Ethics in Research ABIY ZEGEYE INSTITUTE OF BIOTECHNOLOGY ADDIS ABABA UNIVERSITY

Transcription

1 Ethics in Research ABIY ZEGEYE INSTITUTE OF BIOTECHNOLOGY ADDIS ABABA UNIVERSITY

2 Broad View of Ethics Ethics spans human history The norms and standards espoused by society (family, village, school) Unacceptable behavior eschewed and punished through religious establishments (and even the threat of perpetual suffering/distress) Reinforced through wise aphorisms/adages Though shall not covet your neighbors wife (Ten Commandments) First do no harm Oath)

3 Broad View of Ethics It follows then that most people regard ethics akin to simple common sense of right and wrong sensibility of what is acceptable or not Self evident morality Then why so many issues and disputes??? Are there universally accepted ethical standards???

4 Broad View of Ethics Differences and disagreements arise precisely because The that community s/individual s tend to presume that everyone else shares their own set of ethical standards Even when there are some shared ethical norms, the way people interpret, apply and balance these norms through the prism their own values and life s experiences

5 Broad View of Ethics of ethics shows its from the Greek word ethos (character) In very broad sense it defines how individuals chose to interact with one another (even this does not encompass the breadth of ethics) Philosophers: it defines what is good for the individual and society; and establishes the nature of that people owe themselves and one another

6 Broad View of Ethics Laws embody a society s ethical principles Democracies: the majority s Theocracy: leaders of religious establishment Autocracy: an individuals whim **NB: what society general finds acceptable, may not necessarily be ethical** But Laws are formal, ethical norms are informal Laws a narrow; ethical norms tend to be broad and complex Laws are enforceable, ethical norms are not always enforceable What is illegal may be ethical ; and what is unethical may be legal

7 : The Birth Begun at the end of the 2 nd world war Emanated from the horrors and atroci@es commi_ed on human subjects (in the name of scien@fic experiments and progress) The Doctors Trial (Nuremberg) :a list of ethical guidelines for the conduct of research used to convict (with par@cular emphasis on human research) The Nuremburg Code

8 : The Birth The Nuremburg Code (the list of 10 items, may have been influenced by Biblical parallel) 1. Research must voluntarily consent to research 2. Research aims should contribute to the good of society 3. Research must be based on sound theory and prior animal 4. Research must avoid unnecessary physical and mental suffering 5. No research projects can go forward where serious injury and/or death are outcomes 6. The degree of risk taken with research cannot exceed benefits of results 7. Proper environment and for is necessary 8. Experiments can be conducted only by qualified persons 9. Human subjects must be allowed to their at 10. must be prepared to terminate the experiment if there is cause to believe that will be harmful or result in injury and death

9 : The Birth Nuremburg Trials where conducted by the allies with the US in the lead but in hindsight the backdrop is nothing but clear 1945 atoms bombs dropped on civilian Studies on effects of on humans was carried out by US funded research from 1944 well into the 70s The Guatemala venereal diseases study ( ) CIA mind control study using LSD (1950s)

10 : The Growth Next major Helsinki (1964) World Medical Independent reviewer Preserving accuracy of research results Items on research on children and mental incompetent Guides on how to obtain informed consent Revised periodically latest in 2000

11 : The Growth In the of ethics in research has evolved beyond human subjects Animal rights Environmental ethics Financial ethics Embryo research (test tube baby, embryonic stem cells) research/gmos/cloning (biotechnology) etc

12 : The Growth As such, specific ethical standards/codes have arisen that define norms of behavior/conduct that suit a par@cular discipline or profession Medical ethicist Legal ethicist Bioethicist Etc

13 : The Lapses Despite refinement of codes, vigilant supervision and enforcement lapses, both big and small have cropped up. Some notable and memorable examples: Rosalind Franklin s x- ray diffrac@on data (1953, Authorship) William Summerlin s black marker skin gran debacle (1974, Fabrica@on) Montagnier accuses Gallo on HIV strain (1984, Integrity) Mar@n Luther King PhD disserta@on (1987, Plagiarism) Boots Pharmaceu@cal coerces Be_y Dong to withdraw JAMA paper on hypothyroidism drug study (1995, Conflict of interest) Jan Hendrick Schon (Bells Labs) whose condensed ma_er and nanotechnology papers were discredited (2002, Falsifica@on, Mentoring)

14 Ethical norms are codified Industry Research Funding agencies Professional

15 and adherence thereof are important because Promote the aims of research (knowledge, truth,) Sets a cornerstone for collabora@ve work (trust, fairness) Accountability to the public (conflict of interest, human/animal safety) Public support (for publicly funded research) Promote moral & social value (human/animal rights, compliance with law)

16 Basic principles/tenants that serve as guideposts/ ingredients/building blocks Honesty (in data, in of harm to human subjects) Objec>vity (avoid bias/self- in peer review, data analysis, experimental design) Integrity (maintain consistency of thought/words and Carefulness (avoid negligence, keep good records) Openness (share data & ideas, be open to Respect IP (honor patents, copyrights, don t use unpublished data shared by peers, give credit where due, never plagiarize)

17 Confiden>ality (protect obtained from grant and review, trade secrets, records) Responsible publica>on (publish to advance science not your career, avoid Responsible mentoring (help, educate and advise students/protégés ) Respect colleagues (treat colleagues with respect and fairness) Social responsibility (promote social good, prevent social harm) Non- discrimina>on (never discriminate on ma_ers unrelated to scien@fic competence)

18 Legality (know and respect relevant laws & Animal care proper care and respect for animals) Protec>on of human subjects (minimize risk, maximize benefit, dignity, privacy, special care for vulnerable groups) ** Adapted from Shamoo and Resnik (2009) Responsible Conudct of Research, 2 nd ed (Oxford University Press)

19 How do these tenets influence our ethical standards in conduct of research?

20 1. Authorship Increasingly most research in bio- research) are Persons listed as authors must have contributed to both research and Persons must approve final version All authors will be equally responsible for content The order in which authors are listed must be jointly decided by all authors Persons whose does not meet the criteria should be acknowledged (consent of contributor is needed)

21 Authorship (case study) A postdoctoral fellow, Dr. Aklilu, joined the research team of Prof. Gamal. Jeri, a graduate student, had started on an exci@ng project ini@ally conceived by Prof. G. Dr. Aklilu brought on board a wealth of lab experience and helped in carrying out or supervising the graduate students lab ac@vity. Jeri s fiancée helped in wri@ng a spreadsheet macro to analyze the data. When Condie was wri@ng her thesis and manuscript, Dr. Aklilu and Prof. Gamal reviewed the results and approved final version of manuscript.

22 Authorship (case study, cont d) At how should the authorship be decided?? 1. Condie as the primary author 2. Rest by agreement, perhaps Dr. Aklilu as second author because of heavier involvement in actually data 3. Condie s fiancée could be listed as contributor if he consents

23 2. Plagiarism Act of passing off other people s ideas, thoughts, data, words, etc as your own (non- credited) Plagiarism calls into ques@on the integrity of the en@re work, erodes confidence and is punishable by law Can be of two forms inten@onal: copying other s works/words with inten@onal effort to disguise uninten@onal: sloppiness, laziness in paraphrasing others works/words Plagiarism in any form is unacceptable Magnitude of problem rising with ubiquity of internet browsing, but the solu@on to this is also found in advances in technology Excep@on is for common knowledge (eg. Dairy cows provide the large propor@on of milk consumed by humans) Duplica@ve publica@ons are a special case of plagiarism!!!!

24 Plagiarism (case study) Yodit and Yonas publish a paper as co- authors while working in the same lab. Yodit has moved to a different lab and is building on her previous research project. She wishes to use a graph from the previous ar@cle, does she have to cite it? Yes: 1) the data for the graph was a joint effort and 2) she must show that the data is not original

25 3. Peer review Describes the process where a manuscript submi_ed for publica@on is evaluated for its merits (importance, relevance, methods, ethics, completeness, accuracy) by peers in the scien@fic discipline and the editor Depends on two ethical principles Confiden@ality (non- divulgence of informa@on) Avoidance of conflict of interest (recuse oneself) Protec@on of IP

26 Peer Review (case study) Dr. Rice receives an for peer review, which she realizes has his former dorm mate in college as the first author. Should Dr. Rice disqualify herself as reviewer? Not necessarily: If Dr. Rice feels that her close friendship with the author will influence her review, she should contact and consult the editor and apprise him of her If there are sufficient grounds, then she should recuse herself

27 4. Conflict of interest Researchers to the project is in conflict with interest Financial (monetary benefits/loss involved) Moral on moral or religious grounds) Where conflict of interest exists it should be reported, otherwise of research is compromised Integrity of research output will fall into Where present, they could be managed by assigning independent reviewers, of research project, etc

28 Conflict of interest (case study) Dr. Ruth is a study on behalf of a pharmaceu@cal company to test a new drug. She is promised a reward of USD100,000 if the drug is found to be an effec@ve treatment. Does Dr. Ruth face a conflict of interest? Yes. This is a very clear conflict of interest, because the significant reward may bias how she designs the experiment, who she enrolls, how data is gathered and interpreted, etc. Even if she decides to donate the money to charity, she would have passed a red line.

29 5. Data Management Truthful of reliable data Ethical of data Ownership of collected data Retaining and sharing of collected data Clear, responsible and ethical plan for data management must be laid out before embarking on project

30 Data Management (case study) Kinde conducted research on sexual behavior of commercial sex workers. He has published a paper, but is reluctant to disclose data un@l he finishes a book which he hopes will generate more income and a_en@on to the topic. Is it ethical for him to hold off data un@l his book is published? No. Conven@on dictates that once a research output is published, the data should be available immediately. Though his mo@ves may be honorable, the prac@ce will not be condoned.

31 6. Research misconduct This is a broad concept that may overlap with other items - the fabrica@on and/or falsifica@on in designing, conduc@ng and reviewing research - To be called misconduct it: must cons@tute significant departure from accepted prac@ce Commi_ed inten@onally or recklessly Proven by preponderance of evidence - May be prosecuted as a crime or dicsplinary measure at ins@tu@onal level

32 Research misconduct (case study) Two researchers interview data. One that Two asks that deviate from the standard quesionnaire and is leading respondents to answer a certain way and records it as data. Does this cons@tute ethical lapse? Yes. This is akin to fabrica@on of data. Moreover, One is obligated to report such misconduct (whistleblower) without embellishments. Knowingly concealing such misconduct implicates One as unwiwng accomplice.

33 7. Research with human subjects Probably the most challenging topic that embodies many components In summary issues are (Respect for persons): A) informed consent Know what they are gewng into (comprehension of procedures, risks, etc) Not coerced or manipulated (vulnerable groups based on maturity, economic status, etc) Must consent to (voluntariness)

34 - B) Privacy and The right of people to protect themselves and gathered from them (anonymity because may be embarrassing, harmful, etc). This includes data!! - C) Risk benefit and beneficence Research should be geared to help other people.. to do good (beneficence) while it should not cause undue harm to par@cipants - D) Jus@ce Certain groups should not be exploited/overburdened for the benefit of many. Minori@es, women, children, poor, with disability, prisoners, employees and deceased

35 Research with human subjects (case study) Gabrielle s professors asks her to volunteer for a study? Does it cons@tute an ethical lapse. Not necessarily: Gabrielle may be interested in par@cipa@ng. She needs to gather all informa@on and make an informed consent. If she decides to decline and the professor in@mates that her graduate studies are on the line, then this is coercion and unethical.

36 : A Brave New World A story to ponder and contemplate and appreciate the complexity of sewng ethical norms and standards Jared is recently separated from his wife of 6 years. Upset and angry he loses focus while driving and ends up in a near fatal accident. He is hospitalized and on life support. His ex- wife and family are by his side and contempla@ng the op@on given by the doctors to pull the plug. His wife remorseful an sad that they had no children, requests that his semen be extracted and stored. Eventually, Jared passes away. His wife is infer@le so she contacts a reputable clinic to put her in touch with an egg donor. The donor s egg is fer@lized by the cold stored semen of the now deceased Jared. But his wife is also incapable of maintaining a pregnancy and arranges for a surrogate who is paid a heny sum to carry the fetus to term. Upon finding out that their deceased son s semen was taken and produced a beau@ful baby boy, Jared s parent s sue for custody. Counter suits were also filed by the egg donor and surrogate mother. But the one person that started all is this passed away a year ago.

37 : The Future Fast pace of progress is expanding the of science New, previously scenarios arise Increasingly interconnected world, the shared values and norms will probably widen What were earlier thought an gradually fade to become accepted in the face of increasingly mindboggling breakthroughs

38 THANK YOU Resources used in the of this material are A Guide to Research Ethics, University of Minnesota, Center for Bioethics, 2003 What is ethics in research and why is it important? David Resnick What is ethics by M. Velasquez, C. Andre. T Shanks, M Myer