Transcript Human and Animal Research Protections Office (HARPO)

Header image designed by Michelle Jordan, UMBC Creative Services, 2009
Responsible Conduct in Human Research
(BIOL/CHEM 397 – 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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Underlying principles of
responsible conduct of research
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discourage research misconduct and questionable
research practices
ensure integrity of research and scholarly
activities
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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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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.
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Investigator responsibilities
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Become aware – be trained (CITI).
When designing a study, take into consideration the three
underlying ethical principles for conducting research with human
participants: autonomy; beneficence; and justice.
Remember: consideration, clarity, consistency, completeness
Don’t initiate research before obtaining IRB approval.
Obtaining and documenting informed consent for each participant
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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Examples of research
A 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.
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Examples of research
A graduate student investigator compared
cocaine use in college freshman and seniors.
Because she may want to re-interview some
subjects later, she plans to write their names
and phone numbers on their data sheets. She
plans to promise confidentiality, so that
subjects trust her, and to keep the data in her
dorm room in a locked file.
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Examples of research
A researcher wants to collect information from
residents of a nursing home for the elderly.
The investigator planned on getting informed
consent (providing full explanation about the
research) and, by the way of thanking them,
was planning on giving the participants a
piece of candy.
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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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