Research Ethics

Ethics in Research

Research Ethics

Ethics refers to the discipline of distinguishing between what is good and bad, involving moral duty and obligation.
  •  It encompasses a set of moral principles or values that guide behavior and conduct. 
  • Ethics establishes the principle of conduct governing individuals or groups. 
  • In  research, ethics provides guidelines for the responsible conduct of biomedical research. It ensures that research is conducted in an ethical manner, with a focus on protecting the welfare and rights of research participants. In addition, research ethics educates and monitors scientists conducting research to ensure a high ethical standard.

History of Research ethics

  • The development of modern research ethics began from the need to protect human subjects involved in research projects. 
  • The first significant attempt to establish regulations occurred during the Doctors Trial of 1946-1947 in Germany, which took place after World War II. 
  • The Doctors Trial was part of the Nuremberg Trials for Nazi war criminals, where the accused violated basic ethical principles. 
  • The Nuremberg Code emerged from this trial and comprised ten ethical guidelines that emphasized the importance of voluntary consent, societal benefits, scientific basis, avoidance of unnecessary suffering, and the prohibition of research with potential harm or death as outcomes. 
  • The Nuremberg Guidelines laid the foundation for subsequent initiatives, such as the Helsinki Declaration, which aimed to promote responsible research with human subjects. 
  • Another significant document is The Belmont Report, published in 1978 by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which further defined ethical principles in research.

The Nuremberg Code consisted of ten basic ethical principles that the accused violated.

The 10 guidelines were as follows

  1. Research participants must voluntarily consent to research participation
  2. Research aims should contribute to the good of society
  3. Research must be based on sound theory and prior animal testing
  4. Research must avoid unnecessary physical and mental suffering
  5. No research projects can go forward where serious injury and/or death are potential outcomes
  6. The degree of risk taken with research participants cannot exceed anticipated benefits of results
  7. Proper environment and protection for participants is necessary
  8. Experiments can be conducted only by scientifically qualified persons
  9. Human subjects must be allowed to discontinue their participation at any time
  10. Scientists must be prepared to terminate the experiment if there is cause to believe that continuation will be harmful or result in injury or death.

Why study research ethics

  1.  Studying research ethics is a reflection of respect for individuals who participate in research studies.
  2.  It ensures that researchers do not make unreasonable, unsafe, or thoughtless demands on participants.
  3.  Research ethics ensures the sharing of sufficient knowledge among all concerned parties.
  4.  It establishes a common standard for ethical conduct, which has become the norm and an expectation in research activities.
  5.  Research ethics is a professional requirement in disciplines like nursing.
  6. It is also  necessary for accessing participants in health-related research.

Major concerns in research ethics

PLAGIARISM

Plagiarism is the act of passing off somebody else’s ideas, thoughts, pictures, theories, words, or stories as your own. 

 If a researcher plagiarizes the work of others, they are bringing into question the integrity, ethics, and trustworthiness of their research. 

Forms of plagiarism 

  • Intentionally taking a passage word-for-word without proper credit 
  • Unintentionally  (or simply lazy) paraphrased and fragmented texts the author has pieced together from several works without properly citing the original sources
  • NOTE: No form of plagiarism is tolerated by the scientific community, including unintentional plagiarism.

 How to handle plagiarism:

    • Cite all ideas and information that are not your own and / or is not common knowledge.
    • Use quotation marks when using someone else’s words.
    • Clearly indicate the origin of paraphrased sections and provide proper citations.
    • At the beginning of a paraphrased section, show that what comes next is someone else’s original idea (example: these bullet points start out by saying the information originated ……….),
    •  At the end of a paraphrased section, place the proper citation
AUTHORSHIP

Authorship is the process of deciding whose names belong on a research paper.

  • Research often involves collaboration and assistance between experts and colleagues. 
  • Responsible authorship practices require acknowledging contributions and determining joint authorship when necessary, therefore responsible authorship practices are an important part of research.

How is authorship is achieved

Authorship credit should be based only on 

    1. substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 
    2. drafting the article or revising it critically for important intellectual content; and 
    3.  final approval of the version to be published.
    4.  Conditions 1, 2, and 3 must all be met. 
    5. Acquisition of funding, data collection, or general supervision of the group alone does not justify authorship. 

“Can I be a co-author?”

“Sure! But only if you…

  1. Contribute substantially to the research, AND…
  2. Write or revise all or part of the manuscript, AND…
  3. Approve the final version of the entire article.”
  •  Co-authorship requires substantial contribution to the research, writing or revising the manuscript, and approval of the final version.
RESEARCH MISCONDUCT 
Research misconduct is the process of identifying and reporting unethical or unsound research.
  • Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. 
  1. Fabrication is making up or recording false data or results. 
  2. Falsification is manipulating research materials, equipment, processes, or omitting data to misrepresent the research. 
  3. Plagiarism is appropriating another person’s ideas, processes, results, or words without giving appropriate credit. 
  •  Research misconduct does not include honest error or differences of opinion.

General ethical principles

Research with human subjects involves various ethical considerations relevant to nursing practice. Understanding and applying the following principles is crucial for conducting ethical research in Uganda:

  1. Respect for Persons
    • Individuals have the right to make autonomous decisions, and their choices should be respected.
    • People who cannot make autonomous decisions should receive appropriate protection.
    • Voluntary subjects should receive adequate information for decision-making.
    • Example: In a study on informed consent for pediatric patients, nurses must ensure that parents or guardians understand the research purpose, potential risks, benefits, and their right to withdraw their child from participation.
  2. Informed Consent
    • Informed consent ensures that research participants have a clear understanding of the research and voluntarily agree to participate.
    • Information provided to participants should be comprehensive, understandable, and adapted to their abilities and language needs.
    • Participants should not be coerced or manipulated into participating.
    • Example: Before conducting a study on elderly patients’ experiences with pain management, nurses must explain the study purpose, procedures, potential benefits, and risks to the participants, allowing them to make an informed decision to participate or not.
    • Requirements for Informed Consent 

    • 1. When obtaining informed consent from research participants, the information disclosed should include:

      1. Research procedure,
      2. Purpose of the research,
      3. Risks and anticipated benefits associated with participation,
      4. Alternative procedures (especially in therapeutic research),
      5. A statement providing the opportunity for participants to ask questions and withdraw from the research at any time.

      2. Comprehension: To ensure comprehension, researchers must adapt the information to be understandable for every participant. This requires considering factors such as:

      1. Different abilities,
      2. Intelligence levels,
      3. Maturity,
      4. Language needs.

      3. Voluntariness: , informed consent must be voluntary and free from coercion or improper pressure. Participants should have the freedom to make their own decision regarding participation.

  3. Privacy and Confidentiality
    • Privacy and confidentiality are vital in research to protect participants’ sensitive information.
    • Participants have the right to control and keep private information about themselves.
    • Researchers must ensure that data collected during research participation are anonymized and stored securely.
    • Example: In a study on mental health stigma, nurses must guarantee that participants’ identities and personal information are kept confidential to protect their privacy and prevent potential harm.
  4. Beneficence
    • Beneficence is a principle used frequently in research ethics. It means, “doing good”
    • Beneficence means maximizing potential benefits and minimizing potential harm to research participants.
    • Researchers should strive to conduct studies that offer a favorable balance of potential benefits and risks.
    • Participants should not be subjected to unnecessary risks or harm beyond what is necessary for the research.
    • Be prepared to cease research if it is causing harm, and never put participants at a level of risk disproportionate to the anticipated benefits.
    • Example: When conducting a study on the effectiveness of a new nursing intervention for wound care, nurses should ensure that the potential benefits outweigh any potential discomfort or inconvenience experienced by the participants.
  5. Justice
    • This principle means treating people with “fairness
    • This principle aims at preventing the overburdening of some populations in order to apply research findings to other groups.
    • Researchers should avoid overburdening vulnerable populations and ensure equitable access to research opportunities.
    • Examples of vulnerable populations in nursing research may include marginalized communities, children, pregnant women, or individuals with mental health conditions.
    • Example: When conducting a study on healthcare access in rural areas, nurses should ensure that participants from underserved communities have an equal opportunity to participate and benefit from the research findings. 
    • Another Example: let’s consider a research study on the effectiveness of a new medication for managing a chronic disease. To uphold the principle of fairness, the study should aim to include a diverse population that represents various demographic groups. This ensures that the research findings can be applied to a wide range of individuals who may benefit from the medication, without excluding or disproportionately burdening any specific group.

      Like a drug should be tested on pregnant mothers, elderly, so that when it is out, both groups can benefit from it, not carrying out research on only the elderly and yet even pregnant mothers would benefit from it.

The Institutional Review Board (IRB)

These are bodies mandated by state, institutions and organizations to review research proposals in which there are human participants to ensure ethical research. Also called Research and Ethics committees(REC). In Uganda, researchers, including nursing students, should engage with the Research and Ethics committees(REC) to ensure ethical research practices, and prominent institutions in Uganda have Institutional based Research Ethics Committees e.g. The Uganda Christian University REC(UCU-REC), Mengo Hospital-REC, e.t.c.

  • The IRB is a mandated body that reviews research proposals involving human participants to ensure ethical standards are met.
  • The roles of the IRB include balancing potential risks and benefits, 
  • protecting participants from unnecessary harm, 
  • offering proportional compensation, and 
  • ensuring the research is conducted by qualified scientists.
  • The IRB also ensures that informed consent and other research-related documents are readable, understandable, and promote voluntary participation.
  • Example: As nursing students, when planning a research study involving human participants, it is important to submit the research proposal to the IRB for review and obtain ethical clearance before commencing the study. This ensures that the study adheres to ethical principles and safeguards the welfare of the participants.
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