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    Informed consent process

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    1 : By Santosh Zarkariya Informed Consent Form
    2 : Informed Consent Form 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. Informed consent is documented by means of a written, signed and dated informed consent form. The informed consent form, sometimes, is also referred to as patient information sheet (PIS).
    3 : Why informed consent is necessary To protect the subjects rights and safety
    4 : Elements of informed consent Adequate information about the research is given in a simple and easily understandable unambiguous language in a document known as the Informed Consent Form with Patient Information Sheet. Nature and purpose of study stating it as research Duration of participation with number of participants Procedures to be followed Investigations, if any, to be performed Foreseeable risks and discomforts adequately described
    5 : Elements of informed consent Policy on compensation Availability of medical treatment in case of injuries or risk Alternative treatments if available Steps taken for ensuring confidentiality No loss of benefits on withdrawal Contact details of PI or Co-PI in case of emergency or any trial related questions Contact details of Chairman of the IEC for appeal against violation of rights Voluntary participation If test for genetics and HIV is to be done, counseling for consent for testing must be given
    6 : Participant's involved in the informed consent process Subject (patient) Legally Acceptable Representative (LAR) of the subject, who will sign the consent in case of subject is illiterate, unable to give consent (In case of minor (below 18 years of age),dementia, physical injuries etc.) then subject's legally acceptable representative subject should be informed to the extent compatible with his/her understanding and able to give consent. Witness, who will sign the consent in case of subject and LAR both are illiterate Principal/Co-investigator
    7 : Informed Consent Process Always check the current IEC / IRB approved version of ICF is being used Always ICF should be provided is in the language which is better understood by the subject The subject reads the ICF in a quiet area The consent process should not be rushed subject must be given enough time to assess, evaluate and discuss the information they have been before having to make a decision. Subject is giving consent voluntarily If the subject is literate informed consent form should be signed and dated by subject and attending physician conducting the informed consent discussion.
    8 : Informed Consent Process If subject/subject's legally acceptable representative (LAR) is illiterate then ICF should be signed by, an impartial witness. Thumb impression of subject's should be taken, if subject illiterate. Appropriate names signatures and dates are taken A Xerox copy of the signed ICF is given to the subject The original consent form is retained in the subjects study file. The process is documented in the source documents & that the consent was administered prior to initiation of study procedures.
    9 :   How should the consent be documented? This process is documented by means of a written, signed and dated informed consent form.The whole process of informed consent should be documented in the source notes it includes: a) Time and date when patient arrives in the hospital, Who has given the consent form to the subject of which language, date and version number. b) Document all the study related conversation (e.g. doubts /queries and resolution) between subject, investigator and other participant's if any (e.g. Witness or LAR)
    10 : How should the consent be documented? Who has given the answer of any doubt or queries raised by the subject Always ask the subject if there are any questions. Answer them completely and truthfully and write it down in the source notes. The date, time and place where subject signed the consent form, write the details of LAR and Witness (e.g. Name, relation, phone number) if patient is illiterate.
    11 : Informed Consent in special situations In case of Mental incompetence (e.g. - Schizophrenia) and Physical incapacity (e.g.-Paralysis) In such cases consent to be given by legally acceptable representative (LAR) Impartial witness signs, if legal representative is illiterate Subjects consent should be obtained as soon as feasible
    12 : Informed Consent in special situations In case of Children Two consents should be taken One from parents/legally acceptable representative (LAR) and one from the child (e.g. if child is 10-12 years of age). Subject assents (verbal/written), must explain to the extent the child will understand.
    13 : Informed Consent in special situations In case of emergency situation In emergency situations, when prior consent of the subject is not possible, the consent of the subject's legally acceptable representative, if present, should be requested. If legally acceptable representative is not available, enrolment of the subject should require measures described in the protocol and/or elsewhere, with documented approval/favourable opinion by the IRB/IEC, to protect the rights, safety and well-being of the subject and to ensure compliance with applicable regulatory requirements. The subject or the subject's legally acceptable representative should be informed about the trial as soon as possible and consent.
    14 : Fresh or re-consent is taken in following conditions Availability of new information which would necessitate deviation of protocol. When a research participant regains consciousness from unconscious state or is mentally competent to understand the study. When long term follow-up or study extension is planned later. When there is change in treatment modality, procedures, site visits.
    15 : Informed Consent Form documentation: List of some common monitoring Findings   Xerox Copy of signed ICF not given to the subject Investigator dates differ from that of the subject Investigator signs but does not date the ICF Thumb impression present along with a date ICF not administered in the language, the subject best understands Incorrect version of the ICF used Relationship of the impartial witness to the subject no tot mentioned (when required in the consent form). ICF not approved by IEC/IRB
    16 : Case Studies on ICF
    17 : A 52 year illiterate farmer from the outskirts of the city walked alone in the OPD of a Diabetologist who was involved in a T2DM trial After confirming the eligibility and the affirmative decision of the farmer,the consent was taken Describe the ICP and its documentation Case Study
    18 : Case study A 15 year-old unconscious boy is admitted to the emergency room. His parents are with him. The physician on duty is participating in a clinical trial and after an initial assessment he considers the patient suitable for the study. Describe the informed consent procedure.
    19 : Case study Patient SSK can read and understand English and hence has been given the ICF and PIL in English. After having verbally agreed to participate, he signs the ICF in Marathi. What comment you will put in source notes?
    20 : Case study Patient AMK was on his way to office and is a victim of hit and run case. He is rushed to a nearby hospital by an auto-rickshaw driver. AMK is bleeding profusely and has head injury. He is unconscious and is admitted to Critical Care. The physician has participated in a study of a new molecule known to stop blood loss and wants to enroll this patient. Describe the informed consent procedure.
    21 : Case study You are involved in a study on a new drug for worm infestation in pediatric population. The subjects to be included in the study are 8-18 years. You have to train the site staff to obtain consent from such patients. What would you do?
    22 : Case study Patient RST, was illiterate and was accompanied by his minor daughter. Both were explained about the study Both of them were consented to participate and thumb impression was taken The site CRC was taken as an IW Patient enrolled into the study Identify the issue and explain the correct ICP
    23 : Case study A young boy of 9 yrs of age is found eligible for a vaccine trial where his parents are eager to make him participate but the subject is scared of multiple pricks for the blood draws as informed by the PI and hence is reluctant to consent.The parents are insisting the PI to enroll him What is expected from the PI ?
    24 : Answer As per ICMR guidelines- The child’s refusal to participate in research must always be respected unless there is no medically acceptable alternative to the therapy provided/tested, provided the consent has been obtained from parents/guardians
    25 : Thank You

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