REGULATORY AFFAIR (Informed Concent Process and Procedure)).pptx

This presentation based on the Informed Consent Process and Procedure in Regulatory Affairs.

1. REGULATORY AFFAIR Informed Consent P rocess and P rocedure Submitted By: Prachi Pandey, Rahul Pal M . Pharm (Pharmaceutics) Department of Pharmaceuitcs, NIMS Institute of Pharmacy, NIMS University Jhaipur, Rajasthan India. 1 st Year , Ist Sem.

2. CONTENTS Definition History Informed Consent Guidelines The Process of Consent The Plan of Consent Process Element of ICF Components of ICF

3. Inform Consent Process and Procedure A process by which a subject voluntarily confirms his or her willingness to participate in a particular trail, after having been informed of all aspects of the trail 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. The goal of the informed consent process is to provide people with sufficient information so that they can make informed choices about whether to begin or continue participation in clinical research.

4. Declaration of helsinki The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

5. Informed consent guidelines ICMR (Indian Council of Medical Research) “Ethical Guidelines for Biomedical Research on Human use” Published in 2000 and revised in 2006 ICH ICH Guidelines E6 section 4.8 under GCP (Good Clinical Practice)

6. Information provision and sharing by research team Discussion and interaction between research and potential participation True understanding Acceptance or rejection of participant Agreement to participate Follow up End of agreement

7. The Process of Consent

8. Signature needed in Informed Consent Form

9. Elements of Informed Consent Form Essential element : Purpose Risks Benefits Confidentiality Compensation Contact information Voluntary participation

10. Elements of ICF

11. Components of ICF ( A ccording to ICMR guidelines, 2006) Important Information about the Research Study. What is the study about and why are we doing it? Benefits of taking part in the study. Possible risks that might result from being in the study. Certificate of Confidentiality What will happen to the information collected after study period is over. Compensation for being part of the study Possible expenditure to a subject to be part of study.

12. Who can profit from study results. Choices to a subject if they don’t wish to take part in the study. Voluntariness Contact information of subject Contact information of study team. Consent : Name , Signature and Date Parent or LAR : Name , Signature and Date