Institutional Review Board (IRB)

To complete your CITI training, please visit www.citiprogram.org and follow these instructions:

1. Click “Register” (top right corner of screen).
   
   
2. Select Organizational Affiliation – type Western New England University and it will pop up for selection.
   
   
3. Agree to terms.
   
   
4. Affirm that you are an affiliate.
   
   
5. Click “Continue” to create a Username and Password.
   
   
6. Create an account by entering your first name, last name, and university email.
   Then click “Continue to Step 3.”
   
   
7. Create username and password.
   
   
8. Enter a security question and click “Continue to Step 4.”
   
   
9. Enter Country of Residence by beginning to type and it will pop up for selection.
   
   
10. You can choose whether you want to be contacted about additional courses.
    Then click “Continue Step 5.”
    
    
11. You can choose whether you’d like to pay for Continuing Education credits.
    Then click “Continue to Step 6.”
    
    
12. Enter all information with red asterisks (e.g., “Role in Research” à “Principal Investigator, “Student Researcher,” etc.). Then click “Continue to Step 7.
    
    
13. 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).
    
    
14. Click “Complete Registration.”
    
    
15. Finalize registration.

After Registration:

1. Under “Institutional Courses” and Western New England University, click “View Courses.”
   
   
2. Under “Courses Ready to Begin” click “Start now.”
   
   
3. Agree to terms and conditions and click “Submit.”

To Switch Courses or Add a Course go to:

1. Institutional courses menu.
   
   
2. Under WNEU, click “View Courses.”
   
   
3. Then Click “Learner Tools.”
   
   
4. Then click “Add a Course.”

Anyone on campus (including administrators, faculty, staff, students, etc.) who plans to do research involving human participants is required to submit a proposal.

"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)

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.

Yes. The Application Form is available here.

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.

No hard copies need to be submitted. Please send everything electronically to the appropriate intake representative via email with ancillary materials attached.

As soon as you receive a signed approval form from the IRB, you may begin.

One year from the date of approval.

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.

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?).

Yes, you are considered the responsible project investigator.

The IRB committee will provide you with feedback to modify your proposal to increase its chances of approval.

Please contact Institutional Review Board Chair Jessica Carlson at 413-796-2325 or jcarlson@wne.edu.

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.

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.

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.

• Exempt review

• Expedited review

• Full board review

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.

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.

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.

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.

The primary investigator is responsible for immediately reporting any unanticipated problems or adverse effects of the research to the IRB Chair.