Research Ethics Committee
The Rīga Stradiņš University (RSU) Research Ethics Committee was established in 1996. It is in charge of assisting students and academic staff by providing consultations and assessing the ethical aspects of medical research. The Research Ethics Committee acts in conformity with the Regulations of the Research Ethics Committee, international legislation and the regulatory enactments of the Republic of Latvia with regard to biomedical research. The Committee is independent in its decisions.
Research Ethics Committee
- Committee Members
Documents for Submission
- Application to the Research Ethics Committee (see E-8.1 form below) that includes
- the required information,
- the date of submission,
- applicant's and research supervisor's signatures.
- Application for permission to use documented patient data in research studies (see E-8.2 form below) must be submitted in addition to form E-8.1 if the research will be carried out by a student and will involve the use of patient data without the patient’s consent.
- A research protocol (brief description of the study) that includes
- where and how the study will be conducted,
- a description of the methods and equipment that will be used (including forms and informed consent forms for patients or participants, if applicable),
- as well as a description of data processing.
- Please note that you must obtain an affirmative decision from the RSU Research Ethics Committee prior to commencing your research at any medical or other facility!
- Subsequent permission to access medical documentation, use thereof, or working with patients (if necessary) must be obtained from the person or institution responsible for the relevant medical treatment institution (hospital).
Guidelines for drawing up informed consent forms for research participants or patients
- Nature and aim of the study
- Source of funding (if applicable)
- The nature, course and duration of the study, including information on any encumbrances (additional visits, etc.)
- Benefits and risks, including measures to prevent or mitigate risks
- Privacy protection and confidentiality
- Availability of results
- Information on the further use of results, data, biological samples, including for commercial use
- Research participant rights, including the right to refuse to participate or to terminate participation at any time
- Contact information for the researcher and the RSU Ethics Committee
Information on personal data processing
- Detailed information about the personal data that will be processed as part of the study
- Information on the storage of personal data, including the duration of storage and the action to be taken in the event of the person's withdrawal from the study
- Information about the data controller (in student research, the data controller is the student who is conducting the research, unless otherwise agreed with the institution from which the data was obtained)
- Contact information of the data controller
- Right to lodge complaints
General framework for the use of personal or patient data in research
Law on the Rights of Patients
Informed consent – Section 11, Paragraph four of the Law on the Rights of Patients:
- Prior to involvement in a clinical trial, a patient shall be provided information (written informed consent) regarding the relevant clinical trial, its controller and processor, the aim, purposes and legal basis for the processing of personal data, methods, duration, expected benefit and risk, the conditions for implementation of the clinical trial, confidentiality, recipients of personal data and categories of recipients, the period for which the patient's personal data are stored, information on the transfer of patient’s personal data to third countries, as well as information regarding the right to withdraw from participation in the clinical trial at any time and and the right to lodge a complaint to the supervisory authority.
General Data Protection Regulation (GDPR)
Art. 13, recital 33 of the GDPR:
- Data subjects/patients/volunteers should be allowed to give their consent to certain areas of scientific research when in keeping with recognised ethical standards for scientific research. Data subjects should have the opportunity to give their consent only to certain areas of research or parts of research projects to the extent allowed by the intended purpose, i.e. the data subject must be proactive in making the decision: it is desirable to separate the stages of the research in the informed consent and to allow the data subject to agree separately to each, for example to consent to the use of medical records if this is not the main purpose of the research but rather an additional function to collect information.
Questions to be answered by the researcher to clarify legal aspects
- Who is conducting the research?
- Who is the initiator or in whose name will the research be conducted?
- What is the nature of the study?
- Research description.
- Why is this research necessary?
- How will the data be processed?
- Finding patients, taking tests, using medical records, etc.
- What methods will be used?
- Analysis, interviews, observation, medical history, etc.
- Cooperation partners?
- Hospitals, laboratories, etc.
- How long, how, where and in what format will the data be stored?
- Anonymised/pseudonymised, servers, databases, on paper/digitally
- Who will be provided with the data and results, or where will the results be published?
- Cooperation partners, databases, etc.
- Where will the research participants/patients be found?
- Hospitals, laboratory databases, via phone, or social networks, etc.
- How will patients' informed consent be drawn up?
Laws and regulations related to the use of patient data recorded in the documents, including in research that is part of the study process
Sections 10 (7), (8) and (81) of the Law on the Rights of Patients sets out requirements for the use of patient data in research studies.
With patient consent to participate in the research:
(7) Patient data registered in medical documents may be used in a trial if one of the following conditions applies:
- the patient cannot be directly or indirectly identified according to the information to be analysed;
- the patient has provided written consent that the information regarding them may be used in the specific trial.
Studies where data is to be used without patient consent (retrospective studies):
(8) Patient data registered in medical documents may also be used in trials without complying with the conditions referred to in Paragraph (7) of this Section, if the following conditions exist concurrently:
- the trial is being carried out in the public interest;
- a competent State administration institution has authorised the use of patient data in the specific trial in accordance with the procedures specified by the Cabinet;
- the patient has not previously prohibited the transfer of their data to a researcher in writing;
- patient consent cannot be obtained with commensurate means;
- the trial’s public health benefit is outweighs the restrictions on the right to privacy.
The competent state administration institution is the Centre for Disease Prevention and Control (CDPC). Cabinet Regulation No 446 Procedures for Using Patient Data in Specific Research/ 04.08.2015
For student research studies that plan to use data without patient consent (retrospective studies):
(81) Patient data registered in medical documents may be used to develop research studies within study programmes that are part of the Healthcare direction at an educational institution, and that don’t comply with the provisions of Paragraph (7) of this section provided that the following conditions exist at the same time:
- the research work has been developed in the public interest as part of a first or second level professional, bachelor’s, master's or doctoral higher education medical programme;
- patient consent cannot be obtained with reasonable means;
- the public health benefit of the research study outweighs the restriction of the right to the inviolability of privacy;
- the patient has not previously prohibited their data to be transferred for research purposes;
- the Ethics Committee has evaluated the research study’s compliance with Clauses 1, 2 and 3 of this Paragraph, approved the research protocol, permitted the use of patient data for the particular study by assessing its compliance with the principles of research ethics and personal data protection requirements and the scientific and social value of the work.
Central Medical Ethics Committee (CMEC)
- The ethical issues of biomedical progress related to social problems;
- Moral values and norms […] in genetic, sex selection, transplantation and other scientific research (scientific qualification is attested by a doctoral degree awarded by the doctoral degree awarding council (doctoral committees). The equivalence of a scientific degree obtained abroad takes place in accordance with international agreements binding on Latvia);
- biomedical research that involve people in accordance with medical ethical standards;
- the compliance with ethical principles in genetic research, the creation of a genome database and the operation of its main processor.
Cabinet Regulation No 9 Statutes of the Central Medical Ethics Committee/ 13.01.1998.
Genome Research Council
Genetic research can be commenced if the genetic research programme or project in question has received:
- A positive decision from the Genome Research Council;
- The permission of CMEC.
In order to be able to export (ship) coded tissue samples or descriptions of health conditions outside Latvia, an application must be submitted to the Genome Research Council.
Centre for Disease Prevention and Control
The CDPC issues permits for the use of patient data recorded in medical records in a specific research where consent cannot be obtained (retrospective studies).
Cabinet Regulation No 446 Procedures for Using the Patient Data in a Specific Research/ 04.08.2015
RSU Research Ethics Committee
The Committee examines the applications from lecturers and students (from RSU or other universities) and expresses its opinion regarding:
- research relating to professional care (clinical trials);
- biomedical research in basic medical disciplines;
- respect for personal data, ethics, confidentiality and the protection of privacy rights in research.
State Agency of Medicines
To detect, or test the clinical and pharmacological activity of investigational medicinal products, adverse reactions, etc., you need to be authorised by the State Agency of Medicines.
Cabinet Regulation No 289/ 23.03.2010
Authorisations from hospitals’ scientific institutions
An authorisation from the relevant scientific institution or a responsible official at the relevant hospital (in accordance with the procedures laid down in the internal laws and regulations of the hospital) must be obtained In order to implement the planned research or any part thereof at a medical treatment institution or hospital.
Applications are processed during Research Ethics Committee meetings that take place on the last Thursday of every month. If an application is received after the last Thursday of that month, it will be processed on the last Thursday of the following month.
There are exceptional cases when the Research Ethics Committee can meet twice a month if it has received many applications. Please note that the Research Ethics Committee does not meet in July and August.xx