ICMR-DBT Guidelines for Stem Cell Research – overview MCQs With Answer

Introduction:

The ICMR-DBT joint guidelines for stem cell research provide the ethical, scientific and regulatory framework for conducting stem cell work in India. This blog presents an overview of those guidelines tailored for M.Pharm students preparing for exams on regulations and legislation. The multiple-choice questions focus on governance structures (NAC-SCRT, institutional committees), permissible versus prohibited research (embryo culture limits, reproductive cloning, germline modification), requirements for clinical translation, donor consent and biosafety oversight. Each question reinforces key provisions, practical compliance steps and the rationale behind restrictions, helping students understand how research integrity, patient safety and public policy shape stem cell science in India.

Q1. Which area is primarily governed by the ICMR-DBT National Guidelines for Stem Cell Research?

• Regulation of stem cell research and therapy in India
• Approval of generic drug pricing
• Certification of traditional herbal medicines
• Registration of medical devices

Correct Answer: Regulation of stem cell research and therapy in India

Q2. What is the name of the national apex body established to oversee stem cell research and therapy in India under these guidelines?

• National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT)
• Central Drugs Standard Control Organization (CDSCO)
• Drug Controller General of India (DCGI)
• National Ethics Advisory Board (NEAB)

Correct Answer: National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT)

Q3. Which institutional committee is required to review and monitor stem cell research within a research institution?

• Institutional Committee for Stem Cell Research (IC-SCR)
• Institutional Animal Ethics Committee (IAEC)
• Drug Safety Monitoring Board (DSMB)
• Clinical Trial Site Management Committee (CTSMC)

Correct Answer: Institutional Committee for Stem Cell Research (IC-SCR)

Q4. Derivation of new human embryonic stem cell (hESC) lines under the guidelines requires which of the following?

• Approval and registration with IC-SCR and oversight by NAC-SCRT
• Only local Institutional Animal Ethics Committee approval
• Automatic approval if conducted in a private laboratory
• No oversight if embryos are surplus from IVF

Correct Answer: Approval and registration with IC-SCR and oversight by NAC-SCRT

Q5. Which of the following activities is explicitly prohibited by ICMR-DBT stem cell guidelines?

• Reproductive cloning of human beings
• Basic research on adult stem cells in vitro
• Characterization of established cell lines
• Preclinical safety testing in appropriate animal models

Correct Answer: Reproductive cloning of human beings

Q6. What is the widely accepted limit for in vitro culture of human embryos stated in international and reflected in these guidelines?

• Culturing embryos beyond 14 days or formation of the primitive streak is not permitted
• Embryo culture is allowed indefinitely with institutional approval
• Embryos may be cultured for up to 6 months for research purposes
• There is no limit if embryos are anonymized

Correct Answer: Culturing embryos beyond 14 days or formation of the primitive streak is not permitted

Q7. How do the ICMR-DBT guidelines treat germline genome editing intended for reproductive use?

• Germline editing for reproductive purposes is prohibited
• Permitted after peer review without further oversight
• Allowed if parents give informed consent
• Allowed only for agricultural applications

Correct Answer: Germline editing for reproductive purposes is prohibited

Q8. Before initiating a first-in-human clinical trial of a stem cell therapy, which approvals are generally required under the guidelines?

• Approval from NAC-SCRT and regulatory clearance from CDSCO/DCGI
• Only institutional ethics committee approval is sufficient
• Approval solely from international collaborators
• No approvals are required for cell therapies derived from autologous cells

Correct Answer: Approval from NAC-SCRT and regulatory clearance from CDSCO/DCGI

Q9. What is required for the import or export of human stem cell lines according to the guidelines?

• Prior approval from competent national authorities such as DBT/NAC-SCRT
• No formal permissions if cells are from a commercial source
• Only a material transfer agreement without regulatory approval
• Approval from the local hospital administration alone

Correct Answer: Prior approval from competent national authorities such as DBT/NAC-SCRT

Q10. Which is a mandatory component of donor consent for human biological material intended for stem cell research?

• Specific, informed consent detailing intended uses, storage and future research
• Verbal consent with no documentation
• Consent can be presumed if the donor is undergoing any clinical procedure
• Consent is not required for waste tissues collected during surgery

Correct Answer: Specific, informed consent detailing intended uses, storage and future research

Q11. Under the guidelines, which processing of cells is considered “minimal manipulation” and less likely to change regulatory classification?

• Procedures that do not alter the biological characteristics or function of the cells
• Genetic modification to enhance stem cell potency
• Combining cells with novel biomaterials that alter function
• Ex vivo expansion with transgene insertion

Correct Answer: Procedures that do not alter the biological characteristics or function of the cells

Q12. What restriction applies to creating human-animal chimeras under these guidelines?

• Breeding animals that may transmit human germ line contribution is prohibited
• All forms of human-animal chimeras are freely permitted without oversight
• Human cells may be introduced into animals and offspring released without review
• There are no restrictions if the animal is non-mammalian

Correct Answer: Breeding animals that may transmit human germ line contribution is prohibited

Q13. What is recommended for cell lines produced in research according to ICMR-DBT guidance?

• Characterization, quality control and deposition in registered cell banks where appropriate
• Immediate commercial sale without quality checks
• Destruction after a single experiment to avoid sharing
• Unrestricted distribution without documentation

Correct Answer: Characterization, quality control and deposition in registered cell banks where appropriate

Q14. Non-compliance with the ICMR-DBT stem cell guidelines can lead to which consequences?

• Suspension of research activities, institutional action and possible legal consequences
• Automatic approval of the research retroactively
• Only a request to publish the results publicly
• No action unless harm has occurred

Correct Answer: Suspension of research activities, institutional action and possible legal consequences

Q15. From which source is derivation of human embryonic stem cell lines generally permitted when ethical conditions are met?

• Surplus embryos from in vitro fertilization (IVF) with documented donor consent
• Embryos created solely for research without consent
• Commercially purchased fetal tissue sold for profit
• Embryos obtained without donor information

Correct Answer: Surplus embryos from in vitro fertilization (IVF) with documented donor consent

Q16. Which committee is typically responsible for biosafety review of genetically modified stem cell work at an institution?

• Institutional Biosafety Committee (IBSC)
• Institutional Finance Committee
• Local Police Oversight Panel
• Student Research Club

Correct Answer: Institutional Biosafety Committee (IBSC)

Q17. What is the guideline position on commercial sale of donated human reproductive material or embryos?

• Sale or commercial trading of donated reproductive material is prohibited
• Commercial sale is permitted with institutional approval
• Sale is allowed only for international buyers
• Commercial sale is unrestricted if donors consented orally

Correct Answer: Sale or commercial trading of donated reproductive material is prohibited

Q18. How should donor identity and personal data be handled under the guidelines?

• Donor identity must be kept confidential and research data de-identified
• Donor details should be published with research findings
• Donor identity can be sold to third parties
• Personal data need not be recorded at all

Correct Answer: Donor identity must be kept confidential and research data de-identified

Q19. Who jointly issued the National Guidelines for Stem Cell Research that govern ethical and regulatory practice in India?

• Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT)
• World Health Organization alone
• Ministry of Finance and Ministry of Agriculture
• Pharmaceutical Industry Association alone

Correct Answer: Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT)

Q20. Which ethical principles are emphasized throughout the ICMR-DBT stem cell guidelines?

• Respect for persons (autonomy), beneficence (risk–benefit), justice and safety oversight
• Speed of publication above participant welfare
• Profit maximization as the primary objective
• Mandatory use of all donated tissues regardless of consent

Correct Answer: Respect for persons (autonomy), beneficence (risk–benefit), justice and safety oversight

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