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

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

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 Compliancewww.umbc.edu/research

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 4 ORA/Research Protections and Compliancewww.umbc.edu/research

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 5 ORA/Research Protections and Compliancewww.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. Nazi Medical Experiments Tearoom Sex StudyTHN1412 Drug Trial Milgram Experiments Tuskegee Syphilis experiment Henrietta Lacks Guatemala syphilis experiment The Monster StudyStanford Prisoner Experiment ORA/Research Protections and Compliancewww.umbc.edu/research

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 7 ORA/Research Protections and Compliancewww.umbc.edu/research

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. 8 ORA/Research Protections and Compliancewww.umbc.edu/research

“ “Doing the Right Thing” in Human research 9 PrincipleApplication Respect for persons Individuals should be treated as autonomous agents Persons with diminished autonomy are entitled to protection. Informed consent Subjects, to the degree that they are capable, must be given the opportunity to choose what shall or shall not happen to them The consent process must include three elements: information, comprehension, and voluntariness. Beneficence Human subjects should not be harmed Research should maximize possible benefits and minimize possible harms. Assessment of risks and benefits The nature and scope of risks and benefits must be assessed in a systematic manner Justice The benefits and risks of research must be distributed fairly. Selection of subjects There must be fair procedures and outcomes in the selection of research subjects Code for the proper and responsible conduct of human research have been incorporated into how researchers interact with people and how universities conduct business. Led to creation of 45CFR46 - Protection of Human Subjects (the Common Rule) Incorporate the foundations of ethics in human research Requirements for IRBs Provide for protection from risks and safeguard from harm Create procedures for compliance ORA/Research Protections and Compliancewww.umbc.edu/research

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 ORA/Research Protections and Compliancewww.umbc.edu/research

Research ethics fall within RCR Data Acquisition, Management, Sharing and Ownership Accurate collection of data and managed properly for confidentiality and privacy purposes Conflict of Interest & CommitmentManagement of real or perceived interference to assure that the interests do not adversely influence the research Research MisconductAvoid and deal with issues of egregious behavior (i.e. fabrication, falsification, or plagiarism – FFP) Publication Practices & Responsible AuthorshipAccurate report of the results and an honest and open assessment of the finding Mentor / Trainee ResponsibilitiesClear understanding of mutual responsibilities/proper supervision and a commitment for a productive environment Peer ReviewEvaluation by colleagues with similar knowledge and experience for self-regulation of the discipline CollaborationCollaborative research roles should be clarified early discussing and reaching agreement on the details Human SubjectsProtection of subjects and compliance with relevant Federal regulations as well as institutional guidelines and policies Research Involving AnimalsHumane care and use and compliance with relevant Federal regulations as well as institutional guidelines and policies ORA/Research Protections and Compliancewww.umbc.edu/research

RCR cases Gerrman education minister quits in plagiarism case – Baltimore Sun, February 10, ,0, story?track=rss Hwang Woo-Suk South Korea Stem cell research Indicted on fraud, embezzlement, and bioethics violations Andrew Wakefield British gastroenterologist No Ethics Review Board approval Guilty of failure to disclose CoI, medical and scientific misconduct The Lancet and British Medical Journal retracted papers Eric Poehlman Obesity scientist First scientist to be imprisoned for falsifying information on a grant application Plead guilty to falsifying 17 NIH grant applications and fabricating data in 10 of his papers ( ) Diederik Stapel Dutch Psychologist Admitted that he had falsified data in some of his publications Many/most of his experiments never happened 150 publications he co-authored are under review 14 of 21 PhD theses that he supervised are in question ORA/Research Protections and Compliancewww.umbc.edu/research More examples at

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 Compliancewww.umbc.edu/research

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 Compliancewww.umbc.edu/research

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 Compliancewww.umbc.edu/research

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 Compliancewww.umbc.edu/research

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 Compliancewww.umbc.edu/research

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 Compliancewww.umbc.edu/research

19 Questions ORA/Research Protections and Compliancewww.umbc.edu/research