Header image designed by Michelle Jordan, UMBC Creative Services, 2009
Responsible Conduct in Human Research
(spring 2010)
updated: 02/22/2010
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In brief
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Purpose of research compliance
Ethics behind/regulations governing research
human research
Definitions
Involvement of the IRB
Types of review
The “Bottom” line
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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.
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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
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Circle of compliance
Administration
Compliance
Units
Research
Compliance
Researchers
Compliance
Committees
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
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45CFR46 - Protection of Human Subjects - ensures minimal
standards for the ethical treatment of research subjects based on past history
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Foundations of ethics in human research
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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:
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Systematic investigation that contributes to
generalizable knowledge
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"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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Institutional Review Board (IRB)
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Required by Federal regulation
Provides assurance to comply with the rules and
regulations oversight for the university's human research
use program
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Ethical review of research
Ensure participants rights are protected and that they are safeguarded from
risk and harm
Compliance with federal guidelines and principles
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IRB oversight
Safeguards from harm
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Emotional or psychological harm
Social harm
Financial harm
Legal harm
Protections from Risks
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greatest risk is often a breach of confidentiality
risk could lead to social stigma, loss of employment, embarrassment , etc.
Opportunities for voluntary participation
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the “consent process” – the process that involves a conversation
that most of the time uses a document
Purpose, Procedures, Confidentiality, Risks, Benefits , Freedom to withdraw
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IRB Membership
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Members include:
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Scientists and non scientists from various disciplines on campus as well as
graduate and undergraduate student members, including:
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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
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Assessment of classroom management strategies
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Action research
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Analysis of census data
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Publicly available information recorded in such a manner that subjects cannot be identified
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Surveys or interviews of nonvulnerable adults about nonsensitive topics
Minimal Risk
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Research where disclosure of the participant’s identity might result in negative legal, financial, economic or social
consequences
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Longitudinal or repeated-measures studies
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Interviews or surveys on sensitive topics where the subject can be identified
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Studies involve the possibility of a moral wrong
More than Minimal Risk
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Research studies that involve vulnerable populations, or involve special circumstances. Sensitive topics include: sex,
drugs, alcohol use, suicide.
May not require IRB review
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Activities that are not hypothesis driven
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Data collected for educational or teaching purposes and is not disseminated outside the institution.
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Literature review to support research purpose or research question
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Surveys issued or
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What does an IRB expect of an
application?
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Consideration of how the substantive issues & methods fit with ethical
guidelines & IRB requirements
Clarity in statement of problem, Research Questions & Methods of data
collection
Consistency in content of all documents
Completeness of all materials
C+C+C+C=Successful Protocol
Courtesy of University of Louisville Human Subjects Protection Program Office
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Investigator responsibilities
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When designing a study, take into consideration the three
underlying ethical principles of autonomy, beneficence and justice.
Be informed – be trained
Remember: consideration, clarity, consistency, completeness
Don’t initiate research before obtaining IRB approval.
Renew ongoing proposals each year in a timely fashion.
Stay within the approved scope of the project.
Submit modifications to the IRB and wait for approval before
initiating the change to the research.
Report unanticipated problems and/or adverse events.
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What happens after review?
Annual Continuation and Approval
Expedited board approved human subject protocols at UMBC are approved for a total of five years. A protocol is initially
approved for a period of up to 12 months. Four (4) continuations or renewals may be requested, each for a period of
up to 12 additional months.
Protocol Modifications
Any proposed change to an already approved human subject research protocol, measures, or informed consent document
during the period of IRB approval must be submitted in writing to the IRB immediately for review and approval
Closing a Protocol
Protocol closure may occur when data collection is completed, when basic data analyses are completed and when all
contact with participants has ended.
Reporting Adverse Events
Unanticipated problems involving risks to subjects or others
Protocol Deviations and Violations
Protocol deviations and/or instances of noncompliance with IRB regulations
--------------------------------------------------------------------------------------------------------------------------------------Protocol Monitoring (PAPM)
Post approval protocol monitoring (PAPM) to protect research participants, to educate researchers about human subject
protection issues and to improve the quality of research by detecting errors and/or omissions that might occur when
performing research activities.
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What is the bottom line?
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Be aware - keep ethical foundations in mind
Following IRB conditions and requirements
Be aware of your own ethics
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Protection of Human Subjects
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Must comply with relevant Federal regulations as well as institutional
guidelines and policies
Responsibility for obtaining appropriate approval before conducting
research involving human subject
Need for approval based on if the work qualifies as research, it
involves human subjects, and if it is exempt from IRB (human
research compliance) review
Syracuse University, Research Ethics and Academic Integrity video vignettes, 2002, http://gradschpdprograms.syr.edu/resources/videos.php
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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
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