Institutional Review Board

The Institutional Review Board serves to protect the rights and concerns of human subjects participating in research by New College students or faculty.

What is the IRB/IACUC? IRB stands for Institutional Review Board, and its purpose is to review the various projects and experiments involving human subjects that take place at New College. The IRB/IACUC makes sure that the experiments are conducted under the basic ethical principles of respect to the persons/animals involved, beneficence, and justice.

All research by New College faculty, staff and students involving human or animal subjects must be reviewed and approved in advance by New College’s IRB. This means that if you are going to conduct an experiment involving human or animal subjects,  you need to get IRB/IACUC 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.

Below we’ll give you some tips that can help to make your IRB process as smooth as possible. Students, remember to talk to your advisor/sponsor every step of the way! They are a key resource when it comes to making sure your IRB proposal is accepted as quickly as possible. For a quick overview of the process, check out this helpful presentation, or download a PDF presentation here 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. Since January 2017, the IRB meets monthly to discuss 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 (MOU) section for guidance.

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:

  • Students conducting human subject research as part of their thesis (funded by grant funds or not)
  • Faculty who are the advisor of a thesis student conducting human subject research
  • Faculty and students who are working on any externally funded research (with or without human subject research).

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 irb@ncf.edu 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:

  1. No vulnerable populations in your study (children, prisoners)
  2. Vulnerable populations in your study
  3. ONLY vulnerable populations in your study
  4. IRB members only (this will not be you)
  5. Bio-ethics and/or genetics
  6. Humanities/Oral History projects (this isn’t an exemption from IRB review!)
  7. No human subject training necessary (only choose this if your project has no human subjects but you still need to take RCR training.)

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.

 

RCR

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.

  1. Social and Behavioral
  2. Arts and Humanities
  3. Biomedical and Physical Sciences
  4. Research Staff and Administrators

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.

http://www.nsf.gov/bfa/dias/policy/rcr.jsp   

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*.

*Effective 5/12/2016

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:

The Mentor System

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:

  1. Full Board Review
  2. Expedited Review Requested
  3. Exempt Review Requested

The nature of your project will determine which one you select.

You’ll choose Exempt Review Requested if:

  1. Your subjects are anonymous and at minimal risk.
  2. Your research is on regular classroom activities and tests.
  3. Your research is conducted only by observing your subject and not interacting with them.
  4. You are collecting and studying data that is publicly available.
  5. Your research is for taste/food quality/consumer studies.

You’ll choose Expedited Review Requested if:

  1. Your subjects are at minimal risk but their participation is not anonymous.
  2. Your project is an oral history, is survey-based, is interview-based, or is focus group-based.
  3. You are collecting blood via finger prick or other noninvasive means.
  4. Your research materials were originally collected for nonresearch purposes.
  5. Your data is from voice recordings, video or other digital recordings made for research purposes.
  6. You are applying for a continuation of an already active project.

You’ll choose Full Board Review if:

  1. The risk posed to your subjects is more than minimal.
  2. You are conducting research on sensitive subject matter.
  3. Your subjects are only from vulnerable populations.

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.”

IACUC

The Institutional Animal Care and Use Committee (IACUC) is a board similar to the IRB, but it concerns animals instead of humans. If your project is going to need approval from the IACUC, the process will be overseen by USF’s IACUC board, as New College does not have one. 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 irb@ncf.edu to obtain required approval by an IACUC.

There are several types of applications (however only the first 3 would apply for research on NCF campus):

  1. Use of Animal Tissues – In order to document that appropriate practices of acquisition, use, and disposition of animal tissues are followed, and with appropriate consideration of occupational health and safety, this application must be submitted whenever animal tissues are requested from an IACUC-approved protocol, another institution, or other source.
  2. Study of Wild Animals In or From Natural Settings
  3. Use of Animals in Research  – All vertebrate animal use must first be described in a draft IACUC application and pre-reviewed by University veterinarians.
  4. Establish/Maintain a Mouse Colony
  5. Application for Antisera Production

It is recommended to notify the IRB at least two months in advance of your research or project commencing. 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 NC IRB at irb@ncf.edu to determine the correct form to complete and submit.

Bio-Ethics Compliance

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 Ethics Of Using Medical Data From Nazi Experiments Baruch C. Cohen http://www.jlaw.com/Articles/NaziMedEx.html

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

Why do we need an IRB?

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).

Belmont Report

Nuremberg Code

NCF IRB Policy Guide

Do I need to submit an application?

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

What do I submit?

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.

How do I submit 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.

How often does the IRB meet and when can I expect an answer?

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.

What should I include in my written informed consent document?

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.

What if I want to change something to my approved protocol?

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.

What happens if something goes wrong?

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.

My research is complete. What else does the IRB need?

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.

Current IRB Members

Maria Vesperi, Social Sciences, Chair
Sonia Labrador-Rodriguez, Humanities
John Doucette, Natural Sciences
Alyson Gamble, Science Librarian
Darcy Young, Nonaffiliated 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:

  • The location that is the prime recipient of the research award; or
  • The organization with which the lead Principal Investigator for the study is primarily affiliated or employed (in studies where the research is not funded by an external award); or
  • The location where the following shall entirely or substantially take place: human contact, interactions or interventions with the human subjects, or private, identifiable information is obtained or
  • Upon mutual agreement of the Participating Organizations based on other factors.

To learn more about the MOU and who the participating institutions are, click here.

FOR MORE INFORMATION

For general inquiries regarding grants and contracts, email ORPS@ncf.edu.

For general inquiries regarding IRB applications and information, email IRB@ncf.edu.