Research Development

Human Subjects Institutional Review Board

 

Frequently Asked Questions

 

About the IRB

CITI Training

IRB Approval

IRB Policy on Student Work

IRB Records – Retention, Maintenance

 

 

Who is my IRB Representative?

Each academic school at UIW has a dedicated IRB Representative listed here.

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What are sensitive populations?

Sensitive populations include: minors, fetuses or products of labor or delivery, pregnant women, prisoners, and any individual with a diminished capacity to give informed consent.

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What is sensitive information?

Sensitive information includes information on: sexual attitudes, perferences, or practices; use of alcohol, drugs, or addictive products; illegal conduct; information that could damage a person's reputation or standing; information that could lead to discrimination; mental health; genetic information.

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Do I really need to take CITI training?

Yes. An institution holding an OHRP-approved Federalwide Assurance (FWA) is responsible for ensuring that its investigators conducting human subjects research understand and act in accordance with the requirements of the HHS regulations for the protection of human subjects. CITI training helps to ensure that investigators maintain continuing knowledge of, and comply with ethical principles; federal regulations; written IRB procedures; OHRP guidance; state and local laws; and institutional policies for the protection of human subjects.

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How do I demonstrate my CITI certification when submitting to the IRB?

You do not need to submit a copy of your CITI training certificate. The IRB Coordinator will look up your CITI certificate to ensure you have taken the correct courses, completed with a satisfactory grade (85% overall score), and that the certification is current.

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How long is CITI training good for?

CITI training expires after three years. Once expired, a refresher course is available to maintain coverage.

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When do I need to get IRB approval?

All research projects that will involve human participants must be submitted for review and approval before beginning the study. This includes proposed research involving existing data and previously collected human fluid and tissue samples, as well as advertising or recruitment for the study.

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How long does IRB approval last?

IRB approval typically lasts for one year.

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Do I really have to submit a Continuation/Completion Form? Or can I just let my IRB protocol close itself?

Yes. Before a protocol's annual expiration, an investigator must submit a Continuation/Completion Form. This form lets the IRB know if the investigator will continue work on the approved protocol or close the protocol. Submission is a mandatory component of the IRB lifecycle and failure to submit before annual expiry results in administrative closure of the protocol. As a federally mandated component of administrative closure, a notice of closure and policy violation issent to the investigator's supervising dean.

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I don't have IRB approval, but I have human subjects research I wish to publish or present. What should I do to be in compliance?

The IRB cannot review protocols for projects in-progress or already completed. Per federal regulations, research for presentation or publication cannot be reviewed for IRB approval following the conduct of the research. As soon as you identify a project's potential for publication or presentation stop conducting the research and apply for IRB approval. Data collected prior to the approval date cannot be included in the study.

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Can a student be a principal investigator?

Yes. If the Principal Investigator is a student, then a Faculty Supervisor or Thesis/Dissertation Chair must supervise the project. Supervision is defined as:

  1. Direct knowledge of and responsibility for the direction and completion of the project
  2. Assurance of student compliance with University and Federal human subject protection policies
  3. Filing of required documents which verify revision, amendment, annual continuation, or completion of the supervised protocol

For protocols with a planned duration equal to the duration of a course, the Course Instructor or Faculty Supervisor must ensure that the participating student investigator(s) are informed of the requirement to submit completion or continuation documents. If it is anticipated or determined during the study that the IRB approved protocol will extend beyond the duration of an investigating student’s involvement in the course or graduate program, then a long-term Faculty Supervisor must be designated prior to course, thesis or dissertation completion.

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Do student projects need IRB approval?

If the project is to be used in a classroom setting only to teach research methods, the project may not constitute human subjects research. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor so that they can determine whether IRB review is necessary.

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Are there any student classroom projects that must be submitted to the IRB?

Student classroom projects which include a special subject population or deal with categories of sensitive information must be submitted to the IRB for approval.  IRB approval is required regardless of whether or not the study will produce generalizable knowledge or it will be publically disseminated via presentation or publication.

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What records should investigators keep, and for how long?

The HHS protection of human subjects regulations require institutions to retain records of IRB activities and certain other records frequently held by investigators for at least three years after completion of the research (45 CFR 46.115(b)). In addition, other regulations may apply and require retention of these records for a longer period of time. Documentation of the informed consent of the subjects - either the signed informed consent form or the short form and the written research summary - are records related to conducted research that are typically held by investigators and must be retained for at least three years after completion of the research, unless the IRB waived the requirement for informed consent or the requirement for documentation of informed consent (45 CFR 46.117).

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I'm changing my protocol, but it's a little change. Do I need to submit a Revision/Amendment Form?

If you make any change to the study, including research procedures, instruments, title, research sites, addition or removal of investigators, change of faculty supervisor, number of subjects, consent form, or recruitment materials, the IRB needs to know. The Revision/Amendment Form helps us keep the most accurate, up-to-date records possible and fully comply with regulations.

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