1 Responsible Conduct in Human Research (Fall 2010) Header image designed by Michelle Jordan, UMBC Creative Services, 2009 updated: 08/22/2010
2 In brief Purpose of research compliance Ethics behind/regulations governing research human research Definitions Involvement of the IRB Types of review The “Bottom” line
Circle of compliance 3 Research Compliance Compliance Ensures the ethical review of research
4 “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 Ethical and legal aspects related to human research Who is involved, why are they involved, benefits and risks For individuals, for society Ethical and legal aspects related to human research History teaches us that knowing about the past will help important decisions today http://www.umbc.edu/HARPO/Ethical%20issues%20in%20human%20research%20-%20picture%20show_v2.ppsx 1 http://www.wow4u.com/oprahwinfrey/index.html
“Doing the right thing” Various codes for the proper and responsible conduct of human research have been incorporated into researchers interact with people and how universities conduct business. 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) Foundations of ethics in human research Protection from risks and safeguard from harm Led to creation of 45CFR46 - Protection of Human Subjects 5
6 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) The human research use program is directed by the Institutional Review Board (IRB) whose 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 7
8 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
9 IRB oversight Harms Emotional or psychological harm Social harm Physical harm Financial harm Legal harm Moral harm Risk This risk could lead to: social stigma, loss of employment legal prosecution embarrassment damaged family relationships emotional risks (relive or reveal violence ), which may lead to physical danger Opportunities for voluntary participation 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 The greatest risk is often a breach of confidentiality
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 to improving services and programs of the University More examples are found on the IRB’s website - http://www.umbc.edu/irb/Examplesofresearch.pdf http://www.umbc.edu/irb/Examplesofresearch.pdf 11
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 Protocol Courtesy of University of Louisville Human Subjects Protection Program Office 12
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. 13
What happens after review? 14 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.
15 What is the bottom line? Be aware - keep ethical foundations in mind Following IRB conditions and requirements Be aware of your own ethics
16 Human and Animal Research Protections Office HARPO@umbc.edu http://www.umbc.edu/ressearch/HARPO 410-455-2737 Connect with us: http://harponotes.blogspot.com/ http://www.twitter.com/umbc_harpo http://www.facebook.com/pages/Baltimore-MD/UMBC-Human-and-Animal-Research-Protections- Office/79439894794http://www.facebook.com/pages/Baltimore-MD/UMBC-Human-and-Animal-Research-Protections- Office/79439894794
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