Institutional Review Board (IRB)
The Western New England University Institutional Review Board (IRB) is responsible for reviewing all human subjects research conducted on campus (or by university researchers off-campus). The purpose of this board is to ensure the protection and ethical treatment of all participants taking part in university-related research.
The University has developed a distributed IRB structure in an effort to expedite this process. While higher risk studies are still reviewed by the full board, minimal risk studies can be submitted to the appropriate intake representative (see below). These board members will conduct all exempt and expedited reviews (with the exception of research conducted by investigators not affiliated with the University, which are handled by the Chair). Submissions for full board review must be received at least TEN DAYS prior to the scheduled meeting date (see below). University intake representatives will forward any studies requiring full board review to the Chair for further communication. All other applications can be submitted for review at any time. Applications will be reviewed as promptly as possible, in the order in which they were received.
Online training is required prior to IRB application approval to meet federal requirements for training researchers using human subjects. Online training is offered through the Collaborative Institutional Training Initiative (CITI) Program. The program has been customized to educate researchers regarding activity specific to their domains (i.e., Biomedical vs. Social-Behavioral-Educational). Training must be renewed every three years and certificates of completion can be accessed through the CITI website. Please attach a copy of your CITI certification along with your IRB application. If you already have CITI certification through another institution, you may attach that instead. For instructions on how to access training, please visit the FAQ section. Any further questions regarding training can be directed to the IRB chair.
Intake Representatives during the academic year are as follows:
College of Arts & Sciences:
Dr. Tamara Shattuck, Assistant Professor of Education, email@example.com
College of Business:
Dr. Robert Kleine, Professor of Marketing, firstname.lastname@example.org
College of Engineering:
Dr. Matthew Romoser, Assistant Professor of Industrial Engineering and Engineering Management, email@example.com
College of Pharmacy and Health Sciences:
Dr. Diptiman Bose, Associate Professor of Pharmacology, firstname.lastname@example.org
Applied Behavior Analysis Programs:
Dr. Richard Graff, Assistant to the IRB Chair, Clinical Adjunct Faculty member for Applied Behavior Analysis programs, email@example.com
*Please note: during the summer months, all applications not originating within the College of Pharmacy and Health Sciences or Applied Behavior Analysis programs should be directed to the Chair.
(The application form is an editable PDF file accessible to Adobe Readers 6.0 and more recent versions. It may be downloaded, edited, saved for later printing or revision, and emailed to the the IRB Chair when completed.)
HOW DO I REGISTER FOR/ACCESS TRAINING?
To complete your CITI training, please visit www.citiprogram.org and follow these instructions:
- Click “Register” (top right corner of screen).
- Select Organizational Affiliation – type Western New England University and it will pop up for selection.
- Agree to terms.
- Affirm that you are an affiliate.
- Click “Continue” to create a Username and Password.
- Create an account by entering your first name, last name, and university email.
Then click “Continue to Step 3.”
- Create username and password.
- Enter a security question and click “Continue to Step 4.”
- Enter Country of Residence by beginning to type and it will pop up for selection.
- You can choose whether you want to be contacted about additional courses.
Then click “Continue Step 5.”
- You can choose whether you’d like to pay for Continuing Education credits.
Then click “Continue to Step 6.”
- Enter all information with red asterisks (e.g., “Role in Research” à “Principal Investigator, “Student Researcher,” etc.). Then click “Continue to Step 7.
- Next, you will answer some Course Enrollment Questions. Skip to Question #4 on Human Subjects Research (HSR) and choose the most appropriate option (Biomedical or Social Behavioral Research).
- Click “Complete Registration.”
- Finalize registration.
- Under “Institutional Courses” and Western New England University, click “View Courses.”
- Under “Courses Ready to Begin” click “Start now.”
- Agree to terms and conditions and click “Submit.”
To Switch Courses or Add a Course go to:
- Institutional courses menu.
- Under WNEU, click “View Courses.”
- Then Click “Learner Tools.”
- Then click “Add a Course.”
Who is required to submit an application to the IRB?
Anyone on campus (including administrators, faculty, staff, students, etc.) who plans to do research involving human participants is required to submit a proposal.
What is the definition of research?
"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." (Definition of Research, Office for Human Subjects Research, National Institutes of Health)
Do all projects require a formal review?
No, some projects qualify for an exempt or expedited review (refer to http://www.hhs.gov/ohrp/); however, that determination is made by the IRB. The researcher may request an exempt or expedited review and state their reasons.
Do I need to use a specific form?
Yes. The Application Form is available here.
Can I submit the application by e-mail?
Yes, but this requires establishing and using an electronic signature for each investigator or scanning and sending a signed hard copy of the last page of the application along with the application file.
Do I need to submit any hard copies?
No hard copies need to be submitted. Please send everything electronically to the appropriate intake representative via email with ancillary materials attached.
When can I begin my research?
As soon as you receive a signed approval form from the IRB, you may begin.
How long does the approval last?
One year from the date of approval.
If I want to renew, do I need to go through the entire process again?
If substantial changes have not been made to the original proposal, and no untoward results occurred in the original study, you may be able to go through an expedited review.
What if I have an entire class that is doing research?
First of all, make sure that what you are doing is research (see question #2 above -- "What is the definition of research?") and not an in-class exercise. If you are doing research, you may receive a faster review if you submit one application form as a template and then attach examples. Also, certain research methods (e.g. anonymous surveys) may qualify for an exempt review (see #3 --Do all projects require a formal review?).
If one of my students does a research project, am I responsible?
Yes, you are considered the responsible project investigator.
What if my proposal is not approved?
The IRB committee will provide you with feedback to modify your proposal to increase its chances of approval.
If I have any questions about the process, whom should I contact?
Please contact Institutional Review Board Chair Jessica Carlson at 413-796-2325 or firstname.lastname@example.org.
To whom should I submit my proposal?
Please submit your application to the appropriate IRB intake representative. If your application requires a full board review, this representative will forward your information to the Chair for further communication.
When do full board IRB meetings take place?
The board meets at the end of each month during the fall and spring semesters. Full board meetings are not scheduled during the summer months. Meeting dates/times are updated as the information becomes available and are posted on the main IRB webpage.
How long does the approval process take?
The length of review will vary depending on a number of factors, including the complexity of the study and required revisions, as well as the current queue of studies under review. Our representatives will get to your study as soon as possible.
What are the different types of review?
Full board review
What is the difference between anonymous and confidential data?
With only one method of data collection, a study cannot be both anonymous and confidential. If data are anonymous, it means that no identifying information about participants is obtained (i.e., the researcher cannot tell who a participant is). Keep in mind that too many demographic questions can impact anonymity. With confidential data, the researcher can identify the participants, but has procedures in place to secure this information.
Do I need to submit an IRB application if I’m conducting research off site or in collaboration with another researcher at a different institution?
Yes, a separate application is necessary even if you (or your collaborator) has obtained approval at a different institution. The approval process may be faster in this case, depending on the nature of the research. It is important for our IRB to be aware of all ongoing university-related research.
What happens after I submit my application?
After your materials have been submitted, the intake representative will do one of the following: approve your research, request modifications, or forward your application to the Chair for full board review. Full board review can result in project approval, modification, or rejection of the research.
My study is undergoing a full board review. Do I need to attend?
Although you are not required to attend, it is usually very beneficial to do so as it will greatly expedite the process of clarifying any questions that board members might have. The Chair will discuss this with you after your application is received, and may send you some questions to answer in advance of the meeting.
What if something goes wrong?
The primary investigator is responsible for immediately reporting any unanticipated problems or adverse effects of the research to the IRB Chair.