Topic 2a: Ethical Considerations in Research - PDF

Topic 2a: Ethical Considerations in Research KINS 2205 INTRODUCTION TO RESEARCH METHODS IN KINESIOLOGY Alexandra Harriss KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY  Learning Objectives Discuss reasons why ethical standards are import...

Topic 2a: Ethical Considerations in Research KINS 2205 INTRODUCTION TO RESEARCH METHODS IN KINESIOLOGY Alexandra Harriss KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY  Learning Objectives Discuss reasons why ethical standards are important to the research process in kinesiology Describe the core ethical principles and ethical guidelines and how they shape research planning, data generation, data analysis, and knowledge translation Identify unique ethical considerations for engaging in research with Indigenous peoples Describe processes to ensure research and scientific integrity KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 2  Ethical Standards in Research Engaging in ethical research is the most important responsibility of researchers. Ethics policies are focused on respecting the rights of study participants and protecting them from harm. The terms “ethics” and “respect” are often used interchangeably Ethics should be viewed as on ongoing process and not a single event KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 3  Ethical Policies Henreitta Lacks Black woman whose cells were taken without her knowledge or consent in 1951, leading to significant contributions to medical research. Her cells, known as HeLa cells, were the first to be successfully cultured and replicated outside the human body. HeLa cells have been crucial in numerous scientific advancements, including the development of vaccines, cancer treatments, and understanding cell biology. Unfortunately, Henrietta Lacks died of cervical cancer in 1951, and her story raises ethical questions about the use of human cells in research without informed consent. https://www.youtube.com/watch?v=pgB1IqGp8BE KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 4  Ethical Policies in Canada Research practices and policies have been developed, in part, in response to historical practices of unethical treatment of people in research. “Medical experiments” by Nazi researchers Led to the development of the Nuremberg Code, which is often referred to as the ten commandments of ethical human medical research. For example: Voluntary consent Animal studies -> human studies KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 5  Ethical Policies in Canada Tuskegee Syphilis Experiments, Alabama 1932-1972 Examined the full progression of untreated syphilis among ~400 black men. Told they were being treated for “bad blood” Given aspirin and mineral supplements, even though Penicillin was an identified treatment in the 1950s and despite the Nuremberg Code in 1947. Researchers convinced local physicians to not treat the disease, so they could continue with their study. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 6  Ethical Policies in Canada Willowbrook Institute Experiments, Staten Island, New York, 1956 – lasted for 14 years People living with intellectual disabilities were unknowingly and systematically infected with the hepatitis virus in an attempt to track the infection Researchers argued the ethical nature of their protocol by stating that hepatitis was endemic to Willowbrook and that all patients would eventually contracted the disease. They argued that purposefully infecting patients with hepatitis would provide opportunities for researchers to monitor the course of the disease, which would lead to less severe complications associated with the disease. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 7  Ethical Policies in Canada BC Sexual Sterilization Act: 1933 to 1979 Gave the B.C. Eugenics Board the right to make decisions to sterilize people living in government-run institutions without their consent and without their knowledge of what was happening. This treatment was approved as a means of controlling behavior and ensuring the disability was not passed on to future generations. The Act was repealed in 1979, but the practice continued in the community for a number of years until the Supreme Court of Canada made a decision in 1986. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 8  Ethical Policies in Canada Baylor College of Medicine of Texas (1998) Researchers conducted research in Newfoundland and Labrador that included families with greater than average risk of heart defect. Described how researcher were known as the “Texas Vampires” Took samples of participants DNA, and never shared the data or results! KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 9  Ethical Policies Ethics is the most important responsibility of researchers Ethics policies for research involving humans are focused on: Respecting the rights of study participants Protecting participants from harm KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 10  Ethical Policies Tri-Council Policy Statement: Ethical Conduct for Researchers Involving Humans (TCPS-2; 2022). Joint policy with the three federal funding agencies of Canada All researchers funded by these agencies must adhere to the TCPS 2 KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 11  Ethical Policies The primary purpose of TCPS2 is to ensure the ethical treatment of individuals participating in research and to uphold the integrity of the research process. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 12  Ethical Policies The TCPS2 (2022) covers information on various aspects of the research process including: Balancing Scientific and Social Value Integrity Privacy and Confidentiality Recruitment and Informed Consent Research with Indigenous Communities International Research KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 13  Human Dignity Research is meant to enhance our understanding of the world. Research explores the unknown, it generally carries some risk. For research involving humans to be ethical, participants must understand those risks and freely choose to participate. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 14  Three Core Principles Respect for Persons The TCPS2 (2022) is informed by three core principles that convey the value of human dignity 1. Respect for Persons 2. Concern for Welfare Concern for 3. Justice Welfare Justice KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 15  Three Core Principles: Respect for Persons Respect for Persons: Guidelines to ensure that individuals are treated with respect, dignity, and autonomy. Recognizes the intrinsic value of human beings and the respect and consideration that they are due. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 16  Three Core Principles: Concern for Welfare Concern for Welfare The welfare of a person is the quality of that person’s experience of life in all its aspects. Avoiding exposing participants to unnecessary risks. Consideration for physical, mental and spiritual health of participants. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 17  Concern for Welfare For a research study to be ethically acceptable, the potential benefits of the research should outweigh the foreseeable risks associated with the research. What is a potential benefit? What is a risk? KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY  Concern for Welfare The principle of Concern for Welfare imposes an ethical obligation on researchers and REBs to protect participants from any unnecessary risks. If possible, the research design should avoid, eliminate or minimize risks. This can be done by decreasing exposure to the risk. What would be an example of this? KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY  Three Core Principles: Justice Justice: Refers to the obligation to treat people fairly and equitably. Treating persons equitably implies a fair distribution of the burdens and the potential benefits of the research. This requires researchers to consider participants selection inclusion and exclusion criteria i.e. who do we include and who do we exclude? KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 20  Inclusion and Exclusion Criteria in Brain Injury Research Inclusion: “Subjects were considered to be eligible for inclusion in this study if they had played soccer at the amateur level for more than 5 years, were aged 18–55 years, and had been actively playing soccer for at least 6 months per year.” KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6209057/pdf/radiol.2018180217.pdf  Inclusion and Exclusion Criteria in Brain Injury Research Exclusion: “Exclusion criteria were presence of neurologic disorder; presence of mental disorder such as schizophrenia, bipolar disorder, or psychosis; illicit drug use within the past 30 days; positive urine test for substance abuse; and contraindications to MRI.” KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6209057/pdf/radiol.2018180217.pdf  Three Core Principles: Justice Some questions that merit consideration for justice include: 1. Why choose this group of prospective participants, and not a broader or a narrower one? 2. Is there a sound rationale for who is included in and excluded from participation in the research? 3. Who will be exposed to the risks, and who will experience the possible benefits? KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 23  Three Core Principles These core principles are all interdependent, and all research studies will differ in terms of how these principles are applied. Respect for Persons: Participants can engage in research in a variety of ways and contexts. Concern for Welfare: Different research designs can carry different types of risks Justice: Insuring proper inclusion and exclusion KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 24  Three Core Principles By applying the three core principles, researchers work to balance the two main goals of research: (a) ensuring the necessary protection of participants, (b) fulfilling the legitimate requirements of research. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 25  Research Ethics Most Canadian Universities have adopted the guidelines for the TCPS 2 and are guided by these three core principles. In addition to the TCPS 2, Canadian Universities and Colleges will have: Research Ethics Review Boards (REBs) Human research ethics policies in place. All researchers must adhere to these policies. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 26  Research Ethics: Biohazards Researchers in kinesiology commonly work with biohazards, including blood, sweat, and saliva; researchers must consider how to appropriately handle, store, and dispose of such biohazards. A biohazard is any organism, or its derivative, that could negatively influence another organism. Researchers engaging in biological or medical research, also likely need to apply for biohazards approval from their university. By engaging in a biohazards review process, and obtaining biohazards approval, researchers can demonstrate that they are committed to ensuring that their research adheres to established safety guidelines and regulations. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 27  Research Ethics Biohazards are just one form of risks researcher may be exposed to. It’s important that risks involved in research are not just limited to the participants. For example: One-on-one interviews in a participants home. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 28  Research Ethics It is critical to remember that there is no single ethics policy that can provide answers to all ethical issues that may arise in the research process. It is researchers’ responsibility to apply guidelines to their research. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 29  Process of Consent Researchers must ensure the participants provide free, informed and ongoing consent throughout the entire research process. The TCPS 2 states: 1. Consent shall be given voluntary 2. Consent can be withdrawn at any time 3. If a participant withdraws consent, the participant can also request the withdrawal of their data or human biological materials. Question: Is consent still free or voluntary if participants are given incentives (i.e. money or gift cards?). Let’s try a case study! KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 30  Consent Case Study Case Study: Dr Strong is testing a new muscle-enhancing drug that could be used to treat people with muscular dystrophy (MD). For the clinical trial experimental group, Dr Strong is seeking participants who have MD and, for the control group, those who do not have MD. The two-month drug trial could lead to a medical breakthrough for those living with MD, but the drugs may also have negative health side effects (e.g., nausea, fatigue). Questions 1. What would be the consequence of offering an incentive of $10 to potential participants? What if the incentive were $1000? What if it were $100,000? Would the amount offered as an incentive change the type of participants likely to volunteer for the study? 2. What if the risks of the study were even greater? Would the amount of incentive offered be of even more consequence? 3. Considering the TCPS 2 guidelines regarding the process of consent and incentives, what do you think would be an appropriate incentive amount to offer participants in this study? Why? KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 31  Consent What about participants who lack decision making? i.e. those who lack the capacity to understand their rights and the potential consequences of their participation? Children (6 – 18 years old) Those living with a permanent intellectual impairment Participant assent or their willingness to participant may also be required. Article 3.10 of the TCPS2: “Where an authorized third party has consented on behalf of an individual who lacks legal capacity, but that person has some ability to understand the significance of the research, the researcher shall ascertain the wishes of that individual with respect to participation. Prospective participants’ dissent will preclude their participation.” KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 32  Consent What about partial disclosure or deception? Alterations to the requirement for consent might be possible if various conditions, as outlined in Article 3.7A of the TCPS 2, can be demonstrated. Researchers must be able to demonstrate that the study does not involve more than minimal risk to participants and that the welfare of participants is not adversely affected because of the alteration of consent. As well, researchers must demonstrate that partial disclosure or deception is necessary to answer the research questions and to conduct the study. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 33  Privacy & Confidentiality Privacy: Refers to a person’s right to be free from intrusion from others. Confidentiality: Researcher’s obligation to safeguard entrusted information. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 34  Privacy & Confidentiality Respect for privacy requires that researchers treat the participants personal information in a confidential manner. Researchers need to outline how privacy and confidentiality will be maintained and the strategies used to safeguard their information. What are some strategies they could use? KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 35  Research and Scientific Integrity Researchers funded by the three federal funding agencies (discussed earlier), are expected to adhere to the: Tri-Agency Research Integrity Policy. This is outlined in the: Tri-Agency Framework: Responsible Conduct of Research It’s a long read! https://rcr.ethics.gc.ca/eng/documents/Framework2016- CadreReference2016_eng.pdf KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 36  Tri-Agency Framework: Responsible Conduct of Research Outlines the responsibilities of the researcher to ensure that all research processes are open, honest, fair and accountable. Authorship Record Keeping Rigor KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 37  Research Misconduct Research integrity is compromised when there is research misconduct. This can occur when proposing, performing, reviewing or reporting the results Three types of research misconduct: 1. Falsification 2. Fabrication 3. Plagiarism KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 38  Falsification Falsification occurs when changes are made to the research (e.g., omitting data) so that the research record does not accurately represent the research that took place. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 39  Plagiarism Occurs when a researcher takes another person’s ideas, words, or research results and does not provide that person with credit (Includes self-plagiarism). Example: Dr. Paul McCory, chair of the influential Concussion in Sport Group (CISG) – more information here “The world-renowned concussion expert Dr Paul McCrory has been accused of 10 more cases of plagiarism, prompting experts to question how much original research the neurologist has produced and whether he deserved the hundreds of thousands of dollars in research grants he has received” “There’s no excuse for any form of plagiarism, including self-plagiarism,” he said “It is still dishonest and unethical.” KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 40  Fabrication Fabrication occurs when a researcher makes up data and then records or reports on such data. Example: Dr. Cory Toth, Professor at the University of Calgary: more info here. “Dr. Cory Toth is now working as a neurologist at Burnaby Hospital. He resigned after university investigators confirmed fudged data in nine of his team’s studies” KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 41  Fabrication in a Grant Proposal Vijay, who has just finished his first year of graduate school, is applying to the National Science Foundation for a predoctoral fellowship. His work in a lab where he did a rotation project was later carried on successfully by others, and it appears that a manuscript will be prepared for publication by the end of the summer. However, the fellowship application deadline is June 1, and Vijay decides it would be advantageous to list a publication as “submitted” rather than “in progress.” Without consulting the faculty member or other colleagues involved, Vijay makes up a title and author list for a “submitted” paper and cites it in his application. After the application has been mailed, a lab member sees it and goes to the faculty member to ask about the “submitted” manuscript. Vijay admits to fabricating the submission of the paper but explains his actions by saying that he thought the practice was not uncommon in science. The faculty members in Vijay’s department demand that he withdraw his grant proposal and dismiss him from the graduate program. 1. Do you think that researchers often exaggerate the publication status of their work in written materials? 2. Do you think the department acted too harshly in dismissing Vijay from the graduate program? 3. If Vijay later applied to a graduate program at another institution, does that institution have the right to know what happened? 4. What were Vijay’s adviser’s responsibilities in reviewing the application before it was submitted? KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 42  Check Your Understanding 1. What does the TCPS 2 state about free or voluntary consent? Please provide three points. I. Why is the consent process vital in research? II. What are some possible consequences if this process isn’t undertaken or is done incorrectly? 2. What are the three core principles of the TCPS2? 3. Identify and explain the three areas of academic misconduct. KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 43  References 1. Research Methods in Kinesiology" by Kent C. Kowalski, Tara-Leigh F. McHugh, Catherine M. Sabiston, and Leah J. Ferguson (Edition 2) 2. Research misconduct: National Academy of Sciences, National Academy of Engineering (US) and Institute of Medicine (US) Committee on Science, Engineering, and Public Policy. On Being a Scientist: A Guide to Responsible Conduct in Research: Third Edition. Washington (DC): National Academies Press (US); 2009. RESEARCH MISCONDUCT. Available from: https://www.ncbi.nlm.nih.gov/books/NBK214564/ 3. TCPS2: https://ethics.gc.ca/eng/documents/tcps2-2022-en.pdf KINS 1100 LAB 01 ANATOMICAL TERMINOLOGY 44