FAQs

FAQs

QUESTION

ANSWER

What is the difference between the CUNY “HRPP” and the “IRB”?

The CUNY Human Research Protection Program, or "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 and RF CUNY staff.  The HRPP encompasses various activities and roles, oversees the

CUNY HRPP includes 5 University Integrated Institutional Review Boards (IRBs) and HRPP offices at CUNY central and at the local college campuses.  The IRBs are charged with reviewing and approving research that involves human subjects.

When is CUNY HRPP/IRB review required?

CUNY HRPP or IRB review is required when ALL of the following criteria are met:

1. The investigator is conducting research or clinical investigation;
2. The proposed research or clinical investigation involves human subjects; AND
3.
 CUNY is engaged in the research or clinical investigation involving human subjects.

http://www.cuny.edu/research/compliance/human-subjects-research-1/hrpp-policies-procedures/HRPP_IRB_Review_Required.pdf   

What is ‘research’?

Research means:  “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Systematic means that the activity

  • Attempts to answer research questions (this is sometimes framed as a hypothesis).
  • Is methodologically driven and collects data in an organized and consistent way.
  • Includes a plan to analyze the data, be it quantitative or qualitative data,
  • Draws conclusions from the results.
     

Generalizable means that the results:

  • may be shared through publications and presentations
  • are intended to benefit other researchers, scholars and practitioners in the field of study.
  • contribute to an already established body of knowledge or a theoretical framework
  • are expected to be generalized to a larger population
  • are intended to be replicated in other settings.
     

Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations).

However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.

http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.102

http://www.research.uci.edu/compliance/human-research-protections/researchers/activities-irb-review.html

What is a ‘human subject’?

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:

    (1) Data through intervention or interaction with the individual; or
    (2) Identifiable private information.

http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.102

What is ‘identifiable private information’?

Identifiable means that the identity of the subject is or may readily be ascertained by the investigator or associated with the information.  This includes data that contains direct identifiers (name, email address, SSN, student ID, etc.), and data that is linked to identifiers via a code list.  This also includes data that contains data points that could identify an individual due to uniqueness or when combined with other data. 

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.102

I am interviewing experts about a specific topic for my research.  Are these experts ‘human subjects’?

It depends.  It depends on the types of questions being asked, the purpose of the questioning, and how the responses will be reported or analyzed.

A “human subject” is a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.

Asking a living individual questions would be a form of ‘interaction’ with that person.  However, research that involves only asking experts questions about policies or practices and reporting on those policies or practices, and does not ask questions about that individual or any type of analysis based on the individuals, would generally not constitute research with human subjects. 

If your research involves interviews with experts, contact the John Jay HRPP office for guidance.

When is CUNY considered ‘engaged’ in human subjects research?

CUNY is considered engaged in a particular human subjects research project when CUNY employees or agents obtain, for the purposes of the research project,

(1) data about the subjects of the research through intervention or interaction with them; 
(2) identifiable private information about the subjects of the research; or
(3) the informed consent of human subjects for the research.

CUNY applies OHRP Guidance on Engagement of Institutions to determine CUNY's engagement in all research, regardless of funding.

http://www2.cuny.edu/wp-content/uploads/sites/4/page-assets/research/research-compliance/human-research-protection-program-hrpp/hrpp-policies-procedures/HRPP_IRB_Review_Required.pdf

I’m a John Jay adjunct.  Can I serve as PI on a non-exempt human subjects research project?

CUNY adjunct faculty who wish to serve as PI for non-exempt human subject research must obtain prior written approval from the Vice Chancellor for Research. To request an approval, the adjunct faculty must submit the following documents to the University Director for Research Compliance:

1) A completed CUNY Adjunct Faculty Request to Serve as a Principal Investigator (PI) on an IRB Application form;
2) Documentation of approval from the Provost of the CUNY college where the adjunct faculty has an appointment; and
3) Current CV of the adjunct faculty member requesting the approval.

http://www.cuny.edu/research/compliance/human-subjects-research-1/hrpp-policies-procedures/PI_Qualifications7-8_14.pdf

 

I’m a John Jay graduate student.  Can I serve as PI on an IRB application?

 

CUNY students and postdoctoral scholars may serve as PI on an IRB application only with the supervision of their faculty advisor or research program director.     

http://www2.cuny.edu/wp-content/uploads/sites/4/page-assets/research/research-compliance/human-research-protection-program-hrpp/hrpp-policies-procedures/PI_Qualifications7-8_141.pdf           

I’m John Jay faculty but I advise a student at the Graduate Center; will my student’s project be reviewed at John Jay or at the Graduate Center?

A CUNY student may serve as PI on an IRB application and be advised by a faculty member at a different CUNY college.  In this situation, the IRB application will be routed to the HRPP Office of the CUNY college where the faculty advisor has a primary affiliation. 

I’m an undergraduate student conducting a project for a research methods class.  Do I need to submit my project for HRPP/IRB review?

Generally speaking, projects undertaken to satisfy a class assignment where the project is not designed to contribute to generalizable knowledge and the results are not intended to be shared outside of the classroom would not be considered ‘research’ by CUNY HRPP definition and therefore would not require CUNY HRPP/IRB review.

http://www2.cuny.edu/wp-content/uploads/sites/4/page-assets/research/research-compliance/human-research-protection-program-hrpp/hrpp-policies-procedures/HRPP-IRB-Review-Required.pdf

I’m an undergraduate student conducting research as part of the McNair Scholars Program, the Macauley Honors Program, or another program/project that is intended to result in a publication or presentation at a conference.  Do I need to submit my project for HRPP/IRB review?

CUNY HRPP/IRB review would be required for a project that is intended to contribute to generalizable knowledge through publication or presentation of findings, and that involves ‘human subjects’. 

http://www2.cuny.edu/wp-content/uploads/sites/4/page-assets/research/research-compliance/human-research-protection-program-hrpp/hrpp-policies-procedures/HRPP-IRB-Review-Required.pdf

I am using existing data to conduct a secondary data analysis; do I need to submit my project for review?

It depends.  Some research involving only a secondary analysis of existing data would not be considered ‘research with human subjects’, some research with existing data would be ‘exempt’ from the requirement to obtain IRB review, and some research with existing data would require IRB review by either expedited procedures or the convened board. 

If your research involves analysis of existing data, contact the John Jay HRPP office for guidance.

What does the IRB want to know?

The IRB is charged with evaluating specific criteria for approval.   Your application to the IRB should include adequate information in all fields and documents so that the IRB can evaluate these criteria.

  • Risks are minimized (Beneficence)
  • Risks are reasonable in relation to benefits (Beneficence)
  • Selection of subjects is equitable (Justice)
  • Informed consent is sought and documented (Respect for Persons)
  • Data will be monitored for safety (when appropriate) (Beneficence)
  • Privacy and confidentiality will be maintained (when appropriate) (Beneficence)
  • Additional protections are in place for vulnerable populations --children, pregnant women and prisoners

What is the difference Exempt, Expedited Review, and Full Review?

Some categories of research are ‘exempt’ from the requirement to obtain IRB review.  When you submit your application, you can indicate if you are submitting for an ‘exempt determination’.  In order to qualify for exemption, your research must involve no greater than minimal risk, and all research procedures must fit into at least one of six specific categories.  If any of your procedures do not fit into one of those categories, or if your research involves prisoners or prisoner data, then your project will not be exempt.  This determination is made by the HRPP coordinator and/or the IRB reviewer, and is not made by the researcher.

Research that presents minimal risk but does not qualify for exemption may be reviewed by ‘expedited review’ if the procedures fall into one or more designated categories.  Expedited review means that the research proposal is reviewed by a designated IRB reviewer rather than a committee of reviewers. 

Research that presents greater than minimal risk, and research that is minimal risk but does not fit into one of the categories, is reviewed by the convened board.

The determination as to whether research qualifies for exemption or requires either expedited or convened review is made by the HRPP office and/or the IRB, and is never made by the researcher. 

http://www2.cuny.edu/wp-content/uploads/sites/4/page-assets/research/research-compliance/human-research-protection-program-hrpp/hrpp-policies-procedures/Exempt-Review-2012-09-052.pdf

http://www2.cuny.edu/wp-content/uploads/sites/4/page-assets/research/research-compliance/human-research-protection-program-hrpp/hrpp-policies-procedures/Expedited_Review_2012-09-28.pdf

http://www2.cuny.edu/wp-content/uploads/sites/4/page-assets/research/research-compliance/human-research-protection-program-hrpp/hrpp-policies-procedures/Convened-Review_2012-09-28.pdf

What does it mean to say that research is ‘minimal risk’?

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.

How long will it take for my project to receive IRB approval?

It depends.   When an application is received by the John Jay HRPP Office, the HRPP coordinator conducts an administrative pre-review of the application to ensure that all required information and documents are included, to request revisions to information that is inconsistent, unclear, required or disallowed by CUNY policy, or that would otherwise affect the IRB review process, and to evaluate other requirements.  If any revisions or additional information are suggested or required, the application is returned to the PI with comments.  This process continues after the application is resubmitted, until such time as the HRPP coordinator determines that the IRB will have the information necessary to review and approve the project.   The IRB (whether a single IRB reviewer conducting an expedited review, or a convened board) may also request revisions or additional information to ensure that the criteria for approval are met. 

Generally speaking, the John Jay HRPP office aims to complete the pre-review process within 3-5 days of submission.  Applications that are routed for expedited review are generally reviewed within 1-2 weeks.  Applications that require convened review are assigned to the next available meeting agenda.

How can I speed up the IRB review process?

  • Plan ahead!  Give yourself adequate time to get it right.
  • Submit an application that is complete, accurate, clear and consistent. 
  • Ensure that the information in your application is consistent with the details provided in your study documents.
  • Use the current CUNY document templates and recommended language for your consent and screening documents. 
  • Ensure that all personnel are up to date on Human Subjects Research training, and attach the CITI completion certificates for all personnel.
  • Respond to any requests during the pre-review and IRB review processes in a timely and thorough manner, making changes as necessary and providing a point-by-point response.
  • For students and postdocs:  work with your faculty advisors and obtain guidance in developing your application.
  • Reach out to the John Jay HRPP Office if you encounter technical problems or to request a consultation.