Institutional Review Board

Utah Valley UniversityOffice of Undergraduate Research and

International ProgramsAndrew Creer, Ph.D. – IRB Chair

Nancy L. Bartlett – IRB Administrator

For Human Participants in Research

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Why know about the IRB?

• UVU encourages scholarship and research.

• The University strongly encourages research, presentations, and publications from all faculty members.

• Many kinds of research will involve human subjects.

• Any research data collected from human subjects needs to be reviewed through the IRB process.

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IRB Training Outline

1.What is the IRB and its mission?

2.Why do we need an IRB?

3.How hard is the process?

4.How do we prepare?

5.How do we do it?

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1. What is the IRB?

The IRB is the entity with the jurisdiction for reviewing and approving all research involving human subjects carried out by the faculty, staff, or students of UVU.

IRB paperwork must be submitted before research can be approved. IRB approval must be obtained before the data collection can begin.

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What is the IRB’s Mission?

• Reviewing proposed research involving human participants in order to protect them against potential risks of research participation while promoting high-quality studies;

• Educating the larger university community about ethical issues in human participants research;

• Overseeing compliance with federal, state, and university regulatory requirements for human participant research.

The IRB furthers the University’s research mission by:

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2. Why do we need an IRB? Adherence to IRB guidelines helps to assure the

highest quality research at UVU.

The IRB process ensures that UVU-associated research does not harm participants in any way.

Federal laws mandate that institutions of higher education that are participating in any type of government-sponsored research have an IRB.

All universities and nearly all colleges have IRBs.

To publish in reputable journals, faculty often must demonstrate that the research has gone through an IRB process.

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3. How hard is the process?

Piece o’ Cake!

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4. How do we prepare?Before IRB paperwork is started, the researcher(s) should have planned the research study and outlined specific research methods. This may include (but is not limited to) the development of the following:

• problem statement• research purpose• research questions or hypotheses• literature review• research design• population and sample selection• measures and/or instrumentation• data collection procedures• data analysis procedures• plans for minimizing risks to participants

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5. How do we do it? (more questions!)

a.Who needs to submit the packet?

b.What are the IRB paperwork requirements and processes?

c.How long does it take?

d.What are the three levels of review?

e.What if I need help?

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5a. Who submits the packet?

It is the responsibility of the principal investigator (PI) to submit proposed research for approval. Approval by the IRB does not relieve the PI from the obligation to follow procedures and rules of the University and any other regulatory body involved with the research. For student research, the advisor or faculty member must be either the PI or the Co-PI.

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5b. What are the IRB paperwork requirements and processes?

Refer to the following handouts:

IRB Process – At a Glance

Form A – Record of IRB Submission

Form B – Application for Approval for the Use of Human Subjects in Research

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IRB Packet Review

Form A – Record of IRB Submission

Form B – Application for Approval for the Use of Human Subjects in Research

Blank Instrument

Informed Consent Letter or Form

Permission Letters (if applicable)

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5c. How long does it take? The IRB is committed to move packets through the process as quickly as possible. Once the completed packet is submitted to the IRB, the entire process (if the packet needs no revisions) should take approximately:

Exempt (1-2 weeks) Expedited (2-3 weeks) Full Review (4-6 weeks)

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Determination of Review Level

First, the IRB Chair, in conjunction with the IRB, determines the level for review.

The UVU Investigator’s Handbook for Human Participants includes a detailed description and list of examples. Even with this document you may have questions because there are so many possible types of research.

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5d. What are the review levels?

Exempt Review

Expedited Review

Full Board Review

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What is exempt research? The exempt categories are determined by the federal regulatory agencies and include research of minimal risk in the following situations:

The study of some educational practices Survey interview of adult subjects or public

figures (non-sensitive topic areas only) Observation of non-institutionalized adults

and minors under some circumstances Demonstration or service projects under the

“Social Security Act”

University of Minnesota

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What is exempt research? (cont.) Other examples include:

• Research conducted in established or commonly accepted educational settings.

• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures, or observation of public behavior, as long as anonymity of respondents and confidentiality of answers which could result in risk is maintained.

• Research involving the collection or study of existing data, documents, records…, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

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What is an expedited review?

Expedited review categories are designated by federal regulatory agencies. Expedited review covers research that involves only minimal risk procedures such as those requiring the drawing of small amounts of blood, removal of dental plague, moderate exercise by normal volunteers, the study of individual or group behavior where the behavior is not manipulated and the subjects are not exposed to any stressful situation.

University of Minnesota

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What is an expedited review? Research involving materials that have been collected or will

be collected solely for non-research purposes (such as medical treatment or diagnosis).

Collection of data from voice, video, digital, or image recordings made for research purposes.

Research on individual or group behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

(See Handbook for more)

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What is a full review?

Research involving more than minimal risk to the subject requires review by the full IRB.

Full review covers all research not falling into the two prior categories.

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5e. What if I need HELP?

Department Chair

Your School’s IRB Member(s)

Colleagues who have successfully gone through the process

Websites (www.uvu.edu/irb)

Andrew Creer, Ph.D. or Nancy L. Bartlett

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IRB School Representatives

Business: Letty Workman Education: Vessela Ilieva University College: Chitra Duttagupta Humanities: Joylin Namie, Karen Mizell, David R.

Connelly, Brian Birch, Jeff Bulger, David Knowlton Science & Health: Heath Ogden, Andrew Creer Technology & Computing: Cheryl Hanewicz Unaffiliated: Cameo Johnson, Nancy West, James

Prichard

QUESTIONS?

Utah Valley University

For further information see the Institutional Review Board website at www.uvu.edu/irb or email irb@uvu.edu

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