Policy

Our policy is that

  • The patient’s health must always come first
  • Ensure patient privacy and security when participating in a clinical trial
  • Respect the patient’s right to a good and equal treatment in which neither race, religion, political opinion nor social position may affect
  • The staff can not use its authority in force so that he / she interferes with the patient’s right to decide over himself
  • Responsible for a professional care
  • Patient confidentiality
  • Develop professional competence of staff continuously

We are committed to follow the laws that apply to clinical drug trials, such as: 

  • Patient Data Act - required to maintain individual medical records in health care
  • Medicines Act – Clinical studies are ethically allowed to be conducted to investigate drug properties
  • Public Access to Information and Secrecy Act – For all who work in health care
  • Privacy Act PUL – with a view to protecting people’s personal privacy, so it is not violated. PUL will be changed from May 25, 2018 to General Data Protection Regulation (GDPR)
  • Patient Injury Law / Pharmaceutical Insurance – health care provider must have a medical insurance that provides compensation under the Act
  • Biobank Act – aimed at protecting individual privacy in the collection and storage of tissue samples
  • Ethical Review Act – Act on Ethical Review of Research Involving Humans

Ethical background

  • Nürnberg Code
  • Helsinki Declaration

The purpose is to protect the individual and respect human dignity in research. Drug testing may take place only after the protocol approved by both the MPA and by the Ethics Committee. ProbarE may at any time be reviewed by both the sponsor, the MPA, EMEA (European Medicines Agency) and FDA (U.S. Food and Drug Administration).

The Ethics Committee will ensure that human rights and fundamental freedoms are always taken into consideration while taking into account the interest of that new knowledge can be developed through research. People’s welfare should take precedence over social and scientific value. Research may be approved only if the risks it may pose to the patient’s health, safety and personal privacy is outweighed by its scientific value.

The patient

Patients should be given on both verbal and written information about the trial order, the methods that will be used, the expected benefits and possible risks, and any effort that the trial can bring. This information should be given the patient without pressure to participate in the trial and the patient should be informed of their right to waive their participation at any time she / he wants without suffering retaliation.

If the patient wishes to stop, she / he remains free to follow up on the respective reception if desired. A patient’s refusal to participate in a trial may never affect the patient-physician relationship. Physicians have a duty to stop a trial with the patient if the disadvantages are found to be greater than the benefits.

After assurance that the patient has understood the information written consent should be given voluntarily by the patient. Patients should be informed that all data is handled with complete confidentiality.

The staff

All staff involved in the study trial must have documented training in GCP – Good Clinical Practice – and should be confident with the rules and standards that this entails. Personnel should also have good knowledge of scientific methodology, good knowledge of the drug studied and experience of the medical care of patients who are planned to be included in the trial.

It requires a documented track record of participation in clinical trials. Staff shall have the relavant qualifications, appropriate for the task and have access to resources throughout the conductance of the trial. Maintenance and advancement of knowledge should be continuous.

Staff must not be dependent of the sponsor, including economic interests which may result in financial gain. Staff must be reachable for the patient during the study trial, for any questions via phone or mail items. In a clinical trial staff shall follow generally accepted rules and laws governing research and government guidelines.

GCP can be summarized briefly:

  • Laws, regulations and policy should be supportive of the work
  • You should ensure patient privacy and patient safety
  • Development of data must be of high quality
  • A collaboration between many professions

On completion of the study period, patients should be offered follow-up. Information of which studied medication was given to the patient during the trial should be given to the patient after the drug trial is completely finished.