Ethical Basis for Conducting Human Studies

Declaration of Helsinki:

It is the statement of ethical principles for medical research involving human subject including research on identifiable human material and data.

Declaration of Helsinki is mainly binds to physicians but it is the property of humanity.

Evolution:

  • Original version: 18th Meeting, Helsinki (1964)
  • First revision: 29th Meeting, Tokyo (1975)
  • Second revision: 35th Meeting, Venice (1983)
  • Third revision: 41st Meeting, Hong Kong (1989)
  • Fourth revision: 48th Meeting, Somerset West (SA) (1996)
  • Fifth revision: 52nd Meeting, Edinburgh (2000)
    • First clarification, Washington (2002)
    • Second clarification, Tokyo (2004)
  • Sixth revision: 59th Meeting, Seoul (2008)
  • Seventh revision: 64th Meeting, Fortaleza (2013)

 Points to be taken:

  • Every physician should promote and safeguard the health, well-being and rights of those who involved in research.
  • The purpose of research is to understand the causes, development and effect of diseases and improve preventive, diagnostic and therapeutic interventions.
  • It`s physician responsibility to protect the life, health, dignity, integrity, privacy and confidentiality of research subject.
  • Physician must consider the ethical, legal and regulatory norms and standards for research involving human subjects.
  • Research must be conducted by individuals with the appropriate ethics, scientific education, training and qualifications.
  • Appropriate compensation and treatment for subjects who are harmed in research must be ensured.
  • Research involving humans may be conducted only if objective outweighs the risks and burdens to the research subjects.
  • The design and performance of each research study must be clearly described and justified in protocol.
  • In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.
  • The protocol must be submitted for review and approval of ethical committee before it begins.
  • Every precaution must be taken to protect privacy of research subject and confidentiality of personal information.
  • Every research study must be registered in a publicly accessible database before recruitment of first subject.

Informed Consent:

Informed consent is a mutual agreement process between a healthcare professional or (a medical practitioner) and competent volunteer (or patient) to enlighten about consequences to make a choice to accept or reject investigational trail or treatment.

It is the legal and ethical right of the human being where the subject has an opportunity to be an informed participant in their health care decisions.

Informed consent is a process that includes following steps:

  • Advising on the possible risks and benefits of the
  • The risks and benefits of other options, including not getting treatment.
  • Ask questions and get them answered to your satisfaction.
  • Discuss the plan with family or advisors.

Elements of Informed Consent:

The IC includes following elements

  • The nature of trial/intervention and its procedure
  • Reasonable alternatives to the proposed trails
  • Risks, uncertainties and benefits related to each trail
  • Assessment of volunteer/patients understanding
  • Acceptance of volunteer/patient

Components of Informed Consent:

Three main important components of the IC are Disclosure, Capacity and Voluntariness.

Disclosure:

The healthcare professional should provide the necessary and adequate information to the volunteer in a layman language and assess the understanding level.

Capacity:

The ability of the volunteer to understand and judge possible outcomes of his decisions

Voluntariness:

It is the ethical right of human to decide to participate or not voluntarily and should not be forced.    

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