Human Participants (IRB), Animal Use in Research

• IRB Application
• IRB Exempt Application
• Human Subjects Amendment Application
• Human Subjects Extension Application
• Application for Waiver of HIPPA

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.

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.