Header image designed by Michelle Jordan, UMBC Creative Services, 2009
Responsible Conduct in Human Research
(Success Seminar)
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In brief
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Ethics/Regulations
What is research
Involvement of the IRB
Types of review and the consent process
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.
1 http://www.wow4u.com/oprahwinfrey/index.html
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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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Medical research
Social and Behavioral Research
Foundations of ethics in human research
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Freedom from harm
Privacy
Voluntary participation
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Purpose of compliance
Required by the federal government as well as the University
of Maryland
 Ethical review of research
 Ensure participant’s rights are protected and that they are
safeguarded from risk and harm
 Compliance with federal guidelines and principles
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Department of Health and Human Services
University of Maryland System
U.S. Department of Education
Protection from risks and safeguard from harm
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Understand what research is:
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Research: Systematic investigation that contributes
to generalizable knowledge
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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.
Human Subjects: 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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The IRB
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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
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Individuals not affiliated with the Campus who represent
the concerns of the Community
Provides assurance to the federal government that
UMBC will comply with the rules and regulations
and provides oversight for the university's
human research use program
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Safeguards from harms
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Emotional or psychological harm
Social harm
Physical harm
Financial harm
Legal harm
Moral harm
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Protection from risks
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The greatest risk is often a breach of
confidentiality
This risk could lead to:
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social stigma,
loss of employment
legal prosecution
embarrassment
damaged family relationships
emotional risks (relive or reveal violence ), which may lead
to physical danger
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Enhancing voluntary participation
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Involves the consent process
It is a “Process” or a “Conversation” that most of the time uses a
“Document”
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Research statement
Purpose
Procedures
Confidentiality
Risks
Benefits
Freedom to withdraw statement
Contact info for the investigator and the IRB
Signature and date line
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Types of research:
Low or less than minimal risk
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Educational research - improving educational practice in educational settings (no clinical and counseling research)
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Educational tests - use of educational tests (cognitive, diagnostic, aptitude, achievement) where subjects cannot be identified, directly or through
identifiers linked to the subjects.
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Surveys, questionnaires, interviews, or observation not involving "sensitive" topics, such as criminal or sexual behavior, alcohol or drug use on the
part of the participants unless anonymity is guaranteed and informed consent cannot be reasonably obtained (i.e. anonymous observations).
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Preexisting data/samples that are publicly available and the data is deidentified and uncoded and stripped of identifiers. If on the IRB’s list of preapproved data holders , no need for IRB review
Minimal Risk
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Survey or interview procedures where responses are recorded in such a manner that subjects can be identified, and if known outside the research,
could reasonably place the subject at risk of criminal or civil liability
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Research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol, unless data
is recorded in such a fashion that identities are kept secure and protection mechanisms put in place
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Deception
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Research which include minors (under the age of 18) as participants
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 completed by University personnel for the intent and purposes of improving services and programs of the University
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Types of Approval
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Exempt
Federal regulations specify that certain types of research pose no or very low risks
to participants, a minimal review from the IRB is required.
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Expedited
Activity must not involve no more than minimal risk to subjects. The regulatory
definition of "minimal risk" is the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of themselves
than those ordinarily encountered in daily life or during the performance of
routine physical or psychological examinations or tests and falls within list of
expedited procedures
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Full Board
Full board review is performed by the whole committee and reviews studies that
are more than minimal risk, involve vulnerable populations, or involve
special circumstances. Sensitive topics include: sex, drugs, alcohol use,
suicide.
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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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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 for an
investigator?
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Be trained and fully aware
Following IRB conditions and requirements
Reporting progress of research
Be aware of your own ethics
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Expectations from the IRB?
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When in doubt, ask questions; seek help
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 Adverse Events.
IRBs are more than enforcers/regulators
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5523 Research Park Drive
Suite 310
Baltimore, MD 21228
[email protected]
www.umbc.edu/ressearch/HARPO
410-455-3868 (FAX)
Tim Sparklin: 410-455-2737
Mary Lilly: 410-455-3958
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