Introduction Class: Law and Ethics in Research HSC 3492 PDF

Introduction Class: Law and Ethics in Research HSC 3492 INTRODUCTION Semester: SUMMER 2024 Course: HSC 3492 A: Law and Ethics in Research Facilitator: Prof. Maina Muniafu Class days/Time: Tuesday 1.30 – 4.50 pm Class Venue: SC3 Credit Unit: 3.0 Office Hours: M/T/W/R 8....

Introduction Class: Law and Ethics in Research HSC 3492 INTRODUCTION Semester: SUMMER 2024 Course: HSC 3492 A: Law and Ethics in Research Facilitator: Prof. Maina Muniafu Class days/Time: Tuesday 1.30 – 4.50 pm Class Venue: SC3 Credit Unit: 3.0 Office Hours: M/T/W/R 8.00 – 9.00 am Contact: [email protected] CLASS POLICY Mobile phones should be switched OFF during class sessions and only used for designated exercises. Students who come late after class has started will lose the attendance mark (sms/whatsup and unexpected scenarios). A student who misses more than 7 classes will get a zero in attendance and participation. Signing for an absent student results in a 4 mark penalty. UNIVERSITY MISSION OUTCOMES High order thinking: The ability to collect, analyze and evaluate information and formulate conclusions. Students develop and demonstrate the ability to think critically, analytically and creatively. Literacy: Competence in oral, written, quantitative, and technological skills. Students develop and demonstrate competency in oral and written communication as well as demonstrate scientific, quantitative and technological literacy. Global understanding and multicultural perspective: Awareness, knowledge and appreciation of both the diversity and commodity of cultures. Students acquire these perspectives through formal study of languages, history, literature and the arts and through working, studying and living cooperatively in a radically, ethnically, and culturally diverse environment. Further, students acquire an understanding of economic, historical, political, geographic and environmental relationships on a global basis. UNIVERSITY MISSION OUTCOMES Preparedness for career: Mastery of a field of knowledge and its multi- cultural and multinational application. Such mastery is accomplished through both formal study and various experienced forms of learning such as internships and field experiences. Community service and development: A sense of being part of a community and a desire to be of service to it. Students are given opportunities to participate in community service, citizenship, or social action projects or activities. Leadership and ethics: As part of their growth and development, students formulate and articulate the ethical standards which will guide their professional and personal lives. This is accomplished through formal courses in discipline areas and active engagement of students in leadership roles both inside and outside the classroom. CLOs: By the end of this class you should be able to: 1. State codes of conduct to regulate research activity 2. State the importance of scientific integrity 3. Manage and evaluate a research project, from design to publication, from an ethical standpoint 4. Describe the impact of new technologies and social trends on research ethics 5. Analyze research ethics topics and case studies 6. Explain the nature, functions and scope of Ethical Review Committees TEACHING METHODS Lecture (power point on blackboard per week lessons) Discussions (around selected topics in pairs and groups) The discussions are designed to enhance critical thinking and expansion of knowledge in certain sections of the course. Innovativeness is highly encouraged (also called thinking out of the box). We shall use case studies to explore issues for law and ethics in research. A feature of the course is collaborations and what they entail. These we shall investigate in various ways. Course Assessment AREA PERCENT Attendance 10 Assignment 15 Quizzes 15 Group Work 5 Mid-Semester Examination 25 End-Semester Examination 30 TOTAL 100 Approaches in knowledge acquisition for the course 1. Critical analysis For all the work sessions, look to sharpen your abilities to follow attentively a thread of information while at the same time retaining specific aspects of interest, query and debate among others. You are encouraged to use the tried and tested method of note taking to enhance mental aptitude development in this area. 2. Information analysis This will be important in readings both in class and as one of the assignments. This should be preceded by understanding the information in a selected reading with an appropriate conclusion thereafter. Approaches in knowledge acquisition for the course 3. Co-Creating Innovative Solutions In this instance, the important outcome to presented challenges is finding solutions by working with stakeholders. The learners will work through presented scenarios using standard approaches with an assessment of the degree of innovation in their outcomes/ 4. Writing Intensive This is a writing intensive course and the process requirements will be undertaken within the summer semester. LAW AND ETHICS IN RESEARCH HSC 3492 Maina Muniafu  Fundamentals of Ethics and Bioethics Ethics is about the (moral) values that should be respected by all healthcare workers while interacting with individuals, families and communities. The principles of ethics that are applied to healthcare are commonly referred to as bioethics. These tend to be formalised into codes of practice applicable to various branches of healthcare.  Fundamentals of Ethics and Bioethics Ethics is generally a systematic discipline to define social and individual morality. It prescribes standards of what is wrong and what is right for individuals or society as a whole. These are learned for example from peers and culture.  Theories of Ethics 1. Utilitarianism: An action is considered morally right if its outcomes or consequences are good for the greatest number of the population. This can be captured in the phrase ‘the greatest good for the greatest number’. In this instance, individual rights are disregarded and considers the welfare of the greatest majority is taken as the most important factor.  Theories of Ethics 2. Deontology: It is ethics that is based on rules or rights. Deontology considers the way that things are done rather than focusing just on the consequences. At its core is “the respect for fundamental rights”. These include factors such as the right to truth, privacy and the fulfilling of promises. In addition, it considers the rightness or wrongness of an action. Examples include the fact that it is good to obey the law, pay taxes or to follow the commandments of a religious belief.  Principles of Ethics 1. Truthfulness and Confidentiality Truthfulness is about telling the truth to someone who has the right to know the truth. This concept urges you as a professional not to lie. Confidentiality is the concealing of knowledge or information as a matter of rights or obligations (can you keep a secret?) As a professional, you keep a secret due to the certainty of the harm that it will cause.  Principles of Ethics TYPES OF SECRETS Natural secret: Information which, if revealed, is harmful by its nature. It is considered natural due to natural law or from the very nature of the case. Promised secret: Information that we have promised to conceal after receiving it and which, if broken, leads to public mistrust. Professional secret: Knowledge learned while performing a duty. If revealed, it will harm the client, the profession and the society that obtain services from the profession.  QUICK EXAMPLES 1. Your learn that a friend is dating a partner of another friend. 2. A teenager (a neighbour) who knows you are in the medical profession asks you the best way to get rid of her pregnancy. 3. Your greatest friend reveals to you that they pay zero for electricity month in month out from tapping into the network. 4. A surprise birthday party is in the offing for a lecturer that the class kind of likes.  Principles of Ethics 2. Autonomy and informed consent Autonomy refers to the fact that every individual has a right of self-determination, independence and freedom to make their own choices. This means that you as the professional must respect the decision of the client even if you do not agree with it. Informed consent means that each person who has any sort of procedure done to them in a healthcare context should give their approval for that procedure to be done to them. An important aspect is that the client must be provided with all the possible information before they make their decision.  Principles of Ethics 3. Beneficence This the aspect of ethics of doing good to your client as a professional. In this instance, as a professional, you will be looking to do something for your client that improves their health situation in any given circumstances.  Principles of Ethics 4. Nonmaleficence This is the an aspect of ethics in which as a professional must avoid doing harm, either intentionally or unintentionally, to your clients. As a professional, you must not abandon a client who needs your service.  Principles of Ethics 5. Justice. Justice entails three important factors which are fairness, equality and impartiality. Two types of justice are: a. Distributive justice: Refers to the fact that individuals have the right to be treated equally regardless of ethnic group, gender, culture, age, marital status, medical diagnosis, social standing, economic level, political or religious beliefs, or any other individual characteristics. The bottom line is that EVERYONE should be treated in the same way.  Principles of Ethics b. Social justice: It is based on the application of equitable rights to access and participation in all aspects of goods and services provided in a society, regardless of their individual characteristics. Everyone should have access to the same things that might improve their health. As a professional, ensure that you enable the inclusion and empowerment of all people living within your area to exercise their rights.  Case Scenarios With your selected scenario: i. Identify as many the ethical and legal issues or concerns that are at play within it. ii. Provide a solution where possible to the issues (giving reasons that would appear to be ethical).  Case Scenarios 1. As you speed to USIU-A for your exam, a traffic officer stops you and apart from over speeding, finds 10 faults with the your car that break the laws of the road for your country which require heavy fines and an appearance before a traffic court. An alternative would be a “small persuasive chat” from you can see you getting to your exam on time. 2. As a community leader (who gives time to an outlet well stocked with all manner of drugs), you are concerned about the interactions of the secondary school going students with a significant percentage of pregnancies amongst the girls. 3. During an epidemic you get a medic job and interventions include getting funds and other resources. Your community has placed all their hope in you being one of several that were severely affected.  Case Scenarios 4. A client walks into your outlet in need of medication. You notice an addition problem of a skin discolouration, a symptom of an infection that the client is not aware of. However, this client has a serious disagreement with some very close dear friends of yours. 5. In an awareness campaign for communities, which has an element of free drug distribution, you are assigned a much larger area compared to your colleague, yet you do not own a car. 6. A person you owe some money needs admission into a medical facility that you work at in the payment and records section. They are unable to raise the requisite payments and will be turned away despite the urgent need for immediate treatment.  RECAP OF GENERAL PRINCIPLES OF ETHICS Truthfulness (about telling the truth to someone who has the right to know the truth) Confidentiality (concealing of knowledge or information as a matter of rights or obligations ) Autonomy (a right of self-determination, independence and freedom to make their own choices) Informed consent (giving of approval after being provided with all the possible information before making a decision). Beneficence (of doing good to your client as a professional) Nonmaleficence (avoid doing harm, either intentionally or unintentionally, to your clients) Justice (fairness, equality and impartiality) USE OF ANIMALS IN RESEARCH HSC 3492 Maina Muniafu Animal Numbers in Global Science Research  ANIMALS IN RESEARCH Moral status of animals Do animals have a moral status? Should non-human beings be given moral consideration that humans give each other? Humans on the other hand, in sharing biological features and reducing internal prejudices over time, considers itself as being a special species. This includes social capacities such as developing family ties, solving social problems, expressing emotions, sustaining conflicts, having sex for pleasure, using language and thinking abstractly among others.  ANIMALS IN RESEARCH HUMAN PRESPECTIVES (DO YOU FEEL ANYTHING FOR AN ANIMAL?) Humans feel that only they have a free will and thus a personhood that allows them to dominate and even decide the fate of other non-humans. Like other primates, humans have teeth and guts designed for an omnivorous diet.  ANIMALS IN RESEARCH A basic driving force has been the drive for high energy foods in this type of diet and also food security where animals are domesticated for ease of access as opposed to hunting expeditions. Concern in research centres around practices by humans to non-human beings that cause pain, discomfort, suffering and death. It has led to a modification in many practices towards animals in research (in addition to those in the food sector).  Rules and regulations relating to the use of animals in research In a legal sense, animals are considered as property rather than persons. This is based on them lacking sophisticated cognitive abilities (such as self-consciousness, self-knowing, sequential learning, visual perspective taking, understanding the experiences of others, intentional action, planning, imagination and empathy, among others). Different positions include: Permitted animals can be used for food with limiting of pain and cruelty. All animal research should be banned because it violates the rights of animals (Animal Right Groups).  Rules and regulations relating to the use of animals in research Some animals can be used for research (Utilitarian view) under specific conditions. Thus experiments that harm the animals crucial interest or involve human petty interests must be avoided. WHAT TO AVOID Invasive procedures Constant confinement Processes that lead to ultimate death Experiments that are designed to enhance the important, replaceable, or trivial interests of humans or other animals such as those for cosmetics or household products since there are many non-animal tested alternatives and many options already available for consumers.  Rules and regulations relating to the use of animals in research Certain psychological experiments, such as those in which infant primates are separated from their mothers and exposed to frightening stimuli in an effort to understand problems teenagers have when they enter high school. Could permitted experiments be those with the probability of satisfying crucial or important interests for many who suffer from some debilitating or fatal disease is high, and the numbers of non-human animals whose crucial interests are violated is low?  Prevention of Cruelty to Animals Act (2012); KENYA. The law states that cruelty towards an animal is prohibited (specifically vertebrates). These include committing violence on the animal, overworking it while unwell, starvation and denial of water, abandonment, poisoning, careless surgery procedures, hunting and killing in a cruel manner, and prolonging the life of an animal in great pain.  Prevention of Cruelty to Animals Act (2012); KENYA. It further prohibits placement of traps and snares that cause unnecessary suffering to an animal and failing to check on a trapped animal, as well as wilfully poisoning of animals. Slaughtering an animal in a manner that causes unnecessary suffering is also prohibited (humane slaughter introduced) as well as cruel training with whips and electric shocks.  Ethical considerations in the use of nonhuman animals (3Rs) 1. Replace animal experiments wherever possible by other methods such as mathematical modelling, or an in vitro biological system. 2. Reduce the number of animals used with only the number required to obtain reliable data must be used in an experiment. 3. Refine the methods used to ensure minimal suffering and cruelty to the animal subjects.  Guidelines for using animals in a research project The use of animals in medical research is increasing worldwide but some regions lack comprehensive guidelines. Various uses in a country like Kenya includes the use of animals for basic research, antibody development and production as well as pharmacology and toxicology studies. Undergraduate veterinary and medical education facilities use animal dissections for anatomical illustrations. Organs are isolated and used for physiological demonstrations, and whole animals are used for demonstrating surgical techniques  Guidelines for using animals in a research project Important factors should include: a. An emphasis on the 3R’s framework (Reduction, Refinement, Replacement). b. Establish animal use and care committees in institutions. c. The use of appropriate chemicals for euthanasia, anaesthesia and anesglesia. d. Build proper animal houses and ensure good animal care.  Guidelines for using animals in a research project e. Put in place mechanisms for proper animal acquisition, transport, medical care, biosecurity, quarantine, stabilization, species separation, surveillance, diagnosis, treatment and control of diseases. Include enforcement mechanisms to policies and legislation at the national level. f. Proper reporting of animal experiments and enhanced transparency in protocol review and compliance with national or institutional guidelines for the care and use of animals.  Possible Readings https://grants.nih.gov/grants/olaw/guide-for- the-care-and-use-of-laboratory-animals.pdf https://www.ncbi.nlm.nih.gov/books/NBK540 52/ https://ccac.ca/Documents/Standards/Guideli nes/Experimental_Animals_Vol1.pdf  Scientists and of animal welfare groups Roles and responsibilities include: i. Ensure that all correct protocols are followed when using animals in research. ii. Activism in proper animal welfare (KPCA, Donkey Welfare Group, Livestock Care, etc) iii. Expand on the 3Rs especially refinement and replacement. iv. Engage in awareness campaigns towards animal welfare especially in research. HISTORY OF RESEARCH ETHICS HSC 3492 Maina Muniafu  The History of Research Ethics Nuremburg Code Onset of consent in research came about after the Nuremburg trials in 1947 where Nazi physicians and medical administrators were found guilty on charges for atrocities committed in the name of medical science. Although the tribunal recognized that certain types of medical experiments were ethically justified, they observed that there were basic principles that needed to be observed in order to satisfy moral, ethical and legal concepts. These points form the Nuremberg Code.  Nuremburg Code The voluntary consent of the human subject: The person involved should be so situated as to be able to exercise free power of choice without the intervention of any element of force, deceit or any form of coercion. Experimental validity: The experiment should be such as to yield fruitful results for the good of society. Other principles: avoidance of unnecessary harm and the importance of scientifically qualified researchers.  Thalidomide In the late 1950s, thalidomide was approved as a sedative in Europe; it was not approved in the United States by the FDA. The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the foetus. Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent. Some 12,000 babies were born with severe deformities due to thalidomide.  Thalidomide U.S. Senate hearings followed and in 1962 the so-called “Kefauver Amendments” to the Food, Drug, and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers were required to prove to the FDA the effectiveness of their products before marketing them.  The Tuskegee Case (1932-1972) A research project was conducted by the U.S. Public Health Service. Six hundred low-income African-American males, 400 of whom were infected with syphilis, were monitored for 40 years. Free medical examinations were given but the subjects were not told about their disease. Even though a proven cure (penicillin) became available in the 1950s, the study continued until 1972 with participants being denied treatment. In some cases, when subjects were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. Many subjects died of syphilis during the study.  The Tuskegee Case (1932-1972) The study was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its existence was publicized and it became a political embarrassment. In 1997, under mounting pressure, President Clinton apologized to the study subjects and their families. Awareness of these studies created a demand for more stringent regulations regarding informed and voluntary participation in human research. Outcomes  The Declaration of Helsinki It was a formal statement of ethical principles published by the World Medical Association (WMA) to guide the protection of human participants in medical research. The declaration was adopted in 1964 by the 18th WMA General Assembly, at Helsinki. It formally disallowed non-therapeutic research on non- consenting subjects. This thus rules out children and vulnerable populations. (PLWD, Old people, PLWA, Poor people, Mentally Challenged individuals, etc). This poses the ethical question of discrimination since such groups cannot benefit from research.  Highlights of Principles in the Declaration of Helsinki Protecting Patient Health. Knowledge Cannot Trample Rights. Additional Considerations. Following Local Regulatory Norms. Risks, Burdens and Benefits. Vulnerable Groups and Individuals. Scientific Requirements and Research Protocols. Research Ethics Committees.  National Research Act (1974) The National Research Act of 1974 was passed because of the publicity from the Tuskegee Syphilis Study. The act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. This commission was tasked with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioural research involving human subjects. It was also tasked with developing guidelines that should be followed to assure that such research is conducted in accordance with these ethical principles.  Belmont Report Principle Application RESPECT FOR PERSONS INFORMED CONSENT  Individuals should be treated as  Subjects, to the degree that they are autonomous agents. capable, must be given the opportunity  Persons with diminished autonomy are to choose what shall or shall not happen entitled to protection. to them.  The consent process must include three elements: o information, o comprehension, and voluntariness. o BENEFICENCE ASSESSMENT OF RISKS AND BENEFITS  Human subjects should not be harmed.  The nature and scope of risks and  Research should maximize possible benefits must be assessed in a benefits and minimize possible harms. systematic manner. JUSTICE SELECTION OF SUBJECTS  The benefits and risks of research must  There must be fair procedures and be distributed fairly. outcomes in the selection of research subjects.  Emerging of the Concept of Risk This has evolved from the need to respect and protect persons in medical research. For children, surrogate consent comes from parent/guardian who is assumed to have their best interests at heart. Additionally, the two principles of non- maleficence and beneficence reduce risk through the two complementary tracts of seeking to do no harm and to maximize potential benefits for a client.  Emerging of the Concept of Risk Research ethics committees have been strengthened over time. These are charged with examining studies to determine whether or not there is an acceptable balance of risk and potential benefit. They target especially vulnerable participants, such as children, and others who have a diminished capacity for decision-making. Within the research, the principle of justice requires that the burdens of research participation are distributed equally and, in addition, the potential benefits of research are accessible to all.  2. RISK ASSESSMENT Risk assessment is an estimate of the likelihood of adverse effects that may result from exposure to certain health hazards, such as pollutants in the environment. It involves considering the severity of consequences if a person is exposed to a hazard, combined with the likelihood of it happening. It has a risk analysis stage followed by risk evaluation. Both these come after the identification of hazards and the risks that they pause.  a. Risk Analysis Risk analysis is about evaluating the significance of issues that contribute to risk. It is thus a process for comprehending the nature of hazards and determining the level of risk. Information for risk analysis can include current and historical data, theoretical analysis, informed opinions, and the concerns of stakeholders. Risk analysis includes risk estimation via probability.  Risk Estimation Probability ratings in this example represent:  High: likely to be experienced seven times out of ten in a time period by an individual  Medium: may be experienced four times in a time period by an individual  Low: may occur once or twice during a time period  b. Risk Evaluation The process of comparing an estimated risk against given risk criteria to determine the significance of the risk. Rank the risks in your scenario using the below matrix Severity ratings in this example represent:  High: major fracture, poisoning, significant loss of blood, serious head injury, or fatal disease  Medium: sprain, strain, localized burn, dermatitis, asthma, injury requiring days off work  Low: an injury that requires first aid only; short-term pain, irritation, or dizziness  Example 3: Risk Assessment for a Day Care Centre HH Disinfectant Water pollutants Overcrowding Bacteria Temperature extremes Intestine worms Falling M Playground Pesticides Viruses, Anxiety Stress Isolation L Noise Cycle accidents CO Rodents Falling out of windows, electric sockets Swallow toys Violence LOW MEDIUM HIGH  CLASS EXERCISE 1. Pick a country in Africa 2. Are there any documented research misconducts in its past history? 3. What was the outcome? SCIENTIFIC MISCONDUCT IN RESEARCH ETHICS HSC 3492 Maina Muniafu  Concerns There has been increasing concern about threats to scientific integrity including: Fraudulent academic research Plagiarism Manipulation and suppression of data by pharmaceutical companies as well as academic- industry collaborations Exploitative mentoring of students Abuses of animal and human research subjects Misuse of funds Lax institutional oversight.  Scientific Misconduct in Research 1. Misappropriation of Ideas: Taking the intellectual property of others, perhaps as a result of reviewing someone else’s article or manuscript, or grant application and proceeding with the idea as your own. 2. Plagiarism: Utilizing someone else’s words, published work, research processes, or results without giving appropriate credit via full citation. 3. Self-plagiarism: Recycling or re-using your own work without appropriate disclosure and/or citation.  Scientific Misconduct in Research 4. Impropriety of Authorship: Claiming undeserved authorship on your own behalf, excluding material contributors from co-authorship, including non-contributors as authors, or submitting multi- author papers to journals without the consensus of all named authors. 5. Failure to Comply with Legislative and Regulatory Requirements: Wilful violations of rules concerning the safe use of chemicals, care of human and animal test subjects, inappropriate use of investigative drugs or equipment, and inappropriate use of research funds.  Scientific Misconduct in Research 6. Violation of Generally Accepted Research Practices: Include the proposal of the research study, manipulation of experiments to generate preferred results, deceptive statistical or analytical practices to generate preferred results, or improper reporting of results to present a misleading outcome. 7. Falsification of Data: Rather than manipulate the experiments or the data to generate preferred results, this transgression simply fabricates the data entirely. 8. Failure to Support Validation of Your Research: A refusal to supply complete datasets or research material needed to facilitate validation of your results through a replication study.  Scientific Misconduct in Research 9. Failure to Respond to Known Cases of Unsuccessful Validation Attempts: Published research that is found to be flawed should be retracted from the journal that published it. 10. Inappropriate Behaviour in Relation to Suspected Misconduct: Failure to cooperate with any claims of misconduct made against you, failure to report known or suspected misconduct, destruction of any evidence related to any claim of misconduct, retaliation against any persons involved in a claim of misconduct, knowingly making false claims of misconduct. WHY IS RESEARCH INTEGRITY IMPORTANT?  Importance of Research integrity 1. Research integrity is considered as an essential part of good scientific practice. This is mainly due to the fact that with it, the goals of science and for promoting cooperation and trust among scientists are achieved. Factors such as data fabrication, falsification and manipulation lead to falsehoods, errors, and biases that impede the quest for truth, explanatory knowledge, and other goals of research.  Importance of Research integrity Some scientists and institutions refuse to share their data, results and methods which together with the keeping of inadequate records hinders the advancement of science. Cooperation and trust among scientists is essential to many different aspects of research methodology and practice including collaboration, peer review, publication, and the replication of results. For example, scientists who submit papers for publication must be able to trust that reviewers will not steal their ideas or use data, methods, or results without permission.  Importance of Research integrity 2. Research integrity makes science accountable to the public by ensuring that scientists adhere to ethical standards and produce socially beneficial results. Scientists who violate ethical standards or produce harmful results betray the public’s trust and undermine support for research. Abuses of human or animal research subjects, mismanagement of funds, fraud in academic or industry research, violations of laws and regulations, and other ethical transgressions can weaken the public’s trust in science and produce harmful results that harm individuals, society, or the environment  RECAP OF GENERAL PRINCIPLES OF ETHICS Truthfulness (about telling the truth to someone who has the right to know the truth) Confidentiality (concealing of knowledge or information as a matter of rights or obligations ) Autonomy (a right of self-determination, independence and freedom to make their own choices) Informed consent (giving of approval after being provided with all the possible information before making a decision). Beneficence (of doing good to your client as a professional) Nonmaleficence (avoid doing harm, either intentionally or unintentionally, to your clients) Justice (fairness, equality and impartiality)  APPLYING THE PRINCIPLES OF ETHICS TO SCIENTIFIC RESEARCH 1. Honesty: Scientists should communicate honestly with each other, research sponsors and institutions, government agencies, and the public. An example is prohibitions against data fabrication and falsification. 2. Due care: Scientists should avoid careless errors and strive to reduce or control biases in research. This for example care implies putting in place rules for managing conflicts of interest and keeping research records. 3. Openness: Scientists should share data, results, methods, and tools. 4. Fair credit: Scientists should allocate credit fairly. This calls for rules that assign authorship on papers and enforces prohibitions against plagiarism. 5. Respect for peers and students: Scientists should treat their students and colleagues with respect.  APPLYING THE PRINCIPLES OF ETHICS TO SCIENTIFIC RESEARCH 6. Respect for property: Scientists should respect physical and intellectual property. 7. Respect for research subjects: Scientists should show appropriate respect toward human and animal research subjects. They must follow the rules for research with humans, such as standards for obtaining informed consent, protecting subjects from risks, and safeguarding confidentiality. 8. Respect for the law: Scientists should obey institutional policies and legal rules that apply to their work and promote compliance with policies and rules. They thus are obligated to obligations to obey the institutional policies and legal rules pertaining to one’s research and to report people who violate policies or rules.  APPLYING THE PRINCIPLES OF ETHICS TO SCIENTIFIC RESEARCH 9. Non-discrimination: Scientists should not unfairly discriminate against peers or students. This implies prohibitions against discrimination in admissions to graduate programs, hiring or promotion. 10. Stewardship of resources: Scientists should make effective use of physical, financial, and other resources. 11. Social responsibility: Scientists should maximize benefits and minimize harm to society, public health, and the environment. In doing so, it is their duty to educate the public about research, to communicate with the media, and to provide policy-makers with expertise and advice. 12. Freedom: Scientists should respect the right to freedom of inquiry and debate.  APPLYING THE PRINCIPLES OF ETHICS TO SCIENTIFIC RESEARCH Research institutions can help to ensure that ethical standards are upheld by developing, promulgating, and enforcing policies that reinforce these standards; by sponsoring education and training in research ethics; by promoting ethical management and leadership; and by auditing and overseeing research. (Shamoo and Resnik 2009, Macrina 2005, Steneck 2007, National Academy of Sciences 2005)  Measures against Scientific Misconduct 1. Barring a researcher who commits misconduct under a grant or contract from receiving any further funding. 2. Institutions may demote, suspend, or fire individuals who commit misconduct. 3. Professional associations may revoke the membership or privileges of individuals who commit misconduct, and journals may require authors to withdraw papers impacted by misconduct. 4. Researchers who have committed misconduct may be convicted of criminal charges, such as fraud or misuse of funds.  Discussion Points 1. Point out the challenges in observing ethical standards in research papers for ordinary university students all over the country 2. Pick one of the ethical principles and relate it to your research at this point in time. Ethical and Statutory Regulation (Ethical Frameworks) HSC 3492 Maina Muniafu  Definitions ETHICS Comprises guidelines and principles that inform people about how to live or how to behave in a particular situation. LAWS Consist of a set of rules and regulations STATUTE A written law passed by a legislative body.  Definitions STATUTORY Required, permitted, or enacted by statute. Relating to rules or laws which have been formally written down. REGULATION A rule or directive made and maintained by an authority  Definitions A STANDARD is a collection of rules allowing a system to organize itself optimally and to function optimally according to its goal. A LEGAL STANDARD is inscribed in law whereas a moral standard is not. Infringement of a legal standard can lead to penal, judicial or civil punishment, whereas infringement of a moral standard can lead only to societal sanctions. However, they work together to enable a society to organize itself and to consider the effect of acts impacting on its survival.  Definitions STATUTORY REGULATION Is the creation of substantive and procedural rules through legal statute. A statutory framework is a set of standards which are set out as a requirement usually backed by legislation (get examples). Statutory regulations are put in place to ensure that an organization or individuals belonging to it is/are following the official rules (get examples).  Definitions Statutory regulations exists to protect the public against the risk of poor practice. They work by setting agreed standards of practice and competence by registering those who are competent to practice and restricting the use of specified protected titles to those who are registered. These standards include education, training, behaviour and skills among others.  Definitions ETHICAL REGULATION Refers to a policy of supporting ethical behaviour. Ethical regulations describe practices that must be followed in order to fulfil a professional obligation. Whereas ethical rules are general guiding principles that are not binding, regulations introduce a legal angle with a set of rules that have to be followed. Ethical standards are a set of principles established by the founders of the organization to communicate its underlying moral values. This code provides a framework that can be used as a reference for decision making processes.  Definitions ETHICAL FRAMEWORKS A framework for making ethical decisions FACT: Decisions about “right” and “wrong” can be difficult, and may be related to individual context or indeed community perspectives. Ethical frameworks are thus perspectives useful for reasoning what course of action may provide the most moral outcome. In many cases, a person may not use a reasoning process but rather do what they simply feel is best at the time.  LAW, MORALITY AND ETHICS Law and morality consider whether acts in society are legal and moral in respect to legal and moral standards If, as they exist, are considered to have a positive effect then they will be promoted in a society. If not, such acts will be suppressed. With bioethics, the acts are studied to identify the ethical issues and solutions are proposed, by evaluating the benefits and risks, to determine whether the acts really do have a positive or negative effect on the survival of society. This creates a systematic approach that leads to the maintenance of or changes to legal and moral standards.  BRAIN STIMULATORS Does your society (USIU-A/Out there in the community) have clear moral norms of positive or critical morality? If yes, provide some examples. Are these well covered by legal and moral standards? Are they enough to make your campus/country’s citizens to conform to the norms of the society?  USIU-A STUDENT HANDBOOK Cafeteria Regulations Jumping of the queue or cutting in is not allowed. Anyone found or reported to have done so will be subject to disciplinary sanctions. After eating at the Cafeteria, you are expected to return your used dishes and utensils to the carts. Messy tables are unpleasant for those who follow you.  USIU-A STUDENT HANDBOOK Students are not allowed to use other students Identity Cards (IDs) to buy food from the Cafeteria. Severe disciplinary sanctions will be imposed for any breach of cafeteria or other university regulations. NB: Smoking is NOT Allowed In the Cafeteria or anywhere On Campus  USIU-A STUDENT HANDBOOK 1.4. TRANSPORT Students (including those on internship assignments) are NOT allowed to use transport allocated to staff and faculty. The University has zero tolerance on theft and drug crimes. Lost items should be handed over to the Administration block Security desk for recording.  USIU-A STUDENT HANDBOOK Car Park Motorists are requested to adhere to the Campus speed limit of 10KPH. Photos and Videos Photo taking and/or video filming of the campus is prohibited except for academic purposes with permission of the lecturer.  USIU-A STUDENT HANDBOOK 1.5.2 Campus Crime If you experience or witness a crime, report it to the DVC, Student Affairs, Director of Operations, Dean of Students or Head of Security. A victim who reports a crime to such campus authorities may request anonymity to the extent practicable and permitted by local law.  USIU-A STUDENT HANDBOOK 4.0 POLICIES AND REGULATIONS 4.1 Guidelines on Posters and Use of Official Electronic Media on Campus a) All posters and SAC related activity posters, flyers, advertisements, notices related to student activities and by students, MUST be approved and stamped by the Student Affairs Council (SAC). The Sports Committee approves adverts for sports.  USIU-A STUDENT HANDBOOK 5.1 Conduct Jurisdiction All students regardless of where they live are members of the academic community with the same basic rights and responsibilities. All students are subject to the code of conduct. The university may deal with violations whether they occur on or off campus. Students are expected to abide by the laws of Kenya and the policies of USIU.  USIU-A STUDENT HANDBOOK Students who violate the law may incur penalties prescribed by civil authorities. Disciplinary action at the university will not be subject to challenge on the grounds that criminal charges involving the same incident have been dismissed or reduced.  USIU-A STUDENT HANDBOOK 5.1.1 Conduct Regulations A student who is found in violation of any of the following regulations is subject to the sanctions provided in this policy. Interfering with the freedom of any person to express his/her views, including invited speakers Probation Level 1 Disruption or obstructions of teaching, research administration, disciplinary proceedings or other university activities.-Probation Level II.  USIU-A STUDENT HANDBOOK 5.1.3 Disciplinary Charges Any member of the university community or university department may bring up charges against any student. Such charges must be written and filed in the office of the Dean of Students or designee. Alcohol consumption is NOT allowed during any University related travel or function.  USIU-A STUDENT HANDBOOK 5.4.2 Policy Regulations Littering: It is against this policy for members of the University community to litter the compound, facilities and buses with food and drinking containers, chewing gum/chocolate wrappers, straws & straw wrappers, serviettes, waste papers and careless disposal of unwanted material. Such items must be properly disposed of in dustbins or disposal containers as provided for.  REGULATIONS IN COMMUNITIES Mainly follow the laws set by the government as derived from the constitution and other regulatory bodies. The govern many aspects of peoples lives including permits, entertainment, human to human interactions (property, relationships, injustices, etc). Within specific communities there are accepted norms and practices outside of which penalties are apllied.  Designing Ethical Frameworks Many ethical issues that are on the legislative agenda, such as those with respect to bioethics have moral norms that are controversial, vague or still evolving. In many instances, law itself proves to be not a very effective instrument. For this reason, the process of legislation on ethical issues is structured as a process of interaction between the legislature and society or relevant sectors of society, so that the development of new moral norms and the development of new legal norms may reinforce each other.  Designing Ethical Frameworks An ethical framework should be designed in such a way that it is an effective form of communication which facilitates an ongoing moral debate and an ongoing reflection on issues. This is the best method to ensure that the practice remains oriented to the ideals and values that the law tries to realise.  Consequentialist framework Focuses on the future effects of the possible courses of action, considering the people who will be directly or indirectly affected. Its key consideration is what outcomes are desirable in a given situation? The ethical conduct to consider in this case is whichever one will achieve the best in order to produce the most good.  Consequentialist framework ADVANTAGE Very pragmatic since it focuses on the results of an action. It helps in situations involving many people, some of whom may benefit from the action, while others may not. DISADVANTAGE it is not always possible to predict the consequences of an action, so some actions that are expected to produce good consequences might actually end up harming people.  Duty framework Focuses on the duties and obligations that the health workers have in a given situation. In the work process, they need to consider what ethical obligations they have and what things they should never do. Ethical conduct in this case is defined by doing one’s duties and doing the right thing, and the goal is performing the correct action.  Duty framework ADVANTAGE Creates a system of rules that has consistent expectations of all people so that if an action is ethically correct or a duty is required, it would apply to every person in a given situation. DISADVANTAGES it can appear cold and impersonal, in that it might require actions which are known to produce harms, even though they are strictly in keeping with a particular moral rule. It also does not provide a way to determine which duty we should follow if we are presented with a situation in which two or more duties conflict.  Virtue framework It attempts to identify the character traits (either positive or negative) that might motivate health workers in a given situation. The concern is around what kind of person each should be and what their actions indicate about our character. Ethical behaviour as whatever a virtuous person would do in the situation, and the health workers seek to develop similar virtues.  Virtue framework ADVANTAGE It allows for a wide range of behaviours to be called ethical, as there might be many different types of good character and many paths to developing it. DISADVANTAGE It makes it more difficult to resolve disputes, as there can often be more disagreement about virtuous traits than ethical actions.  General Ethics and Statutory Regulations in Kenya 1. Public Officers (THE PUBLIC OFFICER ETHICS ACT, 2003) (http://kenyalaw.org/kl/fileadmin/pdfdownloads/ Acts/PublicOfficerEthicsAct.pdf) 2. Pharmacy and Poisons Board, Kenya (PPB) (https://pharmacyboardkenya.org/clinical-trials) 3. PPB (Guidance to Sponsors and Investigators for Conduct of Clinical Trials during the COVID-19 Pandemic in Kenya) 4. National Guidelines for Ethical Conduct of Biomedical Research in Kenya.pdf Biomedical Research and Clinical Trials in Kenya A plant on the USIU-A campus, Bridelia micrantha, captures your interest with its recorded ethnobotanical abilities that include anti-diarrhoea, antibacterial, wound healing, reducing ulcers among others. Let us highlight a few sections of PPB clinical trials regulations through applying a practical approach. A key question is “What will the clinical trials guidelines require of you as a researcher as you seek to bring it into mainstream treatment regimes”?  Assessing Ethical Frameworks for Professions 1. What are the ethical challenges and requirements for the specific profession? 2. Into which ethical framework does the profession fall? Business Person Police Officer Engineer Teacher Pharmacist Doctor Lawyer Nurses Biomedical Research and Clinical Trials in Kenya a. Can you identify any ethical framework in the paper (what type if so)? b. Are there any legislative anchors? 1. What would be your challenges in meeting the application requirements looking at the guidelines? 2. What would be your positives and limitations as an investigator in such research at this point in your career? 3. Which would you consider to be the ethical issues in the medical care of participants? 4. Highlight the protocols of research involving children.  National Guidelines for Ethical Conduct of Biomedical Research in Kenya. a. Can you identify any ethical framework in the paper (what type if so)? b. Are there any legislative anchors? 1. What would be your challenges in meeting the application requirements looking at the guidelines? 2. What would be your positives and limitations as an investigator in such research at this point in your career? 3. Which would you consider to be the ethical issues in the medical care of participants? 4. Highlight the protocols of research involving children. Ethical Planning and Research Projects HSC 3492 Maina Muniafu  General Research Design Research is defined as a process of arriving at effective solutions to problems through systematic collection, analysis and interpretation of data STEPS IN A RESEARCH DESIGN 1. Formulating the research problem/question 2. Create Null Hypothesis 3. Review Literature 4. Design data sampling method 5. Collect data 6. Analyze data 7. Interpret data 8. Draw conclusions  i. Ethical Planning for Research ETHICAL CONSIDERATIONS IN RESEARCH DESIGN These have to be included in the following research aspects: a. Sampling. b. Informed consent. c. Voluntary participation. d. Do no harm. e. Confidentiality. f. Anonymity. g. Only assess relevant components. h. Ethical Research Reporting  Sampling Sampling is the first step in research design. It is important that the research provides an explanation on why a particular group of participants is selected. It further needs to explain why a certain people or groups are left out. In some cases, sampling must seek to protect the respondents (e.g. through anonymity). In addition, if the sample includes children or special needs individuals, additional requirements such as parental permission must be addressed.  Informed Consent Informed consent states that an individual must give their explicit consent to participate in the study. It is an agreement of trust between the researcher and the participants which is frequently captured on a form. Participants should understand that: i. They are taking part in research. ii. Understand what the research requires of them.  Informed Consent Important information to help in this includes the purpose of the research, the methods being used, the possible outcomes of the research, as well as associated demands, discomforts, inconveniences and risks that the participants may face. Where informed consent cannot be obtained, researchers must fully explain why this is the case.  Voluntary Participation An individual should at no point feel any coercion to participate in a study. This includes any type of persuasion or deception in attempting to gain an individual’s trust. Participants may withdraw at any point of the research and such withdrawals must not impact negatively on their participation in future research. Furthermore, explanations for withdrawal are not required.  Do no harm Researchers must do everything possible to protect study participants (Nonmaleficence). They must let the participants know the benefits that will accrue from the research (Beneficence). However, the researchers should not exaggerate or even understate the benefits. A focus on minimising risk is important since rarely do researchers seek to intentionally harm the participants. One way is to assess the risk to benefit ratio. If possible risks outweigh the benefits, then this calls for an abandonment or redesign of the study. Risk of harm also requires researchers to measure the risk to benefit ratio as the study progresses.  Do no harm Where there is the possibility that participants could be harmed or put in a position of discomfort, there must be strong justifications for this. More planning around the project will have to be carried out to show how participant harm (or discomfort) will be reduced. In addition, participants can be informed of the potential harm and their consent obtained with a post participation debriefing if they do accept to participate.  Types of harm Physical harm to participants. Psychological distress and discomfort. Social disadvantage. Harm to participants financial status. An invasion of participants privacy and anonymity. Thus, together with anonymity and confidentiality, avoiding deceptive practices when designing the research and providing participants with the right to withdraw from the research at any time minimises the risk of harm to them.  Confidentiality Confidentiality is the state of keeping or being kept secret. The confidentiality of the information supplied by research subjects must be respected. Harm may occur to the participants after data collection when it is not treated confidentially usually during storage, its analysis, or during the publication process. Any disclosure of information requires permissions from the participants. This is to avoid any negative legal implications of disclosing information about the participants. Wording of reports is therefore very critical in preventing disclosures of participant identity.  Anonymity Anonymity calls for protecting the identity of participants. It refrains from identifying the ethnic or cultural background of respondents, referring to them by their names or divulging any other sensitive information about a participant It is a stricter form of privacy than confidentiality, since the identity of the participant remains unknown to the research team.  Anonymity It is thus more difficult to achieve than confidentiality as participants in some disciplines are usually known to the program coordinator. On the other hand, some studies will require researchers to request participants for permission not to protect their identity.  Only assess relevant components In a research project it is tempting to use the opportunity to collect all sorts of data for evaluations that are of interest to groups conducting the program/initiative but not relevant to the program nor will be to the group who are involved in the program. It is thus important to keep the evaluations simple and focused on the project objectives.  Ethical research reporting Researchers must strive for honesty in all scientific communications. They must: a. Honestly report data, results, methods and procedures, and publication status. b. Not fabricate, falsify, or misrepresent data. c. Not deceive colleagues, research sponsors, or the public. d. Ensure that all written articles are original and should make significant contribution to knowledge by presenting findings that will be interesting to be read by other scholars.  Ethical research reporting Paper to be submitted for publishing if it is well researched, written and adheres to the necessary research ethical guidelines. Researchers should adhere to guidelines which are associated with authorship, copyright and patenting policies, data sharing policies and confidentiality rules in peer review. This is especially because research requires cooperation and coordination among different people and diverse disciplines, institutions, standards which are ethical so as to foster collaborative efforts. Important qualities to foster between institutions include trust, accountability, mutual respect and fairness.  Scenarios 1. Create a sample design following the steps outlined above. 2. Pick out important ethical considerations in each of the project design aspects and explain how they apply to the respondents. 3. Outline any challenges in the application of the listed ethical considerations. 4. How will the reporting be best done for your study?  Research Scenarios 1. Collection of malaria incidence data from health centres and homes in a lakeside region with an aim of introducing proven treatment regimes and preventative measures. 2. Assessing pharmaceutical drugs in Roysambu outlets to determine percentage of fake drugs. 3. Research on impacts of improved diets on the growth of primary school children in Mathare Slum, Nairobi with a control experiment of ordinary diet. 4. Use of psychosomatic treatment regimes in a mental health unit versus the rate of patient recovery. 5. Assessing lifestyles of a mixture of university students in Roysambu/Kasarani areas to determine health correlations. 6. Effects of prolonged social media use on anxiety levels and identifying alleviating measures.