Frequently Asked Questions

Frequently Asked Questions

Frequently Asked Questions



The IRB process can be confusing.  While we have tried to make the process as clear and simple as possible, there are sure to be questions.  Here are the answers to the most frequently asked questions.  If you do not see the answer to your question here, please contact the IRB.

What is an Institutional Review Board and why is it important?
How does the IRB work?
How do I know if my project needs to be reviewed?
How do I submit an IRB application
What is research?
What activities do not count as research?
What is exempt research?
D
oes exempt research need to be reviewed?
Does an "expedited/delegated" review mean I'll get approved faster?
Do I need to submit if I'm only doing a survey?
What if it is an anonymous survey?
What is the difference between anonymous and confidential?
What is an unanticipated problem or adverse event?
Can I edit my IRB application after hitting the "Submit" button?
Do instructors need IRB approval for class research projects?
When does my CITI Training Certificate number expire?
What about training completed before the new common rule?



What is an Institutional Review Board?
The Institutional Review Board (IRB) is an independent committee established to review and approve research involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects. Informed consent is an important component.

Utica University's board was created and is operated according to state and federal mandates. They are required to review research that is conducted by students, faculty, and staff.


How does the IRB work?
The IRB works with federal guidelines to review research proposals from the point of view of the human subjects, to be sure that the research is safe, ethical, and fair to participants. Anyone at the university who is pursuing research (students, faculty, and staff) must present a proposal for review and receive approval before proceeding. The board members are appointed by the Provost.

How do I know if my project needs to be reviewed?
If the research involves human subjects, it needs to be presented to the IRB for review. 

According to the IRB, a project is human subjects research if the researcher obtains data through interacting with one or more people or through obtaining identifiable private information. 

Some projects may or may not be exempt from review. According to federal guidelines, the IRB (not the investigator) should determine whether each human subjects research project is exempt from review, eligible for expedited review, or required to undergo full review. If students wish to generalize their conclusions or disseminate their findings, they should complete either the IRB Research Proposal Template and submit all appropriate materials to the IRB before beginning the research. If the IRB determines that the research needs a delegated or convened review, the researcher will be instructed to complete the IRB application.

How do I submit an IRB application?
IRB applications to conduct research involving human subjects are submitted via an online form.  You may start completing the application and return to finish completing it at a later time. The application consists of multiple sections, and you can save your information on a given page (button at bottom of the page) and move between sections using the "Go to:" drop down box in the upper right corner. The application requires Utica University email addresses for all investigators that are part of the research. If you have investigators from outside of Utica University, you can add their name, email address and certificate number to the proposal on the 'Additional Information' section of the proposal. Once you have entered all of your information and reviewed it for accuracy and consistency, the submit button is on the very last section page. Note that there is a Word template version of the IRB application which can be used for draft purposes and to give to a professor or faculty advisor before submitting the actual application online.
 
Under Federal law human subjects research is defined as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."
 
What activities do not count as research?

The following activities are deemed not to be 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. The Utica University IRB has taken the position that oral history projects do not need to be reviewed and approved by the IRB. However, it should be noted that every effort should be made to protect the human subjects involved.

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

 
What is exempt research?
Exempt research is research that does not need to be subject to full board review. The most common categories of exempt research are:

Benign behavioral interventions - behavioral (not biomedical) interventions in conjunction with collecting information from an adult subject through oral or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and certain conditions are met. The regulations also add that benign behavioral interventions are:
• Brief in duration
• Harmless
• Not likely to have a significant adverse lasting affect on the subjects
• The investigator has no reason to think the subjects will find the interventions offensive or embarrassing.

Accepted Educational Settings - Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
 
Educational Tests - Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
 
(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination.
 
 
Existing Data - Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or the information is recorded by the investigator in such a manner that the subjects cannot be identified directly or through identifiers linked to the subjects.
 
 
Does "exempt" research need to be reviewed?
Yes, it does, except for oral histories which the Utica University IRB has determined do not need to be reviewed and approved by the IRB. For all other research, only the IRB can decide whether or not research is exempt. All research involving human subjects needs to be proposed, the IRB will then decide whether the research is exempt under law or if it needs further review. The Application for Exempt Status form is used to request exempt status from the IRB.

Does an "expedited/delegated" review mean I'll get approved faster?
Not necessarily, expedited/delegated simply means a different process of review. Expedited/delegated means that the proposal does not need to be reviewed by the whole committee during a convened meeting, only by select members. However, a well written and perfectly formed proposal for full/convened review could take the Board less time to review than a poorly organized and poorly written proposal that is expedited/delegated.
 
Do I need to submit if I'm only doing a survey?
Yes, any research involving humans, including surveys needs to be presented to the IRB. In most cases research involving only surveys is considered exempt. The Application for Exempt Status form needs to be submitted to the IRB for review and determination.

What if it is an anonymous survey?
The IRB will determine if it is truly anonymous or if the information provided by the participants reveals the subject's identity.  See the distinction provided below regarding the difference between anonymous and confidential.

What is the difference between anonymous and confidential?
   Anonymous means not identifiable by name OR some other identifier (e.g., ID number), so the individual cannot be discerned in any way. No one (not even the researcher) can link an individual person to the responses of that person.
   Confidential means private, secret, not universally available, or known only to a select few. The researcher can (or could) identify individuals who participated in the study, perhaps through a code. Although the identities will be recorded, the information will only be used for specific purposes related to the project and outlined to the participant in the consent form. The identity of the participants will never be known to the public.

What is an unanticipated problem or adverse event?
An unanticipated problem generally includes any incident, experience, or outcome that meets ALL of the following criteria:
(1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents,such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
(2) related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
(3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
The term adverse event in general is used very broadly and includes any event meeting the following definition: "Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research." Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.

If you submit your application you can "withdraw to edit" it until the IRB begins to review it at which point this will no longer be an option. If you are no longer able to "withdraw to edit" your application, you may contact the IRB at irb@utica.edu and ask for your application to be "Returned for Revisions." 
 
If the goal of the class project is to learn about conducting research or how to implement a particular procedure—in other words, if the goal is purely educational—IRB approval is not required. Also, if the outcomes of the class project are not disseminated outside the class setting, IRB approval is not required but instructors teaching courses that fall under "Research Methods" must fill out all appropriate paperwork which can be found at http://www.utica.edu/irb/forms_guides.cfm.


CITI training is valid for 3 years. Valid, unexpired training is required to submit an IRB proposal. If you do not remember your certificate number you can always log back into the training site and retrieve it.
 
Due to the many changes instituted as part of the 2018 revised common rule, the Utica College IRB requires that the required training be completed by students, faculty and staff who expect to be undertaking or overseeing research in 2019 and beyond, and all IRB Committee Members. Training modules are specifically designed for each of these groups.

 
 

Contact Us

Maria DeGiglio

Maria DeGiglio

Chair
irb@utica.edu
(315) 792-3122

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