Research Ethics And Integrity Basics
InstructionsResearch Ethics And Integrity Basics
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.
Module Introduction
Video Transcript
We need look no further than the development of treatments and vaccines for combatting the coronavirus pandemic to understand the incredible potential for benefits.
But research does not always lead to benefits; it might also involve people, animals and resources in fruitless efforts and, at worse, it might cause great harm.
In this module, we consider some of the ethics and integrity issues that are associated with research across disciplines.
Case Studies In Mexico
Case Study Feedback
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.
Case Study: Clinical Research
Case Study Review
Placebo Summary
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?Research Ethics In Different Disciplines
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.
Research Integrity
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.
Research With Human Participants
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.
The Need For Informed Consent
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.
The Need To Minimise Harms
The Need To Respect Privacy
What Is Personal Data?
End Text
End Of Module Quiz
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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 affirmative consent for the processing of their personal data.
- Data Minimization: Organisations are required to collect and process only the personal data that is necessary for the specified purpose, and they must limit the retention of data to the minimum necessary timeframe.
- Data Subject Rights: Individuals have enhanced rights over their personal data, including the right to access, rectify, erase, restrict processing, and portability of their data.
The GDPR applies not only to organisations based in the EU but also to any organisation that processes personal data of individuals within the EU, regardless of the organisation's location.
Golden Rule
The Golden Rule is a moral rule that is found in cultures and religious traditions around the world. In essence, it states that one should treat others as one would like others to treat oneself. The Golden Rule encourages empathy, compassion, and reciprocity in human interactions, emphasising the importance of considering the perspectives and wellbeing of others. Here are some of the formulations:
In Buddhism: "Hurt not others with that which pains yourself." (Udana-Varga 5.18)
In Christianity: "So whatever you wish that others would do to you, do also to them, for this is the Law and the Prophets." (Matthew 7:12, English Standard Version)
In Confucianism: "Never impose on others what you would not choose for yourself." (Analects 15.24)
In Judaism: "What is hateful to you, do not do to your fellow: this is the whole Torah; the rest is the explanation; go and learn." (Talmud, Shabbat 31a)
In Islam: "None of you [truly] believes until he wishes for his brother what he wishes for himself." (Hadith of the Prophet Muhammad, Sahih al-Bukhari and Sahih Muslim)
Informed Consent
Informed consent refers to the voluntary agreement by an individual to participate in a particular activity, undergo a procedure, or receive a treatment after being provided with relevant information about the risks, benefits, alternatives, and implications involved. Informed consent is a fundamental ethical and legal principle in healthcare, research, and various other contexts where individuals may be asked to make decisions that might impact their wellbeing.
In research, informed consent is essential to protect the rights and welfare of research participants. Researchers are required to obtain informed consent from participants before involving them in a study, and participants have the right to withdraw their consent at any time without penalty.
Misrepresentation
Misrepresentation refers to the act of providing false, incomplete, or misleading information with the intention of deceiving or misleading others. It involves presenting something inaccurately or in a way that creates a false impression or understanding. For instance, making false or exaggerated claims about a product (like a drug) or service (like a treatment option) in advertisements or promotional materials.
Personal Data
Personal data encompasses any information that relates to an identified or identifiable individual. It includes data that can directly identify a person, such as their name, address, email address, social security number, or phone number. It also encompasses data that, when combined with other information, could identify an individual, such as their date of birth, place of birth, gender, or biometric data.
In the context of data protection and privacy regulations, such as the General Data Protection Regulation (GDPR) in the European Union, personal data is subject to specific legal protections and requirements regarding its collection, use, disclosure, and security.
Piracy
Piracy in research refers to the unauthorised or unethical reproduction, distribution, or use of academic or scholarly work without proper attribution, permission, or acknowledgment of the original authors or copyright holders.
Plagiarism
Plagiarism is the act of presenting someone else's work, ideas, or creations as one's own without proper attribution or acknowledgment. It involves copying or closely paraphrasing the words, thoughts, or creative expressions of others and passing them off as original or independent work.
Randomised Controlled Trial
A randomised controlled trial (RCT) is a type of scientific study designed to evaluate the effectiveness of a particular intervention or treatment. In an RCT, participants are randomly assigned to one of two or more groups: the treatment group, which receives the intervention being tested, and one or more control groups, which may receive a placebo or standard treatment, or no treatment at all. RCTs are often described as ‘blinded’, which is implemented to minimise bias in the study. In single-blind trials, participants are unaware of their treatment assignment, while in double-blind trials, both participants and researchers are unaware of who is receiving the test intervention and who is receiving the control (standard treatment, placebo or no treatment).
Randomised controlled trials are broadly considered the gold standard for evaluating the efficacy and safety of medical treatments and interventions.
Systematic Review
A systematic review is a comprehensive and rigorous method of summarising and synthesising existing evidence for a specific research question or topic. It involves systematically searching, selecting, appraising, and analysing relevant studies from the literature to provide a comprehensive overview of the available evidence.
Systematic reviews are broadly considered the highest level of evidence in evidence-based practice and are widely used to inform clinical practice, policymaking, and decision-making in various fields.
