CDSCO Guidelines for Audio-Visual Recording Quiz
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Questions and Answers

What is one of the key ethical principles that stakeholders and researchers are expected to follow in the context of donation of biological material?

  • Ensuring donors are commoditized for biomedical research
  • Maintaining confidentiality and privacy of donors (correct)
  • Ensuring donors are exploited for commercial gain
  • Publicly sharing donor information
  • In the context of donation of biological material, what must be adequately explained to donors regarding procedural risks?

  • Specific benefits of the donation
  • Potential side effects of the donated material
  • Risks associated with local or general anesthesia during collection (correct)
  • Legal implications for the donor
  • What important information must be included in the information sheet provided to donors?

  • The donor's personal contact information
  • Risk factors related to transmittable diseases (correct)
  • Procedures for commercialization of donated material
  • Details of potential genetic disorders in the donor's family
  • Under what circumstances might cell lines/products generated from donated material be shared with other scientific groups?

    <p>If there are exceptional circumstances</p> Signup and view all the answers

    What important aspect should donors be informed about regarding cell lines/products generated from their donated material?

    <p>The potential for genetic manipulation and commercialization</p> Signup and view all the answers

    Why is it crucial to inform donors about screening for transmittable diseases and risk factors during donation?

    <p>To ensure informed decision-making by donors</p> Signup and view all the answers

    What happens to Intellectual Property Rights (IPR) of biological material in the event of commercialization?

    <p>They do not vest with the donor</p> Signup and view all the answers

    What efforts should be made if commercialization of biological material brings financial benefits?

    <p>Pass on the benefits to the donor/community</p> Signup and view all the answers

    What processing may be necessary to obtain stem cells in large numbers from human adult tissues?

    <p>Processing, enrichment, and/or in vitro expansion may be necessary</p> Signup and view all the answers

    Why are innovative surrogate assays needed for testing the potency of stem cells?

    <p>Due to lack of suitable animal model system</p> Signup and view all the answers

    In what type of facility should stem cells or their products/derivatives be processed according to the guidelines?

    <p>CDSCO licensed Good Manufacturing Practices (GMP) compliant facility</p> Signup and view all the answers

    Why may some manipulations such as processing and enrichment be needed for stem cells obtained from human adult tissues?

    <p>To enhance their utility</p> Signup and view all the answers

    What is the primary reason for donors not receiving direct financial benefit or Intellectual Property Rights (IPR) in the provided text?

    <p>To encourage altruistic donation without financial incentives</p> Signup and view all the answers

    What is the exception where research may provide a direct medical benefit to the donor?

    <p>Autologous transplantation situations</p> Signup and view all the answers

    What responsibility does the entity collecting oocytes have towards the donor, as mentioned in the text?

    <p>Providing appropriate health care and compensation for any complications</p> Signup and view all the answers

    How long can information related to derived stem cells or cell lines be archived according to the text?

    <p>10 years or more</p> Signup and view all the answers

    What is emphasized in the text regarding the confidentiality of donor identities?

    <p>The identity of donors shall be kept confidential at all times</p> Signup and view all the answers

    What aspect should the IC-SCR and IEC ensure about subjects when reviewing proposals for human gametes, embryos, and somatic cell donation?

    <p>Subjects do not belong to vulnerable groups</p> Signup and view all the answers

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