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 Committee 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 Committee to the University of Miami IRB (HSRO).
Informed Consent in Research
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
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.
Consent to Contact for Future Research
Consent to Contact provides an opportunity to patients to be entered into a registry whereby allowing a research team to contact them if they meet criteria for an Institutional Review Board (IRB) and Jackson Health system (JHS) approved research study. Patients can consent to be contacted for future research at the time of their appointment with Jackson Health System.
Consent to Contact may or may not be an appropriate recruitment method for populations involving sensitive diagnoses and will be considered on a case by case basis. For more information on Consent to Contact process please visit this link.
To learn how a researcher can receive a list of patients at Jackson Health system who have agreed to Consent to Contact please email JHS-CTO-Research-Tickets [email protected]
Frequently Asked Questions (FAQ)
What is Consent to Contact?
Consent to Contact provides you with an opportunity to be entered into a registry whereby you allow a research team to contact you if you meet criteria for a research study. If you do, a study team may contact you about studies that may interest you.
Who will contact me?
Members of the Jackson Health System/University of Miami research study teams will call you. The member can be anyone involved in the study and who can answer questions about the study (doctor or scientist in charge of the study, a study nurse, or research coordinator).
When will I be contacted?
The research team will contact you only if information in your electronic health record shows that you are a good fit for the study.
What happens if I say no?
Consent to Contact is completely voluntary. Your decision will not affect your care at Jackson Health System/University of Miami.
What happens if I say yes?
We will ask you to sign a form. This form is for our records and yours. You will receive a signed copy. The form tells you what you need to know about Consent to Contact and who to call if you have any questions.
If I say yes, does this mean I will be in a research study?
No, you are only giving the Jackson Health System/University of Miami permission to contact you to ask if you want to participate.
What kinds of research studies are we talking about?
There are many kinds of research studies, from surveys, registries to clinical trials which test an investigational drug or medical device to see if it is safe and effective for treating a disease or condition.
Are there benefits in signing up for Consent to Contact?
You will have the opportunity to hear about research studies where you might be a good fit to participate. You may be part of innovative and groundbreaking research studies at Jackson Health System/University of Miami. People participate in clinical trials for a variety of reasons. Some volunteers say they participate to help others and to find cures. Participants with an illness also participate to possibly receive the investigational treatment.
Will I be contacted by more than one research study team from UM?
You might be contacted to participate in several different research studies, but you do not have to participate in any of them. Consent to Contact only allows the researchers to tell you about the study. After you hear about the study, you decide if you want to participate.
Will Jackson Health System/University of Miami researchers have access to my electronic health record if I sign up for Consent to Contact?
No, Jackson Health System/University of Miami researchers will not have access to your electronic health record. The research study team that will call you for their study may know about an existing medical condition or treatment you have received, including potentially sensitive medical information you may not want the research study team to know you have, such as your HIV status or mental health conditions. They may receive this information to see if you are a good fit for a study.
How will I know the call is about Consent to Contact?
The caller will identify themselves as a member of the Jackson Health System/University of Miami research study team. They will refer to Consent to Contact when they make the first contact with you.
What if I change my mind and do not want to be contacted?
You can change your mind at any time. If you no longer want to be contacted, you may tell the research study team member calling you or call (305) 585-7226 at any time or email [email protected] . If you tell us you do not want to be part of Consent to Contact, we will stop giving your information to Jackson Health System/University of Miami study teams.
I have more questions about this. What should I do?
Please send your questions to [email protected] or call (305) 585-7226.
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. Below you will find the resources needed for a successful submission.
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. Below you will find the resources needed for a successful submission.
ONENESS Research Solution
The ONENESS Research Solution (ORS) is a centralized patient data repository shared between Jackson Health System and the University of Miami that allows the research community at both institutions to generate counts using de-duplicated and de-identified patient data based on research requirements. Please click here for more information. ONENESS Research Solution – Miami CTSI – University of Miami Clinical and Translational Science Institute.
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
Pre-Approval Documents:
Jackson staff now has access and can take courses in the CITI Training Program. Select your organization affiliation: Public Health Trust/Jackson Health System Instructions: Register as a “Learner” using the following link: Research, Ethics, Compliance, and Safety Training (citiprogram.org)
- Clinical Trials Office Application
- Study Calendar
- JHS Online Orientation Cerner
- EMR Access Form
- Workflow Template
- Pre-submission Budget Request Questionnaire
- Pathology Bypass Letter
Post-Approval Documents:
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.
Research Policies
The research policies can be found below and under the JHS Policy Manual in Jackson Health System Portal. To schedule a training, please contact [email protected].
- Policy# 800 Clinical Trials Office
- Policy # 801 Verification of Privileges for Research
- Policy # 804 Adverse Events Involving JHS Study Subjects
- Policy # 819 Participant Enrollment & HIPAA Authorization Notification
- Policy # 821 Research Encounter Ticket
- Policy # 835 Accessing and Duplication of Medical Records for Research Purposes
- Policy # 843 Financial Conflict of Interest in Research
- Policy # 844 Procurement of Medical Devices for Use in Clinical Research
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
The research policies can be found below and under the JHS Policy Manual in Jackson Health System Portal. To schedule a training, please contact [email protected].
- Policy# 800 Clinical Trials Office
- Policy # 801 Verification of Privileges for Research
- Policy # 804 Adverse Events Involving JHS Study Subjects
- Policy # 819 Participant Enrollment & HIPAA Authorization Notification
- Policy # 821 Research Encounter Ticket
- Policy # 835 Accessing and Duplication of Medical Records for Research Purposes
- Policy # 843 Financial Conflict of Interest in Research
- Policy # 844 Procurement of Medical Devices for Use in Clinical Research
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:
- For General Inquiries: [email protected]
- For Data Requests and EMR access: [email protected]
- For ICF/HIPAA authorization Submissions: [email protected]
Contact Us
Location:
- River Landing 1500 NW North River Drive, Miami, FL 33125
Contact Us:
- Office number 786-466-2360
Email:
- For General Inquiries: [email protected]
- For Data Requests and EMR access: [email protected]
- For ICF/HIPAA authorization Submissions: [email protected]