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Essential skills in health research and scientific writing

This presentation is of the training on "Essential Skills in Health Research and Scientific Writing" that was help in Soba Teaching Hospital in Khartoum, in collaboration with the Sudanese American Medical Association (SAMA).
It was a 4 days training given on a rate of one session per week. It was almost all skills-based hands-on training.

Day 1: The theoretical part was an Introduction to the Knowledge Management Cycle and where research fits in this model. The practical part was how to conduct an online review of literature

Day 2: The theoretical part was about the responsible conduct of research, and scientific misconduct, with focus on plagiarism. The practical part included the installation and the use of Reference Manager, including how to import the references found in the LR (given in session 1) in a database in the Reference Manager software.

Day 3: The theoretical part covered the basics of scientific writing in English. The practical part included writing, and re-writing some pieces, using the provided phrasebanks and verbs 'cheat-sheets'.

Day 4 was on the writing for publication, including detailed description of the peer-review publication model and how it works. We also touched very briefly, due to time constraints, to an overview and two examples of ethical issues in research. The practical part included writing an effective cover Letter to the editor, choosing proper manuscript title, and writing an informed consent.

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Essential skills in health research and scientific writing

  1. 1. Essential Skills in Health Research Dr Ghaiath MA Hussein, MBBS, MHSc. (Bioethics) Doctoral Researcher, University of Birmingham, UK Email: ghaiathme@gmail.com
  2. 2. This Course: what it is (or not)? This course is: • Interactive, skill-based training • Building on your previous research knowledge • Aiming to introduce you to practical skills through group work • A chance to develop your research skills and outcomes This course is NOT • Series of lectures • Not an introduction to research methods • A course where you listen, take notes and go home!
  3. 3. Who are we? • I’m Ghaiath… you? • Tell me about your current or recent research activities
  4. 4. Why are we here? • Learning objectives: KMC • What is it? • Where research fits? LR • Which literature? • How/where to find? • How to cite? General skills • Online forms • Reference Management software
  5. 5. Where are we in R&D? Source: http://www.worldmapper.org/display.php?selected=165
  6. 6. Where are we in R&D? Expenditure on R&D as % of GDP (2013):[1] • Arab world: 0.5% • China (2%), • EU (2.3%), • USA (2.8%), • Israel (4%) Number of researchers (per 1,000,000 population) [2] • Morocco : 864 • Argentina: 1,236 • Malaysia: 1,643 • Slovenia: 4,255 • Israel: 6,494 Published scientific papers (1996 -2013):[3] Egypt (42nd): 104,784 Brazil: 529,841 Israel: 247,561 India: 868,719 Turkey: 348,836 USA: 7,846,972
  7. 7. What is Research?  “Research” is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.  Systematic methodological scientific approach for basic facts around a certain problem in order to find solutions based on these facts. Research on Humans: The systematic undertaking of activities that involve the collection of human personal data, measurements, and/or biological samples for purposes that are not related to clinical management of a health condition
  8. 8. Research in Context...the KMC Generation Dissemination SynthesisUtilization Assessment Statistics
  9. 9. “Good” research: Good Science & Good Ethics “Good” Evidence: near-top to hierarchy of Evidence Evidence-Based Healthcare: Better practice that is based on best evidence Better health status Better Research is Better Health
  10. 10. What Makes Good Research? Good Science Good Ethics •Problem selection •SMART objectives •Proper methodology •Proper analysis •Fair subject selection •Favorable Risk-Benefit Ratio •Independent Review •Informed Consent
  11. 11. Criteria of “Good” Science Research • Systematic: The research developed, implemented and reported in a systematic manner. • Methodological: Adopt & use skillfully the research methods, materials, approaches in order to ensure reliability of the results & findings. • Scientific: The research should be scientifically sound through utilizing scientific approaches, tools and techniques.
  12. 12. Criteria for Good Ethics: WhatMakesResearchEthical? 1. Social or Scientific Value 2. Scientific Validity 3. Fair Subject Selection 4. Favorable Risk-Benefit Ratio 5. Independent Review 6. Informed Consent 7. Respect for the potential and enrolled subjects
  13. 13. References 1. World Bank’s interactive website: http://data.worldbank.org/indicator/GB.XPD.RSDV.GD.ZS 2. World Bank website: http://data.worldbank.org/indicator/SP.POP.SCIE.RD.P6?ord er=wbapi_data_value_2011+wbapi_data_value&sort=desc 3. SCImago. (2007). SJR — SCImago Journal & Country Rank. Retrieved December 09, 2014, from http://www.scimagojr.com
  14. 14. Research-to-publication Cycle Overview on research skills
  15. 15. Research: where to start? Idea/ observation Proposal ConductReporting Publication
  16. 16. Essential Research Skills Before conduct (Prepare) During conduct (Do) After conduct (Disseminate) Review of literature Research methods (Q&Q) Reference management Proposal writing Design of data collection tools Scientific writing Grant writing (and hunting) Data analysis (Q&Q) Writing for publication Research ethics Plagiarism Publication ethics Cross-cutting skills: • Critical thinking • Leadership skills • Project management • Presentation (communication) skills • Resource (Time) management • Scientific writing
  17. 17. REVIEW OF LITERATURE (LR) Definition Why do we need it? When do we need it? How to do it? Disclosure: The following slides are modified from the University of Toronto writing website: http://www.writing.utoronto.ca/advice/specific-types-of-writing/literature-review
  18. 18. Definition: What LR is? • A literature review (LR) is an account of what has been published on a topic by accredited scholars and researchers. • LR is an evaluative report of information found in the literature related to your selected area of study. • It should describe, summarise, evaluate and clarify this literature. • Generally, the purpose of a review is to analyze critically a segment of a published body of knowledge through summary, classification, and comparison of prior research studies, reviews of literature, and theoretical articles.
  19. 19. What LR is NOT? • It is not just a descriptive list of the material available, or a set of summaries • A literature review is more than the search for information, and goes beyond being a descriptive annotated bibliography. • The following is NOT a LR: Annotated bibliography List in text format Ibrahim , S. D. (1995). Outcomes of Intervention X on Pregnant women, Soba Hospital." BMJ 2/3, 34-38. This article discusses the effect of the intervention X on pregnant women delivering in Soba Teaching Hospital. It also discusses the implications for reducing factor Y on these women. IBRAHIM and BANNAGA (1965) conducted experiments on pregnant women in STH, basing on the theoretical investigation of X interaction complemented by type Y. It showed that the numerical results were in reasonable agreement with laboratory experimental data."
  20. 20. Why/When do we need LR? • LR can help in finding, developing, and/or fine-tuning your RQ. • Determine the nature/method of your research Find Research questions • What is not known/established? • What is not well known? • What was not well-studied? • Cross-referencing Define gaps & references • Strengths & weaknesses • Theoretical base • Comparison of findings • Critical appraisal Establish relations
  21. 21. Do and Don’t in LR • All works included in the review must be read, evaluated and analysed (cf. annotated bibliography), • Relationships between the literature must also be identified and articulated, in relation to your field of research. • LR must be defined by a guiding concept (e.g., your research objective, the problem or issue you are discussing, or your argumentative thesis). • Works which are irrelevant should be discarded and those which are peripheral should be looked at critically.
  22. 22. Where to search? • Library (institutional, professional, organizational) • Archives • Reports Offline • Journals websites • Publishers’ databases • Institutional databases • Institutional libraries Online
  23. 23. Before going online… remember! • The printed resources have almost always been thoroughly ‘peer- reviewed’, and systematically catalogued and cross-referenced • On the Internet "anything goes." • Don't rely exclusively on Internet resources. • Narrow your research topic before logging on. • Before you start your search, think about what you're looking for, and if possible formulate some very specific questions to direct and limit your search • Know your subject directories and search engines. • There are several high quality peer-reviewed subject directories containing links selected by subject experts • Keep a detailed record of sites you visit and the sites you use. • Keeping track is necessary so that you can revisit the useful ones later, and also put the required references in your paper.
  24. 24. • BioMedCentral: http://www.biomedcentral.com/ • PubMed Central (PMC): http://www.ncbi.nlm.nih.gov/pmc/ • Google Scholar: http://scholar.google.com
  25. 25. Online Literature Search • A good literature search involves the following steps which should be worked through systematically: 1. Background reading and preparation 2. Working with your title: identify search terms 3. Identify the resources to search 4. Search using search techniques 5. Collate your results Source: Liverpool Hope University Doing a literature search: a step by step guide. URL: http://www.hope.ac.uk/media/liverpoolhope/contentassets/documents/library/help/media,1256,en.pdf Other helpful guides can be found on the following links: https://becker.wustl.edu/sites/default/files/RespLitSearch.pdf http://www.birmingham.ac.uk/facilities/hsmc-library/faqs/literature-searching.aspx
  26. 26. LET’S GO ONLINE! Task: In your laptops/computers, use the University of Birmingham literature search strategy form to conduct an online search of literature in your relevant area of research.
  27. 27. Reference Management 06.01.2015
  28. 28. Outline • Revise the LR task • Overview on Responsible Conduct of Research • What are the Reference Management Software (RMS)? • Why do we need them? • How to choose which RMS? • How to use them in: • Importing references from the internet to your PC/Laptop • Building references databases • CWYW (Cite While You Write) • Transfer references among databases and RMS
  29. 29. How was your task? • What is easy/just ok/hard? • What was the easiest part? • What was the hardest part? • How many words you managed to gather? • How many references you found/used?
  30. 30. BeforeWeGetOurhands Dirty!
  31. 31. Research Misconduct (FFP) Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. • Fabrication is making up data or results and recording or reporting them. • Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results. • Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. • Research misconduct does not include honest error or differences of opinion. • Research misconduct includes the destruction of, absence of, or accused person's failure to provide research records accurately documenting the questioned research.
  32. 32. Forms of misconduct • Falsification • Obfuscation • Fabrication • Plagiarism • Self-plagiarism • Ghost writing • Bare assertions • Improper authorship • Misappropriation • Bibliometric inflation • Violation of ethical standards regarding human and animal experiments http://en.wikipedia.org/wiki/Scientific_misconduct
  33. 33. Office of Research Integrity (ORI)’s Definition of Plagiarism • … plagiarism to include both the theft or misappropriation of intellectual property (IP) and the substantial unattributed textual copying of another's work. It does not include authorship or credit disputes. • … the unattributed verbatim or nearly verbatim copying of sentences and paragraphs which materially mislead the ordinary reader regarding the contributions of the author. • The theft or misappropriation of IP includes the unauthorized use of ideas or unique methods obtained by a privileged communication, such as a grant or manuscript review.
  34. 34. RMS: What they are? • It is software for scholars and authors to use for recording and utilising bibliographic citations (references). • Once a citation has been recorded, it can be used time and again in generating bibliographies, such as lists of references in scholarly books, articles and essays. • These software packages normally consist of a database in which full bibliographic references can be entered. • It can usually be integrated with word processors so that a reference list in the appropriate format is produced automatically as an article is written, reducing the risk that a cited source is not included in the reference list. Source: http://en.wikipedia.org/wiki/Reference_management_software
  35. 35. RMS: What they do? Source:(http://www.istl.org/11-summer/refereed2.html) 1. Import citations from bibliographic databases and websites 2. Allow organization of citations within the RM database 3. Allow annotation of citations 4. Allow sharing of the RM database or portions thereof with colleagues 5. Allow data interchange with other RM products through standard metadata formats (e.g., RIS, BibTeX) 6. Produce formatted citations in a variety of styles 7. Work with word processing software to facilitate in-text citation
  36. 36. Examples of RMs Reference Management Software (http://en.wikipedia.org/wiki/Reference_management_software) Open source Retail Web-based •BibDesk •Docear •Ilibrarian •JabRef •KBibTeX •Pybliographer •Referencer •Wikindx •Zotero • Biblioscape • Bookends • Citavi • Papers • Qiqqa • Sente •BibSonomy •Qiqqa •Wikindx •WizFolio •Zotero
  37. 37. 1. Install your RM of choice 2. Do your online search 3. Build a new database 4. Transfer the reference from the web to your database 5. Use the references you imported in your document
  38. 38. References • Reference Management Software: a Comparative Analysis of Four Products, Ron Gilmour, and Laura Cobus-Kuo, (http://www.istl.org/11-summer/refereed2.html) • Wikipedia: http://en.wikipedia.org/wiki/Reference_management_software
  39. 39. What is it? Different types of scientific writing Why/When do we need it? Linguistic and technical tips 13.01.2015
  40. 40. A reminder first ...the KMC Generation Dissemination SynthesisUtilization Assessment Statistics
  41. 41. Before writing… you need to decide… Example Why are you writing this? Academic requirement, dissemination, advocacy and promotion Who is/are your audience? Supervisors, journal editors, colleagues, conference attendees What are the requirements of the audience? University’s guidelines, manuscript template, word limits, time limits Which language you have to use? Lay, simplified technical, pure technical, Arabic, English, mixed Which ‘technology’ you will use? Word processers, presentation design, poster design, photo editors
  42. 42. Today: Two sets of skills Editorial Common features of SW Common mistakes for NNS Tips to make our SW better Technical Organizing your document Dealing with long documents Tips to for formatting
  43. 43. Common features of SW Your scientific writing should be: • Precise: words mean what they meant to mean • Concise: meanings delivered with the least number of words, & least complication • Logic: each section builds on the previous • Systematic: flows in structure • Appropriate language: correct, readable, suitable for purpose, and understandable
  44. 44. To achieve them you need… Divide your piece into (sub)headingsStructure • IMRAD • Familiarize with the templates (journal, university, grant, etc..) Present your work graduallyLogic • Give enough background • Clear objectives, and description of methods • Clear presentation of results • Conclusions arise ‘logically’ from results Keep it short!Language • Read a lot, Write a lot, Submit a lot, and get rejected! • Keep phrase banks, verb cheat sheets, grammar cheat sheets, etc.. • Share your drafts with colleagues
  45. 45. Common language mistakes in SW As non-native speakers (NNS) of English, we are more prone to: • Wordiness: using numerous words in long sentences to get the message across • Transfers: what works in my language will work in English • Assertiveness: use of either too weak or too assertive verbs • Inappropriate structure: wrong syntax, grammar, spelling, and punctuation • Misuse of tables and figures: tables and figures are too few, too many, or poorly presented • Inappropriate citation: lack, or excessive, or inadequate use or acknowledgment of others’ works
  46. 46. Common language mistakes in SW • Wordiness: using numerous words in long sentences to get the message across Example: “Since its independence, the Sudan has witnessed a number of political regimes that had different approaches to the administrative division of the Sudan, including the administrative division of the Sudan into either regions or states varied from 5 regions in the latest democracy that lasted from 1985, following the outage of the former president Jaffar Numeiri until 1989 when a military coup took place, to 25 states before the separation of the southern part of the country to the currently 18 northern Sudanese states.” • What do you think? Task: write it down in a better way
  47. 47. Examples of other mistakes Mistake Example of mistake Correction Transfers/ Mistranslation what works in Arabic will work in English ‫عام‬ ‫استغالله‬ ‫على‬ ‫السودان‬ ‫حصل‬ 1965. Sudan got its abuse in 1956. Assertiveness use of either too weak or too assertive verbs “this study clearly shows that factor X has caused a very huge improvement in the clinical outcome” “the findings of the study strongly suggests that factor X could be a significant factor to the improvement in the clinical outcome” Inappropriate structure: wrong syntax, grammar, spelling, and punctuation “the outlayers were excluded from the analysis” “the outliers were…” “assessment of factors affecting prevalence of DM in pregnant women revising Soba Hospital, case study of Khartoum” Correction?
  48. 48. Tips for better writing • Keep sentences short. Connect with clauses. (See Sudan example above) • Maintain the tenses consistent all over your piece • Use synonyms and idiosyncrasies for variability • Define acronyms (and other jargon) when used • Nominalization: (-tion)it makes your writing looks smarter, but lacks the ‘who’ • If you are to choose between clarity and wordiness; choose clarity • Use positive; avoid passive voices (if possible)
  49. 49. Tables & figures • What is wrong with this table? Men Group 1 Men group 2 Rats Serum Protein A (Mg/l) 100 158 - Blood glucose (mmol/L) 102 160 154 Weight (average) 138.8989 150.8 1.6588887 Activity level 0 5 8 Data on different responses
  50. 50. What is wrong with this figure? Diagram of response at different days after treatment Days after treatment
  51. 51. Let MS Word Works for You 1. Dividing your document: page breaks 2. Use of Styles and Headings 3. Table of contents 4. Review and Track Changes 5. Spelling and grammar check 6. Readability scores
  52. 52. Why do we need to publish? Where to publish? Tips to writing for publication What to do before, during, and after manuscript submission? Common pitfalls in attempts to publish 20.01.2015 This section is largely based on Springer Author Academy available free online: http://academy.springer.com/
  53. 53. Why do we need to publish? • Contribute to knowledge • Gain academic prestige • Career Promotion • Peer-pressure • Better CV - better job • Required by the grant/donor • Writing for money?
  54. 54. Where to publish? • Peer-reviewed scientific Non peer-reviewed Peer reviewed Non peer-reviewed • Scientific (specialized) journals chosen on: - Impact factor - Reputation - Readability - Relevance to specialty - Open access - Length restriction - Publication fees • Newsletters • Bulletins • Social media (blogs) • Professional social media: - Academia.edu - LinkedIn.com - ?Slideshare.com - ResearchGate.com
  55. 55. Overview on the publication process: Manuscript preparation • Choose your journal • Read & follow author’s guide Submission • Register on online submission • Letter to the editor • Text manuscript • Tables & figures Peer review & Decision • The (section) editor reviews • Only if editor is convinced; sent to peer review • Reject, major changes, minor changes, or accept as such Publication • Review the proofs • Accept the proofs • Share the publication
  56. 56. Manuscript Preparation • Before writing  Read/discuss on the topic you want to publish in  Identify what you want to publish  Identify why do you want to publish  Decide on the key message  Decide on the best manuscript type  Agree on tasks (who will do what when?)  Decide on the journal  Read the journal’s author’s guide (template, structure, style, etc..)  Agree on authorship (defined later)
  57. 57. it is NOT all about the manuscript The following MUST be submitted with the manuscript: • Cover letter • Abstract: Introduction, Rationale/Objectives, Methods, Results, Discussion, Conclusion, • Manuscript: • Tables • Figures 1. Title 2. Authors’ names, titles, affiliations, contacts 3. Keywords 4. Abstract 5. Introduction 6. Rationale/Objectives 7. Methods & Material 8. Results 9. Discussion 10. Conclusion/Recommendations 11. Limitations 12. References 13. Acknowledgment 14. COI Statement
  58. 58. Manuscript should be: • Tell an interesting story (why is it important?) • Novel • Timely • Clear, concise, correct, and readable • Use evidence and argument (counter-argument) • Use non-text representation • Use well designed cases, examples, vignettes, etc.. • Use up-to-date references (at least 75% of references from the last 5 years) • Follow the journal’s requirements and ethical guidelines
  59. 59. • IMRaD structure (Introduction, Materials and Methods, Results, Discussion and Conclusions) • IMRD is mainly for submission NOT necessarily for writing • Writing can start simultaneously from results, introduction, materials, etc. • Abstract is usually the last section to write • Discussion & conclusion should not be written before results
  60. 60. Cover letter • It is a letter you send to the editor to ‘sell’ him/her your work • It explains why the editor would want to publish your manuscript • Bad example: • “Dear Editor-in-Chief, I am sending you our manuscript entitled “Large Scale Analysis of Cell Cycle Regulators in bladder cancer” by Researcher et al. We would like to have the manuscript considered for publication in Pathobiology. Please let me know of your decision at your earliest convenience. With my best regards, Sincerely yours, A Researcher, PhD” Source: http://academy.springer.com/journalauthoracademypart2submittingandpeerreview/node/3668#.VL3ojiuUfXo
  61. 61. Cover letter … cont. Commonly used phrases include: • Please find enclosed our manuscript, “[manuscript title]” by [first author's name] et al., which we would like to submit for publication as a [publication type] in [name of the journal]. • To our knowledge, this is the first report showing… • We believe our findings would appeal to the readership of [journal name]. • Please address all correspondence to: • We look forward to hearing from you at your earliest convenience. All cover letters should contain these sentences: • We confirm that this manuscript has not been published elsewhere and is not under consideration by another journal. • All authors have approved the manuscript and agree with its submission to [insert the name of the target journal]. Source: http://academy.springer.com/journalauthoracademypart2submittingandpeerreview/node/3668#.VL3ojiuUfXo
  62. 62. Tips for persuasive cover letter • Address the editor with his/her name and title • Write the date • Write the title and the type of the submitted manuscript • Write a paragraph about your study • Be brief without a lot of background • Specify its objective and what makes it unique • Couple of statements on the methods you used and your main findings • Why your findings could be interesting and why they suitable for publication in this particular journal ? • Use the required statements (se examples above) • Sign with the corresponding author’s name and contact • End by “Yours sincerely” Source: http://academy.springer.com/journalauthoracademypart2submittingandpeerreview/node/3668#.VL3ojiuUfXo
  63. 63. Abstract • A summary of the content of the journal manuscript • A time-saving shortcut for busy researchers • A guide to the most important parts of your manuscript’s written content • Many readers will only read the Abstract of your manuscript then decide whether they want to read the rest of the paper. • Therefore, it has to be able to stand alone. • Make sure you follow the proper journal manuscript formatting guidelines (including word count) when preparing your abstract. Your Abstract should answer these questions about your manuscript: • What was done? • Why did you do it? • What did you find? • Why are these findings useful and important?
  64. 64. An Effective Title An effective title should: • Grab attention and Attract readers • Be concise and accurately describe the contents of your manuscript,. • Convey the main topics of the study • Highlight the importance of the research and makes people want to read further Poor Example: • Does Vaccinating Children and Adolescents with Inactivated Influenza Virus Inhibit the Spread of Influenza in Unimmunized Residents of Rural Communities? (This title has too many unnecessary words) • Influenza Vaccination of Children: A Randomized Trial (This title doesn’t give enough information about what makes the manuscript interesting) Effective example: • Effect of Child Influenza Vaccination on Infection Rates in Rural Communities: A Randomized Trial • This is an effective title. It is short, easy to understand, and conveys the important aspects of the research. • TIP: Write down a few possible titles, and then select the best to refine further. Ask your colleagues their opinion. Spending the time needed to do this will result in a better title.
  65. 65. Introduction, Materials and Methods, Results Introduction Materials and Methods Results Adequate Use subheadings Do not interpret the results Relevant Use past tense Use subheadings Up-to-date Detailed enough for reproducibility Present in a logical order Balanced State all statistical tests and parameters Use the past tense Subheading may be needed Use figures and tables ; however, refer to in the present tense. Do not duplicate data among figures, tables, and text Adequately cited Include the results of statistical analyses in the text (usually by providing p values when statistically significant)
  66. 66. Discussion & Conclusion • They answer the question: What do your results mean? • Discuss your conclusions in order of most to least important. • Compare your results with those from other studies: Are they consistent? If not, discuss possible reasons for the difference. • Mention any inconclusive results and explain them as best you can. You may suggest additional experiments needed to clarify your results. • Briefly describe the limitations of your study to show reviewers and readers that you have considered your experiment’s weaknesses. • Discuss what your results may mean for researchers in the same field as you, researchers in other fields, and the general public. How could your findings be applied? • State how your results extend the findings of previous studies. • If your findings are preliminary, suggest future studies that need to be carried out. • At the end of your Discussion and Conclusions sections, state your main conclusions once again.
  67. 67. Effective Use of References • Why we use them? • Establish where ideas came from • Give evidence for claims • Connect readers to other research • Provide a context for your work • Show that there is interest in this field of research • Be sure to cite publications whose results disagree with yours. • Never cite a publication based on what you have read in a different publication (such as a review), or based only on the publication’s abstract. • Use reference management software
  68. 68. Why manuscripts get rejected? • Poor structure (including not following journal’s requirements) • Lacks of necessary details • Has poor or no new science/knowledge (not novel or genuine) • Lack of clarity (content, hypotheses, science, or language) • Poor or inappropriate use of references: not up-to-date, Plagiarism • Contains theories, concepts, or conclusions that are not fully supported by its data, arguments, and information • Does not provide enough details about materials and methods • Describes poor experimental design, or faulty or insufficient statistical analysis • Lack of ethical requirements
  69. 69. Final talk about ethics • Informed consent • Conflict of interests • Plagiarism and scientific misconduct • Authorship
  70. 70. What Makes a Good Research? Good science Good Ethics •Problem selection •SMART objectives •Proper methodology •Proper analysis •Fair subject selection •Favorable Risk-Benefit Ratio •Independent Review •Informed Consent
  71. 71. Criteria of “Good” Science Research • Systematic: The research developed, implemented and reported in a systematic manner. • Methodolic: Adopt & use skillfully the research methods, materials ,approaches in order to ensure reliability of the results & findings. • Scientific: The research should be scientifically sound through utilizing scientific approaches , tools and techniques.
  72. 72. Criteria for Good Ethics: WhatMakesResearchEthical? 1. Social or Scientific Value 2. Scientific Validity 3. Fair Subject Selection 4. Favorable Risk-Benefit Ratio 5. Independent Review 6. Informed Consent 7. Respect for the potential and enrolled subjects
  73. 73. What’s Research Ethics?  It is the field of ethics that systematically analyze the ethical and legal questions raised by research involving human subjects.  Its main focus is to ensure that the study participants are protected and, ultimately,  that clinical research is conducted in a way that serves the needs of such participants and of society as a whole. It works when and only when it is applied before the research is conducted
  74. 74. History of Research Ethics Pre-World War II • Research standards left up to the discretion of the individual researcher World War II • Experiments conducted on inmates of Nazi concentration camps • 1945-1949 - Trials in Nuremberg, Germany– physicians convicted of crimes against humanity
  75. 75. Year Benchmark 2013 WMA updates DOH (Brazil) 2010 TCPS updated 2008 WMA updates DOH (Seoul) 2004 WMA updates DOH (Tokyo) 2002 WMA updates DOH (Washington) CIOMS Guidelines updated 2000 WMA updates DOH (Edinburgh) 1998 Tri-Council Policy Statement (TCPS)published in Canada 1996 WMA updates DOH (South Africa) 1993 CIOMS guidelines for biomedical research involving human subjects 1991 US CFR title 45, Part 46 issued CIOMS Guidelines for Epidemiological studies 1989 WMA updates DOH (Hong Kong) 1983 WMA updates DOH (Venice) 1981 US Common rule updated 1979 The Belmont Report 1975 WMA updates DOH (Tokyo) 1966 Dr. Beecher’s Article “Ethics and Clinical Research” 1964 World Medical Association (WMA) published the Declaration of Helsinki (DOH) 1947 The Nuremberg Code 1900 Walter Reed’s ‘consent’ for yellow fever experiments Pre-1900 Edward Jenner smallpox vaccines
  76. 76. 18th and 19th Centuries • James Lind “scurvy study in sailors - Salisbury • Edward Jenner cowpox vaccine test • 1897 Giuseppe Sanarelli yellow fever test 1900 Walter Reed established several [first ever] “safeguards” • Self-experimentation • Only adults would be enrolled in research • Written informed consent • Reimbursement (inducement)
  77. 77. Nazi Doctors’ Experimentation
  78. 78. InternationalResearchGuidelines Nuremberg Code (1947) - As a result of WWII Nazi experiments - First international code in research ethics • Voluntary consent absolutely essential (restricting research with infants, children, developmentally challenged, etc.) • Risk/Benefit Analysis essential to ethics review • Scientific Soundness is important to ethics review
  79. 79. The NurembergCode (1947) The first provision of the code requires that “the voluntary informed consent of the human subject is absolutely essential.” The code provides other details implied by such a requirement: • Capacity to consent • Freedom from coercion • Comprehension of the risks and benefits involved • Experiment to be conducted by highest qualified persons The code on the web: http://ohsr.od.nih.gov/nuremberg.php3
  80. 80. The Declarationof Helsinki (DOH)  The World Medical Association created the Declaration of Helsinki in 1964 and amended regularly since 1975 The main issues emphasized were:  “The well-being of the subject should take precedence over the interests of science and society”  Consent should be in writing  Use caution if participant is in dependent relationship with researcher  Limited use of placebo  Greater access to benefit
  81. 81. WorldMedicalAssociationWMA (1964) Respect for Persons – people are not a means to an end; researchers have duty to protect life, health, privacy and dignity of research participants Standard of care must be best available, even for control group Proxy consent and assent for vulnerable populations
  82. 82.  More than 400 African- American men with latent syphilis were followed for the natural course of the disease rather than receiving treatment.  Continued after penicillin available  40 wives infected, 19 children born with congenital syphilis TUSKEGEE SYPHILIS STUDY, ALABAMA ( 1932 – 1972 )
  83. 83. The Belmont Report (1979) 1972: the public became aware of the Tuskegee study 1974: the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established. 1978: the commission submitted its report titled, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Those principles respect for persons, beneficence and justice are accepted as the 3 fundamental principles for the ethical conduct of research involving human participants.
  84. 84. CouncilforInternationalOrganizations ofMedicalScience(CIOMS)Guidelines(1993) • Informed consent • Research in developing countries • Protection of vulnerable populations • Distribution of the burdens and benefits • Role of ethics committees
  85. 85. Is it over?... Torvan trial in Kano, Nigeria  Kano Trovan clinical trials in 1996, on pediatric age group, during the worst ever meningococcal meningitis.  Lack of proper Governmental authorization and informed consent during the studies publicized in 2000, by Washington Post.  Court trial and release of investigation panel reports stalled in Nigeria.  Suit for 5.8 billion USD moved to the USA and report leaked there too.  Settlement out of court being discussed.
  86. 86. What’s ethically unique about molecular biology and biotechnology? ETHICAL ISSUES IN RESEARCH ON HUMANS
  87. 87. Very rapidly progressing…
  88. 88. Very wide possibilities… • Identification of the genes responsible for human diseases, • Identification of the mutations underlying a vast number of phenotypes • health care (medical), crop production and agriculture, non food (industrial) uses of crops and other products • Examples: • biodegradable plastics, vegetable oil, biofuels), and environmental uses. • manufacture of organic products (e.g. milk products) • Used to recycle, treat waste, cleanup sites contaminated by industrial activities (bioremediation), and • to produce biological weapons.
  89. 89. EXAMPLES OF THE ETHICAL ISSUES IN RESEARCH • Benefit/harm analysis • Vulnerability (Risk-Vulnerability Matrix) • Informed Consent • Fairness and equity in research participation • Privacy and confidentiality • Conflict of Interests (COI) • integrity & publication ethics
  90. 90. Informed Consent
  91. 91. Definition “Autonomous authorization of a medical intervention…by individual patients/participants“ (Beauchamp and Faden, 2004) It's the practical expression of patient's autonomy, and the respect for him/her personality
  92. 92. Components of FIC: 1. "Disclosure" refers to the provision of relevant information by the clinician and its comprehension by the patient. 2. "Capacity" refers to the patient's ability to understand the relevant information and to appreciate those consequences of his or her decision that might reasonably be foreseen. 3. "Voluntariness" refers to the patient's right to come to a decision freely, without force, coercion or manipulation.
  93. 93. Disclosure VoluntarinessCapacity
  94. 94. 1. Disclosure This refers to the process during which physicians provide information about the proposed research to the participant.
  95. 95. Eight Required Elements [45CFR46.116(a)&21CFR50.25] 1. Statement that study in research and information on purposes / duration / procedures / experimental procedures 2. Reasonably foreseeable risks or discomforts 3. Reasonably expected benefits 4. Alternative procedures
  96. 96. Eight Required Elements Cont. [45CFR46.116(a)&21CFR50.25] 5. How confidentiality will be maintained 6. Information on compensation for injuries (unless minimal risk) 7. Contact persons for information on research, injury, subject’s rights 8. Voluntary participation, no penalty or loss of benefits for refusal or withdrawal
  97. 97. Six Additional Elements 1. Statement that there may be risks which are unforeseeable 2. Under what circumstances investigator could terminate subject’s participation 3. Additional costs to subjects 4. Consequences of subject’s withdrawal from research 5. Statement that will be told of new findings 6. Approximate number of subjects in study
  98. 98. Forms of Consent Normally, should be provided by participants themselves. • Deferred consent: is where the subject is entered into a research study and consent is gained from surrogates after a specified period of time for continuation of the subject’s inclusion in the trial. • Prospective informed consent : represents an attempt to canvass support in advance from a population considered at risk of developing a serious illness. • Surrogate consent (SDM): ideally a substituted judgment made by a person responsible for health care decision-making for a particular patient under the relevant legislation
  99. 99. Waiver of Informed Consent REC must find and document that the following criteria have been satisfied:  Poses no more than Minimal risk research  Waiver or alteration will not adversely affect the rights and welfare of the subjects  Research could not practicably be carried out without the waiver or alteration  Does not involve a therapeutic intervention  Subjects will be provided with additional pertinent information All of the above must apply
  100. 100. Documentation of Informed Consent  Written consent document  Language understandable to the subject or the subject’s Legally Authorized Representative (LAR)  Signed by subject or subject’s LAR  Copy SHALL be given to subject  Opportunity to read before signing
  101. 101. Principles for ProvidingInformationto the Participant: Make it clear; avoid jargon Use language appropriate to the patient's level of understanding in a language of their fluency Pause and observe patients for their reactions Invite questions from the patient and check for understanding
  102. 102. Principles for Providing Information the Participant: Cont. Invite the patient to share fears, concerns, hopes and expectations Watch for patients' emotional response: verbal and non-verbal Show empathy and compassion Summarize the imparted information Provide contact information (and other resources)
  103. 103. 2. Capacity: Refers to the presence of a group/set of functional abilities a person needs to possess in order to make a specific decisions (Griso and Applebaum, 1998). These include:  To UNDERSTAND the relevant information  To APPRECIATE the relatively foreseeable consequences of the various available options available.
  104. 104. 3. Voluntariness: • Refers to a participant’s right to make participation decisions free of any undue influence. Influences include: • Physical restraint or sedation • Coercion involves the use of explicit or implicit threat to ensure that the treatment is accepted • Manipulation involves the deliberate distortion or omission of information in an attempt to induce the subject’s participation
  105. 105. Voluntariness • Free of undue influence • Persuasion: appeals to reason • Manipulation • Coercision: explicit or implicit threats • Force: restraint or sedation
  106. 106. MANIPULATION • Distortion of facts or omission • Non-coercive alternation of choices • Undue financial payment • Undue influence, government funding only at grade eight for hpv
  107. 107. Practical Challenges to a "Fully Informed Consent" • Diagnostic uncertainty • Complexity of medical information • Linguistic and cultural differences • Overworked health personnel • Paternalistic approach in doctor-patient relationship in developing countries, including Sudan.
  108. 108. CONFLICTS OF INTEREST (COI) Conflicts of interests
  109. 109. What is an interest? • An interest may be defined as a commitment, goal, or value held by an individual or an institution. • Examples include a research project to be completed, gaining status through promotion or recognition, and protecting the environment. Interests are pursued in the setting of social interactions.
  110. 110. What is COI? • COI exists when two or more contradictory interests relate to an activity by an individual or an institution. • Conflicts of interest are “situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator’s judgement in conducting or reporting research.” AAMC, 1990
  111. 111. What is COI? Cont. • “A conflict of interest in research exists when the individual has interests in the outcome of the research that may lead to a personal advantage and that might therefore, in actuality or appearance compromise the integrity of the research.” NAS, Integrity in Scientific Research
  112. 112. Levels of COI • Researchers • The REB should assess the likelihood that the researcher’s judgment may be influenced, or appear to be influenced, by private or personal interests, and assess the seriousness of any harm that is likely to result from such influence or from the mere appearance of undue influence (TCPS, 200)
  113. 113. Levels of COI Conflicts of Interest by REB Members • It is of the highest importance that members of the REB avoid real or apparent conflicts of interest . • For example: when their own research projects are under review by their REB or • when they have been in direct academic conflict or collaboration with the researcher whose proposal is under review.
  114. 114. Levels of COI Institutional Conflicts of Interest • Situations may arise where the parent organization has a strong interest in seeing a project approved before all ethical questions are resolved. • The REB must act independently from the parent organization. • Institutions must respect the autonomy of the REB and ensure that the REB has the appropriate financial and administrative independence to fulfill its primary duties.
  115. 115. What comprises COI? • Stock ownership • Paid employment Board membership • Patent applications (pending or actual) • Research grants (from whatever source) • Travel grants and honoraria for speaking or participation at meetings
  116. 116. What comprises COI? Cont. • Gifts Membership of lobbying organizations • Relationship with the National Research Ethics Review Committee, or with possible reviewers of the paper • Relationship with organizations and funding bodies Membership of a government advisory board
  117. 117. Is it always bad? COIs may result in: 1. Loss of objectivity 2. Reordering of priorities towards applied research 3. Degradation of the nature of science as an open and collegial enterprise 4. Exploitation of trainees 5. Transfer of time and interest to Commercial ventures
  118. 118. • In May 2004, the pharmaceutical giant Pfizer agreed to pay $430 million to settle a lawsuit by a former employee turned whistle-blower, who was joined in the lawsuit by the U.S. federal government and 11 state governments. • The lawsuit exposes various marketing practices by the company Warner-Lambert – later bought by Pfizer.
  119. 119. • Leading academic researchers were paid to deliver promotional lectures at educational events and to publish favorable reports on the off-label use of its epilepsy drug, Neurontonin. L. Kowalczyk “Pfizer Drug Strategy Probed: States Question Marketing Tactics for Neurontin,” Boston Globe, October 18, 2002,
  120. 120. Conflicts Can Occur at all Levels of Research • In reviews/awarding of grant • In ethics review of grant • In recruitment of participants • In analysis of data • In presentation of data
  121. 121. The Case of Nancy Oliveiri • In 1996, Olivieri found that the drug she was researching (deferiprone, active iron-chelating agent ) at the Hospital for Sick Children in Toronto was showing unexpected potential risks to some patients in the trials. • The drug company sponsoring her research abruptly terminated the trials and issued warnings of legal action against Olivieri should she inform her patients at the Hospital for Sick Children of the risks, or publish her findings.
  122. 122. The Case of Nancy Oliveiri Cont. • The manufacturer (Apotex) issued more legal warnings to deter Dr Olivieri from communicating this second unexpected risk of L1 to anyone. • However, she published her findings in the New England Journal of Medicine and
  123. 123. The Case of Nancy Oliveiri Cont. • She was subsequently dismissed from her position as Director of the Hospital for Sick Children Program of Hemoglobinopathies. • Apotex was planning to donate USD 100 Million to the University of Toronto
  124. 124. The Case of Nancy Oliveiri • After more than seven years of legal battle, an independent committee of inquiry into the matter vindicated Olivieri and concluded that neither the university nor the hospital offered her appropriate support in her conflict with the drug company. • Olivieri was reinstated to her position at the Hospital for Sick Children and her actions have also been vindicated by several other independent reports.
  125. 125. The other side of the story • Deferiprone is the only effective orally active iron- chelating agent licensed for the treatment of patients with thalassaemia major and other disorders of transfusional iron overload. • It is the only alternative to deferoxamine—a drug that has to be given by daily subcutaneous infusions and fails in many patients worldwide because of the lack of compliance, high cost, toxicity, or hypersensitivity.
  126. 126. The other side of the story • No other clinicians using the drug had found evidence for long-term liver damage and her interpretation of the data was immediately questioned in letters to the New England Journal of Medicine. • Four of her patients in whom liver fibrosis had been suggested also had hepatitis C and all five had iron overload—both causes of liver fibrosis.
  127. 127. LET’S DEBATE…! What do you think? OR ?
  128. 128. Practical Steps to resolve • Disclosure / transparency • Stringent analysis of COI, • Review of contracts between funders and researchers • Close external monitoring • Blinding of study, when possible • Restrict review of colleague’s work • Peer review of manuscripts
  130. 130. What is Ethical Review? • It is a process by which research proposals are reviewed for their compliance and accordance with the national/international ethical principles & guidelines for research involving human subjects.
  131. 131. Research Requiring Ethics Review All research involving living human subjects by collecting identifiable information or materials including: Research with human remains, cadavers, tissues, biological fluids, embryos and fetuses. Interviews, surveys and questionnaires. Secondary data analysis of data from living human subjects.
  132. 132. Research exempt from Ethics Review: Research about living individuals in the public arena or artists, based exclusively on publicly available information. Participant observation of public demonstrations, political rallies and public meetings. Quality assurance studies, performance reviews or normal educational testing.
  133. 133. Thispresentationandmorematerialcanbefoundonline: http://www.slideshare.net/ghaiath https://www.youtube.com/ghaiathme You may also contact me on my email: ghaiathme@gmail.com