INFORMED CONSENT PROCESS AND PROCEDURE.pptx

INFORMED CONCENT PROCESS AND PROCEDURE IN CLINICAL TRIALS

1. INFORMED CONSENT PROCESS AND PROCEDURE Sumit Kumar kar Reg.no:170523886013 M PHARM Department of pharmaceutics

2. DEFINITION: Informed consent 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. Informed consent is documented by means of a written, signed and dated informed consent form. The main goal of the informed consent process is to educates people with sufficient information such as the risks, benefits and alternatives of the clinical study or research or intervention so that the people/subject can make informed choices about whether to begin or continue participation in clinical research.  

3. After providing detailed information about the clinical study to the potential subject, the researcher seeks the subject consent on their participation in clinical research. So, the subject must be competent to make a voluntary decision about whether to undergo the procedure or intervention. There are some regulations and guidelines for how and in what manner the informed consent is to be obtained from the study.

4. INFORMED CONSENT GUIDELINES: ICMR (INDIAN COUNCIL OF MEDICAL RESEARCH) “Ethical guidelines for biomedical research on human subjects” published in 2000 and revised in 2006. ICH (INTERNATIONAL CONFERENCE FOR HARMONIZATION) ICH guidelines E6 section 4.8 under GLP (good clinical practice).

5. PROCESS OF CONSENT: STEP-1: DISCUSSION Informed consent discussion with subjects or L.A.R (legally authorized representative) who are willing to participate in trial disclosure of essential information. STEP-2: REVIEW Review of information by researcher.

6. STEP-3 : CONCERNS Satisfaction of all trial related queries of subjects.     STEP-4: TIME Provide sufficient time to decide whether participate or not and inquire about any aspects of trials.  

7. STEP-5: WILLINGNESS If the subject willing to participate in trial. STEP-6: SIGNATURE Informed consent form should be signed and personally dated. Finally, the informed consent process provides following to the subject. A signed dated copy. Patient information sheet. Necessary contact details.

8. The process of consent includes the following criteria: Right environment and location should be selected to obtain consent. Involve multiple health care personnel as necessary. Include family members in the process as warranted. Ensure that the subject or Legally Authorized Representative is competent. Ensure that the subject or LAR has sufficient understanding. Continue the process of consent throughout the study.  

9. Who can sign the informed consent form? Subject or Legally Acceptable Representative (LAR). Person conducting review of consent. Impartial witness.

10. ELEMENTS OF INFORMED CONSENT PROCESS: An informed consent resides on its three critical and essential elements including voluntarism, information disclosure, and decision-making capacity . For an ethically valid and real informed consent, these critical elements are required to be essentially employed and adequately present while informed consent is expressly sought from a research subject.  

11. VOLUNTARISM: It is an ability of an individual to judge freely and independently and in the absence of coercion, what is good, right and best subject to his/her own situation, values and prior history. For an ethical and valid consent, the subject's decision has to be a voluntary one. Voluntarism of an individual may be affected by various factors such as intellectual and emotional maturity to make complex decision; illness-related considerations such as psychological effects of dreaded or incurable diseases or severe mental disorders ; religious and cultural values ; relationship with caregiver including economic and care burden ; and undue influence or coercion for research participation.

12. INFORMATION DISCLOSURE: Information disclosure refers to providing information that is necessary for a patient to make an informed decision and is one of the essential elements of a valid informed consent. For a valid consent, information provided to a research subject should include: Nature and purpose of study. Health condition for which research is proposed. Probable risk and benefits. Nature and risks associated with research participation. Right to withdraw at any time.

13. DECISION MAKING CAPACITY: It is the ability of an individual to understand and appreciate the nature and consequences of health decision and to formulate and communicate decisions regarding health care. Decision capacity depends upon cognitive capacity and voluntarism.   COMPONENTS OF INFORMED CONCENT FORM (according to ICMR guidelines): Important information about the research study. What is the study about and why we are doing it?

14. 3. Benefits of taking part in the study. 4. Possible risk that might results from being in the study. 5. Certificate of confidentiality. 6. What will happen to the information collected after study period is over. 7. Compensation for being part of the study. 8. Possible expenditures to the subject to be part of study. 9. Who can profit from study result. 10. Choices to a subject if they don’t wish to take part in the study. 11. Voluntariness. 12. Contact information of subject. 13. Contact information of study team. 14. Consent: Name, signature and date. 15. Parent or LAR: Name, signature and date.