Ethical Research Practices For Research with Human Subjects

by Elizabeth Oommen George
Ethical Research Practices For Research with Human Subjects

Research that involves human subjects can be a delicate and complex matter that requires meticulous attention to ethical research practices. However, this wasn’t always the case; a few decades ago, researchers were not required to take consent from human subjects. This changed in 1947, when the Nuremburg Code laid the blueprint that ensured the rights of subjects in medical research. This was followed by the Belmont Report and the Declaration of Helsinki that emphasised the need for the protection of human subjects and the importance of following ethical research practices. Today, conducting bio-medical and scientific research with human subjects involves adhering to prescribed ethical research principles set by individual countries and their regulatory bodies. In this article, we will explore the importance of ethical research practices, and what researchers should keep in mind to meet global standards when conducting research with human participants.

Table of Contents

Importance of ethical research practices

Ethical research methods ensure that researchers do not exploit the vulnerability of their subjects, and that all necessary precautions are taken to prevent harm. Following ethical research practices is also essential to protect the reputation and credibility of researchers and their institutions.

Upholding human dignity

The basic ethical research principle is the preservation of human dignity. It demands that researchers treat each participant with respect, acknowledging their autonomy and individuality. While it can be easy to treat them impersonally as subjects for your experiments, be mindful that they are humans and must be treated with respect, including ensuring consent, confidentiality, and the right to withdraw.

Ensuring unbiased selection

Research ethics extends beyond individual interactions to address systemic issues of fairness and justice. Researchers are expected to consider potential biases and ensure inclusivity in their participant selection. Ethical research practices demands there be no discrimination based on gender, race, or any other characteristic.

Safeguarding participant welfare

Ethical research methods prioritize the welfare of human subjects and researchers are obligated to minimize potential harm and maximize benefits. Here, rigorous risk assessment and risk-reduction strategies are crucial components. For instance, if a medical study involves experimental treatments, careful monitoring and ethical oversight are mandatory to safeguard participants’ health.

Guaranteeing the validity of research

Ethical research practices are not just about ethics; they are also about the quality and validity of research outcomes. When ethical principles are upheld, it enhances the credibility of the research, which is then more likely to be trusted and accepted by the scientific community and society at large.

Building public trust

Amid rampant skepticism and misinformation, demonstrating a commitment to ethical research practices can help researchers gain the trust of the public, funding agencies, and regulatory bodies. This trust is essential for the continued advancement of scientific knowledge.

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9 Ethical research practices for researchers

It is crucial for researchers to adhere to ethical research practices to ensure that their work is not only scientifically valid but also socially responsible. The ultimate driving factor should be to ensure the well-being and rights of participants and this can be achieved with proper planning. Here are some key professional, institutional, and global standards that researchers must keep in mind and follow while conducting ethical research with human participants.

  1. Understand ethical research guidelines: Researchers must know and follow the ethical research principles set by organizations, such as the American Psychological Association (APA) or the World Medical Association (WMA). Researchers must also get the required approvals from Institutional Review Boards, which assess the ethical aspects of the research, ensuring that participants are adequately protected.
  2. Lay down participant criteria: The criteria for selecting participants must be very specific and clearly laid out and researchers should strictly follow these without any dilution. This ethical research practice ensures that there is no deviation or bias in the selection of volunteers, which could impact the outcome of the research.
  3. Clarify recruitment and participant criteria: During the recruitment of participants, researchers must clearly mention that the research process is experimental. One should avoid making undue promises of positive outcomes of an experiment. Researchers must ensure that participants have a clear understanding of the nature and purpose of the research, as well as the risks and benefits of participation. Participants must be free to make an informed decision to participate in the research voluntarily.
  4. Ensure informed consent: One of the most important things that researchers need to ensure when conducting experiments involving human subjects is to take their consent without deception or coercion. A formal consent form examined and approved by an Ethics Committee or Institutional Review Board must be completed by the volunteer before they can participate in any study. This is to ensure that the research teams and the participants’ needs are in agreement. These consent forms also have information on rights of withdrawal and how volunteers should be paid for their participation in the research experiment.
  5. Avoid deceptive practices: There may be instances where the researcher may not be in a position to reveal the exact nature of the experiments being conducted or where the volunteers are not aware of the purpose of the research. This happens mostly in cases where such acts will result in altering the phenomena under study. In these cases, an ethical research practice is to mention this in advance and justify the same.
  6. Take necessary precautions: Sometimes experiments may involve an element of risk, which can involve physical or psychological distress and discomfort, and an intrusion into volunteer privacy. However, when conducting experiments using ethical research methods, researchers must take all precautions and strive to mitigate any potential harm to participants.
  7. Monitor experiments: While you may have taken the necessary precautions, it is critical that the participants’ status be monitored during the course of the experiment. Along with looking at the progress of the experiment, the focus here is to see if the participants are facing any harm or discomfort and to act to mitigate these risks at the earliest possible instance.
  8. Maintain confidentiality: Ensuring the volunteer’s confidentiality and anonymity is an important ethical research practice. Researchers must safeguard the privacy of volunteers and ensure that their personal details are not disclosed without their consent. This can be done by storing data securely to prevent unauthorized access and by using pseudonyms or codes to protect participants’ identities.
  9. Acknowledge their right to leave: Researchers should be aware that experiments involving human subjects entail an important condition, that is, the right to withdraw. This important ethical research principle gives volunteers the right to walk out at any stage in the research process. If volunteers choose to walk away from the study, researchers must know that they cannot be enforced or pressurized to participate under any condition.

Finally, it’s critical to understand that ethical research practices are not optional. Researchers must ensure their research design and methodology are sound, that any potential conflicts of interest are identified and managed appropriately, and that the study is conducted in an unbiased and transparent manner. By embracing ethical research methods and principles, researchers contribute to the advancement of knowledge while safeguarding the rights and well-being of those who participate in their studies.

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