1. Double blind trial

Refers to the study subject(s) and/or investigator(s) are unaware of the treatment assigned but monitor and data analyst(s) are aware of the treatment assigned.

Refers to the study subject(s) and/or investigator(s) and monitor are unaware of the treatment assigned but data analyst(s) are aware of the treatment assigned.

Refers to the study subject(s) and/or investigator(s), monitor and data analyst(s) are unaware of the treatment assigned.

Refers to the study subject(s) and/or investigator(s) and data analyst(s) are unaware of the treatment assigned. Monitors are aware of the assignments.

2. The objective of phase-II trials is to determine

The maximum tolerated dose in humans, pharmacodynamic effect and adverse effects

The minimum tolerated dose in humans, pharmacodynamic effect and adverse effects

The maximum tolerated dose in humans and pharmacodynamic effect

The effect of the drug on the disease condition


3. The first Helsinki Declaration was in the year

1948

1954

1958

1964

4. Principle of privacy and confidentiality upholds which of the following ethical principles?

Beneficence

Non-malfeasance

Autonomy

Justice

5. Principle of professional competence is

Beneficence

Non-malfeasance

Autonomy

Justice

6. All these are responsibilities of an IEC except

To protect the dignity and rights of the investigator

To protect the dignity, rights and well-being of the potential research participants

To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs

To assist in the development and the education of a research community responsive to local health care requirements

7. As per revised Schedule Y of the Drugs and Cosmetics Act, 1940, amended in 2005, the Ethics Committee approving drug trials should have in the quorum at least one representative from the following groups except

One basic medical scientist (preferably one pharmacologist)

One clinician

One legal expert or retired judge

One institutional representative

8. Expedited Review is

The researcher needs to hurry the proposal

Proposals presenting not more than minimal risk to research participants

Proposals which present less than minimal risk fall

All research presenting with more than minimal risk

9. The decision taken by the IEC on the proposal is based on

Chairman's decision

Majority vote

A broad consensus after the quorum requirements are fulfilled

Institutional policy

10. IECs may waive off the requirement for informed consent in the following instances except

Study on disease burden of HIV/AIDS

Review of guidelines

Discarded blood after the lab test has been performed

Newly discovered drug

11. The investigator can obtain informed consent by using

Deception

Only after the prospective participant is adequately informed

Seek consent from the prospective participant before fully disclosing the purpose of the study

Verbal consent

12. Ancillary care means

Subject is provided treatment for complaints other than the one being studied

Subject is provided treatment for the adverse effects of the treatment

Subject is provided medical care for lifetime

Subject is provided care only for the permanent disabilities that occur during the period of study

13. The following research is permitted in women except

To test the efficacy and safety of a drug for reducing perinatal transmission of HIV infection from mother to child

Trials for detecting foetal abnormalities

For conditions associated with or aggravated by pregnancy

For an anti-asthmatic drug trial

14. In an international collaborative research

The local institution policy is more important than that of the sponsor or the host country policy

The local sponsor policy is more important than the institution or the host country policy

The host country policy is more important than that of the sponsor or the local institution

The local institution, the sponsor or the host country policy are to be given equal importance for research

15. Phase-IV trials are necessary for

Approval of a new drug

Marketing

May be required by the Licensing Authority for optimizing its use

Pricing of the drug

16. The medical management of the adverse event is the responsibility of

The investigator

The sponsor

The institution

The Government

17. In Cross-Sectional Epidemiological Studies

The available records are examined

The study participants are directly contacted only once

The study participants are directly contacted many times

The study participants are directly contacted at the beginning and at the end of the study

18. Community participation in an epidemiological research should be

From the design of the study

From the beginning of the investigation

Involved only when the results can affect the community

Throughout the study

19. In pedigree studies

Family members need to know the diagnosis of the subject

Family members need not know the diagnosis of the subject

Only close relatives need to know the diagnosis of the subject

Only the spouse of the subject needs to know the diagnosis

20. In pedigree studies, the following problems could arise except

Revealing who else in the family has agreed to participate may lead to breach of confidentiality

Recruitment of the subject through advertisements in the media

If a proband is used, out of personal interest s/he may put undue pressure on relatives to enrol in the study

Direct recruitment by telephone calls, etc. may be seen as an invasion of privacy by the family members

21. To maintain confidentiality in a genetic study

The sample must be anonymised and analysed

The results of the sample must be linked to the patient

The results of the sample may be linked to the patient, if it directly benefits the patient

The results of the sample must be delinked from the patient

22. Ethically, the results of the positive genetic testing can be informed

By the investigator to all the persons likely to be affected by the gene

By the investigators to the Government

By the patient to whomsoever s/he wants

The benefit to the other members of the family overrules the need for confidentiality of the patient

23. Screening of a newborn should be done when

A test is available for testing the condition

A test is available and no treatment is available for treatment

A test is available and an effective treatment is available

As part of the Governmental programme

24. Screening of children for genetic disease must be undertaken

When parents wish for it

Only with the assent of the child

As a programme for improving the community health

At the request of the orphanage head

25. Somatic cell gene therapy

May be permissible for the purpose of preventing or treating a serious disease when it is the only therapeutic option

May be permissible for the purpose of preventing or treating a common disease even when there is an effective treatment

May be permissible for the purpose of preventing a serious disease

Is never permissible

26. To prepare a 'gene construct' the permission must be obtained from

ICMR and IEC

Central Ethics Committee of ICMR

Health Ministry and DCGI

National Bioethics Committee of the DBT

27. Repository activities involve all of these except

The collectors of tissue samples

The repository storage and data management centre

The recipient investigators

Dissemination of information on the samples stored

28. The identity of the Repository from which the samples were obtained

Must be revealed in all reports, patents or copyrights arising out of the samples

Must not be revealed in all reports, patents or copyrights arising out of the samples

Only when patents are obtained

Only when copyrights arising out of the samples are involved

29. Ownership of the biological specimen rests with

The community

The donor

The family of the donor

With the donor and the family, if the donor is deceased

30. Prenatal diagnosis should be available

To parents who request it and plan for an abortion

To parents who request it but oppose abortion

To parents who have a genetically affected child

To parents who want a perfect child

31. In which of the following conditions may prenatal diagnosis be performed to protect the health of the mother?

Morbid anxiety in the mother

Genetic disease in the mother

Systemic lupus erythematosis

Eclampsia

32. All these are features of brain death except

The presence of deep coma

The absence of any spontaneous respiration

The presence of low body temperature

The absence of pupil reactions and eye movements

33. Donation from a live donor should be restricted in

Bone marrow

Liver

Kidney

Eye

34. The responsibility of providing the information to the donor involved in research involving transplant, and of making sure that s1he understands fully the implications of what is to be done and what he or she consents to, rests entirely on the

Director of the research project

Investigators at the site

Institutional head

Head of the Ethics Committee

35. In all these countries a "Living Will" or advance directives is accepted except in

Australia

India

England

Ireland

36. The tissue/organ from the following source should not be used for transplantation:

Embryo

Live born foetus

Dead born foetus

Blastocyst

37. The final authority on Research on Foetal Tissue or Organs for Transplantation is

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

Institutional Committee for Stem Cell Research and Therapy (IC-SCRT)

Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) and IEC

Health Ministry

38. In termination of pregnancy

Mother can terminate her pregnancy as she wants to donate foetal tissue for her older child

In a spontaneous abortion consent of the mother is essential for use in transplantation research

In a spontaneous abortion consent of the father is essential for use in transplantation research

The aborted foetus cannot be used for research

39. When collecting umbilical cord blood for bio-banking, to protect the blood, it should be collected

When the cord is seen in the vagina

As soon as the baby is born

On normal clamping of the cord

After the cord is cut

40. Transplantation of organs from the animals to humans is banned because of the fear of/that

Transplanted person may get the psychological character of the transplanted animal

Transmitting disease from the animals to humans

Increased chances of rejection

Organ may not be sufficient to support the human body

41. The transfer of an adult cell nucleus into an egg that has had its nucleus removed to asexually create an embryo without the fusion of sperm and egg is known as

Cloning

Reproductive Cloning

Therapeutic Cloning

Cell Nuclear Replacement

42. All these are permissible areas of research in stem cells except

In vitro studies on established cell lines from any type of stem cells

In vivo studies with established cell lines from any type of stem cells

In vivo studies on experimental animals (other than primates) using foetal/adult somatic stem cells

Creation of a zygote by IVF, SCNT or any other method with the specific aim of deriving a hES cell line for any purpose

43. Reproductive cloning

Is a prohibited area for research

Can be undertaken at the request of the couple

Can be undertaken with permission from the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT)

Can be undertaken with permission from the Institutional Committee for Stem Cell Research and Therapy (IC-SCRT)

44. In assisted reproductive procedures, informed signed consent has to be obtained from the

Mother

Father

Donor of the sperm or ovum

All of the above

45. The semen bank assumes the responsibility in selection of the suitable donor on the following terms

The blood group of the donor and the recipient should match

The donor should be healthy with reasonable expectation of good quality of sperms and need not have proven fertility

The physical characteristic and mental make-up of the donor should match as closely as possible to that of the spouse of the recipient

Donated semen must be used immediately to prevent transmission of infections

46. An embryo shall be stored

Indefinitely

For not more than five years

For not more than three years

For not more than one year

47. A child born through assisted reproductive technique is presumed to be the legitimate child of

The Ovum donor

The Sperm donor

The couple who are married and consented for therapy

The couple who are not married and consented for therapy

48. In case of a child conceived by surrogate motherhood

Adopting parents have an obligation to inform the child of its biological parents

The child has a right to seek information on the identity of genetic parent(s) or surrogate mother

The child does not have any legal rights on the adopting parents

Adopting parents have no obligation to inform the child of its biological parents

49. The Chairman to deliberate and work out the formula to be followed to determine the quantum of compensation in case of clinical trial related injury other than death was

R.K. Jain

A.K. Agarwal

Y.K. Gupta

Mira Shiva

50. The base amount in case of injury or death is determined by

The minimum wages of the skilled workers

The minimum wages of the unskilled workers

The minimum wages earned by the victim

The maximum wages earned by the subject in his/her lifetime of the unskilled workers

Write short notes on any four of the following in 200 -300 words each. Each carries five marks.

51. Phase-3 Trials

52. Ethical problems in conducting research among mentally challenged

53. The difference between a vaccine trial and a new drug trial

54. Wavier of consent for research proposal

55. Guidelines for unrelated live organ donor