Chapter 6: Research

• Bioethics


  The study of the ethical issues emerging from advances in biology and medicine
• Principles of Ethics in Research


  • Nuremberg Code
  • Declaration of Helsinki
  • Belmont Report
• Ethics


  An understanding of the nature of conflicts arising from moral imperatives and how best we may deal with them
• Ethical principles


  General rules that operate as a foundational rationale for the numerous specific ethical guidelines and assessments of human behavior
• Research


  A process of systematic inquiry that entails collection of data; documentation of critical information; and analysis and interpretation of that data/information, in accordance with suitable methodologies set by specific professional fields and academic disciplines
• Research Ethics


  The application of fundamental ethical principles to research activities which include the design and implementation of research, respect towards society and others, the use of resources and research outputs, scientific misconduct and the regulation of research
• Importance of Research Ethics


  • Ethical strategies ensure the integrity of the research results and protect the safety of patients who volunteer to participate in the trials
  • Ethical parameters help prevent participants from being exploited or treated unfairly by the research team
  • Adherence to ethical principles encourages transparency and rigorous methodology, hence increasing the credibility of study findings
  • Ethical norms serve as a barrier to exploitation, encouraging fair and courteous treatment of individuals
• Principles of Ethics in Research

  • Respect for the Human Person
  • Informed Consent
  • Beneficence and non-maleficence
  • Justice
  • Confidentiality & Data Protection
  • Integrity
  • Conflict of Interest
• Respect for the Human Person


  All participants in research must take part voluntarily, free from any coercion or undue influence, and their rights, dignity and autonomy should be respected and appropriately protected
• Informed Consent


  Research participants are adequately and properly informed regarding the nature of the research project
• Beneficence and non-maleficence


  Researchers should do good to and should not harm one's patients, clients or research participants
• Justice


  Research participants should be treated fairly
• Confidentiality & Data Protection


  Individual research participant and group preferences regarding anonymity should be respected and participant requirements concerning the confidential nature of information and personal data should be respected
• Integrity


  Research should be designed, reviewed and undertaken to ensure recognized standards of integrity are met, and quality and transparency are assured
• Conflict of Interest


  The independence of research should be clear, and any conflicts of interest or partiality should be explicit
• Indian Council of Medical Research (ICMR) is the apex body to formulate, conduct, coordinate and promote biomedical research
• Statement of General Principles of ICMR

  • Principles of essentiality
  • Principles of voluntariness, informed consent and community agreement
  • Principles of non-exploitation
  • Principles of privacy and confidentiality
  • Principles of precaution and risk minimization
• Principle of voluntary participation


  Participants are not coerced or forced to continue with the experiment against their will. Recognizes their right to make decisions about their own well-being and to withdraw from the experiment if they feel it's necessary for their health or comfort.
• Termination of studies


  Scientist in charge must be prepared to terminate the experiment at any stage if they have probable cause to believe that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
• The Declaration of Helsinki was created in 1964 by the World Medical Association (WMA)
• World Medical Association (WMA)


  International representative organization for members of the medical community including doctors, researchers, dentists, and more. Does not have any legal authority.
• The WMA was established in 1947 to handle the growing concern of unethical medical practice which became more apparent during and after World War II
• Declaration of Helsinki

  Ethical guideline, rather than a document with international legal implications. Set the standard for ethical human experimentation conducted by researchers. Balances the interests of humanity and individual patients who are part of clinical trials.
• The Declaration of Helsinki has had significant influence on many medical governing bodies and guidelines
• Basic principles of the Declaration of Helsinki

  • Respect for individuals
  • The right to make informed decisions
  • Recognition of vulnerable groups
• The Declaration of Helsinki has been revised six times, in 1975, 1983, 1989, 1996, 2000, and 2008
• The fifth revision in 2000 caused considerable controversy, and the U.S. FDA refused to refer to the new version and instead continued using the document from 1989
• In 2006, the U.S. FDA discontinued referring to the Declaration of Helsinki at all, and the European Commission only uses an older version from 1996
• This lack of cohesion has weakened the Declaration of Helsinki's influence over the years, but it is still viewed as a pioneering effort to ensure that patients involved in clinical trials are treated with fairness around the world
• Revisions of the Declaration of Helsinki

  • 1975
  • 1983
  • 1989
  • 1996
  • 2000
  • 2008
• The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic methods, procedures and treatments
• Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights
• The obligation to protect research subjects lies solely with the physician or other healthcare professionals, and should never be delegated to the research subjects, regardless of their consent
• Medical research should be conducted in a manner that minimizes possible harm to the environment
• Groups that are underrepresented in medical research should be provided appropriate access to participation in research
• Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured
• Before conducting any medical research involving humans, it is essential to thoroughly evaluate the anticipated risks and challenges to both individuals and groups involved, weighing them against potential benefits
• Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group
• The research protocol must be submitted to the ethics committee before starting the study. The committee must be transparent, independent, and qualified, considering local and international regulations without compromising subject protections
• Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information