Key to compliance is following Rutgers policies. Important research-related policies include these:
For more comprehensive information, please visit the Rutgers Office of Regulatory Affairs.
Want personnel assistance? For questions regarding human subjects and animal research, contact the School of Nursing’s IRB specialist Mylka Benitez, (973) 353-0687. For information about other aspects of compliance, contact the Executive Director of Research Dr. Steven Glogocheski.
Conflict of Interest (COI) Disclosures
A COI is a divergence between an investigator’s financial or other personal interests and the principles of research ethics, such that considerations of personal gain, financial or otherwise, may influence or create the perception of influencing that investigator and compromise the objectivity or appropriate design, conduct or reporting of the research. The Rutgers University Investigator COI Policy requires all employees and other individuals conducting research in association with the University to disclose their interests as described below. These disclosures are reviewed by a departmental monitor, who determines whether a disclosure should be reviewed by the Conflict of Interest Committee.
If the committee determines that a COI exists, the committee will develop amonitoring plan to create distance between the discloser and the situation and thereby protect the Investigator, the University, and the sponsor of any potentially affected research.
How to Disclose
Use your NetID to login to eCOI, the University’s electronic management system, and activate the Create My Certification button (on the left). After inputting your information, you will be asked to verify your submission twice. (If you don’t generate a confirmation page, you haven’t completed the process.) The submit disclosure button should be clicked on once you are done answering all the questions.
When to Disclosure
- At Proposal Submission: A Financial Conflict of Interest Disclosure must be submitted and active at the time a proposal is submitted for sponsor funding. Here “active” means that the Research Certification was made within the past twelve months.
- At Award Set-up: A Research Certification must be created in the eCOI system once an award is received. If the Investigator has not submitted a disclosure before, he or she must submit one at this time. The award will not be processed until all study team members have submitted and certified disclosures using the eCOI system.
- Annually: Disclosures must be updated at least annually. The eCOI system will regularly notify Investigators to update their disclosures.
- Within 30 days of a new Significant Financial Interest (SFI): A revised COI disclosure must be made within 30 days of discovering or acquiring a new significant financial interest (e.g., through purchase, marriage, or inheritance).
For more information, contact the School of Nursing COI Monitor, the Executive Director of Research Dr. Steven Glogocheski.
Institutional Review Board (IRB)
For assistance with IRB protocols, faculty from all School of Nursing divisions, and students in the PhD and DNP programs should contact Mylka Benitez, who is a certified IRB manager within the Office of Nursing Science. She can be reached at 973-353-0687.
Frequently Asked Questions – IRB
• Contact Mylka Benitez (biascomy@sn.rutgers.edu or 973-353-0687)
• Add your Pro# (Pro20210001) to the subject heading of your email communication
• Every time the IRB or Mylka ask for clarifications, the PI will need to click on the submit button once you have made the clarifications/revisions
• Chairs need to review the eIRB application and documents before submitting them to the SON Department Reviewer (Mylka), who will give the eIRB application and documents a second review
• The ‘Submit Button’ is located under ‘My Activities’ tab, on the left-hand side of the eIRB page
– eIRB User Profile: Everyone on a research protocol will need to update their User Profile
– Click on your name
– Click on the second tab ‘Institutional Status’
– Click on ‘Institutional Affiliation’ then click on Rutgers Student or Rutgers Faculty
• Modules to be completed is: Social/Behavioral/Epidemiologic Research Investigators
• Your primary email must match the eIRB application email for CITI and eIRB to link with each other
• If you have forgotten your CITI Log in please get in contact with CITI
– https://about.citiprogram.org/en/contact-us/
– eCOI is the first tab under ‘My Activities’
– Everyone on the research team will get an email with a link to complete the eCOI
– Please make sure that once you have completed the eCOI you click on the ‘Submit disclosure’ button
• The sponsor for a SON guest account, Asanté Q. Barr.
• GuestProvisioning@ca.rutgers.edu
– Adding a team member to the protocol
– Change of study sites
– Changing the protocol (HRP-503 b, c & d), consent form, flyer, education materials, brochures, etc.
2.) Click on the Modification tab
3.) Go to the left-hand side of the page ‘Current State’ and ‘Pre- Submission’
4.) Click on ‘View Modification’ fill out Modification Request
5.) Question 1.0 ‘You have indicated a change in personnel, enter in each department and/or divisions requiring approval. ****NOTE: Leave blank if departmental review was previously provided.
6.) If you are making changes to any documents previously approved by IRB, the following need to be done
— Submit a tracked change document of the document being modified
— The changes will need to be highlighted. It will help the IRB go directly to the section that is being modified
— Make sure to update the footer of the page, example v1, 1/1/2021 to v2, 2/2/2021
— Submit a clean copy of the document being modified
— Accept all the tracked changes and the document will be ‘clean’ and this is the document that the IRB will stamp
7.) Go back to ‘Current State’ ‘Pre Submission’
— Go to ‘View Modified Study’
—— Upload the modified documents to its section
———- * Example, Consent form will be uploaded to section 13.17
———- * Example, Non-Interventional protocol HRP-503b, will be uploaded to section 7.0
8.) How to complete a closure application
— Go to you eIRB application
— On the left hand side click on Continuing Review
— Then click on Final Report
— Proceed to compete the Final Report application
9.) International Travel/Privacy and Data Security, Data and File Destruction
** Data should NOT be taken out of the country, please follow the directions below:
— All members of Rutgers University are required to adhere to Export Control regulations and Rutgers University Policies when traveling internationally on university business. When traveling you should be concerned with the following:
——– WHO Is Involved? Identify the company, end user, University, Visitor, Colleague, etc.
——– WHAT Are You Doing? When sharing the details of your travel plan, include what are you bringing with you, what are you researching, what materials you are using in your project, whether you are shipping an item, etc.
——– WHERE Are You Or The Data Going? Which country(s)? All countries being visited, not just the starting destination.
——– WHEN Will You Conduct Your Activity? You must allow time to get approval before your activity commences. You may need to wait several months (as the US government processes your license request), if a license is required.
——– WHY Are You Doing The Activity? Identify the purpose of your activity? (Conference, research, collaboration, etc.).
— Privacy and Data Security can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) or information about oneself with others. In the context of research, privacy risk pertains primarily to the methods used to obtain information about subjects. Whereas privacy risks are obviously very low in studies when a subject actually consents to providing personal information, they are much higher, in records-based research, when information is obtained for research purposes without the consent of subjects.
— Once your study has been closed and was archived for the proper amount of time according to Federal Regulations and University Policy, your data and/or files must be destroyed using the proper method. At Rutgers Unversity the Data must be destroyed 6 years after closure of the study.