Research Ethics: a guide for responsible research with human subjects from edX

What's inside

Learning objectives

What research ethics is
Why ethics is necessary in research
What are the main ethical issues in research
How researchers can actively engage with ethics when undertaking research
Which ethical considerations must be made in research involving human subjects
What ethical codes and guidelines researchers must follow and the ethical principles that shaped them
How to assess risks and benefits of research

What the role of a research ethics committee is
What are the criteria for a valid informed consent
How to do research with vulnerable individuals and populations
How to protect participants’ privacy and confidentiality
How to identify ethical misconduct in research and understand how to avoid it
How to critically think of research and apply ethical reasoning

What research ethics is
Why ethics is necessary in research
What are the main ethical issues in research
How researchers can actively engage with ethics when undertaking research
Which ethical considerations must be made in research involving human subjects
What ethical codes and guidelines researchers must follow and the ethical principles that shaped them
How to assess risks and benefits of research
What the role of a research ethics committee is
What are the criteria for a valid informed consent
How to do research with vulnerable individuals and populations
How to protect participants’ privacy and confidentiality
How to identify ethical misconduct in research and understand how to avoid it
How to critically think of research and apply ethical reasoning

Syllabus

Module 0: Course introduction. Introduction to the edX platform, the course team, the main topics and goals covered in this MOOC.

Module 1: Responsibility in research. Discuss the importance of doing responsible research and the role of researchers in society.

Expert speakers module 1 :

Dr. Rene Von Schomberg , Guest Professor at the Technical University of Darmstadt.

Prof. Kim De Keersmaecker , Associate Professor at the Faculty of Medicine of KU Leuven, Head of the Laboratory for Disease Mechanisms in Cancer.

Prof. Giselinde Kuipers , Professor at the Faculty of Social Sciences of KU Leuven, Coordinator of the Centre for Sociological Research.

Prof. Séverine Vermeire , Full Professor at the Faculty of Medicine of KU Leuven, Research Coordinator of the Biomedical Sciences Group.

Prof. Diether Lambrechts , Full Professor at the Faculty of Medicine of KU Leuven, Head of the Laboratory of Translational Genetics (VIB-KU Leuven).

Prof. Liesbet Geris , Professor Faculty of Engineering Science and at the Faculty of Medicine of KU Leuven.

Module 2: Ethics Infrastructure and Governance. Examine the ethical guidelines and the historical scandals that prompted them. Understand the importance of doing a risk and benefit assessment when designing a research project. Examine ethical challenges of clinical research. Learn about the role and mandate of Research Ethics Committees.

Expert speakers module 2 :

Dr. Alice Cavolo , Senior Researcher at the Centre for Biomedical Ethics and Law at KU Leuven.

Prof. Stefaan Callens , Full Professor of Health Law at the Faculty of Medicine of KU Leuven, Member of the Centre for Biomedical Ethics and Law at KU Leuven.

Dr. Raffaella Ravinetto , Senior Researcher at the Institute of Tropical Medicine Public Health Department.

Prof. Dieter Baeyens , Associate Professor at the Department of Parenting and Special Education of KU Leuven, Chair of the Social and Societal Ethics Committee (SMEC) of KU Leuven.

Prof. Minne Casteels , Full Professor of Pharmacology at the Department of Pharmaceutical and Pharmacological Sciences of KU Leuven, Chair of the Ethics Committee Research UZ / KU Leuven.

Module 3: Informed consent: informing participants. Focus on the information that researchers must provide to participants for consent to be valid. Identify key obstacles to an adequate informed consent and learn about the strategies to overcome them.

Expert speakers module 3 :

Dr. David Kirchhoffer , Director of the Queensland Bioethics Centre at the Australian Catholic University’s Brisbane Campus.

Prof. Pascal Borry , Full Professor of Bioethics at the Centre for Biomedical Ethics and Law at KU Leuven.

Kamiel Verbeke , PhD candidate with an expertise on Deception Studies at the Center for Biomedical Ethics and Law at KU Leuven.

Evelien de Sutter , PhD candidate with an expertise on Electronic Informed Consent at the Clinical Pharmacology and Pharmacotherapy unit of KU Leuven.

Dr. Hélène Nobile , Associate Researcher at the Institute for Ethics, History and Philosophy of Medicine at the Medical School Hannover.

Dr. Emilia Niemiec , Associate Researcher at Lund University.

Module 4: Informed consent: obtaining consent. Understand the 'consenting' part of the informed consent and the voluntary nature of the decision to participate in research. Consider how pressures and incentives affect participants’ ability to consent. Reflect on the right to withdraw as a safeguard for voluntary consent.

Expert speakers module 4 :

Dr. Emily Largent , Assistant Professor of Medical Ethics & Health Policy at the Perelman School of Medicine.

Module 5: Vulnerable participants. Understand what vulnerability means in the research context. Focus on the ethical challenges of including vulnerable individuals or groups in research.

Expert speakers module 5 :

Prof. Chris Gastmans , Head of the Centre for Biomedical Ethics and Law at KU Leuven, Full Professor of Medical Ethics.

Dr. Virginia Sanchini , Adjunct Professor of Clinical Ethics at University of Milan, Visiting Research Fellow at the Centre for Biomedical Ethics and Law at KU Leuven.

Dr. Bege Dauda , Postdoctoral Fellow at University of Pennsylvania.

Prof. Angus Dawson , Professor of Bioethics and Director of Sydney Health Ethics at the University of Sydney.

Module 6: Privacy and confidentiality. Be aware of the challenges to maintain privacy and confidentiality in research. Identify the ethical concerns surrounding different types of data.

Expert speakers module 6 :

Leonardo Cervera Navas , Director of the Office of the European Data Protection Supervisor.

Dr. Griet Verhenneman , Data Protection Officer at UZ Leuven, Research Fellow at the Centre for IT and IP Law KU Leuven.

Prof. Mahsa Shabani , Assistant Professor of Privacy Law at the University of Ghent.

Dr. Effy Vayena , Professor of Bioethics at the Swiss Federal Institute of Technology, Visiting Professor at the Centre for Bioethics at Harvard Medical School, Faculty Associate at the Berkman Klein Center for Internet and Society.

Prof. Maarten Larmuseau , Associate Professor of Genetic Genealogy at KU Leuven.

Dr. David Resnik , Bioethicist at the National Institute of Environmental Health Sciences of the National Institutes of Health.

Module 7: Research integrity. Understand the difference between research integrity and research ethics and recognize key values and principles in research integrity. Focus on identifying research misconduct practices and critically reflecting on grey areas of research integrity. Learn how conflict of interest is related to research integrity.

Expert speakers module 7 :

Prof. Kris Dierickx , Full Professor of Medical Ethics at the Faculty of Medicine at KU Leuven, Member of the Centre for Biomedical Ethics and Law at KU Leuven.

Dr. Steven de Peuter , Senior Researcher at the Faculty of Psychology and Educational Sciences at KU Leuven.

Inge Lerouge , Research Integrity Coordinator at KU Leuven.

Prof. Joeri Tijdink , Assistant Professor at the Philosophy Department and at the Ethics, Law and Humanities department of the Amsterdam UMC.

Module 8: Final exam. Final multiple-choice quiz.

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

The course thoroughly introduces students to research ethics with human subjects

Case studies, videos, interviews, and discussions are all included to illustrate how ethical concerns arise in research practice

Students actively engage with ethics by applying ethical reasoning to practical, real-life research scenarios

Instructors from diverse backgrounds offer multi-faceted perspectives on research ethics

Includes interviews and discussions with subject matter experts in research ethics

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Research Ethics: a guide for responsible research with human subjects with these activities:

Compile a list of resources on research ethics

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Compiling a list of resources on research ethics will help you to stay up-to-date on the latest developments in the field and to find additional resources to support your learning.

Browse courses on Research Ethics

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Search for resources on research ethics online.
Compile a list of the resources that you find.
Share your list of resources with your classmates.

Review the ethical principles in research

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Refreshing your knowledge of the ethical principles that guide research will help you understand the importance of ethics in research and how to apply them in your own research.

Browse courses on Ethics in Research

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Read the syllabus and course materials for Module 1: Responsibility in Research.
Review the Belmont Report and the Nuremberg Code.
Summarize the key ethical principles in research.

Participate in a peer review session on research proposals

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Participating in a peer review session on research proposals will help you develop your critical thinking skills and improve your ability to provide feedback on the ethical aspects of research.

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Review the research proposals of your classmates.
Identify the ethical issues that are addressed in the proposals.
Provide feedback to your classmates on their proposals.

Four other activities

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Practice identifying ethical issues in research scenarios

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Practicing identifying ethical issues in research scenarios will help you develop your critical thinking skills and improve your ability to apply ethical principles to real-world situations.

Browse courses on Research Ethics

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Review the ethical principles in research.
Read the case studies and identify the ethical issues involved.
Discuss the ethical issues with your classmates.

Create a poster presentation on a research ethics topic

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Creating a poster presentation on a research ethics topic will help you communicate your understanding of a specific ethical issue to a wider audience.

Browse courses on Research Ethics

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Choose a research ethics topic that interests you.
Research your topic and gather information.
Design and create your poster presentation.
Present your poster presentation to your classmates.

Develop a research proposal that addresses ethical issues

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Developing a research proposal that addresses ethical issues will help you apply the ethical principles you have learned to a specific research project.

Browse courses on Research Proposal

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Choose a research topic that interests you.
Identify the ethical issues that are relevant to your research topic.
Develop a plan for how you will address the ethical issues in your research.
Write a research proposal that includes your plan for addressing ethical issues.

Conduct a research project that addresses an ethical issue

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Conducting a research project that addresses an ethical issue will allow you to apply the ethical principles you have learned to a real-world research project.

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Choose a research topic that interests you and that addresses an ethical issue.
Develop a research plan that includes a plan for addressing the ethical issues involved in your research.
Conduct your research.
Write a research report that includes your findings and a discussion of the ethical issues involved in your research.

Career center

Learners who complete Research Ethics: a guide for responsible research with human subjects will develop knowledge and skills that may be useful to these careers:

Research Ethics Officer

Research Ethics Officers ensure that research involving human subjects is conducted ethically and in accordance with regulatory requirements. This course is a perfect match for those who want to enter this field because it delves deep into the ethics of research with human subjects.

See salaries and explore the career path for Research Ethics Officer

Clinical Research Scientist

Clinical Research Scientists use their scientific knowledge to evaluate the benefits and risks of new drugs and treatments. They also provide support to clinical trials. The course is a perfect match for those who want to enter this field because it delves deep into the ethics of research with human subjects.

See salaries and explore the career path for Clinical Research Scientist

IRB Administrator

IRB Administrators manage Institutional Review Boards (IRBs), which are responsible for reviewing and approving research involving human subjects. This course is a perfect match for those who want to enter this field because it delves deep into the ethics of research with human subjects.

See salaries and explore the career path for IRB Administrator

Research Compliance Specialist

Research Compliance Specialists ensure that research is conducted in accordance with ethical and regulatory guidelines. This course can help build a foundation in understanding the regulations and guidelines that govern research with human subjects.

See salaries and explore the career path for Research Compliance Specialist

Clinical Trials Manager

Clinical Trials Managers oversee the day-to-day operations of clinical trials. They work with researchers, doctors, and patients to ensure that trials are conducted safely and efficiently. This course can help build a foundation in the ethical issues that researchers face and how to address them.

See salaries and explore the career path for Clinical Trials Manager

Biostatistician

Biostatisticians use statistics to solve problems in health care. They design studies, collect data, and analyze results to help understand and improve health outcomes. This course can help build a foundation in the ethical issues that researchers face when working with human subjects.

See salaries and explore the career path for Biostatistician

Health Policy Analyst

Health Policy Analysts use their knowledge of health care and policy to analyze and develop policies that improve the health of populations. They also work with policymakers to advocate for policies that improve health outcomes. This course can help build a foundation in the ethical issues that researchers face and how to address them in the field of health policy.

See salaries and explore the career path for Health Policy Analyst

Science Policy Analyst

Science Policy Analysts use their knowledge of science and policy to help make decisions about how to spend money on research. They also help to communicate scientific findings to policymakers. This course can help build a foundation in the ethical issues that researchers face and how to address them in the field of science policy.

See salaries and explore the career path for Science Policy Analyst

Data Protection Officer

Data Protection Officers ensure that organizations comply with data protection laws and regulations. They also help organizations protect personal data from unauthorized access, use, or disclosure. This course can help build a foundation in understanding how researchers work with data related to human subjects.

See salaries and explore the career path for Data Protection Officer

Health Educator

Health Educators develop and implement educational programs to promote healthy behaviors and prevent disease. They also work with individuals and groups to help them make healthy choices. This course may be helpful if you want to work in this field because it provides a good overview of the ethical issues that researchers face and how to address them.

See salaries and explore the career path for Health Educator

Compliance Officer

Compliance Officers make sure that organizations follow laws and regulations. They also help organizations avoid legal problems. This course can help build a foundation by providing an overview of the ethical issues that researchers face and how to address them.

See salaries and explore the career path for Compliance Officer

Science Journalist

Science Journalists write about science and technology for newspapers, magazines, and other publications. They help the public understand complex scientific concepts and issues. This course may be helpful if you want to work in this field because it provides a good overview of the ethical issues that researchers face and how to address them.

See salaries and explore the career path for Science Journalist

Medical Writer

Medical Writers translate complex medical and scientific information into easy-to-understand language for patients, doctors, and other audiences. They also help develop educational materials and write for websites, magazines, and other publications. This course may be helpful if you want to work in this field because it provides a good overview of the ethical issues that researchers face and how to address them.

See salaries and explore the career path for Medical Writer

Data Analyst

Data Analysts have a background in collecting, analyzing, and presenting data. They help tell data-driven stories that help make decisions. This course can help build a foundation in understanding how researchers work with data related to human subjects. Also, you'll gain experience in constructing arguments and assessing the arguments of others in a constructive way.

See salaries and explore the career path for Data Analyst

Research Project Manager

Research Project Managers lead projects in a wide variety of settings, from universities to government agencies to private companies. This course may be helpful if you want to work in this field because it provides a good overview of the ethical issues that researchers face and how to address them.

See salaries and explore the career path for Research Project Manager