Academic Resources

Office of Research Services

IRB: Frequently Asked Questions
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What is an IRB?

IRBs are committees (mandated by the National Research Act) who review research projects that recruit or involve human participants. The primary responsibility of the IRB is to ensure that all ethical issues concerning the protection of the human subjects who volunteer to participate in research projects are fully addressed. A secondary responsibility is to protect student, faculty, and staff from taking unwarranted risks in generating new knowledge.

The purpose of the IRB is to inform and protect human subjects through the information provided in the informed consent document. During its review of the informed consent and research process, the IRB has the right and responsibility to ensure that a research subject is fully informed of the procedures involved in a study as well as the risks and (when applicable) alternative treatments that are available if participation in a study is refused.

Who needs Human Subjects Tranining? How can I meet the training requirement?

All persons involved in Human Subjects Research must receive human subjects training. This includes: Student and Faculty Investigators, Faculty Advisors and Research Assistants.

Saint Joseph's University subscribes to the CITI Human Subjects training course to meet the human subjects training requirements. All persons involved with a research project must complete this training before final approval can be given.

What types of research must be submitted for possible review by the IRB?

ALL proposed studies involving direct or indirect contribution of human subjects to the research process (e.g., survey, interview, comparison of teaching techniques, etc.) or a human's participation as a research subject (e.g., a dexterity study, physical or mental task, biomedical procedure, audio/video tapes, etc.) must be submitted to the IRB office for determination of the appropriate review procedure in accordance with SJU policy. (These examples are not intended to be inclusive. For additional information or clarification of the review requirements, contact the Research Compliance Coordinator, Jena Fioravanti Burkett, in the Carriage House, on Maguire Campus, at (610) 660-1298.
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What is research?

Research is defined by Federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" [Federal Policy 45 CFR 46.102(d)]. Human subjects are defined by the regulations as ";living individual(s) 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".

Further, research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
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What types of research does the IRB review?

The SJU IRB reviews research involving human subjects if one or more of the following apply:

  • the research is sponsored by SJU, regardless of the location of the project
  • the research is conducted by, or under the direction of, any staff, faculty, student, or other agent of SJU in connection with his or her institutional responsibilities
  • the research is conducted by or under the direction of any employee or agent of SJU using any property or facility of SJU
  • the research involves the use of SJU's non-public information to identify or contact human research subjects or prospective subjects

Special consideration is required for research involving fetuses, pregnant or lactating women, human ova in vitro fertilization, prisoners, children, persons with cognitive impairment, or other potentially vulnerable groups.

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Who is required to obtain advance approval if humans are proposed as subjects of research?

ALL faculty, staff and students (undergraduate or graduate) must obtain IRB approval before involving humans (or data collected about or from humans) as subjects of research. If you are not sure whether this policy applies to your proposed study, please contact the IRB office to get clarification prior to starting work which may not be sanctioned by the university. The IRB is in place to protect both human subjects and Investigators. Failure to obtain IRB approval for research activities may result in a range of legal and disciplinary consequences for the Investigator.
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Do all research activities involving human subjects require a full IRB review?

No. There are certain categories of research which may be granted an exemption from full Board review, or expedited review by a select number of IRB members. See 45 CFR 46.101(b) for general guidelines for exemption.
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What ethical principles guide the IRB in the protection of human subjects?

Three basic principles of ethics are particularly relevant to the protection of human subjects in research. They are:

  • respect for persons: recognition of the personal dignity and autonomy of individuals and special protection of those personswith diminished autonomy;
  • beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm; and
  • justice: fairness in the distribution of research benefits and burdens.

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What are the components of IRB Review?

In reviewing research the IRB gives proper consideration to the following:

  • risks to the subjects
  • anticipated benefits to the subjects and others
  • importance of the knowledge that may be reasonably expected to result from the research
  • consent process to be employed

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What is the difference between the three levels of IRB review (exempt, expedited, and full board)?

Research in the exempt category is exempt from applicable federal regulations, although review by the IRB is still required. Exempt level review research must be anonymous, and at least one of the following must characterize the research:

  • commonly accepted educational settings involving normal education practice
  • educational tests if the information is taken so that subjects cannot be identified
  • (does not apply to children) surveys or interviews that do not deal with sensitive aspects of the subject's own behavior (such as drug use, sexual activity, or criminal activity), or in which the subject's responses would not place the subject at risk of liability, or threaten financial standing or employability
  • (needs not be anonymous) surveys or interviews of elected or appointed public officials or candidates for office
  • (does not apply to children) observation of public behavior that does not deal with sensitive aspects of the subject's own behavior or in which the subject's responses would not place the subject at risk of liability or threaten financial standing or employability
  • collection or study of existing data, documents, records, or biological specimens as long as they are publicly available
  • research or demonstration projects of programs under the Social Security Act or other public benefit or service programs

Research in the expedited category is that which poses no more than minimal risk to the subject involving no more than:

  • collection of hair, nail clippings, baby teeth or teeth in need of extraction
  • collection of excreta, sweat, saliva, placenta and amniotic fluid at delivery
  • non-invasive recording of data from subjects 18 years of age or older using routine clinical procedures (not including x-rays and microwaves)
  • collection of blood samples of limited volume and frequency from subjects 18 years of age or older
  • collection of dental plaque via routine scaling of teeth using accepted techniques voice recordings for research purposes (e.g., of speech defects)
  • moderate exercise by healthy volunteers
  • study of existing data, records, or specimens
  • research where the researchers do not manipulate subjects' behavior and the research will not involve stress to subjects
  • research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required

Research which is neither minimal nor expedited requires the full board category of review.
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If I believe that my project meets the requirements for an "exemption" does that mean I don't have to do anything else?

No. The protocol must be submitted to the IRB office, where the Research Compliance Coordinator will evaluate the "exempt" research status.
"Exempt" (or an "exemption") means only that an activity does not have to be approved by the full IRB.
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Can I, as Principal Investigator or Faculty Advisor, or my Department Head (Chair, etc.) approve an exemption under 45 CFR 46.101(b)?

No. ALL research involving human subjects must be submitted to the IRB Office, each submission must consist of the following completed documents for the Use of Human Subjects in Research:

  • Request for Approval of Research Involving Human Subjects
  • Cover Sheet
  • Informed consent checklist
  • Proposal checklist

These forms are all available from the Office of Research Services Web Page.

If the investigator(s) believe that the research is exempt, they may attach a brief memo requesting approval of their research based on the guidelines that they believe are applicable for an exemption of their proposal.
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How can I obtain an approved exemption?

One original and two complete copies of the signed Protocol for the Use of Human Subjects in Research, with all attachments, must be submitted to the IRB office for review. If the Research Compliance Coordinator approves the protocol for exemption from full-Board review, the researcher will be notified in writing as to the regulatory section under which the protocol was approved as "Exempt." The categories of research which may be considered for "exemption" are listed in 45 CFR 46.101(b).
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Is there any verbal approval that will allow me to start my research after submitting my forms?

There can be no exception to the requirement for advance, written approval from the IRB before any research project involving human subjects is initiated.
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How long does approval of an exemption or expedited review take?

This depends on the information provided (or additional information needed) that clearly explains your proposed research. If the protocol is deemed to be "exempt", clear, complete and all attachments are in order, it is possible to receive approval from the Compliance Coordinator to proceed with the study within 48 hours from the day the protocol is submitted. To ensure an expedient review, you may want to contact the Compliance Coordinator or IRB Chair to arrange an appointment to review your protocol and attachments before formal submission for IRB review. It is recommended that you initiate the review process no less a month before you intend to begin work on the project, as initial reviews may take up to two weeks.
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How long does it take to receive approval for a protocol which much be reviewed by the full IRB?

If the protocol is reviewed by the full IRB, the review cycle could take anywhere from one(1) to (8) eight weeks. The length of the review process depends on many factors, among them: how well the protocol is prepared; the extent of revisions/clarifications requested by the Board; reconciliation of subject numbers, recruitment practices, acceptable consent procedures, etc. On rare occasions, a proposed project may require significant revisions and consideration of a rewritten protocol (and/or attachments) by the Board before final approval is granted. More often, minor revisions may be requested by the IRB and approval may be granted by the Administrator upon receipt of an acceptable response to the IRB's questions/concerns.

In any case, for any type of research requiring an IRB authorization, it is advisable to begin the IRB review process as soon as possible.
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When and how often does the IRB meet?

Presently, the Board typically meets on the second Thursday of each month, during free-period. If it is not possible to secure a quorum of members for a regularly scheduled meeting, the Research Compliance Coordinator will attempt to reschedule the regular meeting for an agreeable date and time.  On occasion, and dependent upon the number of protocols scheduled for review, the IRB may meet twice in one month.
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What is the submission deadline?

Applications for proposal review must be submitted to the IRB by the first working day of the month. Those received after the first working day of the month that cannot be expedited or exempted will likely be scheduled for the following month.
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Where do I send my applications?

Send your applications to:

Jena Fioravanti Burkett
Research Compliance Coordinator
Office of Research Services
Carriage House, Maguire Campus

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How many copies of my protocol must I submit to the IRB office?

One (1) complete original (meaning original signatures must be on one set) must be received in the Office of Research Services for review no later than the first business day of the month to ensure review during that month in the event the protocol requires Full Board Review.  If it is determined that additional copies are necessary, the Research Compliance Coordinator will contact the PI to request they be provided.  

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The site where I intend to conduct my research has its own IRB. Does my protocol have to be reviewed by the site IRB and the Saint Joseph's University IRB? If so, how do I do this?

Some sites of research activity, such as hospitals, community mental health organizations, and other universities, have IRBs to review the research conducted at that site. Each IRB must approve your project prior to implementation.

You may submit your protocol for review to both boards simultaneously or to each board consecutively, whichever you prefer. Each board may request different revisions based on interpretations of the federal regulations. Remember that it is your responsibility as the investigator to notify each board of the decisions of the other board. You must also remember to submit any revisions to both boards and you must receive approval from both boards before implementing any aspect of the research.
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What about changes in the protocol once it has been approved?

All changes in a research protocol must be approved before the change is incorporated into the protocol. These should also be submitted to the IRB using the "Protocol Amendment Form," available from the ORS IRB Forms page.

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