Version 2.0/ 06.10.2016/EN
INFORMATION FOR POTENTIAL PARTICIPANTS
Study:
The Finnish Hematology Registry (FHR): a population-based follow-up study on the emergence, incidence, diagnostics, treatments and outcomes of haematological disorders and hereditary bleeding conditions in Finland
Dear candidate,
We are writing to you to ask if you would like to participate in the study outlined below.
Background
Despite being rare, blood disorders have a significant clinical, scientific and health-economic impact. Comprehensive and up-to-date information on the emergence, incidence, diagnostic methods, available treatments and prognosis of blood disorders is insufficient in Finland, which has an impact on the development of treatments and quality assessment. Due to the increasing restrictions on the standards governing the safety of medicinal products, European and American medicines agencies have started to require systematic follow-up data on the use of new medicinal products and therapeutic substances, such as plasma-derived products. This can only be achieved with the help of a nation-wide registry. The duty to maintain a registry includes disclosing information to foreign registries without identifying information, such as personal identity number or place of residence details.
Together with its subordinate organisations the Hematological Disorders Study and Treatment Group and the Finnish Hemophilia Group, the Finnish Hematology Association (SHY) launched the registry project (The Finnish Hematology Registry, FHR) in 2009. With the help of the registry, the association aims to collect comprehensive data on the emergence, incidence, diagnostic methods, treatments, monitoring and prognoses of blood disorders in Finland. In the future, FHR will be a central tool for planning the treatment of blood disorders and providing consistent treatment in Finland in order to meet the requirements of the standards governing the safety and efficacy of medicinal products.
Study plan:
Everyone who has been diagnosed with a disease affecting blood-forming tissues or the lymphatic system or a hereditary or acquired coagulation disorder is asked to consent to the trial. All participants have been diagnosed with a condition that falls into one of the groups mentioned above. Patients with these disorders usually receive treatment at specialist clinics. Follow-up visits, however, can be arranged at regular outpatient clinics depending on the condition and stage of treatment.
The goal of the study is to collect information about the conditions from patient records. Patient records refer to all information on the disease accumulated at the participant’s treatment unit and treatment, including laboratory test and diagnostic imaging results as well as treatments given and their outcomes. Participation in research will not subject patients to any additional measures. Participation in this study or withdrawing from it will not affect the treatment given to the patients.
After submitting their written consent to participate in the study, the data collected from the participants’ patient records are recorded in a special study database, which will form the Finnish Hematology Registry. The data are saved directly to the electronic database. Basic data collected about the participants are the same, but information specific to each disease is also collected, so the types of data gathered depend on the disease.
Personal identity number is among the types of data to be collected in the study, but it can only be seen by the principal investigators and the staff of the treatment unit. Personal identity number authenticates the participant’s data when they are entered into the system.
In addition to patient records, data for the registry may also be collected from the Population Register Centre’s Population Information System, the Finnish Cancer Registry, Statistic Finland’s causes of death registry, Hospital Discharge Registers as well as parish records, provincial archives and local register offices pursuant to the applicable criteria.
The Finnish Hematology Registry will be built upon the results of this study. The registry will simultaneously consist of components that collect data and components that enable browsing and analysing data. The research project staff and doctors studying and treating haematological disorders can browse the data stored in the registry. The data will be displayed without any identifying information (e.g. ‘male, born in 1954, chronic lymphocytic leukaemia’).
In order to ensure confidentiality of personal data, the database cannot be accessed without a user name and password. Database use is also registered in a log, and the data stored in the log can be used to identify users of the database. Data are entered and browsed via a secure connection. The up-to-date description of the personal data file will available at the treatment centres and online at
In the future, the registry will be a permanent and integral part of patient care. Anonymised information may be disclosed to pharmaceutical companies in joint data collection and analysis projects with SHY.
Benefits and disadvantages
The purpose of the study is to collect information that is not currently available to help develop the treatment of blood and coagulation disorders. Blood disorders are rare as individual diseases, meaning that the data collected from each participant is valuable. The development of new treatments can be streamlined when the nation-wide situation is better understood. While the study might not directly benefit an individual participant, it will improve the treatment of patients with the same or another blood disease in the future.
Participation in the study is voluntary, and not consenting to participate will not affect other treatments in any way. Participants can also withdraw from the study at any time without disclosing the reason. In a case like this, data are no longer recorded and the participant’s personal details are deleted. Data which have already been recorded, however, cannot be deleted due to technical reasons. The recorded data will match the data found in patient records, so changes made to patient records pursuant to the right of access will be imported into the registry where applicable.
If you have any questions, please do not hesitate to get in touch.
On behalf of the project group,
Perttu KoskenvesaLicentiate of Medicine, consultant haematologist, controller
HUH Comprehensive Cancer Center, Hematology Division, tel. +358 (0)50 4286281 / Kimmo Porkka
Professor, clinical director
HUH Hematology Outpatient Clinic
Riitta Lassila
Professor, clinical director, Coagulation Disorder Unit
HUH Hematology Outpatient Clinic / Kari Remes
Professor, clinical director
TYKS Internal Medicine
Study: The Finnish Hematology Registry (FHR): a population-based follow-up study on the emergence, incidence, diagnostics, treatments and outcomes of haematological disorders and hereditary bleeding conditions in Finland
CONSENT
I have read and understood the written description of the study mentioned above and I hereby give my voluntary consent to participate in the study. I understand that participation in the study will not affect the treatment I receive in any way. I can withdraw from the study at any time and it will not affect the treatment I receive later in any way.
I require that the persons carrying out the study take the appropriate information security measures.
I give my consent for
1) an authorised person to collect information from my patient records for the research database
2) my data to be browsed and saved in a secure browser-based environment
3) my data to be disclosed to international registries without my identifying information
Yes No
______
DateSignature
______
Place of domicileName in block letters
______
Personal identity code
Legal guardian or representative on behalf of a person under the age of 15 or a person with a legal guardian:
______
DateSignature
______
Name in block letters
This is the participant’s copy
Study: The Finnish Hematology Registry (FHR): a population-based follow-up study on the emergence, incidence, diagnostics, treatments and outcomes of haematological disorders and hereditary bleeding conditions in Finland
CONSENT
I have read and understood the written description of the study mentioned above and I hereby give my voluntary consent to participate in the study. I understand that participation in the study will not affect the treatment I receive in any way. I can withdraw from the study at any time and it will not affect the treatment I receive later in any way.
I require that the persons carrying out the study take the appropriate information security measures.
I give my consent for
1) an authorised person to collect information from my patient records for the research database
2) my data to be browsed and saved in a secure browser-based environment
3) my data to be disclosed to international registries without my identifying information
Yes No
______
DateSignature
______
Place of domicileName in block letters
______
Personal identity code
Legal guardian or representative on behalf of a person under the age of 15 or a person with a legal guardian:
______
DateSignature
______
Name in block letters
Consent received:
______
Date______
Signature and name in print
This copy is submitted to the registry for information purposes
1