With Sincere Appreciation to Our Retiring Board Members
As your time on the Rutgers Human Subject Protection Program draws to a close, we wanted to express our sincere gratitude for your service. HSPP service is one of the toughest volunteer roles at an Academic Medical Center. Thank you for your contributions and the expertise you brought to our deliberations.
- Nora Cosgrove, RN who has served as an IRB member since 1994 and an IRB Vice Chair since 2004.
-
Florence McAuliffe, PhD who is a Science teacher and an unaffiliated community member for many years.
Surveys
The HSPP/IRB Program begin sending out the General IRB Member Survey and Customer Service Satisfaction Surveys for the website and e-mail interactions. Everyone is encouraged to provide their feedback.
Implementation of a Human Subjects Training Program known as CIRTification
The Rutgers Human Subjects Protection Program (HSPP) IRB will begin offering an educational training alternative option for research involving community partners; the alternative option is known as CIRTification. The rollout of CIRTification at Rutgers will begin soon.
What is CIRTification? The CIRTification is a program developed by Dr. Emily Anderson at the Center of Clinical and Translational Sciences (the University of Illinois at Chicago) to provide the core research ethics in lay language CIRTification is a free, web-based human research protections training program tailored specifically to the needs and roles of community research partners. The program is offered in English and in Spanish. The CIRTification program is a training alternative for individuals in community organizations, with limited understanding of conducting human research and protecting potential research participants. This option provides training that focuses on establishing the skills in community partners to conduct human subject research effectively and safely in their communities.
Who can take CIRTification? The CIRTification program is only for individuals from community organizations who are working with Rutgers faculty, staff, or students on human subjects research.
Any other Information? The community-based partners cannot have access to Protected Health Information (PHI) associated with or derived from a healthcare service event (I.e., from treatment, payment, operations or from medical records). Community-based partners cannot be associated with an institution that has its own Human Subjects Training requirements. More information about CIRTification is coming soon.
Pre-Review Process Update
The Pre-Review SOP's (copied below) have been updated to reflect the revised Pre-Review Team effective immediately.
To begin the Pre-Review process, please upload the relevant documents as WORD documents in Rutgers OneDrive or Rutgers Box (i.e., only one of these folders needs to be used) to allow the pre-review team to make tracked changes/comments See Rutgers OneDrive Instructions below
Share the folder with the pre-review team members listed below:
Angela Cartmell-McGlyn, Sr IRB Manager, ac2200@research.rutgers.edu
Claribel Vega, Sr. Reliance Manager, vegacl@research.rutgers.edu
Cheryl Kennedy, IRB Chair, kennedy@njms.rutgers.edu
Irbprereview@research.rutgers.edu
This Pre-Review should be done simultaneously as you work on the following:
eIRB application (please do not submit the application or upload the documents until they have been pre-reviewed by the pre-review team and then finalized by you).
If your research will be conducted on Robert Wood Johnson University Hospital (RWJUH) New Brunswick property or involve RWJUH New Brunswick patients, their data or biospecimens, then you must submit an application to the RWJUH Research Utilization Group (RUG).
If your research is conducted on University Hospital (UH) property or involve University Hospital patients, their data or biospecimens you must submit a UH Registration and Research Plan through the Office of Clinical Research Administration.
Please refer to our website at https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-program-toolkit and view instructions under ‘Performance Site Approval Forms’ then under University Hospital.
eCOI disclosures/CITI for the Principal Investigator and all research personnel
eCOI - Please click the ‘Create financial disclosure certification in eCOI’ in the eIRB study workspace and select all study personnel.
Any other required approvals applicable to your protocol such as Biosafety, Radiation Safety, Scientific Review Board, University Behavioral Health Care signoff, etc.
Any contracts or agreements applicable to your protocol such as Clinical Trial Agreements, Data Use Agreements
IRB Reliance Agreements, to accept another IRBs approval or for Rutgers to serve as the IRB of record for other sites involved in your research. For information regarding IRB Reliance Agreements please contact the IRB Reliance Administrator: IRBRelianceAdmin@research.rutgers.edu
*Options for studies recommended for Pre-Review after submission in eIRB:
Option 1:
Withdraw the study in eIRB.
Upload the protocol and relevant documents to Rutgers OneDrive or Rutgers Box and share with the Pre-Review Team listed below.
Once you are notified the Pre-Review is complete, address the comments/suggestions as you deem appropriate.
The PI creates and submits a new application in eIRB and submits for IRB review.
Option 2:
Allow the study/modification to proceed through the regular IRB process as submitted without pre-review
II. Pre-Review Completed
We will notify you via email once the pre-review is completed. Please keep in mind that this courtesy pre-review is intended to help expedite the approval process and the comments are recommendations - individual IRB members (who are faculty familiar with a variety of research) may have additional comments during the review process, after you submit your protocol through eIRB.
Log into Rutgers OneDrive or Box to review the comments and address as you deem appropriate.
When your revisions are complete upload the final versions in eIRB before submitting your application.
For research related questions please email irboffice@research.rutgers.edu
III. Instructions for Uploading to OneDrive
Navigate to connect.rutgers.edu. Log in using your Rutgers NetID and password.
If you are already logged into your Rutgers e-mail it will bring you to your email home screen. If you haven’t logged in yet it will direct, you to log in
From your e-mail home screen via connect.rutgers.edu click on the icon in the top left corner (it is a box made up of 9 dots)
Click on “OneDrive.”
Click on the tab “New” (there is a plus sign next to it) and select “folder.”
Create a name for the folder using the following notation: PI FULL NAME AND SHORT TITLE.
Example: “John Doe Perceptions of Masks.” (Please do not simply label it as “IRB” or a similar generic title.)
Click on the folder created.
Click on the tab “Upload” and select the WORD documents you would like to upload.
Return to the previous screen that has the Folder you created.
Highlight the folder you created and click on the arrow icon (to the right of the folder name) to “share”
Select the Pre-Review Team members for your campus (listed above) to share the file with them by entering their e-mail addresses. You may also enter an optional message to the team. Once you have entered everyone you want to share the file with click on send.
The Pre-Review Team will automatically receive an email notification and link to the file
IV. Instructions for Uploading to Rutgers BOX
Link to the BOX website instructions
