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Research Ethics and Integrity Basics
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instruction goal: '''The aim''' To provide learners from different backgrounds and disciplines with an overview of the primary ethics and integrity issues in research '''The learning outcomes''' At the end of this module, learners will be able to: #Explain the importance of ethics and integrity in research. #Describe a range of ethics and integrity issues that can be associated with different types of research. #Summarise the primary ethics issues raised by research with human participants. [https://embassy.science/wiki/Resource:H5P-80 Click here for an audio version of the text above.]
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instruction step title: Module Introduction
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instruction step text: [[File:Mexican town hall.jpg|alt=mexican town hall|center|frameless|600x600px|mexican town hall]] What ethics issues can you identify in the cases mentioned in this short video? You can download the text if you wish to help you formulate your thoughts.
instruction step title: Case Studies in Mexico
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instruction step text: [[File:Pills on a table.jpg|alt=pills on a table|center|frameless|600x600px|pills on a table]] Click on the hotspots to see some of the issues we identified. Many of the ethics issues in research are obvious and there are clear guidelines about how these ethics issues should be addressed. However, research can also generate ethics dilemmas that lead to debate about the best course of action. You will see this in the next example from clinical research. [https://embassy.science/wiki/Resource:H5P-82 Click here for an audio version of the text above.]
instruction step title: Case Study Feedback
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instruction step text: [[File:Woman in laboratory.jpg|alt=woman in laboratory|border|center|frameless|600x600px|woman in laboratory]] Clinical studies commonly include randomised control trials, where the outcomes of two or more groups are compared to test the effects of particular interventions. Sometimes one of the groups is given a placebo (dummy pill) to act as the control, as in this study:
instruction step title: Case Study: Clinical Research
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instruction step text: [[File:Yes or no buttons.jpg|alt=yes or no buttons|center|frameless|600x600px|yes or no buttons]] Read the following opinions, decide who you most agree with, and then move to the next page to see what the Declaration of Helsinki has to say. ==Case Study Review== Read the following opinions, decide who you most agree with, and then move to the next step to see what the Declaration of Helsinki has to say. {| class="wikitable" |[[File:Irecs 1.png|link=Special:FilePath/Irecs_1.png]] |'''Sonia''' This study provides very high-quality evidence for the efficacy of ipilimumab. The findings have the potential to benefit many patients. All the participants knew what was involved and consented to participate. Hence the study is ethical. |- |[[File:Irecs 2.png|link=Special:FilePath/Irecs_2.png]] |'''David''' This study is unethical because the control group should not have been given placebo. Why wasn’t the new drug compared with an existing treatment like interferon alpha? Those in the placebo group effectively went without treatment for three years. |- |[[File:Irecs 3.png|link=Special:FilePath/Irecs_3.png]] |'''Beth''' There are times when, even though there is an existing treatment available, it is ethically permissible to test new treatments against a placebo because this gives a more realistic idea of the effect size and is more useful in the long run. |}
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instruction step text: [[File:Handful of pills.jpg|alt=handful of pills|center|frameless|600x600px|handful of pills]] What does the Declaration of Helsinki say about this? Placebos should only be used: ''Where there are compelling and scientifically sound reasons why it is necessary to determine efficacy or safety, and the patients who receive placebo will not be subject to additional risks of serious or irreversible harm.'' But how do we know what counts as compelling and scientifically sound? And how do we know whether people who receive placebo are being put at risk? As with many ethical guidelines, there can be disagreement about what they mean in practice. In this situation, when making decisions about the design of a study, it can help to remember the Golden Rule. Imagine yourself in the shoes of someone who is being invited to participate. What would you want to know and how would you want to be treated?
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instruction step text: [[File:Words written on the screen.jpg|alt=words written on the screen|center|frameless|600x600px|words written on the screen]] Some ethical issues are common across research disciplines. For instance, all researchers who work with human participants need to think about informed consent and privacy, regardless of their research discipline. Other ethical challenges are more specific to certain research fields. For instance, ethical challenges associated with research in artificial intelligence can be quite different to those involving animal experimentation or archaeology. Watch the following presentations to hear about some of the challenges facing a nuclear physicist, an animal physiologist, and a historian.
instruction step title: Research Ethics in Different Disciplines
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instruction step text: [[File:Lady justice.jpg|alt=lady justice|center|frameless|600x600px|lady justice]] So far in this module, we have only referred to ‘research ethics’ but within this broad domain, a distinction is often drawn between matters of research ethics and matters of research integrity. Both are concerned with morality in research but matters of research integrity focus specifically upon the ethics issues that are associated with trustworthiness in research. Research integrity is needed to promote trust and confidence in all aspects of the research process. In the absence of research integrity, research misconduct can lead to the dissemination of unreliable information. There are many different types of research misconduct. Match the following types to their meanings.
instruction step title: Research Integrity
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instruction step text: [[File:Faces of different people.jpg|alt=Faces of different people|center|frameless|600x600px|Faces of different people]] People can be involved in research in many different ways. For instance, they might be asked to take part in a survey, be interviewed, be observed, or participate in a clinical study. They might also be involved via use of their personal data or biological samples. Here we touch upon three of the primary ethics requirements when research involves humans: # The need for informed consent. # The need to minimise harms. # The need to respect privacy.
instruction step title: Research with Human Participants
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instruction step text: [[File:Consent spelled out on blocks.jpg|alt=consent spelled out on blocks|center|frameless|600x600px|consent spelled out on blocks]] Informed consent is the cornerstone of ethical research with humans. It is of fundamental importance that people understand what a research project is about and provide their consent for taking part. There are seven key ingredients for valid informed consent. Match the following ingredients to their meanings.
instruction step title: The Need for Informed Consent
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instruction step title: The Need to Minimise Harms
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instruction step title: The Need to Respect Privacy
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instruction step text: [[File:Someone putting their thumb up and data appearing.jpg|alt=someone putting their thumb up and data appearing|center|frameless|600x600px|someone putting their thumb up and data appearing]] Do you know what is meant by personal data? Look at the following options and identify those that are personal data.
instruction step title: What is Personal Data?
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instruction step text: [[File:Question mark in speech bubble.jpg|alt=question mark in speech bubble|center|frameless|600x600px|question mark in speech bubble]] You can try these questions to see whether your learning from this module addresses the intended learning outcomes. No one else will see your answers. No personal data is collected.
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instruction step text: [[File:Two peoples hands, one person comforting the other.jpg|alt=two peoples hands, one person comforting the other|center|frameless|600x600px|two peoples hands, one person comforting the other]] Research ethics with humans presents one of the most difficult ethical challenges for a researcher. It might help to remember that research participants often provide a voluntary service to humanity and science without personal gain;they should be treated ethically in return.
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instruction step text: [[File:Person sat at computer in office.jpg|alt=person sat at computer in office|center|frameless|600x600px|person sat at computer in office]] Thank you for taking this irecs module! Your feedback is very valuable to us and will help us to improve future training materials. We would like to ask for your opinions: 1. To improve the irecs e-learning modules 2. For research purposes to evaluate the outcomes of the irecs project To this end we have developed a short questionnaire, which will take from 5 to 10 minutes to answer. Your anonymity is guaranteed;you won’t be asked to share identifying information or any sensitive information. Data will be handled and stored securely and will only be used for the purposes detailed above. You can find the questionnaire by clicking on the link below. This link will take you to a new page;[https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fforms.office.com%2Fe%2FK5LH08FyvQ&data=05%7C02%7CKChatfield%40uclan.ac.uk%7Cde983f54bcc64d66a02908dcd0b50ccd%7Cebf69982036b4cc4b2027aeb194c5065%7C0%7C0%7C638614723283127814%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=shLTj7qPsGmGj0JOoPRZV2LhKbl5XOOhAbo7F%2FWzW7s%3D&reserved=0 https://forms.office.com/e/K5LH08FyvQ] Thank you!
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has remarks: [[File:Blocks spelling glossary.png|alt=blocks spelling glossary|center|frameless|600x600px|blocks spelling glossary]] == Glossary Of Terms == '''Conflict Of Interest (CoI)''' A conflict of interest arises when an individual has multiple interests or relationships that could potentially compromise their ability to act impartially, ethically, or in the best interest of others. This type of conflict typically occurs when personal, financial, professional, or other interests compete or conflict with the individual's duties, responsibilities, or obligations. For instance, when a researcher’s affiliations with external organisations, such as membership of professional associations or advisory boards, create competing loyalties or obligations that could impact their decision-making within their primary role or organisation. '''Fabrication''' In research, fabrication refers to the creation of false information, such as data, qualifications or ethics approvals, with the intent to deceive or mislead others. It involves the manufacturing of something that is not true or the distorting of facts in order to portray a false reality. '''Falsification''' Falsification refers to the act of deliberately altering, manipulating, or misrepresenting data, evidence, or information with the intention of misleading others or distorting the truth. It involves presenting false or fabricated information as genuine or accurate, thereby creating a false impression or narrative. '''General Data Protection Regulation''' The General Data Protection Regulation (GDPR) is a comprehensive data protection and privacy regulation implemented by the European Union (EU). It came into effect on May 25, 2018, replacing the Data Protection Directive 95/46/EC. The GDPR aims to strengthen and harmonise data protection laws across EU member states, as well as to protect the privacy and personal data of individuals within the EU with key principles. For instance: # Consent: Individuals must provide clear and affi…
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Consent and assent for research on children
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Falsifiability and Attractor States in Scientific Theories: A Framework for Evaluating Evidence
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Related To Object
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wiki page sort key: Related To Object

Related Instructions
type: ObjectProperty
page: https://embassy.science:443/wiki/Property-3ARelated_To_Instruction
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wiki page sort key: Related To Instruction
type: wpg

Element
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wiki page content language: en
wiki page sort key: Guide Step Element
type: wpg