HIPAA & Research
Tropical Storm Erika Update
Jackson Health System is open for business and operating as usual.
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
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.
- JHS Authorization for Release of Individually Identifiable Health Information (English)
- Recruiting in the Emergency Department
- Patient Enrollment Form
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.
Office of Research & Grants
Jackson Medical Towers
1500 NW 12th Avenue
Miami, Florida 33136