Welcome to the CF Institutional Research Board.
This website provides the required information, forms and training related to the ethical conduct of research needed to submit an application to the IRB. All individuals (inside or outside the college) who desire to conduct any systematic investigation that involves obtaining any information about CF individuals (administrators, faculty, staff or students) to contribute to generalizable knowledge must obtain official CF IRB approval.
More background on the history and legal requirements for protection of human subjects can be found in the training presentation for Research Review Board members.
The CF Institutional Effectiveness Office acknowledges the assistance of Sinclair Community College and Valencia State College in allowing adaptation and adoption of IRB materials.
The Institutional Review Board is made up of individuals who are authorized to review, approve, require modifications in or disapprove research activities that involve human subjects conducted by or through the College of Central Florida.
The IRB is composed of full-time employees (with the exception of the community and student representatives) with varying backgrounds and expertise to comprehend the nature of the research, as well as other competencies necessary to interpret regulations, relevant law, ethical standards, and standards of professional practice.
The IRB meets quarterly to review applications. The deadline for submitting an application is three weeks prior to a scheduled meeting date. Applications that are received after a deadline will be considered for the next scheduled deadline.
Applications that are eligible for expedited review will be accepted year-round. Email email@example.com to determine the status, timeline and appropriate process for your application.
2019-2020 Committee Members
- Dr. Jillian Ramsammy, VP of Institutional Effectiveness and College Relations
- Dr. Tammi Viviano-Broderick, Dean, E-Learning and Learning Resources
- Carol Blakeman, Senior Professor, Nursing
- Tammy Martineau, Faculty, Health Sciences
- Lisandra Sorrento, Faculty, Health Sciences
- Allison Campbell, non-affiliated local citizen
- Matthew Danuff, CF student
The College of Central Florida holds to the highest standards of ethics in the conduct of all research. The college may disapprove any research project, at any time, if there is evidence of research misconduct. Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
- Fabrication is making up data or results and recording or reporting them.
- Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
- Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
Research misconduct does not include honest error or differences of opinion.
Relevant definitions that guide the IRB process are published in the Code of Federal Regulations, Title 45 Public Welfare Department of Health and Human Services Part 46 Protection of Human Subjects.
Selected definitions are excerpted here for quick reference from U.S. Department of Health and Human Services. Please refer to the Institutional Review Board Guidebook for more detailed information.
- Expedited review: Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
- Federal Policy: The federal policy that provides regulations for the involvement of human subjects in research. The policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the policy applicable to such research. Currently, 16 federal agencies have adopted the Federal Policy. (Also known as the Common Rule.)
- Human subjects: “Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
- Informed consent: A person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence
- Institutional Review Board: A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.
- Longitudinal study: A study designed to follow subjects forward through time.
- Principal investigator: The scientist or scholar with primary responsibility for the design and conduct of a research project. (See also: Investigator.)
- Privacy: Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
- Protocol: The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data
- Random, random assignment, randomization, randomized: Assignment of subjects to different treatments, interventions, or conditions according to chance rather than systematically (e.g., as dictated by the standard or usual response to their condition, history, or prognosis, or according to demographic characteristics). Random assignment of subjects to conditions is an essential element of experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.
- Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Respect for persons: An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
- Retrospective studies: Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.
- Review (of research): The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis.
- Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only “minimal risk.”
- Voluntary: Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject’s decision to participate (or to continue to participate) in a research activity.
Approval, Training and Forms
No research involving human subjects is to be conducted at the College of Central Florida except for research in which the only involvement of humans is in one or more of the categories exempted or waived under 45 CFR 46.101(b)(1-6) or 101(i). This applies to all research involving human subjects conducted by CF faculty, staff and students, and in all other activities that, even in part, involve such research, regardless of sponsorship.
The list of exempt categories and the basis for this policy are explained in the IRB Implementing Procedure adopted by the college.
CF research investigators who intend to involve human subjects in research activities do not have the authority to make an independent determination that proposed research involving human subjects is exempt from the applicable regulations. That determination will be made by the Institutional Review Board, which has been established in accordance with federal regulations by CF to safeguard the rights and welfare of human subjects participating in research at CF.
The IRB chair, designated member, or full membership are responsible for reviewing the preliminary determinations of exemption made by investigators and their supervisors and for making the final determination.
To help you get started, the Office for Human Research Protections of the Department of Health and Human Services provides a decision tree as a preliminary guide to evaluating your project. Does your research activity have to be reviewed by the IRB? Can the review go through the expedited process? Can informed consent be waived?
Once you make a preliminary determination to apply for IRB approval at CF, complete the IRB Participation Request form.
If your research approval is about to expire, or you must terminate your research before it is complete, please submit the Continuing Review/Termination form.
In the event you or participants have concerns about the research, or participants withdraw from the research, please submit the Participant Withdrawal Complaint form.
Changes in research activity that has already been approved by the IRB may not be initiated without IRB approval. Investigators are responsible for reporting any changes to approved research, please submit the Addendum/Modification Request form.
In the event there is an adverse event, or unanticipated problem, please submit the Adverse Event/Unanticipated Problem/Increased Risk Report form.
The Participation Request form will be incomplete until all required documentation is received.
All forms should be submitted to firstname.lastname@example.org.