All faculty or student research involving human subjects – whether funded or unfunded – must be reviewed and approved by D'Youville's Institutional Review Board before being carried out.
The Institutional Review Board (IRB) committee uses federal guidelines to protect the safety, rights, and welfare of research subjects.
- 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.
- Complete the mandatory online National Institutes of Health (NIH) tutorial, which takes about four hours, or equivalent CITI training (see instructions under Register/Login for Training). When you're done, make sure to print out 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.
- 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 Erin Bellavia at firstname.lastname@example.org). Please include your study title and email address in the body of your email submission.
- Human Subjects Research Proposal form (PDF)
- Any supporting documentation
- NIH certificate of completion
- 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.
- 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 Erin Bellavia at email@example.com.
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 2019-2020
All meetings are on Wednesdays at 11 AM in the Library conference room.
NIH-Equivalent CITI training
- Go to https://about.citiprogram.org/en/homepage/
- On the upper right-hand side, click register. Once you register, log in. If you already have a login, click log in on the upper right-hand side instead
- 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.
- 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). Each of those courses is NIH equivalent.
(You may see additional courses you want to take after completing the required one.)
- Take the NIH equivalent course. All certificates are good for 3 years.
Looking for a different option? Try the National Institutes of Health (NIH) tutorial.
Due to federal regulatory agency decisions, there have been significant Common Rule changes to the IRB process. Also, over the past seven months, 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.
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 being followed during the 12 months. In rare instances where minor changes are requested, send an explanatory letter on D'Youville letterhead to Julia Hall (firstname.lastname@example.org) and Erin Bellavia (email@example.com).
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 (firstname.lastname@example.org.). Upon receipt of a study closure form, the IRB will log the study as closed. The researcher will then receive an official closure letter from the IRB. If the IRB does not hear from the researcher before the expiration date noted in the letter, the study will be terminated.
If applicable, The D'Youville IRB will report study closure, termination, or adverse events or mishaps in research to the CHS IRB, and vice versa.
The IRB accepts either CITI or NIH online training. If opting for CITI training, 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
You will receive a certificate upon completion of the course. Similar to the NIH certificate, the CITI certificate is good for three years. Other courses are available for research purposes under our institutional subscription to CITI.
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.