Speaker 1: Hello there and welcome, today we'll be talking about one of the most important components in clinical research and for patients in general, informed consent.

Speaker 2: What is it? Let's find out what everybody really everybody should know. The

Speaker 1: information and consent process must be documented in a logical and chronologically comprehensible way. It's particularly important that the informed consent form is never filled with the date in advance. The patients or the legal representatives must always enter the current date by themselves otherwise nobody can see if the patient really consented prior to the study start or after. Let's talk about the content of the information obtained from every subject. The large size of this document is partly attributable to the fact that certain information is required by GCP as well as by national legislation respectively. The informed consent must contain a note that the clinical study is part of a research project and the purpose of the study and the name of the sponsor including address must also be stated. Also in the case of randomized studies there's a probability of random assignment to study arms. Process related information on the study must be given to an easily comprehensible way. Thus for example it should be explained what randomization actually is. In addition the approach to be complied with in the clinical studies including the invasive procedures and commitments of the trial subjects must be included in the informed consent. The commitments of subjects include for example the reporting of side effects and hospitalizations and following the investigators instructions. Furthermore the experimental aspects of the study must be described in an understandable way for the patient. The next point is reasonably foreseeable risk of inconveniences to the subject and when applicable to an embryo, fetus or nursing infant this information must be provided based on current knowledge. Furthermore the expected benefits to the patient needs to be presented or when there's no intended clinical benefit to the subject should be made aware of this and of the facts from which other patients may derive benefit in the future. Alternative treatments and the compensation or treatments available to the subject in the event of trial related injury must also be provided in the informed consent. Compensation for expenses accrued by the subject in connection with the study must likewise be regulated in the informed consent. This refers to reimbursed value as well as to the rates of possible reimbursement. The ethics committee also receives important information with regard to the compensation via the informed consent. For example whether it can be assumed that the patient is still alive when distributing the compensation. In the case that expenses will arise for the patient within the scope of the study he or she must be informed about this in the informed consent. The volunteer participation and also the possibility of withdrawing consent for participation at any time without giving any reasons must be explained. Furthermore this subject must be informed that refusing to participate or withdrawing from the trial will not result in any detriment or in loss of benefits. It must also be explained to the subjects that other people besides the treating physician may get access to the personal data especially monitors, auditors and inspectors. This does not only refer to trial data but also to the complete medical record including the subjects entire previous medical history. On this occasion it must also be assured in the informed consent that the confidentiality of data remains guaranteed. With regard to the access to personal trial data of subjects some very strict European data protection rules need to be explained. For example in Germany there is the legal requirement to use pseudonymized data only. An example of a commonly used procedure for pseudonymizing would be the use of so-called dummy initials and the date of birth of the subject. Pseudonymization for example by using the last letter of the surname and first name as a dummy initials only makes it impossible for the sponsor to identify a certain subject. Also in the case of the results of the trial being published the confidentiality must always remain guaranteed. It's important to explain that the trial subject or the subject's legal representative will be informed in a timely manner. If during the course of a trial new information becomes available that may be relevant to the subjects willingness to continue participation. This would happen for example if new insights arose regarding side effects or contradiction. Following a corresponding informed consent the subject would then have to decide once again if he or she wish to continue participation. This implies that a new informed consent would then have to be submitted to the trial subject and that he or she must sign and date it prior to further trial related procedures. Another important point within the informed consent is mentioning those people who can be contacted by subjects in the event of questions or trial related injury. These would be for example independent physicians of the National Competent Authority, the coordinating investigator or perhaps the appropriate insurance company. It's important to explain the foreseeable circumstances under which a trial may be terminated. This would be the case if the risk-benefit profile of the study changed towards risk. The expected duration of the trial and the approximate number of subjects must also be mentioned. The informed consent must always be written in the subjects native language. In addition the age group has to be considered. If a subject or the subject's legally accepted representative does not speak your national language the informed consent must be provided in the national language of the subject or the subject's legal representative or an independent witness must be available for the translation. This witness must then co-sign the informed consent form as well. In addition it must be kept in mind that the formulation of the informed consent should be written from perspective of the subject containing sufficiently detailed information which does not confuse them with a large flood of information. Also in the case of different age groups are supposed to be examined in a study it's recommended to provide necessary different informed consents for children, adolescents and adults. According to some European countries for example in Germany and Austria the national regulations require an insurance coverage for the trial subjects. The subject must receive all necessary information concerning insurance in the informed consent that's the contact details of the insurance, the insurance certificates and the insurance conditions. In other countries like in the US and the UK the investigators need a liability insurance coverage which would pay the damage if something goes wrong within a clinical study. I hope you found the information interesting and that you learned something about informed consent and why it's so important in clinical trials. Until next time goodbye.