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The Institutional Review Board

The Structure and Function of the

Institutional Review Board (IRB)

Vahe Grigoryan

IRB Coordinator

vgrigoryan@mednet.ucla.edu

Objectives

• Discuss the role of the Institutional Review Board (IRB) in

human subjects research

• Examine the differences and similarities between QI, EBP

and Research

• Compare the different levels of IRB review

• Identify the different IRBs at UCLA and the types of studies

they review

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The Role of the Institutional Review

Board

The IRB is made up of scientists and nonscientists

“established to protect the rights and welfare of human

research subjects recruited to participate in research

activities …”

Office for Human Research Protections. Institution Review Board Guidebook.

http://www.hhs.gov/ohrp/archive/irb/irb_chapter1.htm

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The Role of the Institutional Review

Board

How does the IRB protect human subjects?

The IRB reviews: • The ratio of risk to benefit for research participants

• The equitable selection of subjects

• Proper consent process

• How well is participant informed of:

• Risks and benefits

• Their rights as participants (i.e. participation is voluntary)

• Continue to monitor safety of subjects after they are enrolled

(http://www.yale.edu/hrpp/members/roles.html)

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Human Subjects

Who are the human subjects commonly involved in nursing

research?

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What is Research

• The IRB reviews all research

involving human subjects

• Research is a systematic

investigation, which includes

research development, testing and

evaluation, designed to develop or

contribute to generalizable

knowledge

(DHHS, 2009)

Systematic investigation is a rigorous problem solving

process with specific steps aimed at testing a hypothesis

Typical steps in the research problem solving process include:

Identify problem or question

Review Literature

Clarify problem - what is purpose?

Define terms and concepts

Define population (strict inclusion/exclusion criteria)

Identify research design (road map)

Data collection procedures

Collect data

Analyze data

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Systematic Investigation

Generalizable Knowledge

What is generalizable knowledge?

• Shared Knowledge - the outcomes draw conclusions which are generalizable beyond a single individual or sample to a larger population with similarities

• Generalizability - based on a rigorous systematic approach which includes the design and method of the project

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Quality Improvement (QI), Evidence-

Based Practice (EBP) and Research?

Definitions of QI, EBP, and Research

• QI - "systematic, data-guided activities designed to bring about immediate,

positive changes in the delivery of health care in particular settings"

• EBP - "the practice of nursing in which the nurse makes clinical decisions

on the basis of the best available current research evidence, his or her own

clinical expertise, and the needs and preferences of the patient"

• Research - "systematic investigation, including research development,

testing and evaluation, designed to contribute to generalizable knowledge"

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(Baily, Bottrell, Lynn, Jennings, 2006; Mosby's dictionary of

medicine, nursing & health professions, 2009)

What is the intent?

• QI - "analyze data to improve systems related to processes and outcomes (i.e. cost, productivity, quality)."

• EBP - "analyze existing data for purposes of ranking evidence that is used to answer a burning clinical, educational, or administrative question that guides practice."

• Research - "validate and refine existing data or generate new knowledge to influence nursing practice, systems, and policies."

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Quality Improvement (QI) Evidence-

Based Practice (EBP) and Research?

Quality Improvement or Research?

Ethical Justification

• QI - Considered an expectation by society for clinical practice to

continuously improve

• Due to the collective enterprise of health care delivery, patients are expected to participate in QI initiatives to help improve the quality of care

• Research - Ethically justified by weighing risks to individual versus

societal benefits from the development of new knowledge

• Publication and dissemination of new knowledge is one way that society benefits from research

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Quality Improvement or Research?

Indicators that project may benefit from IRB review

• Activities pose greater than minimal risk

• A fixed clinical protocol is used that may not be altered by the caregivers and staff

• Activities objective is NOT to improve safety or care that will be sustained over time

• There is randomization of participants

• Collection and analysis of identifiable patient information

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Quality Improvement or Research?

13 Arndt & Netsch, 2012

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Different Levels of IRB

Review

•Full Board Review

•Expedited Review

•Exempt Review

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Full Board Review: (IRB Committee)

Required when greater than minimal risk to subjects

In addition, full board review may be required if:

1) Subjects are randomized

2) Participants are questioned on sensitive topics such as sexual behavior, alcohol use, drug use

(UCLA OHRPP, 2011)

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Expedited Review: (Chair/ Vice Chair)

Minimal Risk to Subjects (Reviewed by Chair or Vice Chair)

• In addition to being of minimal risk to the subject, the procedures in the research must fall within one of seven Department of Health and Human Services (DHHS) expedited review categories:

1. Clinical studies of drugs and medical devices can be expedited if the drug or device is approved by the FDA and is not used experimentally

2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture if certain conditions are met

3. Collection of biological specimens for research purposes by noninvasive means such as hair and nail clippings

(UCLA OHRPP, 2011)

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Expedited Review (cont'd)

4. Collection of data through noninvasive procedures routinely used in clinical practice (i.e. ultrasound, echocardiography)

5. Research involving materials that are collected solely for non research purposes such as medical treatment or diagnosis (i.e. data, documents, records, or specimens)

6. Collection of data from voice, video, digital, or image recordings

7. Data on group characteristics or behavior such as perception, communication, cultural beliefs, social behavior

(UCLA OHRPP, 2011)

Exempt Review

Exempt - very little or no risk to subjects

(reviewed by IRB staff)

• Categories of research that quality for exemption

1. Normal education practices and settings

2. Anonymous educational tests, surveys, interviews, or observations

3. Collection or study of existing data that is available publically or is recorded in a manner that would prevent identification of subjects either directly or indirectly (address, account number etc…)

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The Different IRBs at UCLA 1) North General Campus - reviews research from the College of Letters &

Science and the Professional Schools.

2) South General Campus - reviews social-behavioral research in areas such

as public health, quality of care, quality of life, health prevention and

health education research.

3) Medical IRB 1 - reviews general and internal medicine, infectious diseases,

and ophthalmologic research.

4) Medical IRB 2 - reviews oncology and hematology research.

5) Medical IRB 3 - reviews neuroscience, neurology, psychiatric, drug abuse,

dental research, and related behavioral science research.

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Summary

• The IRB protects human subjects involved in research through various mechanisms

• Differentiating QI, EBP and Research based on intent, generalizability, and risk to participants

• The three level of IRB review based on the level of risk to subjects

• UCLA has five different IRBs divided between the social behavioral IRB and the various medical IRBs

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References

• Arndt, J.V., & Netsch, D.S. (2012). Research study or quality improvement project? Journal of Wound, Ostomy and

Continence Nursing, 39(4), 371-375. doi: 10.1097/WON.0b013 e31825d259c

• Baily MA, Bottrell M, Lynn J, Jennings B (2006). The ethics of using QI methods to improve health care quality and

safety. Hastings Center Special Report, 36(4). Retrieved from:

http://www.thehastingscenter.org/uploadedFiles/Publications/Special_Reports/using_qi_methods_to_impr

ove_health_care_quality_safety.pdf

• Bankert, E. A., & Amdur, R. J. (2006). Institutional Review Board: Management and Function (2nd ed.). Sudbury,

MA: Jones and Bartlett Publishers.

• Fraenkel, J.R., & Wallen, N.E. (2003). How to design and evaluate research in education (5th ed.). New York, NY:

McGraw Hill-Companies.

• Kring, D. L. (2008). Research and quality improvement: Different processes, different evidence. Medsurg

Nursing, 17(3), 162-169. Retrieved from http://www.ajj.com/services/pblshng /msnj/ceoline/2010/

article17162169.pdf

• Krugman, M. (2008). Evidence-based practice: Is it research, evidence-based practice, or a quality improvement

project? Journal for Nurses in Staff Development, 24(3), 137-139. doi: 10.1097/01.NND.0000320651.

49753.5e

• Mosby, Inc. (2009). Mosby's dictionary of medicine, nursing & health professions. St. Louis, Mo: Mosby/Elsevi

• National Science and Technology Council, Committee on Science, Human Subjects Research Subcommittee, Social

Behavioral Research Working Group. (2008). Expedited Review of Social and Behavioral Research

Activities. Retrieved from http://www.nsf.gov/pubs/2008/nsf08203/nsf08203.pdf

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References (cont'd)

• Shirey, M. R., Hauck, S. L., Embree, J. L., Kinner, T. J., Schaar, G. L., Phillips, L. A., . . . Ashby, S. R. (2011).

Showcasing differences between quality improvement, evidence-based practice, and research. The

Journal of Continuing Education in Nursing, 42(2), 57 - 67.

• University of California Los Angeles, Office of Human and Research Protection. (2011, July). Guidance and

procedure: Obtaining and documenting informed consent. Retrieved August 1, 2012, from

http://ohrpp.research.ucla.edu/file/10034/5-3.pdf

• University of California Los Angeles, Office of Human and Research Protection. (2011, September). Guidance and

procedure: Determining which activities require UCLA OHRPP/IRB review. Retrieved August 8, 2012,

from http://ohrpp.research.ucla.edu/file/10005/3-1.pdf

• University of California Los Angeles, Office of Human and Research Protection. (2011, October). Guidance and

procedure: IRB review level-full committee review. Retrieved August 7, 2012, from

http://ohrpp.research.ucla.edu/file/10017/4-2c.pdf

• U.S. Food and Drug Administration. (2012, July). Device advice: Investigational device exemption. Retrieved

August 8, 2012, from http://www.fda.gov/MedicalDevices/ DeviceRegulation

andGuidance/HowtoMarketYourDevice/Investigational DeviceExemptionIDE/default.htm

• U.S. Department of Health and Human Services, Office of Human Research Protection. (1993). Institutional review

board guidebook: Institutional administration. Retrieved on July 18, 2012, from

http://www.hhs.gov/ohrp/archive/irb/irb_chapter1.htm

• Westlake, C., & Taha, A. A. (2012). The institutional review board: Purpose and process. Clinical Nurse

Specialist, 26(2). 66-70. doi: 10.1097/NUR.0b013e3182487d8e

• Yale University. (2009). Human research protection program: Roles and responsibilities. Retrieved July 21,

2012, from http://www.yale.edu/hrpp/members/roles.html

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Questions or Comments?