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Submitting a Research Protocol for IRB Review

Background

The responsibilities of being an investigator conducting human research necessarily raises a number of important ethical issues. These guidelines are designed to provide useful information as to the appropriate conduct of research involving human participants at Cabrini University. The elements of protection discussed here are intended to be guides by which the researcher plans an investigation that is mindful of basic ethical principles.

Research that involves active, human participants must be submitted to a review process that ensures the safety for participating subjects and best research practices. In many cases, determining whether a particular research activity involves human subjects is not difficult, but in some cases, the determination may not be clear. When an investigator is unsure whether research activities involve human subjects, the researcher is encouraged to seek the advice of the IRB chairperson. In all cases, final responsibility for determining whether human subjects are involved in research is the purview of the IRB.

It is the principal investigator's responsibility to adhere to the protocol as it has been approved by the IRB.

1. Prior To Submission

Prior to preparing a research application, investigators should answer the following questions:

  • Does the project involve research?
  • Will the project involve human subjects?

Definitions

Research is defined by the Common Rule as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." The regulations further specify that a project is research if it is "conducted with the intention of drawing conclusions that have some general applicability and uses a commonly accepted scientific method.”

The term Human Subject is defined by Federal regulations (45 CFR 46.102(f)) “as a living individual about whom an investigator conducting research obtains: Data through intervention or interaction with the individual, or identifiable private information.”

Planning the study

The IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full. Please examine the pages for each type of review to determine which type of review your proposed research project will require. Please note that activities related to the study, such as data collection, may not begin until the study is approved by the IRB.

2. Items Required for IRB Project Submission

Please follow this link for a detailed IRB Protocol Submission Checklist.

  1. Proof of Human Subjects Training (valid for only 3 years). Please follow this link for instructions to complete the required ethical training that all individuals involved in research must complete. At the end of the training, you will be given a certificate to include in your IRB application.
  2. IRB Research Protocol Application and supporting documentation with appropriate signatures
  3. Description of the research including purpose and methodology
  4. Research Instruments (Recruitment Flyers, Questionnaires, Interview Guides, etc.)
  5. Consent and/or assent forms for participants
  6. Letters of support or approval from performance sites where data will be collected on appropriate letterhead (i.e., some research requires school district or organization permission).
  7. If other institutions are involved, approval letters from the IRB at the partnering institutions that have reviewed the project.

3. What is the Role of the Faculty Advisor for Student Research?

Please follow this link for Faculty Sponsorship of Student Research checklist.

The role of the faculty advisor is to guide students through the IRB process by discussing general principles of research ethics with the class/student prior to the initiation of any project involving human subjects.

Faculty members who supervise student research are responsible for the protection of human subjects and are required to:

  1. Be familiar with the ethical and regulatory requirements of human subjects research.
  2. Discuss research ethics with the students.
  3. Consider whether projects require IRB review and assist students with the process. Insure that the protocol review forms are complete and all additional documentation is attached.
  4. Monitor student projects, paying special attention to maintaining confidentiality, privacy, level of risk, voluntary participation and withdrawal, and informed consent.
  5. Assure that any unexpected or adverse events are reported to the IRB.

4. Review

The IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full. Please examine the pages for each type of review to determine which type of review your proposed research project will require. Please note that activities related to the study, such as data collection, may not begin until the study is approved by the IRB.

Possible Outcomes of the IRB Review

The initial review process is begun by the submission of a complete protocol application. Your protocol will then be reviewed at one of the three possible levels of IRB review: Level 1) Exempt from IRB review, Level 2) Expedited Review (for minimal risk protocols), or Level 3) Full Board Review (for protocols with more than minimal risk or involve vulnerable populations such as children, pregnant women, incarcerated individuals, and others).

  • Protocols submitted for Exempt Review will generally be processed within two weeks.
  • Protocols submitted for Expedited Review will generally be processed within two to three weeks.
  • Protocols submitted for Full Review must be submitted by the stated deadline in order to be reviewed at the convened IRB meeting for that month.

* Delays may be incurred if submissions are incomplete.

Once the protocol has been reviewed you will receive notice of the outcome. Possible outcomes include:
Approval—There are no changes needed in the study and the investigator can proceed with the research without further delay;

  • Conditional approval—There are minor revisions that need to be made. After the revisions are completed, the study can be reviewed by the IRB and given final approval;
  • Tabled for Later Review—There are major problems or concerns with the study that impact the protection of the human subjects to be involved, and the study must be reviewed again by the IRB at a subsequent meeting after the investigator has addressed all the reviewers’ concerns;
  • Not approved—There are severe problems or concerns. Specific reasons for disapproving research will be communicated to the investigator. The study may not be resubmitted unless completely revised.

The IRB will communicate the decisions made on protocols to the PI, and the FA if applicable, with instructions on how to proceed.

The Forms and Review Timeline page includes specific documents and timelines for completed submissions.

 

Please provide a single Word document with all the required components. Submit your protocol here by enrolling in the Institutional Review Board option on the Cabrini Portal (log-in required).