CDSCO Guidelines for Audio-Visual Recording Quiz

Play an AI-generated podcast conversation about this lesson

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?

If there are exceptional circumstances Signup and view all the answers

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

The potential for genetic manipulation and commercialization Signup and view all the answers

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

To ensure informed decision-making by donors Signup and view all the answers

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

They do not vest with the donor Signup and view all the answers

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

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

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

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

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

Due to lack of suitable animal model system Signup and view all the answers

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

CDSCO licensed Good Manufacturing Practices (GMP) compliant facility 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?

To enhance their utility 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?

To encourage altruistic donation without financial incentives Signup and view all the answers

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

Autologous transplantation situations Signup and view all the answers

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

Providing appropriate health care and compensation for any complications Signup and view all the answers

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

10 years or more Signup and view all the answers

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

The identity of donors shall be kept confidential at all times 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?

Subjects do not belong to vulnerable groups Signup and view all the answers