APPROVED
Lithuanian Bioethics Committee Biomedical Research Expert Group 2016 November 15 decision
Recommendations of the Lithuanian Bioethics Committee for the Informed Person Consent Form
The purpose of these Guidelines is to assist biomedical research clients and researchers in preparing informed consent
forms. The guidelines explain the requirements for the informed consent form and provide examples.
Exemplary formulations are more focused on patients in clinical trials
information, but may be extended to other biomedical research.
It is important to note that the Requirements are common to both clinical and non-clinical applications of the medicinal product
Informed Consent Forms used in biomedical research. Therefore, not all of them are applicable
for a specific research project. For example, if you are planning a retrospective study that will only analyze patients
medical records, you will not include information about the distribution of subjects in the Informed Person Consent Form
into groups, placebo use, and so on.
If questions arise during the preparation of the Informed Consent Form, the Research Ethics Committee may be consulted
(Lithuanian Bioethics Committee (tel .: 8-5 2610632, e-mail: lbek@bioetika.sam.lt), Vilnius Regional Biomedical
Research Ethics Committee (tel .: 8-5 2686998, e-mail: rbtek@mf.vu.lt) or Kaunas Regional Biomedical Research Ethics Committee
Committee (tel .: 8-37 32 68 89, kaunorbtek@lsmuni.lt).
Requirement (explanation) Possible wording (if not verbatim -
must be adapted to the specific study)
1. Purpose of the informed consent form “This form provides you with information about
biomedical / clinical investigation of the medicinal product,
discusses the reasons for conducting the study, the research procedures, benefits, risks, possible inconveniences, and other important things
information. If you choose to participate, we will ask you to sign this consent form, which you agree to the study
follow the instructions of the medical examiner and the study team. By signing this document, you agree
participate in research. Take your time and read this document carefully if you do not understand any word or
statement, be sure to ask the study physician or other members of the study team any questions you may have. Before
you can consult family, friends or your doctor when making a decision. ”
2. Scientific-research goal of biomedical research
“It is important to understand that although you will be given medicines during a biomedical / clinical
preparations, medical examinations or medical procedures, biomedical research is fundamentally different from
normal (daily) clinical practice. The goal of normal (daily) clinical practice is to help you (i.e.
specific person, patient) to cure and / or improve your health. Basic biomedical
The aim of (scientific) research is to acquire new medical knowledge that will help other people with the disease in the future
patient health. In other words, the main goal of this study is not to directly benefit you
health. "
3. Scope of the study and justification as to why the biomedical study is required, what will be studied, the purpose of the study
“The aim of this study was to evaluate the efficacy and safety of investigational medicinal product X in comparison
efficacy and safety with any other medicinal product already authorized and used. At present, doctors
prescribes one or more drugs in patients with Y disease, but none of them is effective enough either
has side effects. This study will make it possible to determine which of the medicines under study is more effective and safer. ”
"Disease X is one of the most common and dangerous diseases in the region. Not available at this time
effective treatments for disease X - only 40%. current treatment with Z is effective in patients with
Therefore, this study will try to find out whether the new medicine X is more effective (safer).
for Z. "
4. Which persons are selected to participate in the biomedical research
“We invite you to participate in a clinical trial of the drug because you have X disease and
you meet the basic test criteria listed. The main criteria for inclusion in this study are as follows
"
5. Name of the customer and, if any, the identity of the customer's representative (if the customer or his representative is a natural person) or
name (if the customer or his representative is a legal entity)
“The sponsor of this clinical trial is X (company name). It is a drug developer and
a for-profit pharmaceutical company conducting clinical trials, which is for researchers and the research-performing medical institution
will allocate the necessary funds for this study. "
“The client of this biomedical research is X (name of the scientific institution). The funds needed for this study will be allocated
Y (name (s) of company (ies), medicines / equipment / substances will be provided free of charge by their manufacturer Z (company
Name (s) of the Member State (s). "
6. Likelihood of joining different study and / or control groups and characteristics of participation in these groups (if
biomedical study is performed with the participation of different study and / or control groups)
"Participants in this study will be divided into two groups by random assignment (like a coin for one year), one
will use study drug XXX and another will receive placebo. Placebo looks and prescribes reminiscent
study drug but has no therapeutic effect. The random route of administration means that it is not a physician-researcher
decides, and the computer program indicates to which group you will be assigned. Each study participant has
equal access (50%) to one of the groups. Because sometimes an improvement in health is alleged
occurs solely as a result of the medicinal product being used (i.e. the subjective psychological ‘placebo effect’),
In drug research, placebo is used to show that the medicine is
effective for objective characteristics rather than for subjective psychological reasons. If you go to placebo
group, you will not be able to take medicines that are usually given to patients with X disease. Without medication, you can
deteriorating your health: ... "
“It is also important to understand that neither you nor the medical researcher will know which group you are in. This will only become clear to the study
or if your health deteriorates and the cause of this deterioration needs to be clarified
(the medical condition was caused by the investigational medicinal product or the absence of standard treatment). "
7. The essence of placebo use (if the biomedical study is performed with placebo)
Example See above p. 6
8. Example of denial of routine health care above p. 6
justification (if subjects are not (or are not) receiving standard treatment at the time of study participation)
See also 14 p.
9. Circumstances and Criteria for Exclusion from the Study “If you do not follow your doctor’s instructions or
participation in the study will significantly worsen your health,
You will no longer be able to participate in the study
“The study doctor or the client has the right to suspend the study or your participation in it at any time. You will not be able to
participate in the study if the study product causes adverse reactions and treatment is required that is not
use in this study, and if you do not attend scheduled visits as indicated, you will not take the study drug or
you will not follow the instructions of other investigators. "
10. Duration of the investigation “The total duration of the investigation is two years.
You will participate for two months, i. y. from the first visit, when you sign the informed consent form, you will have
visit the doctor's researcher 4 more times, once every two weeks. "
11. Number of subjects “It is expected that in this
The biomedical / clinical trial will involve approximately 12,000 people, of whom
about 150 people with severe XXX deficiency. "
12. Countries where a biomedical study is planned (the purpose of providing this information is to allow the study participant
to get an overview of the study (local or global), so only the countries where it is planned are indicated
to conduct an investigation (i.e. not necessarily a complete list of parties in the event of a change of parties in the course of the investigation). If there are a lot of countries
it is possible to indicate, for example, the continent and the number of countries)
13. Methods of information gathering (survey), treatment, diagnosis or other procedures used in biomedical research,
frequency of visits to a biomedical research center
"The study will be conducted in fifteen European countries (including all the Baltic countries) and North America."
“We will ask you to allow a small amount of blood (5 ml) to be taken from a vein for the purpose of this test. We will also ask for an answer to
several questions in the research questionnaire about your symptoms, daily diet, medications, <...>.
The information provided in the questionnaire will be anonymous and will not be used to identify you. "
"Please allow access to your medical records (medical history) on the basis of which data on X will be collected
spread, course and tactics of treatment, development of the disease after treatment. If you agree to participate in the study, you will not have to come and
perform any additional diagnostic or therapeutic procedures. "
"If you agree to take part in the study, you will need to come to <> once. During this visit, the examination doctor will tell you
will perform an X procedure, after which you will take your urine and blood sample (up to 5 ml). Procedure X is performed <. >.
You may experience discomfort during procedure X, but it is painless. Researchers will need to use yours
medical records (medical history) from which data on <. >. "
14. Explanation of what the biomedical research “The following procedures will be performed during the research: Some
procedures referred to in
the procedures used, the planned duration and frequency of visits to the biomedical research center and other circumstances vary
from personal health care provided in accordance with normal clinical practice
electrocardiogram, thyroid and adrenal examination - would not be performed during a routine doctor's visit. "
“Procedure X usually takes about 15 minutes, but this biomedical / clinical study requires
gather more information, so please allow 10 minutes. longer procedure. "
"Typically, 5 ml of blood is taken from a patient to detect XX deficiency, but in this study we also want to look at ZZ factors, so
20 ml of blood will be taken instead of 5 ml. "
15. Expected benefits of the biomedical research to the subject, explaining whether and how the biomedical research can be useful
to the subject
“If the study medicine is effective and you do not get into the placebo group, your health condition may
improve, but there is no guarantee that this will happen. Participating in the study may not improve your health or even
deteriorate. The information obtained during the study will help researchers develop new drugs or treatments in the future
may be of benefit to patients with Z disease. "
16. Possible adverse reactions and / or events, discomfort to procedures or investigational medicinal product
with pain
“You may experience any side effects while taking the study medicine
effects: You may experience other discomforts, such as
time spent traveling to the study site or completing study questionnaires. In addition, investigative procedures will be carried out which:
may cause discomfort: pain or bruising may occur after taking the blood, in rare cases
cases of infections; cardiac examination (electrocardiogram (ECG) is completely painless but sticky electrodes
the skin at the attachment point may be slightly irritated and reddened.
<...> '
17. Inconveniences that may result from participating in a biomedical study
“When you take part in the study, you will have to fill in a diary every day (you will spend about 15 minutes), as well as every three
months you will go to the research center. We will ask you to take some psychological tests whose questions can be unpleasant
memories or feelings. You may not answer your unpleasant questions or refuse to take tests if you feel like it
awkward. "
18. Risks of processing health information “Due to unforeseen circumstances, confidential information may
become available to third parties
you have not given your consent to grant it. "
19. Insurance information (civil researcher of the principal investigator and the client of the biomedical research)
compulsory liability insurance or by a personal health care institution which itself or it
the worker is in a biomedical study in which the person involved is subject to intervention
biomedical research methods have only minor adverse temporary effects on his health,
the sponsor or its employee is a researcher in such biomedical research,
civil
"You are entitled to health damage and related non-pecuniary damage incurred in participating in this study,
remuneration. "
"The health care institution has concluded an insurance contract, which provides for damages that may arise from this
during a biomedical research. "
“The research client and the principal investigator insure the biomedical research client and the principal investigator in civil
compulsory liability insurance. Consequently, you are entitled to health damage and related non-pecuniary damage,
incurred in participating in this investigation. "
liability insurance for patients, covering pecuniary and non-pecuniary damage,
which may arise in the course of such biomedical research)
20. Access to the civil liability insurance contract and where to apply in case of damage
"Only non-interventional research methods that do not pose a risk to your health will be used in this biomedical study,
therefore, biomedical research is not covered by the civil liability of biomedical research clients and principal investigators
insurance. "
“You can get acquainted with the insurance rules at the research site by contacting the researcher doctor. If you think during the study
If you have been injured, consult your doctor. "
21. The right of a person to refuse to participate in the investigation and the consequences of such refusal and the right to withdraw the written consent to participate
in the investigation at any time, without giving reasons and reasons
22. The right of a person to receive routine health care if a person refuses to participate in a biomedical research or
withdraw consent to participate in a biomedical study
23. Procedure for withdrawal of consent to participate in a biomedical research (who to apply, how to write, etc.)
"You are participating in the study voluntarily, so you have the right to opt out, and you can leave at any time once you start."
"If a decision not to participate in a study (eg discontinuation of an investigational medicinal product) would endanger your health,
the investigator will explain how best to proceed in this case. "
"Your decision not to participate or to terminate your participation in the study will not affect the normal course of action
health care. "
"If you decide to withdraw from the study before the end of this period, the investigator will submit and ask you to write a free-form waiver.
request or complete a waiver form. "
24. Explanation that the results of biomedical research, i. y. biomedical research documents prior to consent to participate
data recorded in a biomedical study revocation shall not be deleted
25. Persons who have the right to withdraw their consent in the event of incapacity, limitation of their capacity or
health status cannot be considered to be able to reasonably assess their interests and the fact that will be taken into account
when the incapacitated person is incapacitated, has incapacity or cannot be considered capable of
to judge their interests wisely, the desire to withdraw consent
26. The right of a child who no longer wishes to participate in a biomedical study to terminate its participation in the study, unless
it is against the best interests of the child (if children are involved in the study)
27. The right to be informed about possible treatments in the event of a person's disagreement or withdrawal of consent
“We would like to point out that the results of this study, i. y. in the investigation documents before your consent to participate
data recorded in a biomedical study cancellation will not be destroyed because ....
(we would recommend clarification). "
"If due to the deteriorating health condition you will not be able to decide on further opportunities to participate in the study, at your request
revoking consent to take part in the investigation will be taken into account, but this decision will legally be taken by the spouse if he or she is not present -
one of the parents, adult children or another legal representative (of you). "
"If your child no longer wishes to take part in the study, he or she has the right to withdraw from the study at any time, unless
when discontinuation may result in health problems (eg abrupt discontinuation of the study drug or
treatment regimen may be harmful to your child’s health). Therefore, we ask you before accepting with the child
decision not to participate in the study to consult the investigating physician. "
“If you decide not to take part in this study, your doctor will prescribe the usual treatment for the disease, taking into account all those involved
circumstances - your age, other illnesses, general health, etc. He may prescribe pharmacies for you
to participate in the study (alternatives to participation in the study) of preparations that have already been approved and sold in Lithuania. X
Y groups are usually used to treat the disease
medicinal products (eg A, E, P, etc.) that are fully reimbursed (not reimbursed) by compulsory health
insurance fund. K treatments, special diets, etc. may also be prescribed. The doctor researcher will discuss with you all
the benefits and risks of the possible options. "
28. Entitlement to compensation for the costs and time spent participating in a biomedical research,
the person paying the compensation, the procedure and conditions for the calculation and payment of the compensation
"Participation in biomedical / clinical trials of a medicinal product shall not be remunerated, but
is entitled to compensation for costs incurred or time lost. In this study, the customer will reimburse travel,
on the day of the meal visit, the cost of purchasing contraceptives. These costs will be reimbursed to the medical researcher
on presentation of supporting documents (eg travel tickets, meal or medicine vouchers). "
"There are no financial benefits to participating in this study. Only reasonable costs will be reimbursed (eg transport,
parking) on ​​arrival from home to the study center for scheduled study visits, as well as contraceptive
the cost of purchasing the equipment on the basis of the supporting documents provided. Your request can also be
reimbursed for the time spent on each return visit from the home to the research center and back, as well as for the
time spent in the center. Remuneration is calculated according to the minimum hourly rate approved by the Government of the Republic of Lithuania
remuneration of EUR 2.13 per hour. This amount will be multiplied by the number of hours you specify, but not
for more than 8 hours a day. If you provide the examining doctor with proof of travel expenses
documents and / or a request for reimbursement for time spent on fact-finding visits will be reimbursed no later than the
years. If you provide receipts for travel expenses and / or a request for reimbursement for time spent on research
during the last visit or after you no longer participate in this study, you will be reimbursed within 3 working days of your
application and / or submission of documents. "
29. The right to object to the continued use of health information obtained from biomedical research for the purpose of biomedical research
a study in which he was included in accordance with the procedure established in Article 7 (6) of the Law on the Ethics of Biomedical Research without
consent, at the time when the person refuses to continue to participate in the biomedical study (this information must be provided when
planned investigation of critical conditions, i. y. when subjects will be included without informed consent)
"You have the right to object to the continued use of your health information obtained for the purpose of biomedical research
during this biomedical study. "
"You have the right to object to the continued use of your loved one's health for the purpose of biomedical research
information obtained from this biomedical study. "
30. It has been stated that the health information obtained from a biomedical research, which allows the identification of a person, is
confidential and may be provided only in accordance with the Law of the Republic of Lithuania on Patients' Rights and Compensation for Damage to Health, and
Lithuanian
"Health information obtained from a biomedical research shall be confidential and
may be provided only in accordance with the law on patients' rights and the protection of personal data. "
In accordance with the procedure established by the Law on the Legal Protection of Personal Data of the Republic of Lithuania
31. It is stated that health information obtained from a biomedical study is not considered confidential and may be
published without the consent of the subject, unless such health information can be obtained directly or through the publication
indirect identification
32. Name, legal entity code and registered office of the controller (this information must be provided when
the sponsor of the biomedical research and the controller are not the same legal entity, for example in the case of
the controller is the healthcare institution where the study takes place)
33. Information on the specific measures taken by the biomedical research client, the biomedical research client
a representative and persons carrying out biomedical research in order to preserve the persons involved in the biomedical research,
confidentiality
“Personal information (name, surname or other information about your health) that is not relevant to your health
personally identifiable information) is not considered confidential and may be disclosed without your consent if it is
it is not possible to identify you directly or indirectly after disclosure. "
"The data controller is UAB Mmmm / VšĮ ZZ ligoninė, company code: 00000000000, address:
.................... "
“To protect the confidentiality of your data, you will be given a special code that will be listed on all of them
documents other than the consent form and <. > (these documents will indicate your
personal data). A list in which your name is linked to the code, the security chief investigator in the safe, to
which only he and the authorized researcher have access to. "
“Computers that store electronic research documents and data are password protected. Login codes
only researchers know, these data are updated monthly. "
"Documents are stored in a locker, the key of which is only available to researchers."
34. Explanation of where the personal data will be obtained, i. y. only from the subject himself, from the health care institution
his medical records or other sources (specifying them)
35. It is listed what data about the person will be collected (final from the collection of the person and medical documents
data list)
36. It is clarified who and for what purpose will have access to the data that allow to directly identify the subject
identity (unencrypted data) and to whom and for what purpose only data
directly identify the subject (coded data)
“If you agree to participate in this study, the investigating physician and study staff will use the information you need to perform the study
personal data. Data will be collected on the basis of the information provided by you, in this and other medical institutions
stored medical documents, as well as in state registers, etc. information contained therein. "
See e.g. 34
"By signing this form, you agree that the researchers at the research center, the research control authorities (such as
State Medicines Control Agency, ethics committees) and to commission an investigation by the sponsor (ZZZ)
supervisors will have access to all information collected about you for the purposes of this investigation.
Other people or companies will only be provided with encrypted health data that does not allow you to be identified directly
identities. ("Encode" means that the documents will not contain your name, but a special number that
only a medical researcher will be able to link to you). "
“The data collected will be used by study physicians only for the purposes of this clinical trial. Customer-encoded health data
may use in the conduct of a study by submitting applications for an investigational medicinal product
registration and research, diagnosis or development of medical devices. "
37. If the data will be provided not only to the client of the biomedical research, the person must be informed about the recipients of the data
groups (such as testing laboratories) and access to the data subject's data,
indicating that he should contact the researcher for this
38. For how long will the personal data of the subjects collected during the biomedical research be kept and who will be responsible for it
“Your blood samples (X-rays, magnetic resonance imaging, cardiogram and
etc.) will be sent to research laboratories in other countries. Your researcher has a list of these laboratories and their contact information
information - contact your researcher for this information. "
"All information will be recorded in electronic and paper documents specially designed for the clinical trial
and stored at the study center for XX years after the end of the study. So much time to store data is required by law / customer
in order to ensure data quality and control. Later, your personal data will be destroyed by the investigation
in accordance with the procedure laid down by the Center. The principal investigator / healthcare professional will be responsible for storing documents at the research center
institution together with the principal investigator. "
39. The right of a person to have access to his or her personal data and the right to have inaccurate, incomplete,
inaccurate personal data
“You have the right to know what data has been collected, and you can also demand that it be rectified, destroyed or
suspend the processing of your personal data if you decide to withdraw from the investigation earlier. Then
researchers will no longer collect new information about you, but will not be able to destroy the data collected so far. "
40. Information on the permission of the Lithuanian Bioethics Committee and the Regional Biomedical Research Ethics Committee
a biomedical study or a certificate of approval of the Lithuanian Bioethics Committee to perform a clinical trial of a medicinal product
and phone number, e-mail postal address, registered office address and contact details of these institutions (telephone
contact number, e-mail postal address, registered office address)
“Due to your rights as a research participant, you can apply for permission to carry out this biomedical research / consent to perform it
Lithuanian Bioethics Committee, which issued the certificate for the clinical trial of the medicinal product, Vilniaus st. 16, LT-01402 Vilnius,
tel. (8-5) 2124565, el. e-mail: lbek@bioetika.sam.lt. "
“For your rights as a research participant, you can apply for a permit to perform this biomedical research in Vilnius
Regional Biomedical Research Ethics Committee, M. K. Čiurlionio str. 21/27 (room 231), LT-03101, Vilnius, tel. (8-5)
2686998, el. e-mail: rbtek@mf.vu.lt. "
"For your rights as a research participant, you can apply for a permit to perform this biomedical research at the Kaunas Regional
Biomedical Research Ethics Committee, Lithuanian University of Health Sciences, Mickevičiaus str. 9, LT-44307, Kaunas,
tel. (8-37) 326889, el. E-mail: kaunorbtek@lsmuni.lt. "
41. Permission of the State Medicines Control Agency to conduct a clinical trial of a medicinal product and telephone communication
number, e-mail postal address, registered office address (if a clinical trial of the medicinal product is performed)
42. the permission of the State Data Protection Inspectorate to the data controller to perform personal data processing actions and
telephone connection
“Permission to perform this clinical trial of a medicinal product was issued by the State Medicines Control Agency under the Republic of Lithuania
Ministry of Health, Žirmūnų str. 139 A, LT-09120 Vilnius, tel. 8,673,13235, el. e-mail: vvkt@vvkt.lt;
ArunasVaitkevicius@vvkt.lt. ”
“The permit XX (name of the data controller) to perform personal data processing actions was issued by the State Data Protection Agency
Inspectorate, A. Juozapavičiaus st. 6, LT-09310 Vilnius, tel. (8-5) 2127535, el. e-mail: ada@ada.lt. "
number, e-mail postal address, registered office address
43. Telephone number of the responsible researcher, e-mail postal address, registered office address (if the researcher 's address coincides with the address of the researcher)
center - specify one)
44. Telephone number of the research center, e-mail postal address, registered office address
45. Telephone number of the Customer and / or the Customer's representative, e-mail postal address, registered office address
46. ​​Other circumstances that may influence a person's decision to accept or refuse to participate are explained
in biomedical research
CONTENT OF THE CONSENT. The consent states that: The wording of the text is possible (if it cannot be moved verbatim -
must be adapted to the specific study)
a) The person understood the information provided to him “I have read this Informed Consent Form and
I understood the information provided to me. "
(b) He was given the opportunity to ask questions and received satisfactory answers
(c) has understood that he or, if the consent is given by another person entitled to give consent
a person participating in a biomedical study for whom he consents may withdraw from the study at any time
without giving reasons
"I was given the opportunity to ask questions and I received satisfactory answers."
If the consent to participate in the study is given by the person himself:
"I understand that I can withdraw from the investigation at any time without giving any reason."
If another person consents to the study:
"I understand that a person for whom I give consent to participate in a biomedical research may withdraw from the
without giving reasons. "
(d) has understood that in order to withdraw his consent to participate in a biomedical research, he must do so in writing
to inform the researcher or another person performing biomedical research authorized by him
(e) had sufficient time to consider the information provided to him concerning the biomedical research
(f) understood that participation in the study was voluntary
"I understand that in order to withdraw my consent to participate in a biomedical research, I must inform the researcher in writing.
/ another person authorized by him to carry out biomedical research. "
"I confirm that I have had sufficient time to consider the information provided to me about the biomedical research."
"I understand that participation in this study is voluntary."
g) confirms that the consent is given voluntarily “I confirm that the consent to participate in this
I give free will in biomedical research. "
(h) allow the use of personal data to the extent and in the manner specified in the Informed Consent Form
"I authorize the use of personal data to the extent and in the manner specified in the Informed Person's consent form."
(i) acknowledge receipt of a copy of the informed consent form signed by the investigator or another person
an authorized biomedical researcher
48. FORMALITY REQUIREMENTS
47.1. The intended place is a person or other person with the right to give consent and the researcher or another person
an authorized biomedical researcher:
(a) name, surname
b) signature
(c) the date of signature of the document
d) time
(e) state the grounds for representation
Indicate the date of preparation of the form and / or other identification mark (version, number, etc.) Form
written in a comprehensible manner, without the use of special medical or other scientific terms rarely used
international words
"I acknowledge receipt of a copy of the Informed Consent Form signed by the investigator / other authorized
the person carrying out the biomedical research. "