The Fairfield University Institutional Review Board is charged by the Federal Government with protecting human subjects involved in research. The IRB performs prospective and continuing review of protocols, the informed consent process, and the procedures used to enroll subjects in order to ensure that the human subject research is conducted ethically and in compliance with the Belmont Report, and with applicable federal, state, local and institutional requirements.
If you have any questions about the process of IRB review, please contact IRB Chair Linda Henkel (x3269) On this site, you can find a variety of documents related to the IRB process. For information regarding federal regulations and the ethics of research involving human subjects, click here: Code of Federal Regulations.
How-To-Guides for submitting and updating Protocols, along with external documents concerning IRB regulations, are available by clicking Help > Help above.
For complete information on the protocol submission and review process, please see our Standard Operating Procedures.
Please Note: Submissions cannot be made by undergraduates. If you are an UNDERGRADUATE, your Faculty Mentor must, on your behalf, submit a Protocol under his or her own name.
If you are GRADUATE STUDENT, you can work with your Faculty Mentor to decide how best to submit a Protocol. Either (A) your Faculty Mentor submits it on your behalf under his or her own name, or (B) your Faculty Mentor begins the process on your behalf, creating a blank Protocol from his or her own account, then sharing it to you for editing. Consult your Faculty Mentor for further instructions, as he or she must ultimately submit the Protocol, regardless of whether (A) or (B) is decided on. Click on the "Help" tab above, the "Help" again for a complete "Grad Student Submission Process" guide for you and your Faculty Mentor to properly submit a Protocol. (Improper submissions will automatically be rejected!)
Submitting Your Research Protocol
Step 1: Determine Whether Your Project Requires Review by the IRB
Some research falls outside the scope of IRB review. Federal regulations require that IRBs review only certain types of research involving human subjects. The Federal Regulations under 45 CFR 46.102 defines research that falls under their purview as research in which both criteria (1) and (2) are met:
(1) The research activity involves human subjects -- living individuals with whom the investigator interacts in some way, or about whom the investigator collects private, identifiable information. If you are collecting public information about human subjects, then your research does not involve human subjects and falls outside the scope of the IRB review process.
(2) The activity must be research as defined by the regulations, that is, the activity must be a systematic investigation designed to develop or contribute to generalizable knowledge. This is a very gray area. Not all data collection is intended to produce generalizable knowledge. For instance, many activities that use the methods of scientific research are designed to evaluate the effectiveness of a practice in a particular setting, which is often referred to as "quality assurance" or "institutional research." These activities are typically not viewed by IRBs as falling under their purview, even if they use scientific research methods and use private identifiable information on human subjects.
If your project meets BOTH Criteria 1 and 2, proceed to Step 2. If it does not meet both criteria, submission and review is not required. However, because of the ambiguities in determining what falls within the scope of the IRB, if you are uncertain, it is best to submit a short description of your study to the IRB Chair via email and let the IRB make a determination.
The Office for Human Research Protections (OHRP) provides graphic aids and guides for researchers to determine if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.
To use the HHS determination charts, click here.
Step 2:Determining the Category of Research Your Project Falls Under
Research must be submitted to the IRB with one of the following designations: (a) Exempt, (b) Expedited Review, (c) Full Board Review, (d) Quality Improvement, or (e) Request Delegation to an External IRB.
(a) Exempt Research
Much of the research conducted by Fairfield University researchers qualifies for Exempt status. The most commonly used categories are listed below.
Exemption Category 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Exemption Category 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: () information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
Exemption Category 4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
For more detailed information about these and other
categories, click here.
You can also use this flow chart for determining what category of exemption your project is.
For detailed information on conducting educational research on the scholarship of teaching and learning, click here.
Many research projects conducted by Fairfield University researchers qualify to be reviewed under Expedited Review, for example, studies that involve minimal risk to participants.
Detailed information about the various categories of research eligible for Expedited Review can be found here.
You can also use this flow chart for determining what category of expedited review your project is.
Quality Improvement (QI) projects in healthcare settings involve systematic, data-guided initiatives or processes designed to enhance health care delivery in a particular setting. QI projects identify effective methods, implement the methods broadly , and evaluate the impact or effect of the implemented changes. Click here for more detailed information about QI Projects.
(e) Request Delegation to an External IRB
This category is primarily for studies conducted by faculty and students in the School of Nursing that are biomedical interventional studies (e.g., ones likely to be carried out by students in the CRNA program) that are being conducted at an external hospital or clinical site, and that would necessarily have to be reviewed by that site's IRB. The intention is to more efficiently have PIs have their research reviewed by the IRB with the most relevant expertise and without having to go through a second IRB in a redundant fashion. Click here for more information about Delegating to an External IRB.
Although all research applications must be submitted online through this website, you may use the below Sample Forms for reference.
Make sure to check out the "Help" tab found on the black ribbon at the top of your screen. It includes IRB and ITS Contact Information, links to official Human Subjects Testing reference materials, and detailed PDF tutorial guides on how to submit protocols, Sub-Forms (Annual Reports, Protocol Amendments, and Adverse Event Reports), and more using the Infonetica system.
Informed Consent Templates
The IRB offers the following templates as guides to writing your consent forms. They may be edited to suit the needs of your research. You may choose to create your own consent forms, but we strongly recommend using the below templates, as they have been designed to meet the Section 116: General Requirements for Informed Consent standards. (Should you choose to edit the template(s) or create your own consent form, it must also meet these Federal regulations.) You may wish to download the template(s) appropriate to your research prior to beginning your application, as you may be prompted to upload your consent forms at during the application process if you are applying for Expedited or Full Board Review. Please Note: The IRB does not review the consent process for exempt protocols. In this case, it is the responsibility of the investigator to decide if informed consent is appropriate or not, and if so, what manner in which it is obtained and documented.)
NEW:Research Involving Students as Participants
For detailed information on conducting research when research participants are students, please click here.
NEW: Research on the Scholarship of Teaching and Learning
For information on conducting educational research on the scholarship of teaching and learning, please click here.
Research conducted by Fairfield University investigators in foreign countries remains under University purview and guidelines. While we cannot impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research or for a meaningful consent process. If you plan on conducting research outside the United States, please read this information carefully.
Waiver or Modification of
Under special circumstances, the IRB may permit a modification or complete waiver of the requirements for informed consent. The Federal criteria for modification or waiver can be found in Section 117: Documentation of Informed Consent and should be reviewed by the investigator.
Certificates of Confidentiality
When research involves
particularly sensitive information (e.g., drug use, genetic information, etc.)
that is linked to subject identifiers, the IRB may require that the
investigator secure a "Certificate of Confidentiality" from the
National Institutes of Health, which can be found at the NIH
Certificates of Confidentiality Kiosk.
Any changes to existing protocols
should be reviewed by the IRB, as they may impact the risk/benefit ratio of the
protocol. To submit an Amendment, return to your protocol within Infonetica and choose "Create SubForm" from your protocol's Action menu. (The
tiles on the left.) You will be prompted to describe a summary of your
proposed changes. If your changes require modification of your consent
form, include your consent form along with the summary and use track changes to
highlight the changes you are making.
Annual Reports/Continuing Review
All protocols approved by Expedited or Full Board Review procedures are required to submit an Annual Report providing information about the number of participants tested. The Annual Report Form is a fill-in form that requires basic information about the number of study participants and your protocol's status. Through the form, you will indicate whether you are requesting Continuation of the research or are Terminating the protocol. To submit your Annual Report, return to your protocol within Infonetica and choose "Create Sub-Form" from your protocol's Action menu. (The tiles on the left.) As a reminder to submit this form, you will be sent an automated e-mail 30 days prior to your protocol approval's expiration date. If you fail to submit a Annual Review form, the protocol approval will be terminated and all related research should cease.
In the event that a human subject is harmed as a result of participation in your project, it is necessary that you immediately inform the IRB.To submit your Adverse Event Report, return to your protocol within Infonetica and choose "Create Sub-Form" from your protocol's Action menu. (The tiles on the left.)You should include in your summary your judgment of whether the harm to the subject was a result of their participation in the project or incidental to it. You should also indicate if you think that the event warrants any changes to your protocol or consent form. If so, discuss these potential changes with the IRB before then submitting a protocol Amendment.