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Informed Consent – Making Research Conscientious

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Table of Contents

  • What is informed consent?
  • Why is it necessary?
    • Elements of Informed Consent

Privacy may be argued to be a uniquely human concept. Human right to privacy is a cornerstone of successful democracies. We hold the absolute right in deciding what we want to make public about our private life in most cases, barring exceptional and very rare circumstances.

When we click on the ‘Accept’ or ‘Agree’ buttons after scrolling through the terms and conditions of apps we install or services we sign up for, it is this right to privacy that we are exercising and sometimes waiving. This also applies when we participate in medical or clinical studies. Our participation is conditional on us providing informed consent.

What is informed consent?

Informed consent refers to the practice of seeking permission from human participants before beginning a research study. It involves providing participants with all relevant information they need to make a decision about participating in the study and disclosing their personal information or data for the purpose of the study.

Why is it necessary?

Informed consent is an important aspect of research that involves human participation. It finds resonance in a variety of research subjects ranging from the clinical and medical to the psychological and anthropological. Essentially, it demonstrates respect for individual privacy and autonomy in the research process and ensures patients have a say in the study involving them. This helps to safeguard the health, safety, and dignity of individual participants in a study.

Research governing bodies like the National Human Genome Research Institute take the practice very seriously. The European Union’s General Data Protection Regulations (GDPR) prescribe stringent penalties in cases where informed consent regulations have not been adhered to. Therefore, not only does the practice of seeking informed consent enrich the quality of research, it also ensures fewer legal liabilities.

Elements of Informed Consent

Informed consent is the practice of laying bare one’s motives for research so that the participant can choose to participate or not in the research study. In general, the following information must be included while briefing the participants prior to inclusion in a research work.

  1. Purpose of the research
  2. Description of procedure for participation
  3. Institutions under whose aegis the work is being conducted
  4. Potential risks or benefits to the participants
  5. Information regarding who is privy to the data
  6. Steps taken to ensure confidentiality and privacy
  7. Verbal assurance that the participant can withdraw at any point during the process
  8. Information on dissemination

In addition, the researcher must determine two aspects of the consent sought.

  1. The individual must be mentally and physically able to understand and decide for themselves.
  2. The individual must not be coerced by any external force, either to do with the research process or their personal circumstances.

Informed consent is not necessary for those research studies that do not delve into individuals’ lives or use personal data.
Today, the practice of seeking informed consent is so embedded in the research process that it has itself become a focus of scientific enquiry.

If your study involves human participants or private data, and you are unsure how to go about obtaining appropriate informed consent in the correct manner, do not worry. Elsevier Author Services are well-equipped to guide you through every step to ensure you comply with all requirements for human data publishing ethically.

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