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Updates and Intrigue from the World of IRB

Header image designed by Michelle Jordan, UMBC Creative Services, 2009

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Learning Outcomes Purpose of research compliance Ethics behind/regulations governing research

human research Definitions Role of institutional compliance committees Dilemmas

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“Doing the right thing”“Real integrity is doing the right thing, knowing that nobody’s

going to know whether you did it or not” - Oprah Winfrey 1

Various codes for the proper and responsible conduct of human research have been incorporated into researchers interact with people and how universities conduct business.

Be aware of aspect of being a responsible researcher, know how to conduct research appropriately and understand one’s role in the research process

1 http://www.wow4u.com/oprahwinfrey/index.html

Circle of compliance

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Research Research ComplianceCompliance

Required by the federal government as well as the University of Maryland for the ethical review of research and ensure participants rights are protected and that they are safeguarded from risk and harm

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To do the right thing, know about the ethics 45CFR46 - Protection of Human Subjects - ensures minimal

standards for the ethical treatment of research subjects based on past history

Foundations of ethics in human research Respect for persons – freedom to make a choice and voluntarily

participate Beneficience – freedom from harm with maximizing benefits and

minimizing risks Justice – fair distribution of benefits/risk of participating in

research (impose risks unnecessarily/advantage of benefits who can afford them)

Protection from risks and safeguard from harm

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Understand what research is: Systematic investigation that contributes to

generalizable knowledge "Research" is defined in the Code of Federal Regulations as "a

systematic investigation that contributes to generalizable knowledge" In other words, an investigator will be "engaged in research", has proposed an intention to explore a particular topic, while interacting with a living person and either publish (e.g., in a journal) or present at a conference. 

Living individuals about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information

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Intrigue Fascinate

Captivate http://www.youtube.com/watch?v=y8Kyi0WNg40

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Institutional Review Board (IRB) Required by Federal regulation Provides assurance to comply with the rules and

regulations oversight for the university's human research use program Ethical review of research Ensure participants rights are protected and that they are safeguarded from

risk and harm Compliance with federal guidelines and principles

Supported by the Vice President for Research

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IRB oversightSafeguards from harm

Emotional or psychological harm Social harm Financial harm Legal harm

Protections from Risks greatest risk is often a breach of confidentialityrisk could lead to social stigma, loss of employment, embarrassment , etc.

Opportunities for voluntary participation the “consent process” – the process that involves a conversation

that most of the time uses a documentPurpose, Procedures, Confidentiality, Risks, Benefits , Freedom to withdraw

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IRB Membership Members include:

Scientists and non scientists from various disciplines on campus as well as graduate and undergraduate student members, including: Psychology Africana Studies Information Systems Modern Languages and Linguistics Sociology/Anthropology Public Policy

Individuals not affiliated with the Campus who represent the concerns of the Community

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IRB process

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The IRB reviews:Low or less than risk Assessment of classroom management strategies Action research Analysis of census data Publicly available information recorded in such a manner that subjects cannot be identified Surveys or interviews of nonvulnerable adults about nonsensitive topics

Minimal Risk Research where disclosure of the participant’s identity might result in negative legal, financial, economic or social

consequences Longitudinal or repeated-measures studies Interviews or surveys on sensitive topics where the subject can be identified Studies involve the possibility of a moral wrong

More than Minimal Risk Research studies that involve vulnerable populations, or involve special circumstances. Sensitive topics include: sex, drugs,

alcohol use, suicide.

May not require IRB review Activities that are not hypothesis driven Data collected for educational or teaching purposes and is not disseminated outside the institution. Literature review to support research purpose or research question Surveys issued or completed by University personnel for the intent and purposes of improving services and programs of the

University

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Campus Assessment Coordinating Committee (CACC) created by UMBC to coordinate assessment activities centrally track and authorize survey requests and

improve the quality and usefulness of assessment activities on campus develop an effective strategy for survey management and data collection coordinate and approve internal and external requests to survey UMBC

students, alumni, staff, and/or faculty

CACC approves surveys that require access to institutional data/contact information

Supported by the Office of Institutional Research

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CACC membership

Institutional Research Academic Affairs Human Resources Student Affairs Institutional Advancement Office of Information Technology Residential Life

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CACC process

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CACC responsibilities solicits requests reviews internal and external requests to survey UMBC

students, alumni, staff, and faculty interacts with use and compliance entities (IRB, Registrar/

Alumni Affairs/Human Resources, FERPA and other regulations)

provide advice and guidance with questionnaire design, sampling, etc.

maintains repository for contributed survey reports

Does not replace the functions of the IRB

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Examples of CACC review Importance: Does it provide useful information for academic planning purposes? Does it

provide useful feedback to those providing services to students, alumni, staff, or faculty? Are other peer institutions conducting the survey and will peer data be available?

Dissemination and Use of Information Collected: Who will have access to the information collected and how will they use it?

Content and Design of Survey: Is the survey well designed? Is the content appropriate? Does it follow sound survey methods and practices? Is it of appropriate length? Are the questions easily understood and interpreted?

Population and Sampling Methodology: What is the target population? Is there a sampling strategy? What is the sampling methodology and is it sound? What strategies will be used to ensure adequate response rates? How will confidentiality of responses be ensured?

Timing: Does the project schedule conflict with another approved survey project?

Review and approval usually within two business days

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Student Affairs Research and the IRB Special considerations

Ethical considerations in conducting research Understand and following campus and federal

requirements for conducting an assessment or program evaluation study

Training Type of review Need for review?

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Examples

www.vancouver2010.com

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Example #1

Survey designed to assess the level of student interest and involvement in activities prior to entering campus or during their freshman year. In four years, a similar survey will be administered to seniors to assess the level of faculty support for these activities and evaluate student interest and involvement in courses and initiatives offered at the university to see if the campus is meeting the needs of the students.

Need IRB and/or CACC approval?

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Example # 2A student seeks to learn more about customer

behavior. He plans to share his results with his colleagues in his honor society by posting the outcome on the society web site. He will interview children at local middle schools about their candy purchases. He will record their names and ages.

Need IRB and/or CACC approval?

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Example # 3A survey is proposed to assess the rider-ship of

campus/community transportation. The results will inform the department of performance issues and rider's needs. The data and information gathered will inform scheduling and routing of the campus’ transit routes.

Need IRB and/or CACC approval?

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Example # 4Survey assessment project to measure and understand

the perceptions of the campus climate for a variety of UMBC student subpopulations, such as ethnic/racial groups, commuter and transfer students, and of diversity and/or harassment. The data and results will be used to improve programs and services offered on campus to better serve specific student subpopulations. Results will be also be presented at a conference.

Need IRB and/or CACC approval?

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Example # 5Survey was designed by the National Clearinghouse for

Commuter Publications to better understand the unique needs of off-campus students. It will allow the Office of Off-Campus and Transfer Student Services to improve existing programs and services and the marketing of those programs and services. It could also inspire the creation of new programs within the office.

Need IRB and/or CACC approval?

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5523 Research Park Drive

Suite 310

Baltimore, MD 21228

HARPO@umbc.edu

www.umbc.edu/ressearch/HARPO

410-455-3868 (FAX)

Tim Sparklin: 410-455-2737

Mary Lilly: 410-455-3958