Office of Research Integrity 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
901 N Lake Destiny Rd, Suite 400
Maitland, FL 32751
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