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 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.

Answer

Question

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.