Human Participants (IRB), Animal Use in Research

General Policy

IMPORTANT: The federal regulations for human subjects research have been revised as of January 21, 2019. Major changes include (but not limited to):

1. Changes to informed consent
2. Additions and revisions to exempt categories of research
3. Revised definitions and new terms

Projects proposed by faculty, students, and administrators involving the use of humans or animals as participants in research must be submitted for special institutional review and approval. Generally, funding sponsors and agencies expect that this review process will be completed - and institutional approval obtained - prior to submission of a grant proposal. These reviews are intended to minimize discomforts and/or risks to the participants and to  assure that researchers comply with Federal regulations. Please be advised that all individuals submitting applications or interacting with human participants must obtain a certification demonstrating their knowledge of research ethics. Download the information on the certification exam below.

More information regarding these changes can be found here.

Human Participants

Projects that involve humans as research participants should be submitted for review and approval by the University's Institutional Review Board (IRB). Complete information regarding the University's policies and procedures on the use of humans as subjects can be obtained from the following documents:

Please see the University's Institutional Animal Care and Use Committee for more information on animal use.

Institutional Review Board (IRB)

Newman Hall, Room 106
718-990-1440
irbstjohns@stjohns.edu

Dr. Raymond DiGiuseppe
IRB Chair

Marie Nitopi, Ed.D.
IRB Coordinator

Additional Information

The University’s IRB, or Institutional Review Board, is a federally mandated committee of faculty, administrators, medical doctors and community representatives, which is charged to review and approve all research protocols involving humans as participants and created by anyone affiliated with St. John’s. The IRB exercises its responsibility to protect the rights and welfare of human participants in various categories of research in any way related to the institution. The IRB has authority over approval, modification, ongoing review, verification of changes or suspension or termination of approval of research involving human participants, including St. John’s students.

What is the primary function of the Institutional Review Board (IRB)?
The major function of the IRB at St. John’s University is to provide protection for the rights and welfare of any human participants involved in research. The Board reviews in advance all research proposals from within the University that proposes to involve people as participants. The IRB is guided by ethical principles laid out in the Belmont Report with specific reference to 45 CFR 46, and by the principle of respect for human persons taught by the Catholic Church. The St. John’s University Senate has also created specific conditions for recruiting St. John’s students as research participants.

Who should be aware of the IRB process?
All faculty, students and administrators involved in research connected to St. John’s University should be aware of the IRB procedures and elements of informed consent which must be observed when doing any research that uses people as participants.

What is the Review Process like?
Applications for formal approval of research can be obtained on the St. John’s University website. This application is to be filled out and sent to the IRB in Newman Hall 108. All applications must have the appropriate signatures (i.e. Principal Investigator, Faculty Supervisor, Department Chair and Dean) before the review process can begin. Researchers can refer to the “Guidelines for Protocol Submission” for assistance in the application process.

St. John’s University’s IRB generally holds its monthly Board meetings on the first Monday of each month. After an initial review, the Chair or individual members of the IRB can approve through expedited review or take the protocol to the monthly Board meeting to discuss the application with the other members of the Board. The Board members discuss and vote on approval of the protocol. An application can also be found exempt from review under certain specific conditions, but only the IRB can make this determination of exemption. If the Board does not approve the application, the applicant is informed of the revisions that are needed in order for the application to be approved.

Certification Training
The St. John’s University IRB also now requires all individuals to be certified in working with human participants. Certification can be obtained online here.

Outside Inquiries
At times, the University receives informal inquires from outside sources about doing surveys with our students. Any such request received by anyone should be cleared with the IRB. These informal inquires can be directed to the Chair of the IRB, Dr. Raymond DiGiuseppe at 718-990-1955.

Attention to issues of informed consent and human dignity, which the procedures of the IRB are intended to stimulate and encourage, is an important aspect of the St. John’s mission to educate for ethically empowered decision-making. The members of the IRB want to work with every sector of the St. John’s community to promote that mission.

IRB Members
Dr. Raymond DiGiuseppe, IRB Chair

Dr. Mabel Abraham
Dr. Robert Eschenauer
Dr. Peggy Jacobson
Mr. Jared Littman
Mary Noe, Esq.
Dr. Samuel Ortiz
Dr. Sandra Reznik
Dr. Christopher Vogt
Dr. Jay Zimmerman

IRB Coordinator: Dr. Marie Nitopi

The IRB submission process involves a chain of electronic signatures in the form of St. John’s emails.  In order for these signatures to be valid they must come from St. John’s email accounts.  For example, a student will attach all IRB documents to a St. John’s email, those documents will be sent to the faculty supervisor’s St. John’s email account.  The faculty supervisor will review all documents, approve, and forward all documents to the Department Chair’s St. John’s email account. The Department Chair will review all documents, approve and forward all documents to the Dean’s (or the Dean’s designate) St. John’s email account.  The Dean will review all documents, approve and forward to the IRB: [email protected]

Revisions and approval letters will be done electronically as well.  Please see the step by step process below that must be followed:

Process for Students

  • The student sends an email to his/her Faculty Supervisor with all required IRB documents attached.
  • The Faculty Supervisor forwards the email with the documents to the Department Chair with a statement of approval. For example, “I have reviewed the attached IRB documents and approve.”
  • The Department Chair forwards the email with the documents with a statement of approval to the Dean (or the Dean’s designate).
  • The Dean (or designate) forwards the email with a statement of approval and the running history of approvals to Marie Nitopi, Ed.D., IRB Coordinator, [email protected]
  • The IRB will then save this email as the signature page.

Process for Faculty/Administrators

  • The Faculty/Administrator sends an email with all required IRB documents attached to the Dean (or the Dean’s designate).
  • The Dean (or designate) forwards the email with a statement of approval and the running history of approvals to Marie Nitopi, Ed.D., IRB Coordinator, [email protected]
  • The IRB will then save this email as the signature page.

Procedure for Exempt Applications
The PI completes the form and emails it from their official St. John’s email account directly to the IRB Coordinator [email protected].  It is reviewed and forwarded to the IRB chair. If it is exempt, then that decision is emailed to the PI, dean and chair.  If the PI is a student the application must be emailed to the Faculty supervisor who will then email it to the IRB coordinator.

The purpose for this change is to avoid the burdensome process and delays of the full application process for studies that do not merit IRB oversight under federal and university policies.

Procedure for Amendment and Extension Applications
The PI will email applications for amendments and extensions directly to the IRB coordinator: [email protected] IRB Coordinator. Notice of approval will then be sent to the PI, dean and chair, and when applicable the faculty supervisor.

This process is designed to speed the process of applications that do not merit extensive review while keeping everyone informed.

From the Code of Federal Regulations 45 CFR 46: 116 and 117

Nine Basic Elements of Informed Consent

  • A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
  • A description of any reasonably foreseeable risks or discomforts to the subject;
  • A description of any benefits to the subject or to others that may reasonably be expected from the research;
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  • For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  • An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
  • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
  • One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
    • (A) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
    • (B) A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Additional Elements on Informed Consent Forms When Appropriate

  • A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
  • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent;
  • Any additional costs to the subject that may result from participation in the research;
  • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  • A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject;
  • The approximate number of subjects involved in the study;
  • A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
  • For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Sample Consent Forms

  • For the Consent Language
    This document contains a sample consent form for all participants over 18 years of age. If children are involved between the ages of 13-17, this document must be used in conjunction with a Parental consent form.
  • For Parental Consent
    This document provides a sample form that should be given to parents when involving participants under the age of 18. This document should be used in conjunction with the regular consent form above.
  • For Child Assent
    This document is a sample/script that should be used when working with children 12 and under when providing them with informed consent. Parental Permission is needed prior to asking the child for participation. This document should be used in conjunction with the Parental consent form above.

When must I submit a Request for Approval of Human Participants Research Application Form to St. John’s University’s Institutional Review Board (IRB)?
The principal function of the IRB is to protect individuals who volunteer to participate as human participants in research. The federal regulations (i.e. Title 45 CFR Part 46) define research as: “ a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (§46.102, D). Thus, any project that involves human participants, is carried out at St. John’s University, and meets the above definition is considered research. The regulations define human participants as “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” (§46.102, F). There are, however, recurring questions about what exactly constitutes reviewable research or research-related activities.

Student Projects
Over the years, questions have arisen as to whether certain student’s projects constitute research. For example, in a number of courses (e.g., research methodology) students might be required to carry out “research” projects in which anonymous data from surveys, interviews, or laboratory tasks are collected from class peers or from students outside of class or outside of the University. Because the main purpose of such typically minimal risk projects is to teach students about the process of research and because by their nature they do not lead to generalizable knowledge (that is, they will not be disseminated in a public forum or published), they are NOT considered research and, therefore do not have to undergo IRB review.

On the other hand, in more advanced courses (e.g., Independent Study) student projects are sometimes carried out with the potential intention to present or publish the results of the project. In those cases, IRB review is necessary. Likewise, all master’s thesis and doctoral dissertation research projects that involve human participants must undergo IRB review, since they are research by definition and are considered publications when they are filed with ProQuest (formerly UMI). All such projects must be approved by the IRB before data collection begins. Data that are collected from any type of project prior to or without IRB review, even if such data are preliminary in nature, such as from a pilot study, may not be used later for dissemination (e.g., publication, conference presentation, thesis).

It is also possible that certain student projects that do not constitute research place their participants at some level of risk. For example, a seemingly innocuous survey or interview could conceivably cause a subject considerable amount of stress or embarrassment. Perhaps a student researcher is interested in surveying students for other not uncommon behaviors, such as, under-age drinking or speeding. However, these behaviors are illegal and any breach in confidentiality of such data could conceivably place the subject at some risk, and even neophyte researchers incur some responsibilities when in possession of such knowledge of their peers’ behavior. Such projects can be problematic and therefore the IRB should be consulted before any data are collected. Faculty members are strongly urged to exercise care and judgment in designing such classroom exercises, to incorporate informed consent training into their curricula and to refer individual student projects for IRB review as necessary.

Incomplete or Inadequate Applications
On occasion an IRB application must be returned to the individual because it is either incomplete or so poorly prepared that it cannot be properly evaluated. Therefore, we strongly recommend that faculty carefully review IRB applications (their own as well as those from their students) for accuracy and completeness before submitting them. In addition, everyone should keep in mind that such applications must go through various stages or review and approval (e.g., Department chair, Dean) before they reach the IRB. Thus it pays to carefully plan the research project and craft the application.

Please note: the IRB has begun returning unreviewed protocols which fail to answer the questions posed and refer to an attached methodology section or statement from a thesis or dissertation proposal. The questions must be answered within the protocol form itself. The only attachments required are copies of survey instruments, consent forms, letters of institutional permission (when necessary), correspondence with any other IRB, and the signed pledge of compliance.

Institutional Review Board
Dr. Raymond DiGiuseppe, Chair

Marie Nitopi, Ed.D.
IRB Coordinator
718-990-1440
[email protected]
Newman Hall, Room 106

Modeled after CUNY’s policy for student research with human participants.

Meeting Dates
Institutional Review Board meeting dates for the 2018-2019 academic year are as follows:

March 4, 2019
April 8, 2019
May 6, 2019
June 3, 2019
July 8, 2019
August 5, 2019

IRB applications that require full board review must be submitted by the 15th of the month prior to the meeting date in order to be considered at the following meeting. 

Projects involving the use of animals should be submitted to the University's Institutional Animal Care and Use Committee (IACUC), headed by Dr. Louis Trombetta. The University's IACUC will evaluate the number of animals to be used, the selection of species, and the animals' possible exposure to discomfort and pain. Animal use review and approval is generally governed by regulations outlined in the NIH Publication Guide for the Care and Use of Laboratory Animals. More specifically, animal use is governed by the following federal laws: Animal Welfare Act, P.L. 89-544 as amended by P.L. 91-579, 94-279, and 99-198, and the regulations promulgated in CFR, Title 9, Subchapter A, Parts 14.

Separate from the animal use and care review committee is the Animal Care Center. For information regarding day-to-day operations of, or special needs from, the Animal Care Center, contact the Center's Director. The Animal Care Center reports to the Chair of the IRB.

Important Notice
IRB and IACUC approval is necessary for all projects involving humans and vertebrate animals, respectively. IRB and IACUC approval is not limited to projects funded through external grants.

Contact Information
Institutional Animal Care and Use Committee (IACUC)
Dr. Louis Trombetta
718-990-6025

Animal Care Center
Helen Scaramell, Director
718-990-6086