Procedure Of Taking Informed
Consent
How will we take consent
• Written
• Oral
• Video
• 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.
• 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.
-Waiver of informed consent is to be regarded
as uncommon and exceptional, and must in
all cases be approved by an ethical review
committee.
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.
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.
• Commonly recognized
taking Informed consent.
exceptions
for
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.
Question
Answer
The End
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.
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
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
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.
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