18 Questions
What is one of the key ethical principles that stakeholders and researchers are expected to follow in the context of donation of biological material?
Maintaining confidentiality and privacy of donors
In the context of donation of biological material, what must be adequately explained to donors regarding procedural risks?
Risks associated with local or general anesthesia during collection
What important information must be included in the information sheet provided to donors?
Risk factors related to transmittable diseases
Under what circumstances might cell lines/products generated from donated material be shared with other scientific groups?
If there are exceptional circumstances
What important aspect should donors be informed about regarding cell lines/products generated from their donated material?
The potential for genetic manipulation and commercialization
Why is it crucial to inform donors about screening for transmittable diseases and risk factors during donation?
To ensure informed decision-making by donors
What happens to Intellectual Property Rights (IPR) of biological material in the event of commercialization?
They do not vest with the donor
What efforts should be made if commercialization of biological material brings financial benefits?
Pass on the benefits to the donor/community
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
Why are innovative surrogate assays needed for testing the potency of stem cells?
Due to lack of suitable animal model system
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
Why may some manipulations such as processing and enrichment be needed for stem cells obtained from human adult tissues?
To enhance their utility
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
What is the exception where research may provide a direct medical benefit to the donor?
Autologous transplantation situations
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
How long can information related to derived stem cells or cell lines be archived according to the text?
10 years or more
What is emphasized in the text regarding the confidentiality of donor identities?
The identity of donors shall be kept confidential at all times
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
Test your knowledge on the guidelines set by CDSCO for audio-visual recording in research, with a focus on ethical principles and considerations related to gametes, embryos, and fetal tissues donation. Understand the importance of ensuring donor protection from exploitation and commoditization, as well as upholding confidentiality and privacy.
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