Presentation Transcript

1. Responsible Conduct of Research: Research Involving Human Participants www1.carleton.ca/curo/ethics-and-compliance/ethics
2. Framework for responsible research The Tri-Council (SSHRC, NSERC, and CIHR) funds research in Canada and as such researchers and institutions are responsible for the use of those funds and the integrity of the research. Under the RCR policy researchers shall conduct research with honestly, accountability and be open and fair. Researchers shall follow the requirements of their institutional policies and professional or disciplinary standards. And, researchers shall comply with applicable laws and regulations.
3. Responsible Conduct of Research a. Using a high level of rigour in proposing and performing research; in recording, analyzing, and interpreting data; and in reporting and publishing data and findings. b. Keeping complete and accurate records of data, methodologies and findings, including graphs and images, in accordance with the applicable funding agreement, institutional policies and/or laws, regulations, and professional or disciplinary standards in a manner that will allow verification or replication of the work by others. c. Referencing and, where applicable, obtaining permission for the use of all published and unpublished work, including data, source material, methodologies, findings, graphs and images.
4. Responsible research d. Including as authors, with their consent, all those and only those who have materially or conceptually contributed to, and share responsibility for, the contents of the publication or document, in a manner consistent with their respective contributions, and authorship policies of relevant publications. e. Acknowledging, in addition to authors, all contributors and contributions to research, including writers, funders and sponsors. f. Appropriately managing any real, potential or perceived conflict of interest, in accordance with the institution's policy on conflict of interest in research, in order to ensure that the objectives of the Framework (Section 1.3) are met.
5. Breaches of Research Integrity Policy Fabrication: Making up data, source material, methodologies or findings, including graphs and images. Falsification: Manipulating, changing, or omitting data, source material, methodologies or findings, including graphs and images, without acknowledgement and which results in inaccurate findings or conclusions. Destruction of research records: The destruction of one's own or another's research data or records to specifically avoid the detection of wrongdoing or in contravention of the applicable funding agreement, institutional policy and/or laws, regulations and professional or disciplinary standards. Plagiarism: Presenting and using another's published or unpublished work, including theories, concepts, data, source material, methodologies or findings, including graphs and images, as one's own, without appropriate referencing and, if required, without permission.
6. Redundant publications: The re-publication of one's own previously published work or part there of, or data, in the same or another language, without adequate acknowledgment of the source, or justification. Invalid authorship: Inaccurate attribution of authorship, including attribution of authorship to persons other than those who have contributed sufficiently to take responsibility for the intellectual content, or agreeing to be listed as author to a publication for which one made little or no material contribution. Inadequate acknowledgement: Failure to appropriately recognize contributions of others in a manner consistent with their respective contributions and authorship policies of relevant publications. Mismanagement of Conflict of Interest: Failure to appropriately manage any real, potential or perceived conflict of interest, in accordance with the Institution's policy on conflict of interest in research, preventing one or more of the objectives of the Framework (Section 1.3) from being met.
7. So, why an RCR policy?

8. A Brief History of Human Research Ethics

   Don’t end up on thin ice!
9. Nazi experiments of WWII
10. Experiments included Experiments on twins: of the 1500 twins used by Josef Mengele less than 200 survived. These were children. Freezing experiments Malaria experiments Mustard gas experiments Sea water experiments (drinking sea water) Sterilization experiments Incendiary bomb experiments
11. Nuremberg Doctors’ Trials August 19, 1947, the doctors captured by Allied forces were put on trial in USA vs. Karl Brandt et al., which is commonly known as the Doctors’ Trial. Several doctors argued in that there was no international law regarding medical experimentation they had done nothing wrong.
12. Nuremberg Code 1949 The doctors were found guilty and in response to this claim of no international law the Nuremberg Code was introduced as the first international ethical standard for medical research. There were 10 points to the Nuremberg code and it is the first point that would become the heart of all research ethics codes.
13. Free and informed consent The voluntary consent of the human subject is absolutely essential. This means that: The person involved should have legal capacity to give consent. They should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; They should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.
14. The Nuremberg Code did not stop unethical research The Tuskegee Experiment was conducted by the U.S. Public Health Service and is “the longest non-therapeutic experiment on human beings in medical history.”
15. Tuskegee Syphilis Study From 1932-1972 the United States Public Health Service conducted a study of 399 poor, mostly illiterate black sharecroppers with syphilis. The participants believed they were receiving free medical care and the true purpose of the study being revealed. They were never informed they had syphilis and were never treated for the disease.
16. Purpose and outcomes The purpose of the study was to determine if patients suffering from syphilis were better off not being treated with present day toxic remedies. Patients treatment was intentionally denied and many were given placebo treatments—in order to observe the fatal progression of the disease. At the end of the study only 74 participants were still alive: 28 of the men had died directly of syphilis, 100 were dead of related complications, 40 of their wives had been infected, 19 of their children had been born with congenital syphilis.
17. Revelations of similar study In 2011 it is revealed that the US government with the cooperation of the Guatemalan government in the 1940’s deliberately infected hundreds of Guatemalans; including prostitutes, mentally ill patients and prisoners, with gonorrhea and syphilis to test STD vaccines. None of those infected had given their consent.
18. Recent revelations from Canada In 2013 Ian Mosby uncovered an unethical study involving Aboriginal nutritional experiments Between the 1940’s and 1950’s, 1300 aboriginal persons were subjected to experiments – most were children Government officials were aware of the study
19. The study included… 1942: 300 Norway House Cree, of that group, 125 were selected to receive vitamin supplements which were withheld from the rest. 1947: plans were developed for research on about 1,000 hungry aboriginal children in six residential schools in Port Alberni, B.C., Kenora, Ont., Schubenacadie, N.S., and Lethbridge, Alta.
20. Specific studies One school deliberately held milk rations for two years to less than half the recommended amount to get a 'baseline' reading for when the allowance was increased. At another, children were divided into one group that received vitamin, iron and iodine supplements and one that didn't. One school depressed levels of vitamin B1 to create another baseline before levels were boosted. A special enriched flour that couldn't legally be sold elsewhere in Canada under food adulteration laws was used on children at another school. So that all the results could be properly measured, one school was allowed none of those supplements. Many dental services were withdrawn from participating schools during that time. Gum health was an important measuring tool for scientists and they didn't want treatments on children's teeth distorting results.
21. In summary… “They knew from the beginning that the real problem and the cause of malnutrition was underfunding. That was established before the studies even started and when the studies were completed that was still the problem." – Ian Mosby
22. Declaration of Helsinki (1964) Revised and amended in 1975, 1983, 1989, 1996, 2000, 2002, 2004 and 2008. The World Medical Association established recommendations guiding medical doctors in biomedical research involving human participants. The Declaration governs international research ethics and defines rules for "research combined with clinical care" and "non-therapeutic research." The Declaration of Helsinki is the basis for Good Clinical Practices (GCP) used today.
23. Some key principles in the Declaration Informed consent Minimizing risk Adhering to an approved research plan/protocol Research protocols should be reviewed by an independent committee prior to initiation Research should be conducted by medically/scientifically qualified individuals Risks should not exceed benefits
24. Violations continue Stanley Milgram’s (1960’s) obedience study. The Aversion Project (1971-89)South Africa’s apartheid army forced cures on white lesbian and gay soldiers. Stanford Prison Experiment (1971) Nuu-chah-nulth blood samples (1980’s) British Columbia aboriginals blood samples were used for another purpose
25. The most famous cells in the world Henrietta Lacks Her living cells
26. HeLa Cells In 1951 cancerous cervical cells were removed from Henrietta Lacks without her consent Dr. George Gey successfully created a living line of cells from this sample They were named HeLa, using the first two letters of her first and last name
27. Results A living cell line meant they could be reproduced and used in research. HeLa cells were used by Jonas Salk to test the first polio vaccine, the cells have been used in cancer research, AIDS research, radiation studies, gene mapping, etc. According to author Rebecca Skloot, The Immortal Life of Henrietta Lacks (2010), "more than 60,000 scientific articles had been published about research done on HeLa, and that number was increasing steadily at a rate of more than 300 papers each month.”
28. The tissue sample was taken without her consent and the living cells are a commercial product. Henrietta's family did not know until the 1970’s that she was the source of these cells. Her children and grandchildren were asked to provide blood samples for further studies.
29. Genome mapping March 2013: European Molecular Biology Laboratory published the genome of a line of HeLa cells, making it publicly available for downloading.
30. Lacks family reaches an agreement with NIH Genome study was taken down from the European Molecular Biology Laboratory website. NIH funded research at the University of Washington was about to publish a genome sequencing piece on the HeLa cells when the Lacks family said “not without our consent.” the data from the genome studies should be stored in the institutes’ database of genotypes and phenotypes. Researchers who want to use the data must apply for access and will have to submit annual reports about their research. The HeLa Genome Data Access working group at the NIH will review the applications. Two members of the Lacks family will be members. The agreement does not provide the Lacks family with proceeds from any commercial products that may be developed from research on the HeLa genome.
31. Research Ethics in Canada The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition (2010): Know as the TCPS, the policy applies to all research institutions (universities, colleges and hospitals) that are eligible to receive agency funding.
32. Core Principles of the TCPS Respect for Persons Respecting a person's autonomy Recognizing and respecting diminished autonomy Concern for Welfare Quality of life including physical, mental and spiritual health, economic and social circumstances. Justice Fair and equitable treatment
33. Who ensures ethical research? The researcher Research Ethics Boards (REBs) The public, by making researchers, REB’s and research institutions responsible for their actions
34. Research Ethics Boards Carleton University has two REBs: The Carleton University Research Ethics Board (everything but psychology) The Carleton University Ethics Board for Psychological Research
35. What does an REB do? REBs are mandated to: approve reject propose modifications to suspend or terminate any proposed or ongoing research that is subject to ethics review.
36. REB review is required when… Article 2.1: The following requires ethics review and approval by an REB before the research commences: research involving living human participants; research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.
37. Exceptions to REB review Publically available information (Article 2.2) Observation of people in public places (Article 2.3) Secondary use of anonymous data (Article 2.4) Quality assurance and improvement studies (Article 2.5) Creative practices (Article 2.6)
38. Key parts to an ethics protocol Project description (must be clear) Participants (who are they) Recruitment (how will you identify and recruit them) Risks (what are the risks of the study to participants) Benefits(what are the benefits to participants) Consent (how will you secure participant consent) Use of data (how will you use the information participants provide)
39. Be clear, and concise Your project description must avoid all jargon (the REB is not composed of experts in your field) Acronyms must be spelled out once Define or clarify your use of terms Keep to the point (limit 200 words)
40. Participants Research participants can be a random sampling of the general population or specific group. The participant group will in part determine the research method, recruitment, risks and consent process.
41. Vulnerable populations People without power Children Those traditionally excluded from research The elderly The displaced Circumstances that make a participant vulnerable
42. Recruitment By which means will you identify potential research participants? How will you make contact with potential participants (poster, email, letter)? Recruitment is specific to the study and it must make sense in terms of the study.
43. Recruitment & risk Are potential participants at risk if they take part in this study? Are potential participants a vulnerable population? (How do you recruit them and keep them safe?)
44. Risk to participants Your responsibility as a researcher is to be honest about the risks to participants, to inform them of those risks and take steps to minimize the risks. Risk can be one or a combination of the following: Physical Emotional Psychological Professional Social Legal Spiritual
45. Reducing risks Several parts of a study determine the risk: What is being done (experiment) What is being asked (qualitative) The location of the research The physical, emotional and mental health of participants
46. Benefits of research Most research does not directly benefit research participants. Research benefits society as a whole and contributes to the body of knowledge. Risks should not outweigh the benefits.
47. Informed Consent The heart and soul of research ethics is full and informed consent: Participants must be informed of everything that is required of them. There can be no undue influence, or threat to take part in a study. No excessive incentive to take part in the study.
48. Special Considerations Do participants have special needs? Example: Children, seniors, developmentally challenged persons Can the participants give informed consent? If not, who can?
49. Consent is ongoing Researchers have an obligation to inform participants of all information relevant to their ongoing participation in the research If a project is modified the researcher must inform the participant of the change. The participant has the right to decline further participation or to withdraw from the study. A child who reaches the age of consent during a study must be given the opportunity to consent on their own behalf.
50. Incidental findings A discover is made during the course of the study. The researcher may be obligated to report those findings. Child abuse Fraud Health issues In some cases a researcher is legally obligated to disclose (duty to report)
51. Waiving consent In some instances, consent may not be required: Minimal risk research where there is no adverse effect on the participant Prior consent would make it impossible to carry out the research Research does not involve a therapeutic intervention
52. Written vs. Oral consent Written consent is the standard unless there is a practical or cultural reason to obtain oral consent: Telephone survey Oral tradition or “word as bond” Handshake Impractical (interviews with street people) All consent must be documented.
53. Anonymity and Confidentiality These are not the same thing. Anonymity is the identity of the participant (name, address, work position and location, physical markers, DNA) Confidentiality is about the data and information the participant provides
54. Anonymity Participants do not have to be anonymous. If the participant is well known, or is the only person who can speak to an issue, then you cannot reasonably offer anonymity.
55. Use of data Your commitment to ethical research extends to the safe and secure storage of data and the proper use of that data Participants need to know what will happen with their data. (Destroyed, stored for future research on that topic, or stored and used for related research Data cannot be used for another purpose without the knowledge and consent of the participant
56. Research ethics violations on the use of data Three major misuses of data include: Falsification of data Fabrication of data Plagiarism
57. Falsification of data Matthew Poore(Advanced Liquid Logic Inc.) engaged in research misconduct by falsifying data, while conducting research for National Institute of Allergy and Infectious Diseases and National Institute of Health. He knowingly and intentionally falsified reverse transcription-polymerase chain reaction (RT-PCR) results by reporting the results from previous experiments as the actual results, when the experiments had not been performed. When testing for HIV he also switched two results from negative to positive and one vice versa. He has entered a Voluntary Settlement Agreement for three years and will have to have his research supervised, and will not serve in any advisory capacity to Public Health Service.
58. Plagarism PratimaKarnik(Case Western Reserve University) engaged in research misconduct by plagiarizing when conducting research for The National Institute of Arthritis and Musculoskeletal and Skin Diseases and National Istitutes of Health. She plagiarized portions from a research grant application that she reviewed and other scientific articles. Dr. Karnik has entered a Voluntary Settlement Agreement where her research must be supervised, the institution employing her must submit a certification for all of her applications stating that there is no plagiarized material and she cannot serve in any advisory capacity to Public Health Service for two years.
59. Fabrication Avi Chaudhuri, of McGill University, misused $159,500 of research money. He used his McGill purchasing card to buy a $19,500 mattress designed for people with limited mobility. Following his mother’s stroke he purchased and shipped the mattress and his mother to India. He claimed the mattress was for a study on stroke victims in India. There was no evidence that Mr. Chaudhuri had ever planned a stroke study. During the enquiry Mr. Chaudhurisaid the mattress was in a warehouse in India, but later acknowledged to that it was in an apartment owned by his family in Calcutta.
60. Media, research & ethics Consider what has happen recently around research and the media. MS liberation method: Fast tracking clinical research Is it safe? Is it effective? Voice of MS patients
61. Change your perceptive Consider your research project from the point of view of those you are asking to take part. Consider what the commitment from the participant is to take part in the study. Look at the project through new eyes. Ask the questions a participant would ask.
62. Autism & MMR The results of this media investigation continue to rock the world of research Some key elements of this study: Shoddy research Manipulation of research results Abuse of children Voice of parents
63. Autism study Andrew Wakefield, M.D., UK. Famous for autistic enterocolitis. Basically he made the case that the MMR (measles, mumps and rubella) vaccine cause autism in children. In November 2004, Channel 4 in the UK reported that Dr. Wakefield had applied for a patent on a single-shot measles vaccine before his campaign against the MMR vaccine. Other researchers could not duplicate his findings.
64. Autism study On 28 January 2010, found Dr. Wakefield guilty of approximately three dozen charges, including 4 counts of dishonesty and 12 counts involving the abuse of developmentally challenged children. His research has been declared fraudulent and false. He has had his medical license revoked and all publications on the MMR vaccine pulled. He maintains several thousands of supporters, especially parents of autistic children.

65. Why does this matter?

66. Final word… “We must not see any person as an abstraction, instead we must see in every person a universe with its own secrets, with its own treasures, with its own sources of anguish, and with some measure of triumph.” - Elie Wiesel, from The Nazi Doctors and the Nuremberg Code (1995) by George J. Annas & Michael A.Grodi