Ethics in Research

Ethics is the discipline of telling good from bad, involving moral duty. It's a set of moral principles that guide behavior and conduct for individuals or groups.

In research, ethics provides guidelines for responsible conduct, protecting the welfare and rights of participants. It also educates and monitors scientists to ensure high ethical standards.

Modern research ethics began because of the need to protect human subjects.

• The Doctors' Trial (1946-1947): The first major effort to set regulations happened during this trial in Germany after World War II. It was part of the Nuremberg Trials for Nazi war criminals who violated basic ethical principles.
• The Nuremberg Code: This emerged from the Doctors' Trial, providing ten ethical guidelines that stressed voluntary consent, societal benefits, and avoiding harm. It prohibited research with potential for serious injury or death. This code laid the groundwork for future initiatives.
• Helsinki Declaration: This initiative built on the Nuremberg Guidelines to promote responsible research involving human subjects.
• The Belmont Report (1978): Published by the U.S. National Commission, this report further defined key ethical principles in research.

The Nuremberg Code outlined ten basic ethical principles that were violated during the Doctors' Trial, and which now guide ethical research:

1. Voluntary Consent: Research participants must freely agree to participate.
2. Societal Benefit: Research aims should contribute to the good of society.
3. Sound Basis: Research must be based on solid theory and prior animal testing.
4. Avoid Suffering: Research must avoid unnecessary physical and mental suffering.
5. No Serious Harm: No research projects can proceed if serious injury or death are potential outcomes.
6. Risk vs. Benefit: The risks to participants cannot outweigh the anticipated benefits of the results.
7. Proper Environment & Protection: Participants need a safe environment and protection.
8. Qualified Persons: Experiments can only be conducted by scientifically qualified individuals.
9. Right to Withdraw: Human subjects must be allowed to stop participating at any time.
10. Scientist's Responsibility: Scientists must be prepared to stop the experiment if there's reason to believe it will cause harm, injury, or death.

Two primary ethical concerns in research are plagiarism and authorship:

Definition: The act of presenting someone else’s ideas, thoughts, pictures, theories, words, or stories as your own.

Consequence: Plagiarizing undermines the integrity, ethics, and trustworthiness of a researcher's work.

Forms of Plagiarism:

• Intentionally taking a passage word-for-word without proper credit.
• Unintentionally (or lazily) paraphrasing and piecing together fragmented texts from several works without proper citation.
• Note: The scientific community does not tolerate any form of plagiarism, including unintentional plagiarism.

How to Handle Plagiarism:

• Cite all ideas and information that are not your own or common knowledge.
• Use quotation marks when directly using someone else’s exact words.
• Clearly indicate the origin of paraphrased sections and provide proper citations.
• At the start of a paraphrased section, state that the information originated from another source.
• At the end of a paraphrased section, place the proper citation.

Definition: The process of deciding whose names should appear on a research paper.

Responsible Practices: Research often involves collaboration. Responsible authorship means acknowledging all contributions and determining joint authorship when appropriate.

How Authorship is Achieved: Authorship credit should be based on meeting all three of the following conditions:

• Substantial contributions to the conception and design of the work, or the acquisition of data, or the analysis and interpretation of data; AND
• Drafting the article or revising it critically for important intellectual content; AND
• Final approval of the version to be published.

What Does Not Justify Authorship: Simply acquiring funding, collecting data, or providing general supervision of the research group alone is not enough for authorship.

"Can I be a co-author?" Only if you:

• Contribute substantially to the research, AND
• Write or revise all or part of the manuscript, AND
• Approve the final version of the entire article.

Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion.

• Fabrication: Making up or recording false data or results.
• Falsification: Manipulating research materials, equipment, processes, or omitting data to misrepresent the research.
• Plagiarism: Appropriating another person’s ideas, processes, results, or words without giving appropriate credit.

Research involving human subjects requires careful consideration of several ethical principles, crucial for nursing practice. Understanding and applying these principles ensures ethical research, especially in contexts like Uganda:

• Individuals have the right to make their own choices (autonomous decisions), and these choices should be respected. Those who cannot make decisions independently need extra protection.
• Voluntary participants should receive enough clear information to make an informed decision about joining a study.
• Example: In a study about informed consent for child patients, nurses must make sure parents or guardians fully understand the study's purpose, risks, benefits, and their right to remove their child at any time.

Research participants must clearly understand the study and willingly agree to take part.

Information given to participants must be complete, easy to understand, and adjusted to their language and abilities. Participants should never be forced or pressured to join.

Example: Before a study on older patients' pain management experiences, nurses must explain the study's goal, procedures, potential benefits, and risks, so participants can make an informed decision.

Requirements for Informed Consent:

• Information Disclosure: The following must be clearly communicated:
  • Research procedure
  • Purpose of the research
  • Risks and anticipated benefits of participation
  • Alternative procedures (especially in studies involving treatment)
  • A statement confirming participants can ask questions and withdraw at any time.
• Comprehension: Researchers must adapt information to be understandable for each participant, considering their:
  • Different abilities
  • Intelligence levels
  • Maturity
  • Language needs
• Voluntariness: Consent must be given freely, without any pressure or coercion. Participants must be able to decide for themselves whether to participate.

• Protecting participants' sensitive information is vital.
• Participants have the right to control their personal information. Researchers must ensure that all collected data is anonymized (identifiers removed) and stored securely.
• Example: In a study on mental health stigma, nurses must guarantee that participants’ identities and personal details are kept confidential to protect their privacy and prevent potential harm.

• "Doing good." This means maximizing potential benefits while minimizing potential harm to research participants.
• Researchers should aim for studies where the potential benefits clearly outweigh the risks. Participants should not face unnecessary risks or harm. Researchers must be ready to stop a study if it causes harm, and risks should never be out of proportion to expected benefits.
• Example: When studying a new nursing intervention for wound care, nurses must ensure that the potential benefits for patients outweigh any discomfort or inconvenience they might experience.

• Treating people with "fairness."
• This principle prevents certain populations from being unfairly burdened by research so that others can benefit. Researchers should avoid over-testing vulnerable groups (like marginalized communities, children, pregnant women, or those with mental health conditions) and ensure everyone has fair access to research opportunities.
• Example 1: In a study on healthcare access in rural areas, nurses should ensure people from underserved communities have an equal chance to participate and benefit from the findings.
• Example 2: For a study on a new medication for a chronic disease, fairness means including a diverse group of participants (e.g., pregnant mothers, elderly individuals). This ensures the medication's effectiveness is known for a wide range of people who might benefit, rather than only testing it on one group and then expecting everyone to use it.

This section looks into the bodies and roles that ensure ethical conduct and quality in research involving human participants, particularly within the Ugandan context for nursing and midwifery students.

The Institutional Review Board (IRB), also known as the Research and Ethics Committee (REC), is a crucial body. These committees are mandated by states, institutions, and organizations to review research proposals involving human participants to ensure ethical research practices. In Uganda, researchers, including nursing students, must engage with these committees to ensure ethical research. Prominent institutions in Uganda have Institutional-based Research Ethics Committees (e.g., The Uganda Christian University REC (UCU-REC), Mengo Hospital-REC, etc.).

• Mandate: Reviews research proposals involving human participants to ensure ethical standards are met.
• Roles:
  • Balances potential risks and benefits of the research.
  • Protects participants from unnecessary harm.
  • Ensures proportional compensation for participants.
  • Confirms the research is conducted by qualified scientists.
  • Ensures 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.

The IRC ensures rigorous oversight of research projects:

• The IRC shall be composed of five (5) members, of which at least two (2) must be female.
• All members of the IRC MUST have experience in conducting research and possess a minimum of a Bachelor’s Degree.
• The members of the IRC shall be appointed by the Governing Council / Board of Directors from the names proposed by the Principal.
• All IRC members MUST have appointment letters signed by the Chairperson of the IRC.
• The IRC members shall elect from among themselves a Chairperson and Secretary at their first sitting through a simple Majority vote.
• The IRC may co-opt non-voting individuals to provide technical/specialized advice to the Committee or Trainee as may be deemed necessary.
• The IRC may invite non-voting individuals as observers to attend meeting(s) of the IRC.
• The Principal shall be an Ex-officio member of the IRC.

The IRC plays a vital role in guiding and monitoring research within the institution:

• Ensure adherence to UHPAB research guidelines by the institution.
• Evaluate Trainees’ research topics and provide the necessary guidance.
• Allocate Research Supervisors to each Trainee.
• Review and approve Trainee’s research proposals in liaison with the Principal within a stipulated time.
• Advocate for Trainees’ research interests.
• Develop strategies that support/advance the conduct of academic research and related activities.
• Provide feedback and guidance to the Trainee, Research Supervisors, Governing Council / Board of Directors.

A Research Supervisor is a person with a health-related academic background appointed by the IRC to technically guide the Trainee during the conduct of his/her academic research project.

Roles of the Research Supervisor:

• Guide the Trainee during the selection of the research topic and conduct of the research project.
• Guide the trainee on how to access the required resources for conducting his/her research.
• Ensure that the Trainee’s topic is approved by the IRC before development of the full proposal.
• Provide satisfactory advice and guidance on the conduct of the research and preparation of the research report.
• Ensure that the Trainee complies with the UHPAB Academic Research guidelines.
• Ensure that the Trainee complies with the stipulated deadlines for all the required stages of conducting his/her research.
• Encourage the trainee to fully participate in the planning of his/her research and to take personal responsibility for the decisions made.
• Monitor the progress of the trainee’s research conduct.
• Provide timely, constructive, and effective feedback to the Trainee regarding his/her research work and overall progress.
• Promote good research habits by the Trainee, such as guarding against plagiarism.
• Support the Trainee to perform a plagiarism check of the final report using open source Turnitin software, to ensure adherence to the stipulated similarity index of 30%.
• Support the Trainee to print a similarity index report and attach it to the final report.
• Attend trainee’s presentation of the research proposal.
• Promote a professional relationship with the trainees.

The Trainee has specific responsibilities to ensure ethical and successful research:

• Acquire a copy of UHPAB Academic Research Guidelines.
• Adhere to UHPAB Academic Research Guidelines.
• Identify a research topic and submit it to the Research Supervisor for guidance.
• Present and defend his/her research topic to the IRC for guidance and approval.
• Present and defend his/her research Proposal to the IRC for guidance and approval.
• Conduct his/her own research and Participate in every step of the research process.
• Be available / seek guidance from the Research Supervisor.
• Comply with the research deadlines or stipulated time of every stage of conducting research.
• Facilitate his/her own research.
• Avoid any form of plagiarism in the process of conducting research.
• Perform a plagiarism check of the final report using open source Turnitin software, to ensure adherence to the stipulated similarity index of 30%.
• Print a similarity index report and attach it to the final report.
• Submit research reports to the Principal in time for further transmission to UHPAB.