The Institutional Review Board serves to protect the rights and concerns of human subjects participating in research by New College students or faculty.
Undergoing CITI Training is the first step to getting IRB approval. CITI training will be several hours of reading and quizzes that will train you on the ethical treatment of human subjects.
You can sign up for CITI training here.
If your research includes 1) the use of human subjects, and/or 2) is funded by a federal or flow-through grant or contract, you are required to complete either or both training components. This applies to:
We use the training services of the University of Miami’s Office of Research Education. They have spent years developing a comprehensive system of online training called the Collaborative Institutional Training Initiative (CITI) Program.
Click here to login or, if first time user, click on Register for the CITI Course. If registering for the first time, make sure you select NEW COLLEGE OF FLORIDA as the institution. If you are returning, make sure you remember your username and password. If you forget, the online course will allow you to email the username or password to the email address you originally indicated as your permanent email. Or you may email firstname.lastname@example.org for assistance.
When you’re starting CITI training, you will be asked to select a category of training that applies to your Human Subjects Research (HSR); there are seven categories to choose from:
It will probably be pretty obvious to you which one your project falls under, but if it isn’t remember that you can always ask your advisor/sponsor about it and they will be able to help you choose.
The next step will be to select which category of RCR training you will need to undergo.
NOTE: If you do NOT need human subject research training, but do need to complete responsible conduct in research training because you are assisting on a sponsored research project with a NCF Faculty member, select Group 7 above and select the appropriate group for RCR training below. If in the future, you need human subject research training, you may log back into CITI, select the appropriate human subject research group and complete that separately.
After selecting your HSR section, you will choose a category for your Responsible Conduct of Research training (RCR), there are only four choices here, and it will be pretty obvious which one your project falls under.
New College of Florida is committed to the ethical conduct of research and is in compliance with Section 7009 of the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science (America COMPETES) Act which requires that an institutional plan be in place to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in National Science Foundation (NSF) funded research projects. In January 2010, the NSF implemented a Responsible Conduct in Research (RCR) Policy for all researchers receiving grant funding.
The Principal Investigator (PI) (which could be a faculty member, staff member or student) will be responsible for completing and providing appropriate RCR training for anyone who will work on the PI’s NSF-funded projects. Responsible conduct in research is critically important to everyone at New College. Unethical practices can have a campus-wide effect.
Therefore, New College of Florida requires all personnel that work on research projects funded by federal and flow through funds to complete the appropriate RCR training BIENNIALLY*.
While this would seem not to impact the majority of our community, it does represent a change to our CITI (the Collaborative Institutional Training Initiative) Program and Human Subject Research (HSR) Training. The CITI Program is the training service we use for our HSR training and will be the program for RCR training, as well.
After you choose your categories, you will be ready to start your CITI training!
The Mentor System is the place to upload all your completed documents for IRB review, and hey, since we’re talking about mentors, make sure you’re talking to your mentor AKA your advisor/sponsor about the process of your IRB review.
To access The Mentor System, go to the following link:
Your log-in credentials are the same as your NCF credentials without the “@ncf.edu” part.
When you’re applying, there’s a part of the application that will ask your to choose a “review type,” there will be three categories:
The nature of your project will determine which one you select.
You’ll choose Exempt Review Requested if:
You’ll choose Expedited Review Requested if:
You’ll choose Full Board Review if:
If you are not sure which of these categories your project falls under, then you can take the pre-diagnostic survey. You can find the pre-diagnostic survey in the mentor system. To do so, go to “create new application,” then select “pre-application survey.”
If you plan to use animals (or any component of animals) in your research, project, or classroom instruction, including observational data or the use of animal tissue, please contact the IRB at email@example.com to obtain required approval by an Institutional Animal Care & Use Committee (IACUC). IACUC boards safeguard the protection of animal subjects in all research and development activities, whether externally funded or not. They follow federal policy guidelines, specifically, DHHS (NIH) Public Health Service Policy on Humane Care and Use of Laboratory Animals (Policy) and Guide for the Care and Use of Laboratory Animals.
New College does not have an independent IACUC and therefore utilizes this service via University of South Florida (USF), meaning your application will be routed through the USF system for approval. The IACUC Research Compliance Administrator at USF can be contacted at firstname.lastname@example.org and 813.974.7106. Keep in mind that:
Approval in advance is required before you may begin your research, and the process for IACUC approval can take up to 2 months, so please keep that in mind. Also know that ORPS serves as the administrative support and coordinating arm for the IACUC, and has no authority to review or approve any application submitted.
There are several types of applications (however only the first 3 would apply for research on New College campus):
Guidelines for application completion can be accessed here. The USF IACUC committee meets once a month to review and approve applications.
Your approval is valid for up to three years, however you will be sent a Continuing Review Form each year for you to complete if the research or project is ongoing. If you need to make a modification to your protocol, please notify the New College’s IRB at email@example.com to determine the correct form to complete and submit.
New College of Florida seeks to ensure the safety of all human subjects including those projects that may involve the use of biological or physiological studies on humans or on their material acquired from humans.
As such, the IRB has provided some initial readings on Bioethics as well as a CITI training course specifically designed for those students in the Natural Sciences who will use human subjects as part of their research. It also is designed for students interested in bio-ethics, pre-med, and genetics coursework. It may be used by a variety of biology, bio-chemistry and chemistry professors. Log on to CITI and select Group 5 Bioethics and/or Genetics Training Only.
Selected readings and websites on Bio-Ethics
The Nazi Hypothermia Experiments: Forbidden Data? David Bogod (2004) Anesthesia 59 (12) http://www.blackwell-synergy.com/doi/full/10.1111j.1365-2044.2004.04034.x?cookieSet=1
The Hastings Center is an independent, nonpartisan, and nonprofit bioethics research institute founded in 1969 to explore fundamental and emerging questions in medicine, health care, biotechnology. www.thehastingscenter.org/default.asp
The IRB serves to protect the rights and concerns of human subjects participating in research by New College students or faculty. The IRB also reviews research protocols involving human subjects by others outside the campus wanting to use New College students in their research, although most other institutions will review their work first. The important key is that we are seeking to protect the welfare and health of human subjects.
The board strongly encourages all faculty and students to read the Policy and Procedural Manual.
If you have specific questions that are not addressed below, please direct them to the Human Protections Administrator (HPA),Lee Ann Rodriguez or Coordinator, Hana Boed, in the Office of Research Programs and Services (ORPS).
If you have a senior thesis or an independent research project that will use human subjects, it will require a review. Even if you believe your research to be exempt from review, that does not mean you do not need to seek approval. All research conducted by New College faculty or students that involve human subjects requires IRB review and approval. The most common situation that arises is research conducted in a classroom setting. This type of research does not need approval if the research is not generalizable outside of the classroom setting. The problem exists if that research will be used later on as part of the research that will be generalizable. If you have any plans on using research in the future, obtain approval through the IRB first. Please check with the HPA if you have questions.
In addition, we are asked many questions regarding anthropological and ethnographic research. The American Anthropological Association has adopted a statement on Ethnography and IRB review
The application and other material can be found thorough the Mentor IRB website. Go to https://www.axiommentor.com/login/axlogin.cfm?i=ncf and use your NCF credentials to access the system There, you will find the applications and materials and you will then be able to “start” an application.
The board requires that all applications are completed and submitted electronically including any materials that will be used (such as recruitment material, informed consent forms, etc.). If you are a student, you must enter your faculty advisor in the system. You do NOT have to attach completed training certificates as the certificates are emailed directly to the HPA upon completion of the course.
The IRB will meet at least once per semester. All applications will be reviewed on a continuing basis. Please allow at least 2 weeks for review and approval. The cutoff dates for review and approval are as follows: April 15th for research beginning the following Summer and Fall (June 1 – December 31); November 15th for research beginning January ISP and Spring (January 1 – May 31). If the 15th falls on a weekend, the deadline will be the following Monday. Applications received after these deadlines may not be reviewed in that semester. The IRB does not review new applications over the summer.
This question is asked quite a bit. We have provided you with templates to use that will greatly reduce your informed consent creation. Please note: These templates are not a requirement if you plan on using a written informed consent document. You may prefer to use a “narrative” type document. If so, you may use the structure of the templates provided in the forms section to help you include the right kinds of information.
Even the best laid plans sometimes need modification, especially with research. If you foresee a need to change your protocol procedures in ANY way (examples include but are not limited to, reduction in population pool, change in population selection, survey instrument change, site change, expanding the population pool, etc.), you are required to complete a Modification Request Form, have it signed by the faculty advisor and submit the signed original form to the HPA.
First and foremost, ensure the subjects safety and care. If the adverse event is not life-threatening, be sure complete and Adverse Event Form and submit the form immediately to the IRB after the event, but no later than 10 working days after the event.
Great question! Proper closure of your protocol is just as important as opening one. After all of your data is collected and analyzed and you are completing your thesis or report, remember to complete the Final Report Form, have your faculty advisor sign it (if applicable) and turn it in to the IRB. We will then officially close your protocol.
Maria Vesperi, Social Sciences, Chair
Sonia Labrador-Rodriguez, Humanities
John Doucette, Natural Sciences
Winn Wasson, Social Sciences Librarian
Sandra Justice, Non-affiliated Member
Lee Ann Rodriguez, Administrator
Since January 27, 2016 participating State University System of Florida Institutions entered into an IRB Reciprocity Agreement and Memorandum of Understanding (MOU) concerning the use of each other’s IRB for research that will be conducted by investigators at those institutions. Criteria for determining the reviewing IRB includes:
To learn more about the MOU and who the participating institutions are, click here.