Human Research Protection Program

Human Research Protection Program


The CUNY Human Research Protection Program (HRPP) is responsible for the protection of the rights and welfare of human subjects in research projects conducted at CUNY or by CUNY faculty, staff and students.

The information provided here summarizes select CUNY policies and procedures as a reference for John Jay researchers.  John Jay students, faculty and staff engaged in human subjects research should visit the CUNY website to become familiar with the revelant policies, to access document templates and for additional guidance.

Obtaining IRB Approval for your Research:

All research involving human subjects conducted by John Jay researchers must be reviewed by the CUNY HRPP or IRB and issued an approval or exempt determination prior to implementation. For assistance in determining whether an activity constitutes human subjects research requiring review by the HRPP / IRB, or to set up a consultation to discuss your project, email the John Jay HRPP Coordinator at jj-irb@jjay.cuny.edu

Submitting an Application to the CUNY IRB - How to Use IRBManager

IRBManager is the platform used to make submissions to the CUNY IRB. 

URL :https://cuny.my.irbmanager.com/

Use your CUNY Login (single sign on) credentials to access IRBManager. From the IRBManager home page, select “To login using CUNY Login”.  Use your CUNY Login credentials, where your username is entered as firstname.lastname##@login.cuny.edu followed by the password associated with that username. (More info about CUNY Login here.)

For help using IRBManager:

  • - Visit the CUNY HRPP website  
  • - Access the IRBManager manual posted in the Notices section in IRBmanager
  • - Take advtange of the brief videos posted in IRBManager.
  • - Register for IRBManager training 
  • - Contact Lynda Mules at lmules@jjay.cuny.edu for guidance or assistance, to report technical problems, or to arrange training in IRBManager for your research team or class. 

 

Frequently Asked Questions about IRBManager: 

Q: What is the link for IRBManager?

A: https://cuny.my.irbmanager.com/

Q: How do I log in to IRBManager?

AUse your CUNY Login (single sign on) credentials to access IRBManager. From the IRBManager home page, select “To login using CUNY Login”.  Use your CUNY Login credentials, where your username is entered as firstname.lastname##@login.cuny.edu followed by the password associated with that username.

If you are a CUNY researcher/research personnel who DOES NOT have CUNY Login credentials, contact Lynda Mules at lmules@jjay.cuny.edu for guidance.  

Q. I was added as personnel or faculty advisor to a protocol in IRBManager but I don’t see the project when I log in.  What should I do? 

A. CUNY is aware of a technical issue where some users have duplicate profiles in IRBManager, which prevents them from seeing their migrated IDEATE protocols or any new IRBManager protocols to which they’ve been added as personnel or faculty advisor.  Please email Lynda Mules if you encounter this problem so that the issue can be fixed. 

Q: Is training available for IRBManager? 

A:  Yes!  Training is provided on a regular basis.   Learn more and register for IRBManager training here. 

Sign up here to be notified about this and other training or contact Lynda Mules directly to request training for your research team or class.

Q:  Do I have to upload my current CITI Certifications in IRBManager? 

A. If you have completed CITI training as a CUNY researcher, information related to your CITI training will be linked automatically to your IRBManager profile and will be available to HRPP and IRB reviewers.  However – some action is required in order for this link to occur. To ensure that your CITI training and IRManager profile are linked, please do the following: 

- In IRBManager, Complete the Update My Email Address form, found on the right side menu under “Notices” or under Start Form on User, to add your campus/CUNY email address to your IRBManager profile.

- In  CITI, confirm that your preferred email address is your campus/CUNY email address. The process for confirming and/or changing your preferred email address in CITI is described in Notices in

 

 

As a reminder, the PI and all CUNY research personnel involved in human subjects research are required to complete CITI training in Human Subjects Research, and certification of training is required for HRPP/IRB approval.  All CUNY researchers are also required to complete CITI Training in Responsible Conduct of Research.

Q: As a Faculty Advisor, will I be able to review a student PI’s IRB application in IRBManager before the student PI submits the application for HRPP/IRB processing and review?  

A: Yes.  A student can serve as a Principal Investigator (PI) on an IRB protocol but must identify a Faculty Advisor. As a Faculty Advisor, you have certain responsibilities overseeing the student’s preparation of the IRB application.  When your student submits their IRB application, you will receive an email notifying you of the submission.  You will then be required to access the submission in IRBManager (you can use the link in the email, or you can access the submissions directly via IRBManager) to review and sign-off on the submission.  Follow the steps in the Instructions for Faculty Advisors video, or in the PI Manual (both available under “Notices” in IRBManager) to communicate any required revisions to the student, or to route the submission for HRPP/IRB review. 

Q. Will research personnel be able to create submission in IRBManager on behalf of the PI?  

A. Yes, research personnel will be able to create submissions on behalf of the PI in IRBManager; however, the PI will be required to review and sign off on the submission before it is submitted for HRPP/IRB processing and review.

Migrating Projects from IDEATE to IRBManager: 

 

Q: I had active approved projects in IDEATE.  Are they available now in IRBManager? 

A: CUNY migrated active, approved protocols from IDEATE to IRBManager as “shell protocols”. Expired, withdrawn, complete, or pending protocols were not migrated to IRBManager.

Q: What is meant by “shell protocol”? 

A:  CUNY migrated only basic nformation from IDEATE into IRBManager for active approved protocols.  No substantive content or documents were migrated.

Q.  If only the shell was migrated, how do I get my active approved protocol into IRBManager?  

A. The process for populating migrated projects in IRBManager is manual. The process requires  that you or a member of your research team use the “Copy for amendment” form in IRBManager to copy/paste/attach details and documents from IDEATE into the IRBManager protocol.  Instructions for creating an Amendment are available via a short video and in the IRBManager Manual on the right side of the page under “Notices” in IRBManager.

IMPORTANT:   Are you ONLY creating this submission in order to populate your currently approved protocol information?  

  • - On the Signature page of the “amendment” form, you will see the question “Are you ONLY creating this submission in order to populate your currently approved protocol information?” By answering “yes” to this question, you are indicating that the amendment you’ve created is a direct and accurate representation of the information you previously submitted and for which you obtained approval.  This type of “amendment”, where no changes are requested, will not be routed for review, so it is important that you ensure that the information here is accurate and consistent with what you have previously submitted. 

  • - Generally speaking, at John Jay, this initial “amendment” should only include the details and documents from the approved IDEATE protocol, and any changes should be submitted via a subsequent amendment. If the initial “amendment” does include changes or new information, then you should answer this question “no” and fully describe the changes in Amendment Summary. Any and all changes require submission to and review by the HRPP/IRB, so it is important that you answer this question accurately and that any changes are routed for review. 

There are a few fields in the IRBManager form that are different from or were not present in the IDEATE protocol.  There are also some IDEATE fields that are no longer present on the IRBManager form. If you have difficulty completing a field using text that was included in your IDEATE protocol or are unsure if your response to the field would be considered a “change” or “new information”, please get in touch with Lynda Mules for guidance.

If you do not have support staff who can assist with data migration, or if you have concerns about completing this process and would like support, please get in touch with Lynda Mules.  You can also request help to transfer your IDEATE protocol into IRBManager.

Q. I don’t see my active protocols from IDEATE when I log in to IRBManager. What should I do? 

A. CUNY is aware of a technical issue where some users have duplicate profiles in IRBManager, which prevents them from seeing their migrated IDEATE protocols or any new IRBManager protocols to which they’ve been added as personnel or faculty advisor.  Please email Lynda Mules if you encounter this problem so that the issue can be fixed.

Q: Can I still use IDEATE? 

A: IDEATE is currently accessible but is no longer available for submissions to the IRB. As of February 2022, CUNY IT has determined that IDEATE can only be accessed via a campus computer or VPN. If you are unable to access IDEATE and need assistance accessing your prior applications and documents, get in touch with Lynda Mules at lmules@jjay.cuny.edu.

Q. Will I have access to my IDEATE protocols indefinitely? 

A. No. For active approved protocols that are migrated from IDEATE to IRBManager, you will be able to access IDEATE for a period of time, but there will be a deadline for transferring data from IDEATE to IRBManager. 

Q. What happened to my protocols in IDEATE that are closed or expired? 

A. Researchers are required to comply with CUNY’s Records Retention schedule and any requirements for records retention mandated by sponsors, agreements, etc.  It is recommended that you log into IDEATE and download/save * your closed and expired IDEATE protocols, documents, etc.

 

*To download an application and attachments in IDEATE:  The current approved attachments are accessible and can be downloaded from the LiveList application Attachments tab.  To create a PDF of the application, from the LiveList, go to the Lifecycle Event Manager tab, Submissions, and click “View” under Details for the Initial Application (or the most recent approved Amendment, which would then reflect the current approved application).  A pop-up window will generate; click “Print” in the upper right corner to generate a PDF of that submission.  You can do this for each submission to keep a record in your files.  You can also download the attachments included with each submission via this process.

Informed Consent

The ethical principal of autonomy, or respect for persons, requires that research participants be given the opportunity to choose what shall or shall not happen to them. Informed consent is the process by which research participants are provided information about the research and can make a decision about participation.

Informed consent is a process, not just a document, and involves an ongoing dialogue between the researcher and the participant, beginning with the first stages of recruitment and continuing throughout  the duration of the research. Informed consent is not limited to the presentation and signing of a consent form.  

Researchers  should consider the following when  planning  the informed consent process, and the application submitted to the IRB should include details and documents that address these elements:

  • Include the information that a reasonable person would want to have in order  to  make  an  informed  decision  about  whether  to  participate
    • This must include the basic elements of informed consent delineated in 45 CFR 46.116(b) unless the IRB grants a waiver of informed consent or an alteration of informed consent, or has approved broad consent.
  • Provide the information in a manner and language that is understood by the potential participant
    • When a researcher expects to enroll non-English speaking participants, translations of the English language consent document (and all subject materials, recruitment materials, etc.), must be translated into the language of those participants. 
    • Generally speaking, aim for an 8th grade reading level in the consent form;  avoid the use of jargon and technical language.
  • Provide ample opportunity to discuss that information and for the person to consider participation, ask questions, and have questions answered.
  • Conduct the consent  process in  a  manner  and  at  a  location  that  ensures  privacy
  • Ensure that the information is understood
  • Ensure that consent is provided voluntarily
  • Provide sufficient  opportunities  during  the research to address additional questions and to permit voluntary withdrawal without penalty
  • Ensure that any member of the research team charged with obtaining informed consent is qualified to do so given the nature of the study and the subject population
    • NOTE:  Only  those  individuals  who  are  identified as obtaining informed consent and approved  by  the  UI-IRB  to  obtain consent may do so.

 

TEMPLATE CONSENT FORM DOCUMENTS:

John Jay researchers should always access and use the current CUNY Consent Form templates when creating a consent form for a new project.  These templates are available in the Informed Consent section of the CUNY HRPP website

Additional documents providing tips on the informed consent process and suggested language to include are also available, including the following:

  • Informed Consent Process and Documentation Tip Sheet
  • Guidance: Informed Consent Document and Development
  • Guidance: Suggested Language for Informed Consent Documents
     
CITI Training in the Protection of Human Subjects

CUNY Policy: CITI Training in the Protection of Human Subjects

Human Subjects Protection Basic and Refresher Courses
All CUNY faculty members, postdoctoral scholars, graduate and undergraduate students involved in human subjects research as key personnel must complete the Basic Course in the protection of human subjects prior to Institutional Review Board (IRB) approval of their protocol. Certificate of completion of the basic course is valid for three years and a refresher course is required every three years.

Instructions for creating a CITI account and completing Human Subjects Research training:

  • Go to www.citiprogram.org
  • Create an account / Register (NOTE: if you already have a CITI account because you completed CITI training for another institution, you can log in with your existing account and select “Click here to affiliate with another institution” to affiliate with CUNY and complete any CUNY-specific modules).
  • Select your Organization Affiliation – search for City University of New York (CUNY).
  • Enter the requested Personal Information, then continue through the next few steps (for John Jay, a ‘banner’ number is not necessary).
  • Use your CUNY Email Address as your "Preferred Email Address".
  • Select Take the Human Subjects Basic Course.
  • Select the group appropriate to your research activities.  This will usually be either HSR for Undergraduate Students, or HSR for Social & Behavioral Faculty, Graduate Students & Postdoctoral Scholars (in some cases, the HSR for Biomedical… group may be appropriate).
  • You should download your certificate of completion for your records and attach it to your IRBManager profile if necessary.

All researchers are also required to complete training in Responsible Conduct of Research.  To complete this training, after you’ve created your CITI account, go to Learner Tools for City University of New York (CUNY), select Add a Course, then Take the Responsible Conduct of Research course, then CUNY Researchers.

Additional information on training requirements is available on the  CUNY HRPP webpage