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IRB Instructions and FOrms Selection Page

IRB Bulletin 1: Important Changes to the Regulations Governing Human Subject Research
The federal regulations governing human subject research are changing effective January 19, 2018. There are some important new requirements that all researchers who work with human participants need to be aware of and implement in IRB applications submitted AFTER January 19, 2018. To facilitate the implantation of these rules, a series of emails will be sent to the entire campus. This series of IRB Bulletins will describe the changes that we will have to make to remain in compliance. It is expected that additional changes will be made after the January 19, 2018 date as more information and guidance on the regulations are released by the federal HHS Office for Human Research Protections (OHRP). Some of the changes, such as those relating to informed consent, can be implemented immediately by researchers should they so choose. All IRB Bulletins will be archived on the IRB website for future reference. Each IRB Bulletin will include a description of the change and a discussion of the impact of the change at Southern Connecticut State University as seen by the IRB Chair as of the date of the bulletin. Please note that the discussion will likely change as more information and guidance is issued by the OHRP.

REGULATION: All research reviewed by the IRB must conform to the new rules starting January 19, 2018.
DISCUSSION: The new rule, as it is called, will require adjustment for both researchers and the IRB, and being prepared and educated will make the transition as smooth as it can be. As we go forward, please note:

  1. There will be changes to the IRB application to reflect what will need to be done, so researchers should download the application from the IRB website rather than rely on previously downloaded applications when new submissions are created.
  2. The new rules apply ONLY to research submitted  AFTER January 19, 2018. All research reviewed and approved BEFORE January 19, 2018 does not need to be "updated" next year to conform to the new regulations, though it may be at the discretion of the IRB. This will be down on a case-by-case basis, and in consultation with the researchers.
  3. While the new rules take effect on January 19, 2018, the SCSU IRB process will continue to adapt and changes as the rules are interpreted by the federal Office for Human Research Protections (OHRP) and other institutions after that date. The current SCSU review process, with only minor adjustments, will comply with the new rules, but there may be some opportunities for simplifying our application and review process as new information comes to light.
  4. As we move forward, please contact the IRB Chair, Dr. Jerry Hauselt (hauseltw1@southernct.edu) with any questions

 

 

  

MS Word Format


IRB Application Packet for Human Research Review

 

Size

Application Instructions

  

44KB

Application Forms

 

96KB

Application for Course Instructor Certification

  

Size

Application

  

44KB

Miscellaneous Forms

 

Size

Adverse Event Form

  

23KB

Continuing Review Form

  

29KB

Request for Revision Form

  

25KB

Research Completed Form

  

26KB

Please Note: You can interactively fill out the MS Word form(s) in Microsoft Internet Explorer, and afterward print, sign, and send it in. For the NIH Protecting Human Research Participants on-line tutorial, please click here.