Signatory Child Medical Consent Made Easy

Signatory child medical consent

[Music] hello everyone in this video we will discuss the topic inform consent process clinical trial involves experiment in human beings it is important for researchers to take consent from the interested volunteers before making them part of the investigation here comes the concept of informed consent process according to ica gcp definition inform consent process is a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial after having been informed of all aspects of the trial that are relevant to the subject's decision to participate inform consent is documented by means of a written signed and dated informed consent form in other words informed consent is a process in which healthcare provider educates a patient about the various aspects of the trial such as purpose benefits potential risks alternatives of a given procedure etc after being informed about all the required information interested individuals voluntarily agree to participate in a research study and then sign informed consent form inform consent process is mandatory for all clinical trials inform consent is both an ethical and legal obligation in a clinical trial why is informed consent process important for all the trials every patient has the right to get all relevant information and ask questions before receiving any treatment through this process volunteers will get all required information about the trial during clinical trial inform consent process acts as a safeguard for the protection of human subjects in the research this process ensures that researcher has provided all the required information to the participant which may influence the decision to participate in a particular trial a proper informed consent also provides freedom to potential subjects to say no without feeling guilty or fearing repercussions what are the elements of informed consent 21 cfr part 50.25 contains the elements of informed consent it includes the basic elements which must be present in a consent form and additional elements which has to be provided when appropriate basic elements include purposes risks benefits alternative treatments confidentiality compensation contact voluntary additional elements include unexpected risks termination additional cost consequences of withdrawal new findings number of subjects i have explained these elements in detail in the book mind maps of clinical research basics please refer the book for detailed explanation in a clinical trial both the aspects that is the timing to obtain informed consent and how perfectly it is done are very crucial the investigator or study coordinator are generally responsible to obtain informed consent from the study subjects research staff must remember that unless the informed consent is not obtained from an individual or person's legally authorized representative that person may not be involved as a research subject informed consent must be obtained before the subject is involved in any study related activity however informed consent may be waived in emergency situations if there is no time to obtain consent or if the patient is unable to communicate and no surrogate decision maker is available also not every procedure requires explicit informed consent all potential subjects must have the capacity and competence to provide legally effective informed consent for participation in a particular trial individuals who do not have such ability can only be enrolled in research through consent of their legally authorized representative legally authorized representative is an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure involved in the research informed consent process basically involves disclosure of information by healthcare providers to the patient adequate comprehension by the patient and then voluntary decision to participate in the trial by the patient the consent process starts with the subject recruitment once a potential subject is identified consent interview is conducted by the investigator or other appropriate research staff during this session healthcare provider provides all trial related information to the potential study subject the interested volunteer is free to ask questions to the research team they can take additional time and can also discuss with their family and friends in order to make a decision regarding the participation once the interested individual becomes sure to participate in the trial he or she will sign the informed consent form the consent form must contain information to allow the subject to make an informed decision about the participation in a clinical investigation there are two segments in inform consent form that is patient information sheet which provides information regarding research and consent certificate which is used to document consent and will be signed if volunteer agrees to participate in the trial individuals decision to participate must be voluntary and free from question or any undue influence research team should also inform the volunteer that he or she has a right to withdraw from the study at any time and for any reason without penalty or loss of benefits that he or she would otherwise be entitled to receive documentation of informed consent form should be done properly the information given to the subject which could include information provided orally during the consent interview or written information in the consent form must be in language understandable to the potential subject or legally authorized representative understandable means the information presented to potential subjects is in a language and at a level the subjects can comprehend the consent process may not include excalpatory language through which a subject is made to wave or appear to waive any of his or her legal rights or release or appear to release the investigator the sponsor the institution or its agents from the liability for negligence for example in the event that a patient suffer a research related injury patients medical expenses will be patient's responsibility or that of patients third-party payer informed consent is an ongoing process a participant's consent will be continually asked during the course of the study and the participants will be kept informed of any change to the study along with any other relevant information that may influence their decision to continue their participation in the study for more detailed information of informed consent process please refer the book mind maps of clinical research basics thanks for watching [Music] you