Section outline

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    General

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    • Welcoming message Forum
      Dear MPH and Msc Epidemiology students,
      You are most welcome to the Module 4, Research ethics course unit!
      This course is designed to prepare master (Epidemiology, Field epidemiology and public health) students to their future role of investigators who will be involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. This course introduces the basic concepts, principles, and issues related to the protection of research participants. The course will discuss the principles of ethics in research, the development of contemporary research ethics, and give an overview of the responsibilities of ethics committees and of researchers when conducting a research. Lectures are complemented by practical sessions devoted to case studies, exercises, or critique of current examples of public health studies. This course covers a brief of what is supposed to be known, thus, students are expected to complete a very comprehensive online research ethics course, hosted by FHI 360.

      I hope you will enjoy it


      Albert Ndagijimana, MPH, PhD student
    • Research ethics course syllabus File PDF
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      More details about the course are herewith attached.

      250.5 KB
    • Chat
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      In case you have any question, please raise it up here!

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    Overview of epidemiological studies

    The first week of the course is dedicated to the overview of the course and epidemiological study designs (brief overview).

    The course overview covers the brief awareness on what is intended to be covered in the course over the next seven weeks, with objectives, learning modalities and assessment approaches.

    It is very crucial to overview epidemiological study designs since they are fundamental to ethics in a such way every researcher needs to know his/her study design, its methodological implications, advantages and disadvantages; and ethical implications that are totally different from design to another. 

    • Overview of epidemiological studies File PDF
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      By the end of this session, you will be able to describe the importance of study design in the protection of research participants. It is a brief review since students have already covered the epidemiological study designs during descriptive and analytical epidemiology. 

      1.4 MB
    • E-tivity 1.1_Discussion questions Forum
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      This is open for discussion, as if we are in class! Here are few questions that may guide our discussion:

      1. Looking at each epidemiological study design, what do you think would be the issues with protecting human beings participating in the research?
      2.  How do you think you should act towards protecting human beings taking part in research?

      In case you have other questions related to the study design and protecting human beings participating in research, please raise up your hands.

      Thanks

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    Historical perspective of research ethics and Principles of research ethics

    The second week of the course intends to cover the development of contemporary Research Ethics and Principles of Research ethics.

    It will cover the two objectives of the course:

    1. Apply the three fundamental principles of research ethics in the development, review, and conduct of research involving human participants
    2. Describe the history and importance of human subjects protections

    Over the history, human beings have been subject to unhumane experiments, exposures and manipulations, that triggered the minds of several scientists, thinking about how research/knew knowledge could be generated without compromising the human participants' welfare. Any research should bear in mind that any research conducted aims to comply with the three research ethics principles, which are Respect for the person participating in the research, justice that implies fair recruitment of participants and beneficence that balances risks and benefits. 

    Enjoy the session

    • Historical perspective of research ethics and Principles of research ethics File PDF
      Students must
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      By the end of this session, students will be able to apply the three fundamental principles of research ethics in the development, review, and conduct of research involving human participants

      995.3 KB
    • E-tivity 2.1_Discussion questions Forum
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      Comments and questions are welcome! However, I have some questions for you with regard to this topic:

      1. What do you think we should keep in our minds as ethics principles during any research involving human beings?
      2. Do you think what inspired scientists in terms of historical perspectives can happen in our setting (country), i.e malpractice, harm and other unethical events? If Yes, give some examples and how you think they could be effectively addressed?

      Do you have other questions, please ask them here?

      Thanks

      Albert

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    Ethical issues in research

    The third week is dedicated to ethical issues in research. It intends to enable students behave ethically while conducting a study that involved human beings. They should be aware of all ethical misconducts and think of a way to avoid them. 

    Learning outcomes:

    • Define the role of ethics in research
    • Define and apply basic terms relating to the ethical conduct of research: research misconduct, fabrication, falsification, plagiarism, compliance, ethically prohibited behavior, ethically required behavior, and ethically encouraged behavior.
    • Distinguish between compliance and ethics.

    Learning activities:

    • Think of issues which may arise when informing participants about research and how they should be fixed

    Over to you to critically think of all possible issue that may emerge during the conduct of a research so that you can avoid them, and subsequently avoid possible sanctions that apply in each country.

    • Ethical issues in research File PDF
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      By the end of this session, you will be able to:

      • Define the role of ethics in research
      • Define and apply basic terms relating to the ethical conduct of research: research misconduct, fabrication, falsification, plagiarism, compliance, ethically prohibited behavior, ethically required behavior, and ethically encouraged behavior.
      • Distinguish between compliance and ethics.
      293.9 KB
    • Forum
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      Observations, comments and questions are welcome!

    • Mandatory book to read File PDF
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      Dear students,

      The book entitled "International Ethical Guidelines for Health-related Research Involving Humans" is shared with you to deepen your understanding of all ethical issues emerging when humans are involved. It discussed everything about this course and all chapters that will be covered. As we move along with this course, kindly go back to it and see what WHO says about it and what it recommends to researchers. 

      It was prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO).

      I hope you will enjoy the reading!

      886.9 KB
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    Responsibilities of Research Ethics Committees, human participation in research and research protocol

    The fourth week is dedicated to roles and responsibilities of research ethics review committees, human participation in research and proposal/ protocol review process. 

    At the end, you will be expected to have: 

    • Draft a protocol complying with ethical principles (that can win the ethical approval)
    • Show the ethical considerations (ensuring the human participants' safety) in the protocol

    Over to you to think of all ethical considerations while developing a study proposal and master all steps/processes for ethical approval until the research is done, results disseminated and findings used (still ensuring the participants' safety/welfare)

    • Responsibilities of Research Ethics Committees File PDF
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      At the end of this session, students will be able to describe the responsibilities of Research Ethics Committees in a research environment

      143.9 KB
    • Human participation in research File PDF
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      At the end of this session, students will be able to describe all aspects of human participation in research, with a particular attention to consenting process, protection of vulnerable population and all elements that need critical consideration during ethical review process

      686.7 KB
    • Protocol review File PDF
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      At the end of this session, students will be able to demonstrate how a research protocol review is done, with accent on protocol deviations and violations and how to record them; explain what protocol waivers are, and everything about professional responsibilities.

      676.3 KB
    • Rwanda National Ethics Committee URL
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      Dear students, it is important that you appreciate how the RNEC is doing things in terms of assuring the welfare of human beings participating in research in Rwanda and compare it with the general research ethics principles.

      Enjoy the reading-Please read everything about RNEC, especially the SoPs.

      Albert

    • Forum
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      Any questions!

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    Informed consenting

    • Informed Consent File PDF
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      At the end of this session, students will be able to understand the informed consent process and the use of Informed Consent with research participants before they are involved.

      1.8 MB
    • WHO generic ICFs Folder
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      Dear students,

      TO avoid the bad habits of some researchers who design the ICF at their convenience, please use these shared ones. They have been designed by WHO as templates. To use it, you only fill by editing the RED colored text. The BLACK colored text serves as instructions. When you are designing your ICF, please delete it and only keep the RED colored edited text for the participant. I am not expecting any short and badly designed ICF.

      Regards

      Albert

    • Forum
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      Mark as done

      Any questions?

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    Responsibilities of sponsors and researchers

    This is the last teaching week for the Research ethics course. It is dedicated to responsibilities of sponsors and researchers, community participation in the research process, and professional responsibility

    Though the main researcher or the Principal Investigator remain the main responsible for ethical conduct of the research, the sponsor has a role to play. For instance, there shouldn't be any sponsorship for the study that is unethical, i.e which does not comply with all ethical principles. The community should be informed on the study being conducted and should be the first to benefit the study. Therefore, there is a need for the community to be represented.

    Learning outcome: 

    At the end of this session, students will be able to understand the responsibilities of sponsors and researchers

    Learning activity: You are invited to read the WHO guidelines for health researchers (the corresponding chapter)

    I hope you will enjoy the session

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