Informed consent
- 1. Informed Consent 5/21/20191 DR. GK SHARMA PHARMD
- 2. Introduction Informed consent is a Document or a Process 1. Consent is a continuous process, not a one-time event. 2. Document Useful information for subjects Names and contact information Reminder about study procedures “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.” Goal “The goal of the informed consent process is to provide people with sufficient information so they can make informed choices about whether to begin or continue participation in clinical research.” 5/21/20192 DR. GK SHARMA PHARMD
- 3. Need of IC Understand nature of research. Be informed of purpose, risks, and benefits, and alternative therapies. Make a Voluntary Decision about Participation. Facts Enrol do harm best alternative Potential alternatives Therapeutic misconception 5/21/20193 DR. GK SHARMA PHARMD
- 4. 1. Enroll: Researchers need the person to enroll. 2. Do harm: Research can do harm. 3. Best alternative: Protocols may require specific procedures that may not be the best alternative. 4. Potential alternatives: Researchers may be blinded to potential alternatives. 5. Therapeutic misconception: of research subjects. PROCEES OF IC Discussion Review SignaturesTime Concerns Signature obtained 5/21/20194 DR. GK SHARMA PHARMD
- 5. The process not only includes reviewing and signing the consent document, but may also include the following: Recruitment materials 1. Oral instructions or explanations 2. A question and answer period 3. Assessing subject understanding 4. Providing adequate time for the subject to review the form and consider their participation 5. Providing new findings or study updates as appropriate throughout the study 6. Periodic re-affirmation or re-consent as appropriate throughout the study In developing the consent process in the protocol, the following should be considered: 1. Setting 2. Timing 3. Minimizing Undue Influence 4. Use additional aids 5. Ask open-ended questions 6. Discuss Information provided Comprehension monitored and maintained Decision madeInformation understood 5/21/20195 DR. GK SHARMA PHARMD
- 6. 1. Setting: Generally speaking consent discussions should occur in a private setting where your conversation won’t be overhead by others. 2. Timing: It may take several meetings/discussions before the potential subject not only understands the study but, for those recently diagnosed with a new disease or disorder it may also require additional time to understand the new information and what alternative treatment options may be available. 3. Minimizing Undue Influence: Vulnerable populations such as minors and students are particularly susceptible to influence from authority. Healthcare providers have tremendous influence over patients within their clinical practice. 4. Use additional aids: (videos, brochures, etc.) to explain study procedures and supplement the information provided in the consent document. 5. Ask open-ended questions: to potential subjects to assess their understanding of the study (e.g., “In your own words, tell me…what the study is about; what will happen to you if you decide to be in the study; what risks might you experience; what other options do you have.”). 6. Discuss: the study in the presence of “personal advisors” (friends/family members) who may aid in the subject’s decision making process, with the permission of the potential subject. 5/21/20196 DR. GK SHARMA PHARMD
- 7. Guidelines for Informed Consent 1. The Nuremberg Code, 1947 2. The Declaration of Helsinki, 1964 (2000) 3. The Belmont Report, 1979 4. ICH GCP, 1997 5. ICMR Guidelines, 2000 The Nuremberg Code What is it? Published in 1947 The voluntary consent of the human subject is absolutely essential Person must have legal capacity to consent Should have “sufficient knowledge Inform the subject of The nature, duration and purpose The method and means All inconveniences and hazards Possible effects on health 5/21/20197 DR. GK SHARMA PHARMD
- 8. The Declaration of Helsinki A statement of ethical principles on research involving humans Published by the World Medical Association Developed from the Nuremberg Code Made by physicians First adopted at Helsinki in 1964 Subjects must be Volunteers Informed participants 5/21/20198 DR. GK SHARMA PHARMD
- 9. The Belmont Report Ethical principles and guidelines for protecting humans in clinical research Published in 1979 Identifies three elements of the process Information Comprehension Voluntariness Information All information be provided Conditions under which information provided also important (rapid/ disorganized manner?) Comprehension Adapt presentation of information to subject’s capacities Investigators must ascertain comprehension Special provisions – immaturity, mental disability Voluntariness There must be no coercion or undue influence Understand risks and benefits. 5/21/20199 DR. GK SHARMA PHARMD
- 10. ICMR Guidelines Ethical guidelines for research involving humans “Ethical Guidelines for Biomedical Research on Human Subjects” Published by the Indian Council of Medical Research in 2000 Revised version – 2006 1. Nature and purpose: of study stating it as research 2. Duration: of participation with number of participants 3. Procedures: to be followed 4. Investigations, if any, to be performed 5. risks and discomforts adequately described and whether project involves more than minimal risk 6. Compensations in trial related injury a. Adverse effects of Investigational product(s). b. Departure from approved protocol, scientific misconduct or negligence by the Investigator. c. Failure of an Investigational Product to provide attended therapeutic effect. d. Administration of placebo providing no therapeutic benefits. e. Compensation for injury to a child in utero because of the participation of parent in Clinical. 5/21/201910 DR. GK SHARMA PHARMD
- 11. 7. No loss of benefits on withdrawal 8. Benefit sharing in the event of commercialization 9. Contact details of PI or local PI/Co-PI in multicentric studies for asking more information 10. Contact details of Chairman of the IEC for appeal against violation of rights 11. Voluntary participation 12. If test for genetics and HIV is to be done, counseling for consent for testing must be given as per national guidelines 13. Storage period of biological sample and related data with choice offered to participant regarding future use of sample, refusal for storage and receipt of its result 5/21/201911 DR. GK SHARMA PHARMD
- 12. Elements of informed consent Elements of informed consent Essential Additional Alternativ es Confidentialit y Benefi ts Risks Purpo se Voluntary participatio n Compensat ion Contact informatio n Essential 5/21/201912 DR. GK SHARMA PHARMD
- 13. 1. Protocol number or name of study 2. Purpose of the study. 3. Duration of study and subject involvement 4. A statement that the protocol, and the informed consent were reviewed with the 5. participant, including the risks and benefits of the study. 6. Alternative treatment options discussed. 7. Confidentiality record 8. No of subjects 9. Compensation for injury 10. Time for questions to be asked and answered. 11. Description of the participant’s decision 12. Contact details 13. Travel reabusment 14. Subject responsibilities 15. Subject satisfaction 16. Use understandable language 17. Copy of consent was given to the participant 18. Sign copy of ICF 5/21/201913 DR. GK SHARMA PHARMD
- 14. Additional Additional elements required by federal regulations: 1. Unforeseeable risks: to the subject (or to the embryo or fetus, if the subject is or may become pregnant) 2. Side effects: of a study drug are too severe, the sponsor terminates the study. 3. Additional costs: to the subject to participate (e.g., hospitalization, cost of testing) 4. Consequences of subject withdrawal from the study and procedures for withdrawal: that may be necessary – include whether any adverse health or welfare effects may be anticipated (e.g., the need to taper a drug treatment), 5. New toxicities develop: if findings of a data & safety monitoring board raise safety concerns. Additional elements required for FDA regulated research: 1. A statement that the test article is “investigational” or “not FDA-approved” 5/21/201914 DR. GK SHARMA PHARMD
- 15. Revisions to Informed Consent 1. Informed consent documents must be revised every time new safety information becomes available or there is a change in trial procedures, participant compensation or personnel noted on the consent form. 2. Revisions to the informed consent document must be approved by an IRB/IEC prior to its use, and the informed consent process with the new information and documentation needs to be repeated with every clinical trial participant. 3. The participant is then required to sign the revised form. 5/21/201915 DR. GK SHARMA PHARMD