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.

Submissions to the HRPP / IRB

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. 

IDEATE:

Submissions to the IRB are made through IDEATE, an online platform available here: https://ideate.cuny.edu/home /   

Log in using your CUNY Portal credentials. 

 

GETTING HELP:

  • CUNY has provided a set of IDEATE user documents, available in the Help section in IDEATE.
  • 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

 

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).
  • 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 and attach it to any IRB application you submit, or provide your certificate to the Principal Investigator of any project in which you are involved.

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