E-ISSN 2231-170X | ISSN 2231-1696
 

Protection of Research Participants (Statement On Human And Animal Rights)



Research involving human and animal subjects must adhere to ethical guidelines to protect their rights and welfare. The Indian Council of Medical Research (ICMR) and the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) provide frameworks for ethical conduct in research. Key principles include informed consent, confidentiality, and the humane treatment of animals.

ICMR guidelines:

CPCSEA guidelines:

Human participants:

  • Informed Consent: Researchers must obtain voluntary, informed consent from participants before enrolling them in a study. Participants should be fully informed about the study's purpose, procedures, potential risks and benefits, and their right to withdraw at any time.
  • Privacy and confidentiality: Protecting participants' privacy and confidentiality is crucial. Researchers should take steps to anonymize data, use pseudonyms, and ensure that identifying information is not disclosed without consent.
  • Ethical review: Research involving human participants should be reviewed and approved by an Institutional Review Board (IRB) or Institutional Ethics Committee (IEC).
  • Declaration of Helsinki: All human research should be conducted in accordance with the Declaration of Helsinki, which outlines ethical principles for medical research involving human subjects.

Animal subjects:

  • Ethical treatment: Researchers must ensure the humane treatment of animals used in research, minimizing pain and suffering.
  • The 3Rs: The principles of replacement, reduction, and refinement (the 3Rs) should guide animal research.
    1. Replacement: Using alternatives to animal models whenever possible.
    2. Reduction: Minimizing the number of animals used in a study.
    3. Refinement: Modifying procedures to reduce pain and distress in animals.
  • Ethical approval: Research involving animals should be approved by an Institutional Animal Ethics Committee (IAEC).