Office of Research Administration

1. Office of Research Administration Technology Transfer Research Opportunity Development Sponsored Programs Research Protections & Compliance ORA/Research Protections and Compliance www.umbc.edu/research

2. Working with participants, reducing risks and doing the right thing Responsible Conduct of Research updated: 10/1/2013 ORA/Research Protections and Compliance www.umbc.edu/research

3. Take aways from today • Basic info about the UMBC compliance program • Contributes to the discussion of what it means to be a responsible researcher and how to conduct research “responsibly” • recognize ethical choices, make appropriate decisions and take appropriate actions based on those choices • encourage best practices in the conduct of research and scientific investigations • know that consequences will result from not complying with policies and procedures • Doing the “right thing” ORA/Research Protections and Compliance www.umbc.edu/research

4. Responsible Conduct of Research The aim of discussing research ethics is to encourage integrity in the pursuit of scientific investigation and practice among of scientists, scholars, and professionals. Office of Research Integrity, Department of Health and Human Services ORA/Research Protections and Compliance www.umbc.edu/research

5. Human Research Protections Program • Evaluate risks • Protect the rights and welfare of individual research subjects, • Ensure voluntary participation via the “consent process” – conversation and documentation • Provide assurance to the federal government the institution will comply with the rules and regulations and provides oversight for the institution's human research use program ORA/Research Protections and Compliance www.umbc.edu/research

6. Understand What has Happened in the Past to Help Leads to Ethical and Responsible Research The decisions of our past are the architects of our present  - Dan Brown, “Inferno” History teaches us that knowing about the past will help ethical and responsible decisions today. ORA/Research Protections and Compliance www.umbc.edu/research

7. Understand What Research is and Who are Human Subjects: • Systematic investigation that contributes to generalizable knowledge • "Research" is defined in the Code of Federal Regulations, in part, as "a systematic investigation that contributes to generalizable knowledge“. In other words, for the most part, an investigator will: • be "engaged in research” • proposed an intention to explore a particular topic • interact with a living person and • have a plan to “generalize “ the information  • “Human subjects” are living persons about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information ORA/Research Protections and Compliance www.umbc.edu/research

8. Understand What Minimal Risk Is: • HHS regulations found in Subpart A (46.102) - 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 • Risks associated with the research and consider the subject population (vulnerable people, such as children, older persons, cognitively impaired, etc. may experience different types of risk) and describe procedures to deal with them. ORA/Research Protections and Compliance www.umbc.edu/research

9. “Doing the Right Thing” in Human research ORA/Research Protections and Compliance www.umbc.edu/research

10. Responsible Conduct of Research (RCR) • Part of the planning, conduct, and reporting of research • Ethics protects the interests of the public, the subjects of research, and the researchers themselves in the: • Collection, use, and interpretation of research data • Reporting and reviewing research plans or findings • Relationships among researchers with one another • Relationships between researchers and those that will be affected by their research (e.g. human and animal subjects) • Means for responding to misunderstandings, disputes, or misconduct • Promotion of ethical conduct in research http://research-ethics.net/introduction/what/#research-ethics ORA/Research Protections and Compliance www.umbc.edu/research

11. Research ethics fall within RCR ORA/Research Protections and Compliance www.umbc.edu/research

12. RCR cases • Gerrman education minister quits in plagiarism case – Baltimore Sun, February 10, 2013 http://www.baltimoresun.com/news/nation-world/sns-rt-us-germany-minister-resignationbre9190bg- 20130210,0,5002015.story?track=rss More examples at http://www.umbc.edu/research/ORPC/rcr_training_casestudies_faqs.html ORA/Research Protections and Compliance www.umbc.edu/research

13. FFP Fabrication (making up data or results and recording or reporting them) Falsification (manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record) Plagiarism (taking another person's ideas, processes, results, or words without giving appropriate credit) ORA/Research Protections and Compliance www.umbc.edu/research

14. Research misconduct • Research misconduct means fabrication, falsification or plagiarism in proposing, performing or reviewing research, or in reporting research results. • Research misconduct does not include honest error differences of opinion. ORA/Research Protections and Compliance www.umbc.edu/research

15. Other compliance areas • Animal Care and Use • ethical, appropriate and humane care and use of animals in teaching and research • compliance with federal and state animal-welfare laws • overall purpose is to oversee all research and instruction that involves vertebrate animals, in order to ensure that the highest ethical and animal welfare standards are met ORA/Research Protections and Compliance www.umbc.edu/research

16. Export Controls • Regulations that control distribution of certain exports to foreign nationals and foreign countries • Include: •       information, including technical data, that is transferred  to persons and entities outside the United States; •       physical items, such as scientific equipment, that is shipped from the United States to a foreign country; •       disclosure of verbal, written, electronic, or visual disclosures of controlled scientific and technical information related to the above export controlled items to foreign nationals; •        travel to certain sanctioned or embargoed countries for purposes of teaching or performing research ORA/Research Protections and Compliance www.umbc.edu/research

17. Conflicts of Interest • Occur when university members are in a position or in situations in which financial or other personal considerations may compromise or have the appearance of compromising an employee’s professional judgment in administration, management, teaching, research and other professional activities • Conflicts must be disclosed and, if required, managed in a fashion to , reduce, or eliminate any actual or perceived conflicts of interest. ORA/Research Protections and Compliance www.umbc.edu/research

18. Data Use • Access archives or restricted data sets that may contain identifiable information about individuals for the purpose of conducting research • Involves: • What data will be released or shared • Who has ownership of the data • What, if any, identifiers will be included • And much, much more ORA/Research Protections and Compliance www.umbc.edu/research

19. Questions compliance@umbc.edu http://www.umbc.edu/research/ORPC 410-455-2737 ORA/Research Protections and Compliance www.umbc.edu/research