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 Necessary information for informed consent Minimize

As a potential participant or participant you have the right to be informed on :

  • What the purpose of the clinical trial is;
  • Trial treatments and possibility of random assignment to each treatment;
  • Methods and procedures to be followed or used during the trial ;
  • Alternatives apart from participating in research;
  • Potential or real harms and risks involved in participating;
  • Expected benefits to you as a participant and/or other persons in the trial;
  • Extent to which confidentiality and privacy will be maintained;
  • Available insurance in event of injury or damage caused whilst participating in a trial;
  • Who the contact person is in the event of a trial related injury
    incentives given for participation. Any differences across sites in incentives must be explained;
  • The availability of treatment beyond the duration of the clinical trial;
  • Who the sponsor is and any potential conflict of interests;
  • Proof of ethics committee approval.

All people who are able to give informed consent or on whose behalf a valid informed consent is obtained can participate in clinical trials. Participants include the whole of people from unborn children, children, adults to the older persons, males or females, the very healthy to the critically ill.

You may participate indirectly or passively in a clinical trial by giving your consent for the use of medical information contained in your previous or current medical records that are held by your healthcare provider (e.g doctor).

Guidelines exist by which the suitability of a person to participate in a specific clinical trial is determined. Inclusion criteria are those guidelines which determines who should be included in a trial. Exclusion criteria are those guidelines which determines who should not be included in a specific trial.

Inclusion and exclusion criteria are extremely important, are designed to protect the trial participants and to ensure that the objectives of the trial are achieved without unnecessary complications.


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