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Inform
Consent
Waiver
Presented By :
Manasi Dhamal, Dr. Geetu Mohan,
Adil Shaikh, Aarti Yadgire
www.siroinstitute.com
Content
• Introduction
• Criteria for waiver of consent
• Scenarios for possible Waiver
• Follow up consent
• Example for a request for waiver of IC
• Conclusion
• References
SIRO Clinical Research Institute 2
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Introduction
 Inform consent:- 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
 Inform consent Waiver:- It is a process in which informed consent is
not obtained from subjects, or that eliminates or alters some (or all) of
the elements of informed consent as set forth in Federal regulations (45
CFR 46.116d)
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Criteria for waiver of consent (1/5)
The IRB must ensure that the following 4 criteria are met prior to
approving a waiver or alteration of consent:
1. The research poses no more than minimal risk to subjects
2. The research does not adversely affect the rights and welfare
3. The research not practicable without the waiver
4. Whenever appropriate. The subject will be provided with pertinent
information after participation
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Criteria for waiver of consent (2/5)
1. The research poses no more than minimal risk to subjects
Describe specifically how the proposed research poses no more than
minimal risk to subjects.
Minimal risk – means the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests
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Criteria for waiver of consent(3/5)
2. The research does not adversely affect the rights and welfare
Describe why the waiver will not adversely affect subjects
Consider the following
• Are tests / procedures being done solely for this research or is data
being collected on past procedures that are completed?
• Could the results of research potentially affect the subjects regular
care?
• Would use of their information affect subjects regular care
• Could participation in the study negatively affect the subjects wellbeing
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Criteria for waiver Of consent (4/5)
3. The research not practicable without the waiver
Describe why it would not be feasible to conduct the study without a
waiver or alteration of informed consent
Consider the following
• It is likely that the data being reviewed contain out of data contact
information for subjects?
• Does the number of charts being reviewed make it impractical to
contact each subjects for consent?
• Would identifying and contacting each subject to obtain consent be
prohibitive
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Criteria for waiver Of consent (5/5)
4. Whenever appropriate, the subject will be provided with pertinent
information after participation
Describe whether information resulting from the study will be disclosed to
subjects.
Consider the following
• Will the results from the study have any effect on subjects or their
regular care?
• Are there any anticipated benefits that would change care subjects have
already received?
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Scenarios for possible Waivers
The FDA only permits an IRB to approve a clinical investigation without
participants informed consent in the following circumstances:-
• Emergency Use
• Exception from informed consent for planned emergency research
• Informed consent for in vitro diagnostic device studies using leftover
human specimens that are not individually identifiable
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Follow-up consent(1/2)
In occasional minimal risk studies, the EC may waive consent when
subjects initially cannot consent for themselves, but require consent for
later procedures when subjects recover their capacity to consent.
 Example where follow up consent required :-
The EC approved waiver of consent for a minimal risk blood draw from
patients arriving unconscious at the emergency room.
But if the researcher want any procedures to continue after subjects
become competent to consent or want the subject to participate in follow
up procedures.
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Follow up consent (2/2)
 Contents of follow up consent
• The consent form should clearly describe
• What procedures occurred without the subjects consent
• Why they were performed
• What additionally will be done if consent is given to continue the subject in the
study
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Example for a request for waiver OF IC (1/5)
• The researcher plans to determine whether some specific blood
chemistry values change in individuals undergoing clinically indicated
abdominal surgery and if there is a correlation of changes with the
increased incidence of complications after surgery.
• Proposed research plan is to:
Review the medical records of all individuals who have undergone
abdominal surgery in the past 2 years.
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Example for a request for waiver of IC (2/5)
 Data to be collected
• Diagnosis before surgery
• Type of abdominal surgery
• Specific pre-surgery blood chemistry values
• Specific post-surgery blood chemistry values
• Description of the problems after surgery
• Age range of the individuals.
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Example for a request for waiver of IC (3/5)
• From a preliminary estimate, there are about 5,000 abdominal surgeries
per year at the hospital.
• The researcher will double code the data so that only the researcher
knows the link in the unlikely event the data must be verified for
accuracy.
• The results of the research will not affect the clinical care of the
individuals because the information will not be examined until after
subjects leave the hospital.
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Example for a request for waiver of IC (4/5)
Sufficient justification for IRB to approve a waiver of informed consent :-
• The research involves minimal risk, as the review of subjects medical
records is for limited information
• The information is not sensitive in nature, and the data are derived from
clinically indicated procedures
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Example for a request for waiver of IC(5/5)
• There is an extremely low probability of harm to subjects status
employment, or insurability
• The precaution taken to limit the record review to specified data and
double coding of the data further minimize the major risk, which is
breach of confidentiality
• Contacting subjects to obtain their consent could be considered an
invasion of privacy and cause subjects undue anxiety
16
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Conclusion
Informed consent may be waived in following
 Minimal Risk
• Medical records research
• Observational research on large groups
• Research on tissue/blood samples
 Research in the Emergency setting
• Potential subjects are not competent to give consent at the time of
intervention
• No opportunity to obtain surrogate consent
17
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References
• ICH-GCP E(6) R(2)
• https://irb.ucsf.edu/waiving-informed-consent
18
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Thank you!
www.siroinstitute.com SIRO Clinical Research Institute

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IC Waiver in Clinical Trials I Clinical Research.pptx

  • 1. Inform Consent Waiver Presented By : Manasi Dhamal, Dr. Geetu Mohan, Adil Shaikh, Aarti Yadgire www.siroinstitute.com
  • 2. Content • Introduction • Criteria for waiver of consent • Scenarios for possible Waiver • Follow up consent • Example for a request for waiver of IC • Conclusion • References SIRO Clinical Research Institute 2 3/6/2023 4:25 AM www.siroinstitute.com
  • 3. Introduction  Inform consent:- 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  Inform consent Waiver:- It is a process in which informed consent is not obtained from subjects, or that eliminates or alters some (or all) of the elements of informed consent as set forth in Federal regulations (45 CFR 46.116d) 3 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 4. Criteria for waiver of consent (1/5) The IRB must ensure that the following 4 criteria are met prior to approving a waiver or alteration of consent: 1. The research poses no more than minimal risk to subjects 2. The research does not adversely affect the rights and welfare 3. The research not practicable without the waiver 4. Whenever appropriate. The subject will be provided with pertinent information after participation 4 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 5. Criteria for waiver of consent (2/5) 1. The research poses no more than minimal risk to subjects Describe specifically how the proposed research poses no more than minimal risk to subjects. Minimal risk – means the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests 5 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 6. Criteria for waiver of consent(3/5) 2. The research does not adversely affect the rights and welfare Describe why the waiver will not adversely affect subjects Consider the following • Are tests / procedures being done solely for this research or is data being collected on past procedures that are completed? • Could the results of research potentially affect the subjects regular care? • Would use of their information affect subjects regular care • Could participation in the study negatively affect the subjects wellbeing 6 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 7. Criteria for waiver Of consent (4/5) 3. The research not practicable without the waiver Describe why it would not be feasible to conduct the study without a waiver or alteration of informed consent Consider the following • It is likely that the data being reviewed contain out of data contact information for subjects? • Does the number of charts being reviewed make it impractical to contact each subjects for consent? • Would identifying and contacting each subject to obtain consent be prohibitive 7 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 8. Criteria for waiver Of consent (5/5) 4. Whenever appropriate, the subject will be provided with pertinent information after participation Describe whether information resulting from the study will be disclosed to subjects. Consider the following • Will the results from the study have any effect on subjects or their regular care? • Are there any anticipated benefits that would change care subjects have already received? 8 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 9. Scenarios for possible Waivers The FDA only permits an IRB to approve a clinical investigation without participants informed consent in the following circumstances:- • Emergency Use • Exception from informed consent for planned emergency research • Informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable 9 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 10. Follow-up consent(1/2) In occasional minimal risk studies, the EC may waive consent when subjects initially cannot consent for themselves, but require consent for later procedures when subjects recover their capacity to consent.  Example where follow up consent required :- The EC approved waiver of consent for a minimal risk blood draw from patients arriving unconscious at the emergency room. But if the researcher want any procedures to continue after subjects become competent to consent or want the subject to participate in follow up procedures. 10 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 11. Follow up consent (2/2)  Contents of follow up consent • The consent form should clearly describe • What procedures occurred without the subjects consent • Why they were performed • What additionally will be done if consent is given to continue the subject in the study 11 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 12. Example for a request for waiver OF IC (1/5) • The researcher plans to determine whether some specific blood chemistry values change in individuals undergoing clinically indicated abdominal surgery and if there is a correlation of changes with the increased incidence of complications after surgery. • Proposed research plan is to: Review the medical records of all individuals who have undergone abdominal surgery in the past 2 years. 12 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 13. Example for a request for waiver of IC (2/5)  Data to be collected • Diagnosis before surgery • Type of abdominal surgery • Specific pre-surgery blood chemistry values • Specific post-surgery blood chemistry values • Description of the problems after surgery • Age range of the individuals. 13 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 14. Example for a request for waiver of IC (3/5) • From a preliminary estimate, there are about 5,000 abdominal surgeries per year at the hospital. • The researcher will double code the data so that only the researcher knows the link in the unlikely event the data must be verified for accuracy. • The results of the research will not affect the clinical care of the individuals because the information will not be examined until after subjects leave the hospital. 14 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 15. Example for a request for waiver of IC (4/5) Sufficient justification for IRB to approve a waiver of informed consent :- • The research involves minimal risk, as the review of subjects medical records is for limited information • The information is not sensitive in nature, and the data are derived from clinically indicated procedures 15 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 16. Example for a request for waiver of IC(5/5) • There is an extremely low probability of harm to subjects status employment, or insurability • The precaution taken to limit the record review to specified data and double coding of the data further minimize the major risk, which is breach of confidentiality • Contacting subjects to obtain their consent could be considered an invasion of privacy and cause subjects undue anxiety 16 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 17. Conclusion Informed consent may be waived in following  Minimal Risk • Medical records research • Observational research on large groups • Research on tissue/blood samples  Research in the Emergency setting • Potential subjects are not competent to give consent at the time of intervention • No opportunity to obtain surrogate consent 17 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 18. References • ICH-GCP E(6) R(2) • https://irb.ucsf.edu/waiving-informed-consent 18 3/6/2023 4:25 AM www.siroinstitute.com SIRO Clinical Research Institute
  • 19. Thank you! www.siroinstitute.com SIRO Clinical Research Institute

Editor's Notes

  1. There are no strict rules for deciding when it is “appropriate” to provide additional pertinent information; but the IRB will apply some general standards in considering such requests: If consent is waived because it is not practicable to obtain consent from large numbers of patients for a retrospective chart review study, generally it also will not be appropriate to attempt to contact those patients to tell them about the study retrospectively. If consent is waived because subjects are temporarily incapacitated, it may well be appropriate to provide them with information later, and even, as noted above, to obtain consent for ongoing research.