Institutional Review Board

1. Read the entire D'Youville IRB Manual. Note, the manual is periodically updated according to federal guidelines.

2. Complete the mandatory online Collaborative Institutional Training Initiative (CITI) training (see instructions under the "Register/Login for CITI Training" tab on this page). When done, print a copy of your online certificate of completion. The certification is valid for three years from the date of completion. A researcher can choose from one of the following three courses (including all the modules under each course):

• Biomedical Data or Specimens Only Research
• Biomedical Research
• Social & Behavioral Research.

Other courses are available for research purposes under our institutional subscription to CITI.

3. After you've reviewed the IRB Manual, determine if you are submitting your research as Exempt, Expedited or Standard.

4. Next, submit the following completed forms and documentation electronically to the IRB as a single packet (irbhelp@dyu.edu). Include your Study Title in the subject heading:

• IRB Review Application (choose one)
  • Standard Form
  • Exempt Form
  • Expedited Form
  • Modification Form
• Any supporting documentation
• CITI certificate of completion

5. When your research is concluded, complete the study closure form. The IRB will then log the study as closed, and you will receive an official Closure Letter.

6. If your study is not completed within 12 months, you must submit for renewal. Renewal submissions with no changes can be submitted with an Exempt application. State "Renewal" in parentheses next to the Study Title in the email subject heading and on the application form. Send the Closure Form or Renewal submission to irbhelp@dyu.edu.

DIRB-001 HSRPF Exempt form

DIRB-002 HSRPF Expedited form

DIRB-003 HSRPF Standard  form

DIRB-004 HSRPF Modification form

DIRB-005 Class Project Consent form

DIRB-006 Consent form

DIRB-007 Consent Form-Biomedical Research Form

DIRB-08 Recruitment Email Template

DIRB-009 Worksheet Exemption Determination form

DIRB-010 Worksheet Expedited Review Determination form

DIRB-011 Worksheet Standard Review Determination form

DIRB-012 Response to Comments form

DIRB-013 Conflict of Interest-DYU form

DIRB-014 DYU IRB Study Closure form

DIRB-015 Incident Report form

DIRB-016 IRB Confidentiality Agreement form

DIRB-017 PHS FCOI Disclosure form

DIRB-018 Data-Use-Agreement

Review Invitation Letter

Obtain the Comments Responses Form

• Download or access the comments responses form provided by the IRB.

Review and Understand the Form

• It's crucial to carefully read and understand the instructions provided on the form by the IRB. This will guide you in completing the form properly.

Organize and List Comments

• Transfer each comment from the reviewers onto the form.
• Use the designated space or section provided for each comment.

Provide Point-by-Point Responses

• Respond to each comment directly on the form.
• Ensure your responses are clearly labeled and correspond to the comment numbers.
• Provide concise but detailed responses to each comment.
• Include all necessary information or justifications as required.
• Indicate any revisions or changes you have made to the application in response to each comment. This might include referring to specific sections of your revised application document.

Use Additional Attachments if Necessary

• If the form allows or if requested, attach additional documents or revised sections of your application.
• Ensure these attachments are clearly labeled and relevant to the comments addressed.

Submission

• Email your response to the comments form and other relevant documents to the IRB at irbhelp@dyu.edu

• D'Youville IRB Manual
• IRB Guidance for Student Research and Class Projects
• Misconduct Policy
• PHS Financial Conflict of Interest Policy

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. CITI training is required. 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).

Effective January 1, 2019, all applications must be written in the future tense. Exceptions include previous pilot work, CITI/NIH training, or creation of instruments (past tense), or instances when present tense makes sense (e.g. "I am a Professor of Nursing..."). Any recruitment, research to be conducted, etc. should be in the future tense.

Data Use Agreement. 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 institution of the researcher. 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.

1. On right side of page, go to black box and click CITI, or 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, click “log in” on the upper right-hand side.
4. Once you log in, click on the “add a course button.” Then scroll and view the available courses.
5. Scroll to question 1 and select 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

IRB applications may be submitted at any time.

Exempt and Expedited applications take two weeks to review.

Standard Applications take two months to review.

Due to federal regulatory agency decisions, there have been significant Common Rule changes to the IRB process. These changes are also posted in the IRB Manual under ‘Chapter IV – IRB Application Guidelines.’

• 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 to the approved procedures during the 12 months. In rare instances where minor changes are requested, the investigator(s) should submit an explanatory letter on DYU letterhead to irbhelp@dyc.edu.
• See the IRB webpage for our fillable Study Closure Form. 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.

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, state “Renewal” in parentheses next to the study title in the subject heading of the email and on the application form. Send the Closure Form or Renewal Resubmission to irbhelp@dyc.edu.

• Any adverse events or mishaps during the research must immediately be reported to the IRB. Report this by email irbhelp@dyc.edu.
• If applicable, The DYU 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 in the subject heading of their application and in the body of the email.

If you have any questions, contact irbhelp@dyc.edu.