Contact

Robert Halliday
Chair

(315) 792-3122

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?
How does the IRB work?
How do I know if my project needs to be reviewed?
How do I submit an IRB application?
Does "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?
When does my NIH Training Certificate number expire?
Will a CITI Training Certificate number be accepted?



What is an Institutional Review Board?

An Institutional Review Board (IRB) reviews research proposals in order to be sure of the safety and well-being of human research subjects. The 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 college 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.

How do I submit an IRB application?

IRB applications to conduct research involving human subjects are submitted via an online form. Click the "Forms and Guides" link in the left navigation column and click on the first Forms link on that page called "New Application for Human Subjects Research Approval." 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. 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 questions at the bottom of the page, which can be used for draft purposes and to give to a professor or faculty advisor before submitting the actual application online.
 

Does "exempt" research need to be reviewed?

Yes, it does. 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.


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.

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.

Can I edit my IRB application after hitting the "Submit" button?

If you submit your application you can "withdraw to edit" it until the IRB administer 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 Office of Graduate Studies at ogs@utica.edu or (315) 792-3335 and ask for your application to be "Returned for Revisions."
 
When does my NIH Training Certificate number expire?
NIH training numbers do not expire, and Utica College does not require periodic retraining. If you do not remember your certificate number you can always log back into the training site and retrieve it.
 
Will a CITI Training Certificate number be accepted?
Utica College's IRB will accept either NIH or CITI training, and the online IRB application form will accept either certificate number.  Neither certificate number expires, and Utica College does not require periodic retraining.