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With this form, you create a step-by-step module on research integrity or ethics. This can be used to provide instruction on a particular topic. You might want to use it for a tutorial, teaching material, case analysis tool, or an educational game.

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Module

Instructions for:ParticipantTrainer

Perspective Participant

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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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== 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.

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