Human Research Protection Program

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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 an IRB application is required
• Using IRBManager
• Recruitment of research participants
• Informed Consent
• Deception and Incomplete Disclosure
• Document Templates
• Compensating research participants
• CITI Training

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.

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.

*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 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

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 8^th 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
   

Some research, particularly in psychology, neuroscience, and behavioral research, plans to deliberately withhold information about the purpose of research and/or procedures employed or purposely mislead participants by providing false information about some aspect of the research.

Studies using "deception" intentionally provide misleading or false information. Examples include:

• Participants complete a quiz and are falsely told that they did poorly, regardless of their performance.
• Participants who don’t know they are in a research study are observed to see how they behave when they find valuables (e.g., wallet, laptop) unattended in a public location.
• An anxiety study, in which participants are told to expect mild pain during the course of the study, but no painful procedures are administered.

Studies using "incomplete disclosure" withhold information about the true purpose or nature of the research. Examples include:

• Participants are asked to take a quiz for research but they are not told the research question involves how background noise affects their ability to concentrate.
• Participants are told they are completing a survey to evaluate customer service when the true purpose of the study is to correlate psychological responses with patient care satisfaction.

The use of deception or incomplete disclosure may be appropriate to promote scientific validity by enabling investigators to obtain unbiased data about attitudes and behavior in circumstances where truthful disclosure is considered likely to produce biased responses by participants.

Deception or incomplete disclosure in research should not be used if:
• Non-deceptive alternatives are available;
• The deception is intended to trick people into participating in something they would not want to participate in; and/or
• The deception places participants at significant financial, physical, legal, psychological, or social risk.

When conducting research that involves deception or incomplete disclosure, researchers must ensure that the research meets their discipline’s professional code of ethics, and convey in their application to the IRB how particular consideration has been given to the consent and debriefing process and risk/benefit ratio of the research. 

Research that uses deception or incomplete disclosure will generally require that the researcher request, and the IRB approve, a waiver or alteration of informed consent. 

• 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.

 

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.

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