Define Ethics in research

Ethics is the branch of philosophy concerned with distinguishing right from wrong, encompassing moral duties and obligations.

• It is the study of moral principles or values that guide human conduct and behavior.

• Ethics sets out standards of behavior that govern individuals or groups.

In the context of research, ethics provides a framework of principles for the responsible conduct of scientific investigations, particularly in biomedicine. It’s designed to:

• Ensure research is carried out in a morally acceptable way.

• Prioritize the protection of the well-being and rights of individuals participating in research.

• Educate and monitor researchers to maintain high ethical standards in their work.

History of Research Ethics

The field of modern research ethics emerged from the necessity to protect individuals involved as subjects in research studies.

• A pivotal moment in establishing ethical regulations was the Doctors’ Trial (1946-1947) in Germany, held after World War II.

• This trial was part of the Nuremberg Trials against Nazi war criminals, where defendants were accused of violating fundamental ethical principles through inhumane experiments.

• The outcome of this trial was the Nuremberg Code, a set of ten ethical principles that underscored:

  • Voluntary Consent: Individuals must willingly agree to participate in research.

  • Societal Benefit: Research aims should contribute positively to society’s well-being.

  • Sound Scientific Basis: Research should be grounded in established theory and prior testing, often using animal models.

  • Minimize Suffering: Research must avoid unnecessary physical and mental distress for participants.

  • Avoid Harmful Outcomes: Research should not proceed if serious injury or death are potential risks.

  • Risk-Benefit Balance: The level of risk to participants should be justified by the anticipated benefits of the research findings.

  • Participant Protection: Adequate facilities and safeguards must be in place to protect participants.

  • Qualified Researchers: Experiments should only be conducted by individuals with appropriate scientific expertise.

  • Right to Withdraw: Participants must have the freedom to leave the research study at any point.

  • Researcher’s Duty to Stop: Researchers must be prepared to halt the experiment if there is reason to believe it is causing harm or poses a risk of injury or death.

• The Nuremberg Code became a foundational document for subsequent ethical guidelines, including:

  • The Declaration of Helsinki: Aimed at promoting ethical conduct in research involving human subjects internationally.

  • The Belmont Report (1978): Published in the United States, this report further clarified key ethical principles for biomedical and behavioral research.

Why Study Research Ethics

1. Respect for Participants: Learning research ethics demonstrates a fundamental respect for the individuals who contribute to research studies.

2. Preventing Unreasonable Demands: It ensures that researchers do not place unfair, unsafe, or poorly considered burdens on participants.

3. Knowledge Sharing: Research ethics emphasizes the importance of transparent communication and information sharing among all parties involved in the research process.

4. Establishing Ethical Norms: It creates a shared standard for ethical behavior that is now expected and considered normal practice in research activities.

5. Professional Requirement: In many disciplines, such as nursing, understanding and adhering to research ethics is a core professional expectation.

6. Access to Participants: Ethical conduct is essential for gaining trust and cooperation from individuals needed for health-related research.

Major Concerns in Research Ethics

PLAGIARISM

Plagiarism is presenting someone else’s ideas, thoughts, images, theories, words, or creative works as your own original work.

• When researchers plagiarize, they undermine the credibility, ethical standing, and trustworthiness of their entire research endeavor.

Forms of Plagiarism:

• Direct Word-for-Word Copying: Intentionally using text from another source without using quotation marks and proper citation.

• Improper Paraphrasing: Carelessly or lazily rephrasing text by only changing a few words or sentence structures, and patching together fragments from various sources without adequate attribution.

Important Note: The scientific community has zero tolerance for plagiarism in any form, including unintentional plagiarism.

How to Address Plagiarism:

• Proper Citation: Always cite the source of any ideas, facts, or information that are not your original thoughts or considered common knowledge.

• Use Quotation Marks: Enclose direct quotes from other sources in quotation marks to clearly indicate they are not your own words.

• Clear Paraphrasing and Citation: When you rephrase someone else’s ideas, clearly indicate that the ideas are not your own and provide a full citation to the original source.

  • Introduce Paraphrased Material: Start paraphrased sections by stating that the following information comes from another source (e.g., “According to Smith and Jones…”).

  • Cite at the End: Place the complete citation immediately after the paraphrased section.

AUTHORSHIP

Authorship refers to the process of determining who should be credited as an author on a research publication.

• Research is often a collaborative effort involving contributions from various experts and colleagues.

• Ethical authorship practices are crucial for:

  • Acknowledging all significant contributions to research.

  • Determining appropriate joint authorship when multiple individuals have made substantial contributions.

Criteria for Authorship:

Authorship credit should be granted only to individuals who meet all of the following criteria:

1. Substantial Contribution: Made significant contributions to at least one of the following:

   • The initial concept and design of the research.

   • The acquisition of research data.

   • The analysis and interpretation of the collected data.

2. Manuscript Contribution: Were involved in:

   • Drafting the research article.

   • Critically revising the article for important intellectual content.

3. Final Approval: Have given final approval of the specific version of the article submitted for publication.

Important Note: Simply acquiring funding, collecting data, or providing general supervision of a research group does not, in itself, qualify an individual for authorship.

Co-authorship Requirements:

To be considered a co-author, an individual must:

1. Make a significant and substantial contribution to the research project.

2. Participate in writing or revising the research manuscript.

3. Approve the final version of the entire article before submission.

RESEARCH MISCONDUCT

Research misconduct involves identifying and reporting research practices that are unethical or flawed.

• It is formally defined as fabrication, falsification, or plagiarism occurring in:

  • Proposing research projects.

  • Conducting research.

  • Reviewing research proposals or manuscripts.

  • Reporting research results.

Types of Research Misconduct:

1. Fabrication: Inventing data or research findings and reporting them as if they were real.

2. Falsification: Manipulating research materials, equipment, or processes, or altering or omitting data or results in a way that misrepresents the research findings.

3. Plagiarism: Using another person’s ideas, research processes, results, or words without giving proper credit.

Important Clarification: Research misconduct does not include honest errors or genuine differences of opinion among researchers.

General Ethical Principles

Research involving human subjects raises several ethical considerations that are highly relevant to fields like nursing. Understanding and applying the following core principles is essential for conducting ethical research.

1. Respect for Persons

   • Autonomy: Individuals have the right to make their own decisions, and these decisions should be respected by researchers.

   • Protection for Vulnerable Populations: Individuals with diminished autonomy (e.g., children, individuals with cognitive impairments) are entitled to extra protections.

   • Informed Decision-Making: Voluntary research participants must be given sufficient information to make informed choices about their participation.

   Example: In research on informed consent procedures for children in healthcare, nurses must ensure that parents or legal guardians fully understand the research’s purpose, potential risks and benefits, and their right to withdraw their child at any time.

2. Informed Consent

   • Understanding and Agreement: Informed consent is the process of ensuring that potential research participants have a clear understanding of the research and willingly agree to take part.

   • Comprehensive and Understandable Information: The information provided to participants must be:

     • Complete and thorough.

     • Presented in a way that is easily understood.

     • Adapted to the participant’s abilities, language, and cultural context.

   • Voluntary Participation: Participants must not be pressured, coerced, or manipulated into participating in the research; their consent must be freely given.

   Example: Before conducting a study on how elderly patients experience pain management, nurses are obligated to thoroughly explain the study’s objectives, procedures, potential advantages, and risks to each participant, allowing them to decide freely whether or not to participate.

   Requirements for Informed Consent:

   1. Information Disclosure: When seeking informed consent, researchers must disclose the following information to potential participants:

      1. Detailed description of the research procedure.

      2. Clearly stated purpose of the research.

      3. Description of any potential risks and anticipated benefits associated with participation.

      4. Information about alternative procedures or treatments (especially relevant in therapeutic research).

      5. A clear statement of the participant’s right to ask questions and to withdraw from the research at any time without penalty.

   2. Comprehension: To ensure participants truly understand the information, researchers must tailor the way information is presented to be understandable, considering:

      1. Variations in individual abilities.

      2. Different levels of intellectual understanding.

      3. Participant maturity.

      4. Specific language needs.

   3. Voluntariness: Informed consent must be given freely and voluntarily, without any form of coercion or undue pressure. Participants must feel genuinely free to make their own decision about whether or not to participate.

3. Privacy and Confidentiality

   • Protecting Sensitive Information: Privacy and confidentiality are crucial for safeguarding participants’ personal and sensitive information in research.

   • Control Over Personal Information: Participants have a fundamental right to control and keep their personal information private.

   • Data Security: Researchers must take steps to ensure that data collected during research is anonymized (where possible), stored securely, and protected from unauthorized access.

   Example: In a study exploring the stigma associated with mental health, nurses must guarantee that participants’ identities and personal information are kept strictly confidential. This protects their privacy and helps prevent potential negative consequences due to the sensitive nature of the information.

4. Beneficence

   • “Doing Good”: Beneficence is a core ethical principle that essentially means “to do good” for research participants.

   • Maximize Benefits, Minimize Harm: Beneficence requires researchers to strive to maximize the potential benefits of their research while actively minimizing any potential harms or risks to participants.

   • Favorable Risk-Benefit Ratio: Research studies should be designed to offer a favorable balance between potential benefits and possible risks for participants.

   • Avoid Unnecessary Risk: Participants should not be exposed to risks or harm that are not essential to answer the research question.

   • Duty to Stop Harm: Researchers must be prepared to stop research activities if they discover that the study is causing harm to participants, and should never expose participants to levels of risk that are disproportionate to the anticipated benefits of the research.

   Example: When conducting a study to assess the effectiveness of a new nursing intervention for wound care, nurses must carefully evaluate that the potential benefits of the new intervention (e.g., faster healing, reduced infection risk) are likely to outweigh any potential discomfort or inconvenience experienced by the participants during the study.

5. Justice

   • Fair Treatment: The principle of justice emphasizes treating people fairly and equitably in research.

   • Equitable Distribution of Research Burden and Benefits: Justice aims to prevent overburdening certain populations with research while ensuring that the benefits of research are accessible to all groups who could benefit.

   • Avoiding Vulnerable Population Overburden: Researchers should actively avoid disproportionately targeting vulnerable populations for research if the findings are intended to benefit other, more advantaged groups. Conversely, they should also ensure vulnerable populations are not unfairly excluded from research opportunities if they could potentially benefit.

   • Equitable Access to Research Opportunities: Efforts should be made to ensure equitable access to participation in research for all eligible individuals, regardless of their background or social status.

   Examples of Vulnerable Populations: In nursing research, vulnerable populations might include: marginalized communities, children, pregnant individuals, or people with mental health conditions.

   Example: In a study focused on healthcare access in rural areas, nurses must take steps to ensure that individuals from underserved rural communities have an equal opportunity to participate in the research and to benefit from any improvements in healthcare delivery that result from the research findings.

   Further Example: Consider research on a new medication for a chronic disease. To uphold justice, the study should aim for a diverse participant group that reflects various demographic backgrounds (e.g., age, gender, ethnicity, socioeconomic status). This ensures that the research findings are applicable to a broad range of individuals who might benefit from the medication, without unfairly excluding or disproportionately burdening any particular group. For instance, a drug intended for use across different age groups, including pregnant individuals and the elderly, ideally should be tested on representative samples from these populations to ensure its safety and efficacy for all potential users. Research should not focus solely on one group (e.g., elderly individuals) if the medication is also intended for and could benefit other groups (like pregnant individuals).

The Institutional Review Board (IRB)

Institutional Review Boards (IRBs), also sometimes known as Research Ethics Committees (RECs), are bodies mandated by laws, institutions, and organizations to review research proposals involving human participants. Their primary role is to ensure that all research meets ethical standards. In Uganda, researchers, including nursing students, are expected to engage with IRBs/RECs to ensure ethical research practices. Many institutions in Uganda have their own IRBs/RECs, such as The Uganda Christian University REC (UCU-REC) and Mengo Hospital-REC.

• The IRB is a legally and ethically required committee that reviews research proposals involving human participants to ensure ethical standards are upheld.

Key Roles of the IRB:

• Risk-Benefit Assessment: To carefully weigh the potential risks to research participants against the anticipated benefits of the research.

• Participant Protection: To safeguard participants from unnecessary harm or exploitation.

• Fair Compensation: To ensure that any compensation offered to participants is fair and proportional to their involvement and any potential risks.

• Researcher Qualification: To verify that the research is being conducted by qualified and competent scientists or researchers.

• Informed Consent Review: To rigorously review informed consent documents and other research-related materials to ensure they are:

  • Written in clear and accessible language.

  • Easily understandable for participants from diverse backgrounds.

  • Designed to promote genuine voluntary participation in research.

Example: As nursing students planning a research study with human participants, it is essential to prepare and submit a detailed research proposal to the IRB for review. Obtaining ethical clearance from the IRB before starting any data collection is a crucial step. This process ensures that the research project adheres to all relevant ethical principles and prioritizes the welfare and rights of all participants.