Office of Ethical Research Integrity and Compliance

The Institutional Review Board (IRB) reviews all research conducted at AdventHealth Orlando or by AdventHealth team members and agents to ensure ethical standards, scientific merit and regulatory compliance. The IRB’s primary responsibility is to protect those who volunteer to participate in research studies. The IRB maintains separate web pages.

The AdventHealth Research Institute strives to ensure that research performed at AdventHealth Orlando shall remain free from the introduction of bias related to any identified conflicting financial interest. The ORI administers the AdventHealth Orlando Financial COI in Research policy, manages the receipt and review of financial disclosures, ensures management plans are in place when appropriate, and conducts auditing and monitoring activities related to COI. The Research Oversight Committee (ROC) serves as the COI committee and reviews and provides input into management plans deemed as significant.

Who reviews COI documents related to research at AdventHealth?

• The Office of Research Integrity and Compliance reviews COI documents for all research-related projects at AdventHealth Orlando

Who must complete COI documents?

• Per federal regulation and hospital policy, all those conducting research under the auspices of AdventHealth Orlando, including nonemployees such as volunteers and students, Research Services employees, IRB members and Senior Administration related to research complete a conflict of interest disclosure annually. There is also a COI training requirement which must be updated every four years. Please scroll down to download documents.

Requests for Publicly Accessible Information

Please see below for the AdventHealth Orlando policy for Financial Conflict of Interest in Research. For questions regarding Conflict of Interests in PHS-sponsored studies, a request may be sent in writing or via email. Please specify (1) the full name of the individual, or (2) study for which information is requested and send your request to:

Office of Research Integrity and Compliance
AdventHealth
Attn: COI Official – Public Accessibility Request
800 N Magnolia Avenue, Suite 500

Orlando, FL 32803

[email protected]
407-200-1615

Click here for the COI Training Video

The Research Regulatory team:

• Provides regulatory support for all studies under the AdventHealth Research Institute
• Assists with research credentialing
• Maintains regulatory documents within the eRegulatory application (Florence)
• Completes Institutional Review Board (IRB) submissions for all studies under the AdventHealth Research Institute
• Supports research investigators with Investigational New Drug (IND), Investigational Device Exemption (IDE) and/or biologics applications to the Food and Drug Administration (FDA)
• Functions as a liaison between the IRB of record for each study protocol, the FDA and the investigator, the AdventHealth Research Institute study team, other study teams participating in AdventHealth Research Institute-led multi-site studies, the Sponsor, Contract Research Organization (CRO), Office of Sponsored Programs (OSP) and the research Conflicts of Interest (COI) office

The Research Billing Compliance Program seeks to ensure that AdventHealth researchers use proper billing practices when billing services provided as part of a research study by providing education, information and resources needed, conducting training, ongoing monitoring and facilitating intradepartmental processes.

This is a centralized team for AdventHealth Care System, and there are two separate teams:

Research Billing Review (RBR): reviews all research patient charges to determine

• if the charges are research-related and
• if the charges are research sponsor funded or billable routine care charges

Research Billing Analyst:

• Monitors and audits research billing-related processes
• Investigates issues/complaints
• Provides training and education specific to research billing

This email box should be used for communication about the following:

• Account notifications
• Research patient billing complaints
• Billing compliance review requests
• CPA review requests
• Any other correspondence related to billing compliance

Contact Information:

[email protected]

Attachments

• Research Account Notification Form
• Account Notification Form (Instructions)

Responsible Conduct of Research (RCR) is defined by the National Institutes of Health as “the practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.” The DHHS Office of Research Integrity and Compliance (ORIC) describes RCR as “good citizenship applied to professional life.”

RCR includes such areas as:

• Human subjects research
• Data management
• Research misconduct
• Conflicts of interest
• Mentor and trainee responsibilities
• Publication practices and responsible authorship
• Peer review
• Collaborative science
• Responsible and ethical animal research

Several federal agencies require training in RCR for specific categories of researchers, including the National Institutes of Health (NIH), National Science Foundation (NSF), and U.S. Department of Agriculture (USDA). Additionally, RCR Training is increasingly considered an essential component of a researcher’s training regardless of the source of funding for their research.

The ORIC strives to provide AdventHealth Orlando investigators and research staff with the information and resources necessary to ensure compliance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, all applicable federal and state laws and regulations, as well as institutional policies and procedures. As part of our research compliance program, our office performs auditing and monitoring activities, including GCP monitoring of research studies conducted at AdventHealth Orlando. We also provide one-on-one consultations, onsite training and forms and tools.

Contact Information:

[email protected]

The ORIC provides support and guidance for our research investigators who hold an Investigational New Drug (IND) or Investigational Device Exemption (IDE) for an investigational product included in a research study. This is to ensure compliance with IND and IDE Food and Drug Administration (FDA) regulations and satisfy the FDA responsibilities of being the Sponsor AND the Investigator of an IND or IDE study. We provide support by coming alongside the investigator and study team to provide resources, tools and guidance. Our support includes one-on-one guidance and input to the data collection tools, protocol development, study initiation, tools and templates created to assist with study management, and links to websites that are resources for conducting IND and IDE studies.

Our ROC provides oversight, support and resources for research compliance elements of the Office of Research Integrity and Compliance (ORIC) Research Compliance Program.

ROC responsibilities include:

• Providing accountability to ORI Research Compliance team to execute on the annual Research Compliance Work Plan
• Review cases of serious and/or continuing noncompliance
• Review Significant Financial Interests and associated management plans drafted by the COI Official with the ability to add to the proposed management plan
• Participate in Research Misconduct proceedings

ROC meets at least quarterly, includes up to 12 voting members, and has representation from the following areas:

• AdventHealth Legal Department
• AdventHealth Medical Group (Physician Enterprise)
• Physician representatives
• AdventHealth Revenue Cycle and/or Finance Leadership
• Clinical Operations and/or Nursing representative
• Corporate Responsibility
• AdventHealth Institutional Review Board

How do I register on ClinicalTrials.gov?

• Go to the “Request Contact Information” page at http://prsinfo.clinicaltrials.gov/contactrequest.html
• Enter “AdventHealth” as the PRS (Protocol Registration System) organization account name
• Enter your contact information
• Receive an email from ClinicalTrials.gov with the contact information for your PRS Administrator
• Contact Nicole Warner at [email protected] to set up a user account
• After you receive your account login information, go to the login page at https://register.clinicaltrials.gov/
• After you log in, you will see a “Help” section with links to instructions and informational documents including “Quick Start Guide” and “User’s Guide.” These documents will assist you with registering your trial
• After you enter your clinical trial information, your organization’s PRS Administrator will receive an email from ClinicalTrials.gov, and review your record entry before it is released for publication on the ClinicalTrials.gov site
• Within two to five business days after it is released, you can view the record, including the unique identifier, National Clinical Trial (NCT) number; once your clinical trial has an NCT number, you can modify it and add results
• For additional information, go to http://prsinfo.clinicaltrials.gov/ and/or http://www.icmje.org/

Which trials must be registered in ClinicalTrials.gov?

• Interventional studies of drugs, biologics and/or devices (NOT Phase 1 studies or small feasibility device studies) must be registered as required by law
• If you are conducting a study that is federally funded, it must be registered no later than 21 days after the first subject is enrolled
• Registration is required for journal publication; the International Committee of Medical Journal Editors (ICMJE) has a clinical trials registration requirement for publication
• Please see the Clinical Trials ACT Checklist guide below for more information on whether you need to register your study

Who is responsible for registering the clinical trial?

The “Responsible Party” is defined as:

• The Study Sponsor (IND/IDE holder, NIH Grantee, or the “initiator of the trial”), OR
• The sponsor-designated PI (PI responsible for conducting the trial, has access to and control over the data, has the right to publish the results and can meet all of these requirements)
• If it is a multi-site study, then the primary PI would be the responsible party for ensuring it is registered; it would only be registered once (it would not be registered by each individual site)

What is the ICMJE definition of a clinical trial?

In June 2007, the ICMJE adopted the WHO’s definition of a clinical trial: “Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.