Office of Research

• Sponsors proposed budget.
• The study calendar also completed by the principal investigator, which includes all items and services required to conduct the study.
• Medicare coverage determination guidelines.

• 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 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 and should be consistent with the protocol requirement and institutional guidelines.

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.

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.

• JHS Authorization for Release of Individually Identifiable Health Information (English)
• Patient Enrollment Form

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/HIPAA authorization after they have signed it.

To schedule training, please contact [email protected].

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.

• Device Request Form
• Vendor Registration
• Lobbying Notice
• Lobbying Rules & Regulations

• 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

• 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

• 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

• Study Calendar
• Study Submission Form
• Patient Enrollment Form
• Participant Policies & Procedures

• Navigating Research Studies at JHS – Frontend
• Navigating Research Studies at JHS – Backend