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SUNY ESF Researchers

All new human subjects research conducted by SUNY ESF affiliates will now be reviewed by ������ý University’s IRB. Below we have provided information to help you navigate the process.

If you have an existing approved protocol through Syracuse University’s IRB that requires a modification, please communicate with Syracuse University’s IRB and submit the modification to their IRB. If you have additional questions about this process, please research@esf.edu for information on the transition.

If you intend on submitting a protocol to the ������ý IRB, please make certain you have completed the CITI Social and Behavioral Research-Basic/Refresher course through ESF within the last four years. If you have current CITI human subjects research training through another institution that is current, you will be required to upload that certificate with your protocol submission. If you are a student PI, your faculty advisor must have current training, as well. All study team members must have current training. 

Please contact research@esf.edu for information on CITI registration. 

In order to submit a protocol to the ������ý IRB, you must have a PACS account through ������ý. This account is in addition to an account you may have in PACS through ESF. Please see the following instructions for how to register for a PACS account. These instructions are specific to SUNY ESF affiliates and will need to be followed in order to successfully log into the ������ý PACS IRB interface.

• How to Register and Sign Into PACS    
  Important Note: You may already have an ESF PACS account which is why it is very important to access ������ý’s PACS instance from an incognito window in your web browser or you must clear your cache/search history. If you do not do this, you will have issues registering and logging into PACS.
  
  

  Registration Instructions
  

  1. Open Google Chrome internet browser.
  2. Clear cache/history and/or use incognito window (Ctrl + Shift + N) or use visual instructions below,  and use the following  (see full URL at the bottom of  the page).
     
                                  
  3. To request an account, fill in the webform as instructed in the screenshot below and select “Register”.                                                                   
  4. Once you fill in the registration information, you will receive an email from ������ýPACS@rfsuny.org with  your User Name and Temporary Password. You will be prompted to create a new password after the 1st login. If  you do not receive this email, please check your Spam folder.

  How to Log into PACS for ������ý IRB Access

  1. Open Google Chrome internet browser. 
  2. Clear cache/history and/or use incognito window (Ctrl + Shift + N) or use visual instructions above, and use the following . 
  3.  Fill in User Name from the email noted in item #4 above. 
  4. Password will always be the password you created after you log in the first time using the temporary password from  the email noted above in item #4. DO NOT use your ESF PACS password or @esf.edu username. It will not work.

  PACS:

Please visit our How To Instructions tab, for additional instructions for creating a new submission in PACS, submitting a modification to an existing study approved by the ������ý IRB, etc. 

Please contact the IRB Office staff directly should you have any questions working through this process.

Michele Lukovich, IRB Coordinator, lukovich@binghamton.edu, 607-777-3818

Marissa Barbieri, IRB Associate Director, barbieri@binghamton.edu, 607-777-3918

 

������ý IRB Submission Forms

If you are not sure if you are conducting human subjects research, please use to assist you and/or contact the IRB directly.

NOTE: Do not create a PACS submission until ALL required documents are complete and ready for upload and you have completed the required CITI training.  We require a recruitment script (the email, flyer, etc., you intend to use to solicit participation), as well as supporting documents such as a copy of a survey, interview questions, etc.  If you are a student you must also submit a completed/signed Faculty Statement.  Ensure that you are uploading documents in the designated areas of the PACS smart form. 

For all studies (excluding secondary data analysis), the following templates are required in your PACS submission:

• Protocol Narrative Form
• Informed Consent Template or Exempt Informed Consent Template

NOTE: If participants are under 18, or cognitively impaired, you must secure the consent of parents and the assent of children/cognitively impaired.

• Parental Consent Template

 Required Supporting Documents:

• (required if the Principal Investigator is a student).
• (if conducting research at or in collaboration with an institution/agency/organization or in a classroom).
• Any participant recruitment materials (e.g., email, verbal script, flyer, social media post).
• Any data collection materials and stimuli (e.g., survey, interview questions, stimuli/videos/images).
• CITI training completion certificate if you completed the required training at an institution other than ESF.
• Any other documents relevant to your research.

For Secondary Data Analysis (analysis of existing data) you must include the following document in your PACS submission:

• Existing (Secondary) Data Protocol
• Other supporting documents (i.e. DUA, letter of agreement) relevant to the research

The IRB Office Oversees the Following Categories of Research

Exempt

Research deemed ‘no greater than minimal risk’ and falls under one or more of the . Reviewed by the Administrative Coordinator, Michele Lukovich.

Exempt research: You will receive a response within 2-3 business days after the submission of your initial IRB application and 1-2 business days from receipt of any subsequent requests for revisions and/or documents. Once all the requested revisions and documents are received and accepted, the approval letter will be sent within 2 business days.

Expedited

Research deemed ‘no greater than minimal risk’ and falls under one of more of the . Reviewed by IRB Associate Director, Marissa Barbieri and select IRB members.

Expedited research: You will receive a response within 2-5 business days after the submission of your initial IRB application and 2-3 business days from receipt of any subsequent requests for revisions and/or documents. Once all the requested revisions and documents are received and accepted, the approval letter will be sent within 2 business days.

Full Board

Research deemed ‘greater than minimal risk’. Reviewed by convened meeting of voting members of the IRB.

Upon initial review of a study submission in PACS, the IRB Office may determine that a full board review is necessary if the research appears to pose elevated risk beyond that which is considered, 'minimal' (i.e., risk beyond what one may   experience in daily life).  If that is the case, the IRB Office will determine an appropriate date for a convened meeting of the full board to review the research, and will also reach out to the Principal Investigator with the information necessary to prepare their research, and themselves, for such a review.  Researchers who believe their study may require full board review are encouraged to reach out to the IRB Office for assistance and clarification, as needed.

Additional Information

Study Closures

If your research is at a stage where you are analyzing only de-identified data, your project qualifies for closure.  You can close out your study by accessing your PACS submission and selecting 'Modification/CR'.  From there you will select the 'Continuing Review' option, answer the enrollment questions to the best of your ability, and under 'Research Milestones' select at least the first 4 options, or your study will not be closed.