Office of Research Integrity and Compliance Resources
Documents and Resources
The Institutional Review Board (IRB) reviews all research conducted at AdventHealth Orlando or by AdventHealth employees/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 webpages.
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 Orlando?
- The Office of Research Integrity 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 non-employees 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
Attn: COI Official – Public Accessibility Request
800 N. Magnolia Avenue, Suite 500, Orlando, FL 32803
Click here for the COI Training Video
The accompanying COI Quiz can be found below:
The Research Billing Compliance Program seeks to ensure that AdventHealth Orlando 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.
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 (ORI) 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/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 of their research.
The ORI 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.
The ORI provides support and guidance for our research investigators that 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.
ROC provides oversight, support and resources for research compliance elements of the Office of Research Integrity (ORI) Research Compliance Program.
ROC responsibilities include:
- Providing accountability to ORI Research Compliance team to execute on 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 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:
- AH Legal Department
- AH Medical Group (Physician Enterprise)
- Physician representatives
- AH Revenue Cycle and/or Finance Leadership
- Clinical Operations and/or Nursing representative
- Corporate Responsibility
- AH Institutional Review Board
Registering your Project on ClinicalTrials.gov
How do I register on ClinicalTrials.gov?
- Go to the “Request Contact Information” page, found at http://prsinfo.clinicaltrials.gov/contactRequest.html
- Enter “Florida Hospital” 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 your PRS Administrator, Nicole Warner (at Nicole.Warner@AdventHealth.com), to set up a User Account for you.
- 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 containing links to instructions and informational documents including the following; “Quick Start Guide” and a “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 2-5 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 have to be registered in ClinicalTrials.gov?
- Interventional studies of drugs, biologics, and/or devices (NOT Phase 1 studies or small feasibility device studies) have to 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 has the ability to 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 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.