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 by CUNY faculty, staff and students. John Jay researchers should visit the CUNY website to become familiar with the relevant policies, to access document templates and for additional guidance.

The information provided here summarizes select CUNY policies and procedures as a reference for John Jay researchers on:

When is an IRB application required?

Research involving human subjects conducted by John Jay researchers must be submitted for review in IRBManager and approved by the CUNY IRB or issued an “exempt” determination prior to implementation.

  • Research means:  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
     
  • Human subject means: a living individual about whom an investigator conducting research either 1) obtains information or biospecimens through intervention/interaction with the individual and uses, studies or analyzes the information or biospecimens; or 2) obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens
     

For assistance in determining whether an activity constitutes human subjects research or to set up a consultation to discuss your project, email the John Jay HRPP Coordinator at jj-irb@jjay.cuny.edu

In some collaborative research projects, it may be appropriate for CUNY to rely on the IRB review conducted by another IRB, or for CUNY to serve as "IRB of Record" for another institution. This type of delegated IRB review, where only one IRB reviews the research for more than one institution, requires institutional decision-making and an executed agreement.  For more information, see CUNY HRPP Policy: Non-Exempt Cooperative Human Subjects Research.

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

Submissions to the CUNY IRB are made through IRBManager, an electronic platform found here: https://cuny.my.irbmanager.com

Logging in and First Steps:

  • Log in using your CUNY Login credentials. (More info about CUNY Login here.)
  • Take a few minutes to review the brief videos and access the research manual available under Notices.
  • Complete the "Update my Email Address" xForm to add your campus email address to your IRBManager profile.  This is required for all users but you only need to do this once.
  • Follow the instructions under Notices to confirm that you've used the same campus email address as your preferred email address in CITI; this will enable the link between the two systems so that your IRBManager profile reflects your CITI training.

Submitting an IRB Application ("xForm"):

  • To begin an IRB application for a new project, select “Start xForm” on the left Actions menu, then select “Protocol Form”.  This will generate a new application xForm, which you will complete to provide details about your project. 
    • This is a dynamic form, and your answers to certain questions will generate additional sections and questions.
    • You can navigate via the top dropdown menu or via the ‘next’ buttons at the top or bottom of the page; you will not be able to proceed to a new page using the ‘next’ button if any fields on the current page are unanswered (but you can jump around using the dropdown menu).
    • Some form fields have help text with instructions for what to include; please pay attention and include any details suggested as relevant.
    • On the Attachments page, you will be prompted to attach any documents specific to the procedures, processes, etc. that you’ve selected throughout the form. Do not attach a document that is not relevant to the attachment type; instead, if you think a document type does not apply, review your responses throughout the form to determine if you answered something incorrectly.
    • Please use good document naming conventions, identifying documents with a name that is clear and descriptive, using version numbers and dates, etc.
  • You can return to the application at any time by logging in to IRBManager and accessing the xForm as an “xForm awaiting attention”.
  • When you submit the xForm, it will be routed to:
    • The person identified as “principal investigator” (PI), if you are not the PI and prepared the xForm on behalf of the PI.  The PI will receive an email notification with a link to the xForm, or can access the xForm as an "xForm awaiting attention" on their Dashboard.
    • Your faculty advisor, if you are a student. The faculty advisor will receive an email notification with a link to the xForm, or can access the xForm as an "xForm awaiting attention" on their Dashboard.
    • The HRPP Coordinator, if neither of these situations apply.
  • When you submit the xForm, the status of the form will change from “xForm awaiting attention” to “xForm being processed at a later stage.” 
    • You can find more information about the stage (i.e., faculty advisor signature stage, PI signature stage, HRPP Coordinator review) by clicking on “all my xForms” if you’re using the Bubble Dashboard, or by clicking the hyperlinked forms if you’re using the Power Dashboard.
  • If the xForm is returned to you, it will again be an “xForm awaiting attention”.  You’ll see comments inserted as yellow highlighted notes.  Revise and respond as needed, and resubmit the xForm.  The xForm will again need to be reviewed and signed off on by the PI and/or faculty advisor, as relevant.
  • Take advangage of the Manual for researchers and numerous brief videos on the Notices section in IRBManager.

 

PERSONNEL:

  • Students and postdocs can serve as a PI but are required to designate a faculty advisor. The advisor will need to sign off on the xForm when it is submitted (or can return the xForm to the student PI with comments for revision), and should be involved in the development of the application.
  •  Any CUNY affiliate who will interact with research subjects (obtain consent, collect data, etc.) or have access to identifiable data for the purpose of answering the research questions should be listed in the Research Personnel section.  If you do not find a person’s name using the search function, ask the individual to log in to IRBManager using their CUNY Login  Once this is done, you should then find the name using the search function and add the person to the Research Personnel section.
    • RF employees or other "CUNY researchers" who do not have a CUNY Login may be able to obtain an IRBManager account.  For more information about this process, contact Lynda Mules at lmules@jjay.cuny.edu
  • If you want to give a member of the research team the ability to work on a pending xForm, you can add that person as a Collaborator at the top of the form.  This will give that person the ability to view your form as you’re working on it, to make edits and insert notes, etc. 
    • This is not the same as adding a person to the research team as Key Personnel.
    • If you do not add someone as Collaborator, they will not see your xForm, unless you have submitted the xForm and the PI and/or faculty advisor now has the xForm for review and signature. 
  • No one will see the xForm as a “project” until the IRB review process is underway, at which point the project will be issued a protocol number and will be visible as a project.
     

For help using IRBManager:

 

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?
A
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.

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 

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. Since the migration of shell protocols from IDEATE to IRBManager, John Jay HRPP Staff have worked hard to identify active John Jay projects and to manually populate a majority of those projects in IRBManager. 

For projects that have not yet been fully populated, the process requires that a member of research team, or HRPP staff, 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.

Recruitment of Research Participants

 
Recruitment is the process via which potential research participants learn about a research project.   In the IRB application, you will be required to describe the methods you want to use to recruit participants, provide a step by step description of the process, and attach the materials you intend to use.  The IRB is charged with ensuring that recruitment processes are fair, equitable and non-coercive. The IRB considers privacy and confidentiality of recruitment procedures, and reviews all recruitment materials to be used  in a research project.  Any changes to recruitment processes and procedures, or recruitment materials, must be reviewed and approved prior to implementation.

Recruitment materials must not:
· State or imply a favorable outcome beyond what is described in the consent document;
· Make claims that investigational drugs and devices are safe and effective;
· Emphasize the payment or the amount to be paid, by such means as larger or bold type, or by use of formatting, graphics or backgrounds that would emphasize payment;
· Include exculpatory or coercive language.

- Criteria for IRB Approval

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.  Generally speaking, the expectation is that exempt research (research with human subjects which does not require IRB review) will include a consent process as well, as exempt research is still subject to the ethical principals of the Belmont Report, including autonomy.

  • 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

 

Document Templates
  • Consent Form Templates: 
    • 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.

 

Compensating Research Participants

Compensation refers to anything given to subjects as remuneration for the time and effort related to participating in research. Compensation can be monetary or non-monetary, and can be offered in a variety of forms, including but not limited to cash, gift cards, vouchers, trinkets, partial course credit, and the opportunity to enter a drawing for a prize.

Use of Personal Funds for Research Compensation. Researchers are not permitted to use personal funds to compensate research participants. 

Donation of CUNY tax levy or non-tax levy funds to charitable entities as research incentives. Researchers are not permitted to promise to make donations to charitable entities as a form of incentive to encourage participation in research.

Use of Raffles for Remuneration of Research Participation. Researchers may use raffles as a form of remuneration subject to compliance with applicable law. Raffles are highly regulated in New York City and New York State, as well as in other states. Guidance regarding the requirements for offering a raffle as an inducement is available here.

Partial Compensation. Participants in CUNY research have the right to withdraw from continued participation in a research study without prejudice. If a participant who withdraws was being compensated for their participation, the participant’s remuneration should be determined based on the amount of time the participant spent participating in research activities. For example, a participant who withdraws after completing 50% of the scheduled research activities for that participant should be compensated at 50% of the rate they would have received if they completed 100% of the activities.

Subject Pool Compensation. Researchers who recruit participants from a CUNY student subject pool are required to compensate participants according to the procedures approved by the CUNY IRB for that subject pool. Guidance regarding the creation and operation of student subject pools can be found here.  At John Jay, the Psychology Department has an approved student subject pool, the Research Experience Program, described here.

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.

Responsible Conduct of Research Course
All researchers are also required to complete training in Responsible Conduct of Research within 6 weeks of initiating or becoming involved in 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 and in CUNY Policy on CITI Training in the Protection of Human Subjects