Institutional Review Board

1. Read the entire D'Youville IRB Manual (PDF).
   The guidelines may be periodically updated on the website, should policies and procedures change. The website guidelines, therefore, will remain more current than the ones presented here, as the IRB Manual is more typically updated annually.
2. Complete the mandatory online CITI training (see instructions under Register/Login for Training). When you're done, make sure to print out/save copies of the online certificate of completion. Please note, the certification is valid for three years from the date of completion. If your research is not completed within that time, you will need to complete the tutorial again.
    The NIH tutorial is no longer active.
3. After you've reviewed the IRB Manual, you should understand which type of research you're proposing: exempt, expedited or standard. You'll need to submit the following completed forms and documentation electronically to the IRB committee as a packet (scan and email the packet to irbhelp@dyc.edu). Please include your study title and email address in the body of your email submission. 
   • IRB Review Application (choose one)
     • Standard (PDF)
     • Exempt (PDF)
     • Expedited (PDF)
   • Human Subjects Research Proposal form (PDF)
   • Any supporting documentation
   • NIH certificate of completion
4. Data Use Agreement (PDF). A data use agreement (DUA) allows a researcher to share information (namely a “limited data set”) with a colleague or another person or entity not associated with the study or the researcher’s institution. The data being shared is limited to the data elements essential to the research. Furthermore, an Institutional Review Board (IRB) must be notified if a researcher or institution plans to share a limited data set with a recipient (person or entity) not named in the original IRB application. A DUA is not required if the recipient is part of the trial and is included in the IRB Authorization or waiver of Authorization approval for the trial.
5. Complete the study closure form when your research is concluded. The IRB will then log the study as closed, and you will receive an official closure letter.
   If your study will not be completed within 12 months, you must submit for renewal. Renewal submissions with no changes can be submitted with an Exempt application. Please state "Renewal" in parentheses next to the study title on the application form. Send the closure form or renewal submission to irbhelp@dyc.edu.

IRB applications may be submitted at any time. Allow at least two months for the IRB Review process.

The standard review committee meets once a month. Please refer to the meeting schedule and application due dates. Applications must be received by the specified due date in order to be considered for that month's meeting.

IRB Meeting Schedule 2021

All meetings are on Wednesdays at 11 AM.

Meeting Schedule

• PHS Financial Conflict of Interest Policy (PDF)
• PHS FCOI Disclosure Forms (PDF)
• PHS Investigator Chart (PDF)

1. Go to https://about.citiprogram.org/en/homepage/
2. On the upper right-hand side, click register. Be sure to “Select Your Organizational Affiliation” by typing “D’Youville” into the search bar and selecting it. Do not choose “Independent Learner Registration.”
3. Once you register, log in. (If you already have a login, you should click “log in” on the upper right-hand side instead 
4. Once you log in, click on the “add a course button.” Then you will be able to scroll and view all the courses available to you.
5. Scroll to question 1, and select one of the first three courses: Biomedical Research Investigators, Social & Behavioral Research Investigators, or Research with Data or Laboratory Specimens Only. Choose the one that best applies to you.
   (You may see additional courses you want to take after completing the required one.)
6. All certificates are good for 3 years.

A detailed introduction guide is available at https://support.citiprogram.org/s/article/updated-guide-to-getting-started

Due to federal regulatory agency decisions, there have been significant Common Rule changes to the IRB process. The D'Youville IRB has created a Shared IRB with the Catholic Health System [CHS]. Therefore, in order to comply with federal mandates and align with CHS, several changes to the D'Youville IRB are effective immediately. These changes are also posted in the IRB Manual under ‘Chapter IV – IRB Application Guidelines.’

A shared IRB is an affiliation agreement. In our case, this means Catholic Health will accept the decisions of the D'Youville IRB and allow D'Youville to be responsible for research where the project is taking place at D'Youville or with D'Youville students as the subjects. And D'Youville will accept the decisions of CHS and allow CHS to be responsible for studies where most of the research is taking place at Catholic Health or with patients, staff, or medical records of CHS. This enables researchers to submit projects to one IRB for approval and the other IRB will be notified when approval has been received without going through a second IRB process.

CHS strongly prefers CITI Training over NIH. If your research fits the criteria for the CHS IRB, when your NIH certificate expires, please replace it with CITI training.

• On behalf of the IRB, please share this important information with all faculty and student researchers as soon as possible. Due to federal regulatory agency decisions, there have been significant Common Rule changes to the IRB

process. Also, over the past seven months, the DYC IRB has been creating a Shared IRB with the Catholic Health System [CHS]. Therefore, in order to comply with federal mandates and align with the CHS, several changes to the
DYC IRB are effective immediately. In addition to this memo, the changes are posted on the IRB webpage and are in the IRB Manual under ‘Chapter IV – IRB Application Guidelines.’

Shared IRB with Catholic Health

A shared IRB is an affiliation agreement. In our case, this means the CHS will accept the decisions of the DYC IRB and allow DYC to be responsible for research where the project is taking place at DYC or with DYC students as the
subjects. And, DYC will accept the decisions of the CHS and allow the CHS to be responsible for studies where the research is taking place at the CHS or with patients, staff, or medical records of the CHS. This enables researchers to submit projects to one IRB for approval and the other IRB will be notified when approval has been received without going through a second IRB process.

The CHS requires CITI Training over NIH. If your research fits the criteria for the CHS IRB, please replace your NIH certificate with CITI training when it expires. See our IRB Website and click ‘Register/Login for Training’ for directions on course selection and creating a login and accessing courses. CITI training expires after three years and can be renewed.

If submitting to the CHS IRB, go to this link to create an IRBNet Login, and then to submit to IRBNet.org

https://www.chsbuffalo.org/for-physicians/resources/boards/institutional-review-board

Please contact Katy DeWitt, the IRB Director at CHS, for further information (kdewitt@chsbuffalo.org).

Common Rule Changes

• IRB Full approval to conduct research is for one year. The start date is the date on the Full Approval letter. The annual follow-up/expiration date will be stated on the Full Approval letter, which is 12 months after the start date.
• The IRB expects either a Study Closure Form or a Renewal Submission from the Principal Investigator every 12 months or at the end of the study, whichever comes first. No changes are to be made in the approved procedures during the 12 months. In rare instances where minor changes are requested, the investigator(s)
• should send an explanatory letter on DYC letterhead to Erin Bellavia (bellavie@dyc.edu).
• See the IRB webpage for our fillable Study Closure Form. If a study needs to be renewed after 12 months, Renewal Resubmissions with no changes can be submitted with an Exempt Application. If submitting for Renewal, please state “Renewal” in parentheses next to the study title on the application form. Send the Closure Form or Renewal Resubmission to Erin Bellavia (bellavie@dyc.edu). Upon receipt of a Study Closure Form, the IRB will log the study as closed. The Principal Investigator will then receive an official Closure Letter from the IRB. If the IRB does not hear from the Principal Investigator before the expiration date noted in the letter, the study will be terminated, and a closure letter will be issued.
• Any adverse events or mishaps in the course of the research must immediately be reported to the IRB. Report this by email to Erin Bellavia (bellavie@dyc.edu).
• If applicable, The DYC IRB will report study closure, termination, or adverse events or mishaps in research to the CHS IRB, and vice versa.
• The Informed Consent Letter in the IRB Manual has been updated. Be sure to use this updated Informed Consent only. When submitting an IRB application, applicants should include their STUDY TITLE and EMAIL ADDRESS in the body of the email.

If you have any questions, contact Erin Bellavia (bellavie@dyc.edu).