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INFORMED CONSENT PROCESS AND
PROCEDURES
ABDUL NAIM
M PHARM 1ST YEAR
DEPT OF PHARMACEUTICS
NARGUND COLLEGE OF PHARMACY
CONTENTS
1. DEFINITION
2. INFORMED CONSENT GUIDELINES
3. THE PROCESS OF CONSENT
4. THE PLAN OF CONSENT PROCESS
5. ELEMENTS OF ICF
6. COMPONENTS OF ICF
DEFINITION
:
 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 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.
INFORMED CONSENT
GUIDELINES:
• 1. ICMR (INDIAN COUNCIL OF MEDICAL RESEARCH)
"Ethical guidelines for biomedical research on human subjects"
published in 2000 and revised in 2006
• 2. ICH
ICH guidelines E6 section 4.8 under GLP (good clinical practices)
THE PROCESS OF
CONSENT:
 Choose the right environment and location 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 the subject or LAR has sufficient understanding.
 Continue the process of consent throughout the study.
THE PLAN OF CONSENT
PROCESS:
1. Identify obstacles to participation in study and ways to overcome
obstacles
2. Identify words subject may not understand
3. Compile "frequently asked question" list
4. Decide who will do consent discussion
5. Decide where consent discussion will be held
6. Provide adequate time to explain study to subject.
7. Provide adequate time for subject to read and consider and for
questions to be answered
WHO CAN SIGN THE INFORMED CONSENT
FORM ?
1. Subject or Legally Acceptable Representative (LAR).
2. Person conducting review of consent.
3. Impartial witness.
ELEMENTS OF INFORMED CONSENT
FORM:
A) ESSENTIAL ELEMENTS
1. PURPOSE
2. RISKS
3. BENEFITS
4. CONFIDENTIALITY
5. COMPENSATION CONTACT INFORMATION
6. VOLUNTARY PARTICIPATION
B) ADDITIONAL ELEMENTS
1. Withdrawal criteria.
2. Additional costs to subjects.
3. Statement that there may be risks which are
unforeseeable.
4. Approximate number of subjects in study.
5. Statement that will be told of new findings.
COMPONENTS OF ICF
(ACCORDING TO ICMR GUIDELINES,
2006)
1. Important information about the research study.
2. What is the study about and why are we doing it?
3. Benefits of taking part in the study.
4. Possible risks that might result 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 expenditure to a subject to be part of study.
9. Who can profit from study results.
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.
CONCLUSION:
• Respect for persons demands that legally effective informed
consent be obtained from subjects before they participate in
research. Indeed, informed consent may be the most important
protection for human subjects participating in the clinical trial
studies.
• The information that must be provided in an informed consent
document is specified in (US FDA) 45 CFR 46.116, 21 CFR 50.20,
and ICH GCP 4.8.10.
45 CFR 46.116 & 21 CFR 50.20 general requirements for
informed consent.
informed consent process and procedure .pptx

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informed consent process and procedure .pptx

  • 1. INFORMED CONSENT PROCESS AND PROCEDURES ABDUL NAIM M PHARM 1ST YEAR DEPT OF PHARMACEUTICS NARGUND COLLEGE OF PHARMACY
  • 2. CONTENTS 1. DEFINITION 2. INFORMED CONSENT GUIDELINES 3. THE PROCESS OF CONSENT 4. THE PLAN OF CONSENT PROCESS 5. ELEMENTS OF ICF 6. COMPONENTS OF ICF
  • 3. DEFINITION :  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 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. INFORMED CONSENT GUIDELINES: • 1. ICMR (INDIAN COUNCIL OF MEDICAL RESEARCH) "Ethical guidelines for biomedical research on human subjects" published in 2000 and revised in 2006 • 2. ICH ICH guidelines E6 section 4.8 under GLP (good clinical practices)
  • 5.
  • 6.
  • 7. THE PROCESS OF CONSENT:  Choose the right environment and location 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 the subject or LAR has sufficient understanding.  Continue the process of consent throughout the study.
  • 8. THE PLAN OF CONSENT PROCESS: 1. Identify obstacles to participation in study and ways to overcome obstacles 2. Identify words subject may not understand 3. Compile "frequently asked question" list 4. Decide who will do consent discussion 5. Decide where consent discussion will be held 6. Provide adequate time to explain study to subject. 7. Provide adequate time for subject to read and consider and for questions to be answered
  • 9. WHO CAN SIGN THE INFORMED CONSENT FORM ? 1. Subject or Legally Acceptable Representative (LAR). 2. Person conducting review of consent. 3. Impartial witness.
  • 10. ELEMENTS OF INFORMED CONSENT FORM: A) ESSENTIAL ELEMENTS 1. PURPOSE 2. RISKS 3. BENEFITS 4. CONFIDENTIALITY 5. COMPENSATION CONTACT INFORMATION 6. VOLUNTARY PARTICIPATION
  • 11. B) ADDITIONAL ELEMENTS 1. Withdrawal criteria. 2. Additional costs to subjects. 3. Statement that there may be risks which are unforeseeable. 4. Approximate number of subjects in study. 5. Statement that will be told of new findings.
  • 12. COMPONENTS OF ICF (ACCORDING TO ICMR GUIDELINES, 2006) 1. Important information about the research study. 2. What is the study about and why are we doing it? 3. Benefits of taking part in the study. 4. Possible risks that might result 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 expenditure to a subject to be part of study.
  • 13. 9. Who can profit from study results. 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.
  • 14.
  • 15. CONCLUSION: • Respect for persons demands that legally effective informed consent be obtained from subjects before they participate in research. Indeed, informed consent may be the most important protection for human subjects participating in the clinical trial studies. • The information that must be provided in an informed consent document is specified in (US FDA) 45 CFR 46.116, 21 CFR 50.20, and ICH GCP 4.8.10. 45 CFR 46.116 & 21 CFR 50.20 general requirements for informed consent.