Ethical Guidelines

Ethical Guidelines and Regulatory Documents

National Guidelines (India)

  1. ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017)
    • Issued by the Indian Council of Medical Research (ICMR)
    • Core guidance on informed consent, risk-benefit, privacy, vulnerable populations, and ethics review processes
  2. New Drugs and Clinical Trials Rules, 2019 (NDCTR)
    • Under the Drugs and Cosmetics Act, governed by the Central Drugs Standard Control Organization (CDSCO)
    • Mandatory registration of Ethics Committees and approval process for clinical trials
  3. Good Clinical Practice (GCP) Guidelines – Indian Version
    • Defines responsibilities of sponsors, investigators, and Ethics Committees
    • Emphasizes data integrity, participant safety, and ethical conduct of clinical trials
  4. Biomedical and Health Research Regulations, 2019
    • Outlines approval pathways for academic/non-regulatory human research studies
  5. Information Technology Act, 2000 (with amendments)
    • Pertinent to digital data protection and cybersecurity in research involving electronic health data

International Guidelines

  1. Declaration of Helsinki (World Medical Association)
    • Foundational ethical guidance on human research, particularly for physicians and medical researchers
  2. International Council for Harmonisation – Good Clinical Practice (ICH-GCP)
    • Globally recognized standard for ethical and scientific quality in designing, conducting, and reporting trials
  3. CIOMS Guidelines (Council for International Organizations of Medical Sciences, 2016)
    • Focuses on ethics of international biomedical research, especially in low- and middle-income countries
  4. Belmont Report (U.S.)
    • Outlines ethical principles of respect for persons, beneficence, and justice—widely referenced in human research ethics
  5. UNESCO Universal Declaration on Bioethics and Human Rights (2005)
    • Affirms human dignity, autonomy, and equality in all biomedical activities

Welcome to ACEAS IEC

ACEAS has an Independent Ethics committee named ACEAS – Independent Ethics committee (ACEAS – IEC) is constituted for protection of the rights, safety, and well-being of clinical trial subjects (patients and healthy human volunteers) participating in clinical trials at the sites of Contract Research Organizations, Hospitals, and Clinics, in conformation to the requirements and guidelines of:

  • Good Clinical Practice (GCP), Guidance for Industry, E6, developed by the Expert Working Group (Efficacy) of the International Conference on Harmonization for the Technical Requirements for registration of Pharmaceuticals for Human Use (ICH), for adoption to the regulatory bodies of the European Union, Japan, and the United States.
  • Good Clinical Practice Guidelines for Clinical Research in India, Central Drug Standards and Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, New Delhi.
  • Ethical Guidelines for Biomedical Research on Human Subjects, Indian Council of Medical Research, Government of India, New Delhi.
  • Schedule-Y of the Drugs & Cosmetics Act, 1945.