1 responsible conduct in human research (fall 2009 - undergraduate) header image designed by...
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Responsible Conduct in Human Research(Fall 2009 - undergraduate)
Header image designed by Michelle Jordan, UMBC Creative Services, 2009
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In brief Ethics/Regulations What is research Involvement of the IRB Types of review What does this all mean?
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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
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
Freedom from harm Privacy Voluntary participation
Protection from risks and safeguard from harm
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Protection from risks and safeguards from harms
The greatest risk is often a breach of confidentiality
Safeguards from: Emotional or psychological harm Social harm Physical harm Financial harm Legal harm Moral harm
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Enhancing voluntary participation Involves the consent processIt is a “Process” or a “Conversation” that most of the time uses a
“Document” 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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Understand what research is: Research: 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.
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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Purpose of human research complianceRequired by the federal government as well as the University
of Maryland Ethical review of research Ensure participants rights are protected and that they are
safeguarded from risk and harm Compliance with federal guidelines and principles
Department of Health and Human Services University of Maryland System U.S. Department of Education
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The IRB Members include:
Scientists and non scientists from various disciplines on campus as well as graduate and undergraduate student members
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
Students as Researchers The previous information is important to
remember when planning to conduct research
Faculty advisors play an important role
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Class Projects enrolled in courses learn skills through a
combination of readings, lectures and research activities or projects
expectation for the student to apply what is taught (i.e. use skills outside of the classroom)
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Class Projects Class instructors play active role
Will help choose an acceptable topic Will develop and submit application forms Will advise students on research methods and consent information
procedures Only non-sensitive information may be collected No personal identifiers may be collected These types of projects CANNOT be approved by instructors
participants under the age of 18 deception collection of information about participants‘ sexual history, religious
orientation and views, mental health history, substance use and abuse, etc.12
Class Projects May not collect personal information of a
sensitive nature from participants, they may ask participants to make judgments about behaviors of anonymous others. For example, participants may be asked to read
about a crime and be asked to judge the appropriateness of the sentence as a factor of characteristics of the perpetrator.
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Independent Research projects Student researchers conducting independent
research are, as faculty investigators, required to follow the appropriate application review and approval process
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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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Types of Approval 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.
Educational tests where subjects cannot be identified, directly or through identifiers linked to the subjects.
Surveys, questionnaires, interviews, or observation not involving "sensitive" topics
ExpeditedActivity must not involve no more than minimal risk to subjects. Survey or interview procedures where responses are recorded in such a manner that subjects can be
identified deals with sensitive aspects of the subject's own behavior Research which include minors (under the age of 18)
Full BoardFull 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 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
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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 does this all mean? Be trained and fully aware Following IRB conditions and requirements Reporting progress of research Be aware of your own ethics
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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