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1 Responsible Conduct in Human Research (spring 2010) Header image designed by Michelle Jordan, UMBC Creative Services, 2009 updated: 02/22/2010
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Responsible Conduct in Human Research(spring 2010)
Header image designed by Michelle Jordan, UMBC Creative Services, 2009
updated: 02/22/2010
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In brief 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.
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
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
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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
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
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What does an IRB expect of an application? 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 ProtocolCourtesy of University of Louisville Human Subjects Protection Program Office
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Investigator responsibilities 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?
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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
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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? Be aware - keep ethical foundations in mind Following IRB conditions and requirements Be aware of your own ethics
Protection of Human Subjects 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
www.umbc.edu/ressearch/HARPO
410-455-3868 (FAX)
Tim Sparklin: 410-455-2737
Mary Lilly: 410-455-3958
