Which side will you take? Drug Protector? Human Rights? From the Greek word ETHOS which means behavior or conduct A Glimpse of the PAST… “unethical studies” • Nazi Medical Experiments • Tuskegee Syphilis Study • Willowbrook Study • Jewish Chronic Disease Hospital Study Ethical Codes and Regulations Nazi Medical Experiments Nazi human experimentation was a series of medical experiments on large numbers of prisoners, including children Programs included: Sterilization Euthanasia to produce a population of pure Germans & Aryans Tuskegee Syphilis Study • 1932 – US Public Health Service initiated a study of syphilis in black men in the small rural town of Tuskegee, Alabama • Cont’d for 40 years • To determine the course of syphilis in the adult black male • 2 groups: n = 400 untreated syphilis (treatment group) n = 200 without syphilis (control group) • participants were not informed about the purpose and procedures • Subjects were kept from receiving treatment • No effort to stop the study Willowbrook Hepatitis Study • mid 1950’s to early 1970’s – research on hepatitis at an institution for the mentally retarded • Subjects were children • Parents were forced to give permission for their child in order to gain their child’s admission to the institution • Subjects were deliberately infected with Hepatitis virus • 20 year study Jewish Chronic Disease Hospital Study • In 1960’s – purpose to determine the patients’ rejection responses to live cancer cells • N = 22 – injected with a suspension containing live cancer cells that had been generated from human cancer tissue • Rights of patients not protected, not informed, study was never presented to the research committee of the Jewish Hospital What Happened? • NUREMBURG CODE The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Nuremberg Code -focused on the importance of informed consent. • 1st internationally recognized set of ethical standards •Of course, while it’s essential to have codes, the responsibility for ethical research ultimately lies with the individual researcher. for Persons Research endeavors uphold respect for life, dignity and reputation of both researchers and participants/subjects, with special and appropriate protection for vulnerable groups. Philippine Normal University Code of Research Ethics and Guidelines for Review Youth, cognitively impaired, mentally challenged or people with health issues As researchers, we should respect the Rights of Subject • Right to informed consent • Right to privacy and confidentiality • Right to no harm Informed Consent • Tell participants who is conducting study • Why was subject singled out for participation? e.g. random sample e.g. recently given birth to 1st child etc. • What is the time commitment? e.g. 45 minutes to complete the survey Any benefits for the participant to be expected? Realistically, there are often few direct benefits. Any potential risks, and how have these been managed? Different forms of (informed) consent (informed) consent: • Presumed consent • presumed consent may be ethical when the benefits of the research outweigh any potential physical or social risks • Verbal consent of consent** • Written consent ** it may be impossible to obtain written consent in some types of studies (such as telephone interviews) but wherever possible the consent process should be recorded Sometimes Consent is not Possible • Fake an assault in the street to gauge reaction of bystanders • Who will intervene and who will do nothing? • Problem with the preceding: • witnessing such an attack may be very disturbing to some. • Those who do not intervene may be upset and suffer feelings of low worth. • Those who do intervene may be injured. • Debriefing is mandatory. Informed Consent • Special Populations Difficult for some to give true voluntary informed consent They might lack necessary competency --children --mentally challenged Informed Consent •Others May be Indirectly Coerced (persuade an unwilling person to do something by using force or threats.) —This is WRONG • • • • • • Students Prison Inmates Employees Military Personnel The Homeless Welfare Recipients Key components of informed consent Name and contact details of researcher and participant Aims and objectives of the research project Role of the participant Treatment of material/ information collected Potential risks to the participant Voluntary participation and freedom to withdraw Option of receiving summary of research findings Signature and date of researcher and participant Privacy and Confidentiality • Invasion of privacy occurs when private information is shared without an individual’s knowledge or against his/her will The subject has the right to • Anonymity – exists only if the subjects identity cannot be linked even by the researcher • Confidentiality- exists if the researcher can manage the private information shared by the subject. Issues Relating to the Principle of Respect Justice Research intentions and processes adhere to generally accepted scientific principles. Philippine Normal University Code of Research Ethics and Guidelines for Review “fairness and equity” • Obligation to treat people fairly & equitably • Equal access to benefits/equal share of burdens • Avoid underprotection & overprotection Justice Beneficence Harms and Benefits •One should do good and above all do no harm •Freedom from harm and freedom from exploitation Maximizing Benefits & Minimizing Harms • duty to maximize benefits • To produce benefits to society as a whole, subjects themselves, other individuals in society, advancement of knowledge • Apply principle of “Nonmaleficence” – the duty to avoid, prevent, or minimize harm to others Maximizing Benefits & Minimizing Harms • Participants should not be subjected to unecessary risks of harms • no consequences if the participant withdraws • Debriefing sessions can be used • Freedom from exploitation Key Principles Principle 1.Respect for persons 2.Beneficence 3.Justice Application 1.Informed consent 2.Assessment of risks/benefits 3.Fair selection of subjects Other ethical standards Laboratory Research Animals REPUBLIC ACT NO. 8485 (RA 10631 amendments) AN ACT TO PROMOTE ANIMAL WELFARE IN THE PHILIPPINES, OTHERWISE KNOWN AS “THE ANIMAL WELFARE ACT OF 1998” • SECTION 6. It shall be unlawful for any person to torture any animal, to neglect to provide adequate care, sustenance or shelter, or maltreat any animals or to subject any dog or horse to dogfights or horse fights, kill or cause or procure to be tortured or deprived of adequate care sustenance or use the same in research or experiments not expressly authorized by the Committee on Animal welfare. shelter, or maltreat or The killing of any animal other than cattle, pigs, goats, sheep, poultry, rabbits, carabao, horse, (deer and crocodiles) is likewise hereby declared unlawful except in the following instances: animal is killed after it has been used in authorized research or experiments; and • 6. When • In all the above mentioned cases, including those of cattle, pigs, goats, sheep, poultry, rabbits, carabao, killing of the animals shall be done through humane procedures at all times. hones, (deer and crocodiles), the • For this purpose, humane procedures shall means the use of the most scientific methods available as may be determined and approved by the Committee. The Philippine Animal Welfare Society (PAWS) •PAWS opposes to the use of animals in experimentation PAWS encourages the researchers to apply Three Rs • Reduction – reduce the number of animals being used • Refinement – animals should not feel pain while being experimented on and should be euthanized immediately after the experiment if the can no longer be rehabilitated • Replacement – will promote the use of alternative methods of research and dissection (virtual dissection) Laboratory Research Animals • To approve animal use: • Procedures must avoid pain or discomfort and have sound research design • Procedures involving minor discomfort or pain must include sedation, analgesia, or anesthesia • Animals that would experience chronic pain must be euthanized at the end of the procedure Laboratory Research Animals • To approve animal use: • Living conditions must be appropriate for species • Medical care must be available from veterinarian • Personnel conducting procedures must be qualified • Methods of euthanasia must abide by Committee on Animal Welfare or Bureau of Animal Industry (BAI) rules Other Ethical Issues •One should not cheat, falsify data •One should not plagiarize. Plagiarism • Plagiarism is taking another’s work and passing it off as your own. • When we talk about the decline and fall of the Roman Empire or say, “To be or not to be, that is the question” in normal conversation, we rarely attribute the words to Gibbon and Shakespeare respectively. Useful Definitions: Plagiarism and Self-Plagiarism • Plagiarism: using the ideas or words of another person without giving appropriate credit (Nat. Acad. Press document) • Self-Plagiarism: The verbatim copying or reuse of one’s own research (IEEE Policy statement) Both types of plagiarism are considered to be unacceptable practice by most scientific publications Plagiarism Extends to More than Words • One should always provide references for any • statistics • graphs • tables • numbers, etc. Copy Direct Quotations Exactly • Make sure that you write it precisely, word-forword as in the original. • Also essential that you enclose the quoted text in quotation marks. • Failing to put someone else’s direct text in quotation marks and crediting the author, may lead to accusations of plagiarism. “Plagiarism” Sometimes Not Intentional • Many instances of plagiarism stem from sloppy research rather than through a deliberate desire to cheat. • Many students during the research process take bad notes, e.g. they write down someone else’s text verbatim but forget to include the quotation marks. “Plagiarism” Sometimes Not Intentional • Later when they are writing the actual paper and they refer to their notes, they fail to remember that the text is another author’s and not their own. • So, the golden rule is to take excellent notes, write your whole paper yourself and to document your sources as well and as honestly as possible. “Common Knowledge” and Plagiarism • It is not necessary to document every single statement. • One need not give a reference for stating that President John F. Kennedy was assassinated in 1963. • This fact is common knowledge and belongs in the public domain. • However, if you are referring to Historian X’s thesis that Kennedy was killed by a crime syndicate and not by Lee Harvey Oswald, proper citation to such a theory is requisite. Other Types of Ethical Violations • Duplicate publication/submission of research findings • Unrevealed conflicts of interest that could affect the interpretation of the findings • Misrepresentation of research findings - use of selective or fraudulent data to support a hypothesis or claim SAMPLE Let’s study some researches and the ethical issues that happened or may happen. • The Zika vaccine, with the clinicalsounding name GLS-5700, will first be tested in 40 healthy volunteers. The first tests in humans should start in the next few weeks, Inovio said in a news release. - CNN, June 21, 2016 (http://cnnphilippines.com/world/2016/06/21/First-Zika-vaccine-to-be-tested-in-humans.html) •Study on embryonic stem cells Case study In a class, a teacher notices that male students have performed much better than women students The teacher decided to introduce a new design to the module to provide an experimental context in which he can evaluate differential performance by student gender His research design will involve: •ongoing (process) evaluation of the module •review of marks allocated to male and female students •interviews with students to gauge their perceptions* * interviews conducted before the course ends to ensure that all students are available to participate What are the ethical issues? How might these issues be resolved Case study – ethical issues informed consent must be obtained before students sign up for module it must be an optional not a compulsory the students should not be linked to their work To achieve confidentiality it may be good practice to ask a colleague to conduct the interviews Case study – ethical issues address any fears students may have of being penalised for not taking part or that their participation may positively or negatively prejudice their performance possibility of positive bias Hawthorne effect influencing students’ evaluation of the module Key ethical concerns Research involving a researcher’s students/pupils as research participants raises a number of ethical concerns, including: • Consent • Confidentiality • Competence Potential solutions 1. Minimize risks A. research students/pupils elsewhere B. research other’s students/pupils in your setting C. research but do not assess your own students/pupils D. research your own students/pupils using methods that generate anonymous data unlink-able to assessment E. research your own students/pupils but use anonymous assessment techniques unlink-able to research data F. research and assess your own students/pupils buthave assessments independently moderated/second-marked Summary We live in a fast changing world with the scientific knowledge and new technologies continuously challenge our values. We have to make decisions based on the fundamental values of human dignity. We, the teachers, have more information and more basic knowledge about the very issues that generate these ethical dilemmas. So why not, PRACTICE IT … SHARE IT… and INSPIRE MORE TO DO THE SAME… References • http://www.nasw-michigan.org/?page=Ethics • http://www.asasa.ca/images/services/ethics.png • http://www.asbpe.org/blog/2013/10/15/ithenticate-study-ids-10-plagiarism-formats-worthy-of-attention/ • https://en.wikipedia.org/wiki/Research_ethics • http://www.niehs.nih.gov/research/resources/bioethics/whatis/ • http://www.apa.org/monitor/jan03/principles.aspx • https://researchethics.ca/what-is-research-ethics/ • http://www.socialresearchmethods.net/kb/ethics.php • http://www.admu.edu.ph/code-ethics-research • http://www.ahc.umn.edu/img/assets/26104/Research_Ethics.pdf • Philippine Normal University Code of Research Ethics and Guidelines for Review (1Approved by the Board of Regents on June 11, 2015)