Ethical Principles in Human Research: Belmont & Helsinki

Posted on Mar 25, 2025 in Other university degrees and diplomas

Belmont Report Principles

April 18, 1979, Belmont, USA

Basic Ethical Principles

  1. Respect for Persons: Acknowledging autonomy and protecting those with diminished autonomy.
  2. Beneficence: Do no harm; maximize possible benefits and minimize possible harms.
  3. Justice: Fair distribution of the burdens and benefits of research.

Informed Consent Elements

  • Information

    Subjects must be informed about the research procedure, its purposes, risks and anticipated benefits, alternative procedures (if therapy is involved), and be offered the opportunity to ask questions and withdraw at any time.

  • Understanding

    Researchers are responsible for ensuring the subject comprehends the information. This obligation increases when risks are serious, requiring complete and adequately understood information.

  • Voluntariness

    Agreement to participate must be given voluntarily, free from coercion and undue influence.

Assessment of Risks and Benefits

This requires careful assessment of data, sometimes including alternative ways to achieve the benefits sought. It provides an opportunity and responsibility to gather systematic, comprehensive information about the proposed research. For the researcher, it means examining if the project is properly designed. For a review committee, it’s a method to determine if risks to subjects are justified. For potential subjects, the assessment helps decide whether to participate.

Selection of Subjects

Just as respect for persons requires consent and beneficence requires risk/benefit assessment, the principle of justice demands fair procedures and outcomes in selecting research subjects.

Declaration of Helsinki Guidelines

Helsinki, Finland, June 1964 (and subsequent revisions)

Basic Principles

  1. Biomedical research involving human subjects must conform to generally accepted scientific principles, be based on thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.
  2. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol submitted for consideration, comment, and guidance to an independent ethics committee.
  3. Biomedical research involving human subjects should be conducted only by scientifically qualified persons under the supervision of a clinically competent medical person. Responsibility for the human subject must always rest with a medically qualified person and never with the subject, even though the subject has given consent.
  4. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.
  5. Physicians should refrain from engaging in research projects involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed.
  6. In publishing results, the physician is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.

Medical Research Combined with Professional Care (Clinical Research)

(Details typically follow in the full declaration regarding situations where research is integrated with patient care.)

Non-therapeutic Biomedical Research Involving Human Subjects (Non-clinical Biomedical Research)

(Details typically follow in the full declaration regarding research purely for scientific knowledge without direct therapeutic intent for the subject.)