Procedure Of Taking Informed Consent
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Procedure Of Taking Informed Consent
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How will we take consent• Written
• Oral
• Video
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• The Consent Process:• The subject/representative must enter the date
of signature on the consent document, to verify that consent was obtained before the subject began participation in the study.
• If consent is obtained the same day the study begins, the subject's medical records must have document that consent was obtained prior to randomization.
• A copy of the consent document must be provided to the subject and the original signed consent document should be retained in the study records.
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• From whom the consent will be taken?
NBAC and CIOMS
-Individual informed consent from all competent adult participants in research.
-In the case of an individual who is not capable of giving informed consent, the permission of a legally authorized representative in accordance with applicable law.
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-Waiver of informed consent is to be regarded as uncommon and exceptional, and must in all cases be approved by an ethical review committee.
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Be cautious:
1. In case of children;Consent from a parent or legal representative of each
child and the agreement (assent) of that child has been obtained to the extent of the child’s capabilities and, a child’s refusal to participate or continue in the research will be respected.
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2. Mental and Behavioural disorders patients: the consent of each subject has been obtained to the extent of
that person’s capabilities, and a prospective subject’s refusal to participate in research is always respected,unless, in exceptional circumstances, there is no reasonable medical alternative and local law permits overriding the objection; and,
. In cases where prospective subjects lack capacity to consent, permission is obtained from a responsible family member or a legally authorized representative in accordance with applicable law.
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• Commonly recognized exceptions for taking Informed consent.
1. Use of non-identifying data, since it implicates no reasonable expectation of privacy.
2. Prior consent by the patient,as an exercise of patient autonomy.
3. Research authorized by law.
4. Clear public interest.
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Answer
Question
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The End
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Acknowlegment:•Prof. Harun –Ar-Rashid• Prof.Hasna Begum• Jessica Kiefer• John Grimley Evans and Peter Beck• Pamela a. Andanda• International guidelines for research
bio-ethics.
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NAS Committee Workshop, 12-13 October Day 1 Topics
• Overview of the Human Embryonic Stem Cell Science and Policy Issues
• Derivation and Use of Human Embryonic Stem Cells-General Issues
• Stem Cells and Somatic Cell Nuclear Transfer• Interspecies Mixing and Chimeras• Current Legal and Regulatory Requirements that
May Affect Human Embryonic Stem Cell Research
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Day 2 Topics• Informed Consent and Procurement• Derivation of Stem Cell Lines-Ethical and Policy
Concerns• Patenting, Licensing, and Material Transfer
Agreements in Relation to Human Embryonic Stem Cell Research
• Mechanisms for Oversight of Human Embryonic Stem Cell Research
• Industry Perspective: What is Industry’s Role in Monitoring the Ethics of Human Embryonic Stem Cell Research?
• Serving the Public Interest: Conducting Human Embryonic Stem Cell Research in a Democratic Society
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Credits and Disclosure
Thanks to
– Alta Charo– Leroy Walters– Laurie Zoloth– Fran Sharples– Members of the NAS/IOM Committee on Guidelines for Human
Embryonic Stem Cell Research
Disclosure: I am a member of the Howard Hughes Medical Institute Bioethics Advisory Board.