Academic Resources

Office of Research Services

Submitting a Research Protocol for IRB Review

The Office of Research Services is pleased to announce the adoption of the industry leading IRBNet suite of tools, accessible via the National Research Network, bringing electronic protocol management, on-line submissions and many other important research oversight features to the SJU research community.  We recognize the need to reduce manual and paper-based procedures, streamline protocol submission and review processes and leverage today’s best technologies throughout the research lifecycle.  As an important step toward these objectives, adoption of IRBNet now brings the SJU community a robust set of electronic tools supporting the management, submission, review and oversight of our research protocols. 

Effective January 1, 2013, all protocols (as well as revisions and renewals for Expedited and Full Board protocols) must be submitted electronically via IRBNet, and all review decision letters will be issued electronically via IRBNet.  If you have already completed your application using the old form in our Form Library, please feel free to submit it as an uploaded supporting document, through IRBNet before January 31.  If you wish to use the IRBNet Library form, you will find that it asks for almost identical information, so replicating your application within IRBNet should be fairly straightforward.  After January 31, researchers will be required to utilize the forms within IRBNet.  For detailed instructions that will guide you through your submission, please refer to the Investigator Submission Guide.


Background:

The responsibilities of being an investigator conducting human research necessarily raises a number of important ethical issues. It is hoped that these guidelines will aid in clarifying these issues, and provide useful information as to the appropriate conduct of research involving human participants at Saint Joseph’s University. The researchers' needs must be balanced with respect for the person and rights of participants and of the social groups to which they may belong. Thus, the elements of protection discussed here are intended to be guides by which the researcher plans an investigation that is mindful of and takes into consideration basic ethical principles.

In many cases, the determination of whether a particular research activity involves human subjects is not difficult, but in some cases, the lines can be blurred. When it is not clear to an investigator whether research activities involve human subjects, he or she is encouraged to seek the advice the IRB members or the chairperson. In all cases, final responsibility for determining whether human subjects are being involved in research rests with the IRB.

Under limited circumstances and with the written authorization, approval by another IRB may be acceptable in lieu of approval by the Saint Joseph’s University IRB. Prior approval of the Saint Joseph’s University IRB is not required when part-time or unpaid faculty are not acting as a staff member, employee, or agent of the university, or when the activity does not involve the university, either as represented to subjects or in subsequent publication. However, in such cases investigators holding university appointments must nevertheless obtain approval for the use of human subjects from a duly constituted IRB.

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

Prior to preparing a research application, investigators should determine the following.

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

Definition Of Research
Research is defined by the regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." The regulations further specify "activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes.

Definition Of Human Subject
Human Subject is defined by applicable Federal regulations (45 CFR 46.102(f)) “as a living individual about whom an investigator conducting research obtains:

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

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2. What is the Role/Expectation of the Faculty Advisor?

Faculty advisors may be chosen by the student investigator or assigned to the student. Their role as the 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. Consider whether projects require IRB review and assist students with the process. (If the project involves research in a non-US setting, then considerations of local regulations and customs must be understood and satisfied.)
  3. Discuss research ethics with the students.
    Advise students conducting international studies on understanding the local customs and ethics.
  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.

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3. Items Required for IRB Project Submission:

  1. Proof of Human Subjects Training (valid for only 3 years.) Please follow this link for instructions to complete the required CITI training. Human Subjects Research Training.
  2. Curriculum Vitae or Resume for anyone involved with the Research protocol (PI, FA, Co-Investigators). This may not be practical for most student researchers and in some cases may be waived.
  3. IRB Research Protocol Application and supporting documentation submitted through IRBNet, with apprpriate signatures. 
  4. Research Instruments (Recruitment Flyers, Questionnaires, Interview Guides, etc….) Follow this link for more details about Recruitment Flyers.
  5. 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).
  6. Approval letters from IRB’s at other institutions that have reviewed the project.

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4. Levels and Possible Outcomes Of IRB Review

The initial review process is begun by the submission of a complete protocol application in IRBNet. 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).

  • 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 first working day of the month to be reviewed at the convened IRB meeting for that month. That meeting is typically held on the second Thursday of the month. The PI will be notified of the status of their protocol within two (2) business days following the meeting.

* Delays may be incurred if submissions are incomplete.

* Must be submitted before the first working day of the month to be reviewed at the monthly IRB meeting

The possible actions of the IRB following review are:

  • 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, but full review is not required by the IRB. After the revisions are completed, the study can be reviewed and signed by the Chair of the Board giving final approval;
  • Tabled - 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.
  • Exempt - Certain minimal risk protocols are given exempt status by the IRB.

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

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