Informed Consent Form: Purpose, Definition, Rules, Elements, Process, Exceptions and Advantages.

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1. Informed Consent Form By - Aniket Namdev Student ID 6173

2. There are a millions of volunteers participate in the government and industry sponsored clinical trial each year. Prior to agreeing to participate, every volunteer has right to know and understand what happen during the clinical trial. This is called as Informed consent and this process that can help to decide whether or not to participating in a trial is right for you. Introduction

3. Purpose Prospective subject will- Understand Nature of research. Be informed of purpose, risks, benefits and alternate therapies. Make a voluntary decision about participation .

4. Definition of Informed Consent Definition according to ICH GCP: “ A process by which a subject voluntarily confirms his or her willingness to participate in the particular trial, after having been informed of all aspects of the trials that are relevant to the subject’s decision to participate” Informed consent is documented by means of written, signed and dated informed consent form.

5. What is Informed Consent? Informed consent is a communication process: Between the researcher and the participant. Starts before the research is initiated. Continues throughout the duration of the study. Providing all relevant information to the volunteer/ patient. The patient understanding the information provided Voluntarily agreeing to participate. A basic right.

6. Informed consent allows individuals : To determine whether participating in research fits with their values and interest. To decide whether to contribute to this specific research project. To protect themselves from risks. To decide requirements necessary for the research.

7. In seeking informed consent following information shall be provided to each subject : Description of clinical investigation. Risks and discomfort. Benefits. Alternative procedures or treatments. Confidentiality. Compensation and medical treatment in event of injury. Contacts. Basic elements of ICF:

8. Basic rules regarding presentation of the ICF: The ICF should appear in the subject’s hands, properly filled as: Page 1: Title Each page: the page number, including total pages, other applicable data (e.g. protocol number, version number, stamp of ethics committee approval) Space for signatures and date. A statement that the study involves research experiment The reason for the study Available alternative treatments The details of the study methods Possible/ expected risks, both serious and not serious Possible benefits Contd…

9. A declaration that participation is voluntary, that subjects who refuse to participate or withdraw from the study will not be penalized. Contact information. A declaration regarding confidentiality. Information regarding the procedure to follow if an adverse event occurs. A warning that the study may involve currently unforeseen risks. A statement that the investigator may withdraw the subject from the study without the subject’s consent An assurance that subjects will be informed of relevant.

10. New information: If new information appears, especially medical knowledge, that may affect the subject’s decision to continue participation: The information must be given to the subject The ethics committee should re-examine the study The consent form may need revision. Reasons for revisions may include: Protocol amendments. Recognition of risk to subjects not previously anticipated but not warranting discontinuation of study. Results of interim analyses showing significant changes in anticipated risk, benefit, or efficacy that may affect subject willingness to continue participation. Change of investigator or of study site location.

11. The Consent Process A consent form is provided by the sponsor with the study protocol or created by the site investigator. The consent form is personalized by each site, adding local names and numbers. The consent forms is approved for the use by institutional review board. Investigator or designated study personnel informs the patients about the study, purpose, risks, and potential benefits. Contd…

12. The patient is allowed to read the consent form, ask questions and consider participation. Patient or legal representative signs and dates the consent form. ‘The sponsor and/or IRB may require additional signatures. The patients given a copy of the consent form and study treatment and procedures can be started.

13. Insurance The study must not conflict with the subject’s health insurance. Most studies will insure the subjects from risks arising out of the trial . In the USA: use HIPAA-compliant language.

14. Special considerations: Non- English-speaking subjects Subjects who understand spoken English but cannot read require an oral explanation in the presence of a witness. Subjects who do not understand English may be enrolled if: The contents are translated. The contents are verbally explained in the presence of a witness.

15. Special considerations: Children-1 A child should be respected. A child can make independent decisions after the age of fourteen. One cannot presume that a child will never wish to participate. First try to carry out the trial in adults.

16. Special considerations: Children-2 Two consent forms are required: one for the child (assent), one for the parents (permission). As in adults, assent not required if mental or physical disability renders the child incapable. The ethics committee may waive the requirement of the child’s assent in some situations .

17. Advantages of Informed consent Creates a mutual trust between the patient and the physician by opening the important pathways of communication. Helps patients to take greater measure of responsibility in the course of their treatment by having more extensive knowledge to their condition and its impact on their personal life. Allows the physician to take care of patient more effectively by having more information of patients including the value basis for granting or withholding consent.

18. Thank You