determination guidelines.

Coverage Analysis

A coverage analysis is a review to determine if a research study is deemed a qualifying clinical trial pursuant to Medicare’s National Coverage Decision 310.1. The financial analyst is responsible for conducting the coverage analysis for all research studies including but not limited to device & drug studies before JHS can move forward with approval.

Requirements to perform a coverage analysis

  • The study calendar completed by the principal investigator, highlighting the items and services required for the study.
  • Sponsors proposed budget (what the sponsor is willing to pay)
  • Medicare coverage determination guidelines.

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 Office of Research. 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, It is considered unauthorized if a device or product is brought and used without a purchase order. Procurement is firm in that a vendor is not to approach employees, including physicians on JHS grounds unless they are a registered lobbyist. For more information please refer to JHS Policy 844: “Procurement of Medical Devices for Use in Clinical Research” and the Vendors and Procurement’s website.

Research Policies

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 Office of Research. 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, It is considered unauthorized if a device or product is brought and used without a purchase order. Procurement is firm in that a vendor is not to approach employees, including physicians on JHS grounds unless they are a registered lobbyist. For more information please refer to JHS Policy 844: “Procurement of Medical Devices for Use in Clinical Research” and the Vendors and Procurement’s website.

Contact Us

Location:

  • River Landing 1500 NW North River Drive, Miami, FL 33125

Contact Us:

  • Office number 786-466-2360

Email:

Contact Us

Location:

  • River Landing 1500 NW North River Drive, Miami, FL 33125

Contact Us:

  • Office number 786-466-2360

Email: