Office of Research Administration

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 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.

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 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.

• 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

• 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

• 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

Although not considered research follow these instructions

UM/JHS Emergency Case Instructions

UM IRB:

When seeking to use an unapproved product, it is critical that the patient and his/her licensed physician consider all possible risks because the FDA has not determined whether the products are safe. Such products may, or may not, be effective in the treatment of the condition. See more details at: https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians

When you decide that the investigational product is the best option for the patient:

• Contact the sponsor and obtain authorization;
• Contact the FDA to obtain approval.

For an investigational drug or biologic call (888) 463-6332 or email [email protected]

For an investigational device call (301) 796-7100 or email [email protected].

When time permits, submit the following to IRB for chair concurrence via email to an HSRO analyst or directly to an IRB chair to discuss the use.

1. Patient’s current disease or condition – including the justification of the use
2. Treatment plan/protocol
3. Sponsor’s authorization
4. Consent template (HRP-502) -hrp-502h—template-consent-document–expanded_access.docx
5. eIND (if the use involves investigational drug)- FDA email approval
6. IB or device manual/information

You must submit the completed Emergency Use Report Form (post-use) within 5 days using the electronic Report of New Information Smart Form (RNI)*. Details can be found in chapter 11.1 in the Investigator Manual.

Jackson Health System: In addition to the above information, JHS needs the below which can be sent to [email protected]

• IRB Acknowledgment (if applicable)
• Date of administration/Location of the patient
• Will drug be provided free to the patient and JHS?
• Are any deliverables being requested from the manufacturer?
• If there is a need for a JHS HIPAA authorization contact [email protected]
• Once patient has consented send the Consent to [email protected]

Note, once JHS ORA receives information, the case will be escalated to the CMO and CFO of the facility where the patient will be treated.

Agreements: Manufacturers need to be aware that UM and JHS are 2 different legal entities when it refers to a UM Treating physician. Products will usually be shipped to the treating facility. The parties of the agreement need to be ironed out at the initiation to prevent delays.

*According to the FDA, the emergency use regulation, you can only administer an investigational product once without IRB approval. If there is any possibility that you will need to use the same investigational product with the same patient or with a different patient, you must submit a protocol to the IRB and obtain an IND or IDE from the FDA. The FDA regulations have provisions for expanded access use through a treatment protocol.

Pre-Approval Documents:
The CITI Program is available for JHS Staff to receive a certification to perform research at JHS.
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). For more information on which courses to take, contact [email protected]

• JHS ORA Application
• Study Calendar
• JHS online EMR Orientation
• EMR Access Form
• Workflow Template
• Pre-submission Budget Request Questionnaire (workflow TBD)
• Pathology Bypass Letter
• Order Set Request Form (coming soon)

Post-Approval Documents:

• Research Encounter Ticket
• Monthly Enrollment Report Form
• Pathology Fee Schedule/Request Form
• PACS Research Request Form
• Chart Review Data Request Questionnaire