Outline. Bioethics in Research and Publication. What is ethics? Where do we learn ethics? 6/19/2015

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1 Outline Bioethics in Research and Publication Gertrude Night, PhD Rwanda Agriculture Board What is ethics? History. The purpose of training in research ethics Some ethical principles addressed by research codes Institutional mechanisms for ensuring compliance Causes of unethical behavior Laboratory Management and Equipment Operations Workshop, Rubona, June 15 19, 2015 What is ethics? What is ethics? Norms for conduct Distinguish between acceptable and unacceptable behavior Where do we learn ethics? What is ethics? Professional norms for behavior may be particular to disciplines, institutions, or professions they serve their particular aims and goals. E.g. Research Ethics 1

2 What is ethics? Law and ethics Legal rules govern behavior; ethical norms are broader and more informal An action may be legal but unethical An action may be illegal but ethical Study of ethics related to biology and medicine What is bioethics? Purpose of training on ethics Not commonsense Moreover, interpreted and applied differently in light of different values; hence need for codes/ guidelines Create awareness of issues Stimulate critical analysis of ethical issues Provide principles for dealing with dilemmas History Began with focus on protection of human research subjects First draft of regulations was during the Doctors Trial of (23 German Nazi physicians) The Nuremberg Code: a list of ethical guidelines for the conduct of research with human subjects History 1. Research participants must voluntarily consent to research participation 2. Research aims should contribute to the good of society 3. Research must be based on sound theory and prior animal testing 4. Research must avoid unnecessary physical and mental suffering 5. No research projects can go forward where serious injury and/or death are potential outcomes 6. The degree of risk taken with research participants cannot exceed anticipated benefits of results History 7. Proper environment and protection for participants is necessary 8. Experiments can be conducted only by scientifically qualified persons 9. Human subjects must be allowed to discontinue their participation at any time 10. Scientists must be prepared to terminate the experiment if there is cause to believe that continuation will be harmful or result in injury or death 2

3 History Helsinki Declaration developed by the World Medical Association; Revised periodically since Belmont Report (1979) the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Government laws and regulations for research with human and animal subjects have since been developed Now Education of researchers regarding the ethical principles behind regulations Some principles addressed by research ethics Research ethics has since expanded to include aspects other than guidelines for use of human subjects, encompassing all parts of research from research design to the truthful reporting of results Honestly report methods, data and results Honesty Honesty Do not fabricate (make up or cook ), falsify (manipulate materials, processes or equipment; change or omit data) or misinterpret data Do not deceive colleagues, donors or the public (e.g. CV) Honesty Objectivity/ conflicts of interest Conflicts of interest arise when a person s (or an organization s) obligations to a particular research project conflict with their personal interests or obligations. 3

4 Objectivity and conflicts of interest Ethical guidelines Avoid bias at all stages of the research process Disclose personal or financial interests that may influence the research Discuss how to prevent subjectivity Example of addressing conflicts of interest (NIH) Public disclosure of significant financial interests; Monitoring of research by independent reviewers; Disqualification from participation in all or a portion of the research Divestiture of significant financial interests Severance of relationships that create actual or potential conflicts Diligence Avoid negligence Avoid careless errors Keep good records of the research Openness Share data, ideas, resources, etc. Be open to criticism Be open to new ideas Intellectual Property Respect IP in all its forms (e.g. patents, copyrights) Avoid unauthorized copying of software, data, books, etc. Plagiarism It is the act of passing off somebody else s ideas, pictures, theories, words, or work as your own. Plagiarism is a form of research misconduct Illegal and punishable, equivalent to stealing Zero tolerance, whether intentional or not 4

5 Plagiarism Ethical guidelines Quote the source Use quotation marks if you are using someone else s actual oral or written words Get permission if lifting text or graphics Confidentiality Do not disclose information e.g. Manuscripts for review Grants/ proposals submitted for funding Trade or military information Patient (medical) records Redundancy in publication Duplicate publication Publication of a paper that is very similar to one already published It is a special form of plagiarism It violates international copyright laws, ethical conduct, and cost effective use of resources. Authorship It is the process of deciding authors of a research paper Some contributors should only be acknowledged with brief description of their contributions (with their permission) The International Committee of Medical Journal Editors (ICMJE) lists all requirements for authorship 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published Authorship Include names of people who contributed substantially to the research and writing The first one should be the one closely involved with the research The rest should be decided in order of contribution All authors should accept full responsibility for the content All co authors should agree on the order Acquisition of funding, data collection or general supervision of the research do not justify authorship Your institution? Authorship (cont d) 5

6 The process: Author submits manuscript to journal, and editor sends it to experts in the subject for review. Criteria: The Journal of the American Medical Association Importance Does the research impact health and health care? Usefulness Does the study provide useful scientific information? Relevance Does the research apply to the journal s readers and content area of interest? Sound methods Was the research conducted with sound scientific methods that allowed the researchers to answer their research question? Criteria: The Journal of the American Medical Association (cont d) Sound ethics Was the study conducted ethically ensuring proper protection for human subjects? Were results reported accurately and honestly? Completeness Is all information relevant to the study included in the article? Accuracy Is the written product a true reflection of the conduct and results of the research? Criteria (RAB Conference 2013): Originality, contribution to the field, technical quality, clarity of presentation, depth of research General comment: Is the article sufficiently novel and interesting to warrant inclusion in the RAB conference proceedings? Introduction: Does it describe what the author hoped to achieve accurately and clearly stated the problem/ hypothesis being investigated? Methodology: Are data collection methods and samples collected adequate? Results: Have appropriate analyses / statistics been conducted? Discussion: Have the authors indicated how the results relate to expectations and to earlier research? Conclusions Are conclusions supported by the results? References: Are references made according to the conference guidelines? (cont d) Ethical guidelines Confidentiality of author (or authors) and reviewers Protection of Intellectual Property No conflict of interest (financial, personal, etc.) If conflict of interest occurs, the peer reviewer must inform the journal editor and disqualify themselves if necessary 6

7 Research with animals Uses Animal nutrition studies Testing of new drugs Teaching Ethical guidelines Humane care and treatment Research with animals Ethical guidelines The three R s are: Replace the use of animals with alternative techniques, or avoid the use of animals altogether. Reduce the number of animals used to a minimum, to obtain information from fewer animals or more information from the same number of animals Refine the way experiments are carried out, to make sure animals suffer as little as possible. This includes better housing and improvements to procedures which minimize pain and suffering and/or improve animal welfare Informed consent Disclose to research participants research procedures, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research Informed consent (cont d) Comprehension: Make sure information is understandable to every participant, taking into consideration different abilities, intelligence levels, maturity and language needs. Voluntariness: participation must not be forced Confidentiality and privacy People have a right to privacy Violation of privacy can be embarrassing, harmful and damaging In medical studies, other information is collected as well that might eventually lead to the identification of a person keep it confidential Risks, benefits and beneficence Research strives to do good (beneficence) Risks to participants e.g. testing of a new drug while a benefit may be reaped by other patients in the future Never subject research participants to more risk than necessary, be prepared to cease research if it is causing harm, and never put participants at a level of risk disproportionate to the anticipated benefits 7

8 Justice Prevent overburdening to the populations below to conduct research to apply to other groups: Populations with particular potential for exploitation: Minority groups, women, mentally impaired individuals, children, financially disadvantaged individuals, disadvantaged people living in third world countries, prisoners, the deceased and employees, as well as patients. Legality It is the responsibility of the researcher to Know and obey laws Follow institutional and government policies relevant to the research Ignorance is no excuse! Ethical principles (cont d) Relationships with colleagues Mentorship Non discrimination Social responsibility... Why adhere to research ethics? Promote the aims of research e.g. knowledge, truth, and avoidance of error Promote values for collaborative work e.g. trust, accountability, mutual respect Why adhere to research ethics? Ensure that researchers are accountable to the public Build public support for research issues of quality and integrity of research Why adhere to research ethics? Promote other moral and social values as social responsibility, human rights, animal welfare, compliance with the law, and health and safety 8

9 Institutional mechanisms Many professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics Compliance is overseen by Institutional Review Boards, Ethics Committees, etc. Example 1: ILRI s Institutional Research Ethics Committee (IREC) Example 2: Cornell University s Human Research Participant Protection Program in Office of Research Integrity and Assurance (ORIA) Role of ethics committees WHO: Review proposed studies with human participants to ensure that they conform to internationally and locally accepted ethical guidelines Monitor studies Where relevant, take part in follow up action and surveillance after the end of the research Setting policies or offering opinions on ongoing ethical issues in research Discussion What are the causes of unethical behavior in research (Why do some researchers act unethically)? Causes of unethical practice Moral corruption ( bad apple theory) Stressful/ imperfect environment theory Researchers do not know Scientists have not seriously thought about some issues Traditions that have not been critically examined NO! DON T DO THIS! References A Guide to Research Ethics. University of Minnesota Center For Bioethics Accessed May 29, David B. Resnik, J.D., Ph.D What is Ethics in Research & Why is it Important? National Institute of Environmental Health Sciences. Accessed May 29, rtoons. 9