Grifols is firmly committed to the safety of patients who participate in the clinical trials that it oversees and sponsors. All clinical research led by Grifols or on its behalf adheres to the standards established by the International Conference on Harmonisation Good Clinical Practice (ICH GCP); the protection of human beings under the Helsinki Declaration (1964); and applicable local laws and regulations. The company does everything within its means to protect the rights, safety and well-being of participants in its clinical trials. For Grifols, these principles are most important and should prevail over corporate, scientific or social interests.
All clinical trials follow a detailed protocol to guarantee the safety of participants and the integrity of the collected data. Before the start of any clinical trial, Grifols sends the protocol to regulatory authorities and external ethics committees made up of healthcare professionals and specialists from other sectors to ensure it respects the dignity, rights, safety and well-being of trial participants. Clinical trials do not launch until a favorable decision has been handed down. Once approved, they strictly adhere to the guidelines established by the Ethics Committee, the institution, ICH GCP and applicable regulatory requirements, including approval by the corresponding health authorities.
Each participant must submit a written informed consent form that is personally signed and dated. The Principal Investigator (or assigned healthcare professional) provides appropriate information, resolves any doubts and gives potential clinical-trial subjects sufficient time to make an informed decision on their participation. The participation agreement is strictly voluntary and subjects can freely withdraw their consent at any time during the clinical trial.
In order to assure quality control, Grifols ensures that its standard operating procedures in the conduct of clinical trials and collection comply with protocols, ICH GCP and applicaple regulatory requirements. Moreover, an additional procedure allows clinical personnel to detect and document any potential fraud or misconduct during clinical trials.
Grifols has several measures to promote the transparency of its clinical trial data, which always maintains the anonymity of its subjects. More information on the protocol, status of clinical trials and related results are published on publicly accessible registries such as www.clinicaltrials.gov. Moreover, the results of clinical trials carried out within the framework of the European Medicines Agency (EMA) are published on the EudraCT website.
Grifols discloses the results of many of its clinical trials in international conferences and scientific journals.
For decades, the use of animals in biomedical research has led to significant medical advances for both human and animal health as a means to test the effectiveness and safety of medications. Grifols is committed to the responsible use of laboratory animals in cases in which animal testing is indispensable to develop new life-saving therapies.
Grifols scientists work closely with regulatory agencies and the Institutional Animal Care and Use Committee (IACUC) to guarantee the safe and human treatment of research animals regardless of whether its studies are carried out in university settings or in contracted external laboratories.
All of the Grifols’ facilities are approved by the pertinent authorities in regions where research is conducted. In the United States, facilities are certified by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) or an equivalent organization and possess the highest accreditation possible for laboratories that perform animal testing. In Europe, all laboratories comply with the Directive EU 2010/63 on the protection of animals used for scientific purposes and undergo inspections by the relevant authorities in each country.
The company also adheres to the “Alternatives and the 3Rs” protocol as guidelines in the treatment of animal testing: Replace the use of animals whenever possible or avoid their use altogether; Reduce the number of animals used to a minimum; and Refine the way research is carried out to ensure animals suffer as little as possible.