The Institutional Review Board serves to protect the rights and concerns of human subjects participating in research by New College students or faculty.
The Institutional Review Board (IRB) reviews projects and experiments involving human subjects that take place at New College. The IRB makes sure that the experiments are conducted under the basic ethical principles of respect to the persons involved, beneficence and justice.
All research by New College faculty, staff and students involving humans must be reviewed and approved in advance by New College’s IRB. This means that if you are going to conduct an experiment involving humans, you need to get IRB approval before you can start collecting your data. Depending on your project, the review process can be detailed, as it is very important to make sure your experiment meets ethical standards.
We have some tips that can help make your IRB process as smooth as possible. Students, remember to talk to your advisor/sponsor every step of the way! They are resources to ensure your IRB proposal is accepted as quickly as possible. For a quick overview of the process, download the IRB step by step guide for offline viewing. This video also gives an in-depth look at the IRB and its value to our institution.
You should plan on a minimum of two weeks from the time you submit your IRB application to the time it is initially reviewed. Final approval depends on the adequacy of what is submitted. ORPS initially reviews all applications submitted for completeness and will return the application if it is not complete. The IRB meets monthly to discuss full review protocols and other IRB related matters. The IRB may invite you to these meetings for clarification and discussion of your proposed research.
For researchers (employees or students) of other institutions that wish to conduct research at New College, their protocol must be reviewed and approved in advance by the New College’s IRB. For research that will take place at other State University System of Florida Institutions, please scroll down to the IRB Reciprocity Agreement and Memorandum of Understanding section for guidance.
Click here to access a summary of all changes that took place on January 21, 2019. Links to related sources and detailed handouts and presentations specific to the topics with significant changes.
The Revised Federal Guidelines took effect Jan. 21, 2019. An important revision is that Oral History will no longer require IRB approval. The following activities are deemed not to research: (1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. [§__.102(l)(1)].
The Foundation, and thus SRTG funds, are allowed to be used for compensating human subjects. This pertains to an amount under $25 per participant. Furthermore, students must log a receipt of the cash transactions (under faculty supervision) that must be provided to the CEO. Note that the cash logs must contain the Principal Investigator name(s), the date/time, participant Initials, and participants must affirm via a checkbox that they received the cash with initials in place of signatures. Researcher signs this sheet. The log sheet should never be linked with any data and must be submitted in hard copy instead of email, to the CEO. According to the rules of SRTG funds, students would have to also submit a receipt log that states the IRB protocol number, the project name, the total amount of dollars that went to pay participants, and the student’s name with signature.
Please click here to access all IRB-related forms that you will complete throughout your research process.
Completing 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 a training service developed by the University of Miami called the Collaborative Institutional Training Initiative or CITI Program for short.
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 email@example.com 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 an 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.
New College of Florida is committed to the ethical conduct of research and compliance with federal requirements. Principal Investigators (PI) and their project team (faculty member, staff member and/or student) conducting research with direct or flow-through federal funding are required to complete RCR training BIENNIALLY*. At New College, we utilize the CITI Program for this as well.
Following is the procedure to access the RCR training via CITI.
Step 2: Create an account/register with your NCF email address
Step 3: Choose New College of Florida
Step 4: Choose the RCR training related to your discipline (Humanities, Biomedical or Social & Behavioral) and recruiting population (Vulnerable or Non-Vulnerable)
Step 5: Complete all the RCR required courses with a score of at least 80% for each course
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.”
New College does not have an independent Institutional Animal Care and Use Committee and therefore utilizes this service via the University of South Florida (USF), meaning your application will be routed through the USF system for approval. You may contact the IACUC Research Compliance Administrator at firstname.lastname@example.org and 813.974.7106. All resources can be accessed at USF’s IACUC web page.
All research, teaching activities and field studies involving live vertebrate animals by New College faculty must be reviewed and approved in advance by the USF’s (IACUC). Only faculty, and not students, can request IACUC review and approval.
Approval in advance is required before you may begin your research, and the process for IACUC approval can take up to 3 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.
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 at 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 any 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 through 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 meets monthly during the fall and spring semesters. All applications will be reviewed on a continuing basis. Please allow at least 2 weeks for review. To ensure your protocol is reviewed in time for research starting in the ISP session/spring semester, please submit your application by the Friday following fall break. To ensure your protocol is reviewed in time for research beginning in the summer/fall semester, please submit your application by the Friday following spring break. .
This question is asked quite a bit. Templates with required language are available here.
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 with the authorization of your faculty advisor and submit the form to the HPA via the Axiom Mentor system.
First and foremost, ensure the subject’s safety and care. If the adverse event is not life-threatening, be sure to complete an 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 into the IRB. We will then officially close your protocol.
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.
Sherry Yu, Social Sciences (Chair)
Uzi Baram, Social Sciences
Don Colladay, Natural Sciences
Nicolas Delon, Humanities
Feng Hao, Non-affiliated member
Clifford Lundin, Admissions
Tania Roy, Natural Sciences
Hana Boed, Administrator (Ex-Officio)