1. Minimum members constitute Institutional ethics committee.







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2. The purpose of agreements between ICMR with International Organizations/Institutions regarding International Collaboration in Biomedical and Health Research in India has been for:

Exchange of scientific information

Exchange of scientists technicians for training under the projects

Joint execution of scientific projects including support in the procurement of scientific equipments.

All of the above

3. Wrong appropriation of another authors language, thoughts, ideas and expression as ones original work is

Fabrication

Plagiarism

Selective omission of data

None of the above

4. For International Collaboration in Biomedical and Health Research in Indian ICMR operates in close cooperation with the:

Indian Ministry of Health and Family Welfare

Ministry of Science and Technology

Ministry of External Affairs

All of the above

5. Ideally, the research participant's identity is not known to the researcher. This is called:

Anonymity

Confidentiality

Deception

Desensitizing

6. Researchers can ensure confidentiality by

Using identification numbers or pseudonyms for participants

Not discussing participants in any data gathering with others

Keeping any identifying information separate from the data

All of the above

7. How often does the Health Ministry Screening Committee (HMSC) meet?

1 month

3 months

6 months

12 months

8. Basic principles of ethical research include all except:

Right to withdraw

Deceptive practices

Informed consent

Anonymity

9. Components of ethically valid informed consent for research includes:

Disclosure

Understanding

Competence

All of the above

10. The strongest evidence for causality comes from which of the following research methods?

Experimental

Causal -comparative

Correlational

Ethnography

11. Possible Improvements Techniques for Informed Consent includes:

Conducting a demographic analysis of the research projects geographical location

Hiring professionals to translate all the information related to the experiment

Taking extra time to fully explain the informed consent form

All of the above

12. International Clinical Trial Day is being held on every year.

24 January

07 October

28 June

20 May

13. Which of the following is best form of research?

Single blind clinical trial

Double blind clinical trial

Randomized controlled trial

Meta analysis

14. Phase O of clinical trial is related to

Micro -dosing

Animal experimentation

Pharmacovigilance

Pharmaeconomical analysis

15. Which of the following is most commonly used animal for research purpose?

Guinea pigs

Rat

Frog

Dog

16. Transgenic animals are used:

To study the biological functions of specific genes

To develop animal models for diseases of humans or animals

To produce therapeutic products

All of the above

17. Research participants must give before they can participate in a study.

Guidelines

A commitment

Informed consent

Private information

18. The Euthanasia for experimental animals should meet the following requirements except:

Minimum physiological and psychological disturbances

Compatibility with the purpose of study and minimum emotional effect on the observer and operator

Should be done in animal rooms and free from environmental contaminations

Method should be reliable, reproducible and safe to the personnel involved

19. Following are the Non -living in vitro systems can be used to reduce replace animals in experimentation except

Mechanical models

Computer simulation

DNA recombinant technology

Organ bath

20. Identify the term that refers to a post-study-interview in which all aspects of the study are revealed, reasons for the use of deception are given, and the participants' questions are answered.

Desensitizing

Debriefing

Dehoaxing

Deploying

21. Which of the following is not correct for Housing and Environmental requirement in case of Guinea Pig?

Average Weight 400 -500 gms

Temperature 22 -24°C

Humidity 30

Photocycle (Light: Dark) 12 :12

22. Methods of Euthanasia NOT acceptable for any species is

Stunning

Electrocution

Decapitation

CO2 inhalation

23. Forms of scientific misconduct includes:

Fabrication

Falsification

Plagiarism

All of the above

24. The Health Ministry's Screening Committee (HMSC) takes decision on

National research proposals

State research proposals

International research proposals

All of the above

25. Consent process in collaborative research in medicine includes:

Freedom to take part

Freedom to deny participation

Provision of understandable information

All of the above

26. The guidelines of animal ethics in India are issued by

INSA

CDSCO

HMSC

MOHFW

27. Animal ethics is related to use of animals for:

Household purposes

Animal experimentation

Animal breeding

All of the above

28. Conflict of interest is NOT applicable to

Author

Editor

Reviewer

Reader

29. In phase III of clinical trial minimum participants required.

10

100

1000

500

30. Which of the following is most commonly used for research involving tuberculosis?

Rat

Guinea pig

Mice

Monkey

31. The composition of Institute Ethic Committee includes:

One legal expert or retired judge

One philosopher/ ethicist/theologian

One lay person from the community

All of the above

32. In which of the following phases of clinical trials of drugs, ethical clearance is not required?

Phase I

Phase II

Phase III

Phase IV

33. Which of the following need(s) to be obtained when doing research with children?

Informed consent from the parent or guardian

Assent from the child if he or she is capable

Informed consent from the child

Both and

34. Good Clinical Practice is not required in

Pre -clinical phase

Phase I

Phase II

Phase IV

35. In which year, Indian Research Funds Association (IRFA) was established?

1911

1949

1955

1936

36. In which animal model pre -clinical trial of antiemetic drugs cannot be performed?

Monkey

Mouse

Guinea Pig

Dog

37. The valid informed consent for research includes

Disclosure

Understanding

Competence

All of the above

38. Randomised Control Trials (RCTs)

Are not required to be based on the concept of equipoise

Always have a control arm that uses placebo

Are considered to be the 'gold standard' for determining efficacy and safety in clinical research

Are always"double blinded"

39. The process of introducing an exogenous geneinto a living organism so that the organism will exhibit a new property and transmit that property to its offspring is known as

Xenotransplantation

Conventional breeding

Cingenesis

Transgenesis

40. The act of publishing the same data and results in more than one journal or publication refers to which of the following professional issues?

Partial publication

Duplicate publication

Deception

Full publication

41. Who is responsible for the trial and for the rights, health and welfare of the subjects in the trial?

Subject

Investigator

Institute

Government

42. Phase IV of clinical trial is mainly concerned with:

Dose ranging

Efficacy assessment

Pharmacokinetic analysis

Post marketing surveillance

43. Fresh or re-consent is taken in following conditions except:

Availability of new information which would necessitate deviation of protocol

When long term follow-up or study extension is planned later

When there is change in treatment modality, procedures, site visits

All of the above

44. Which of the following is necessary in obtaining informed consent?

A description of the statistical analyses that will be carried out

A description of the purpose of the research

A description of the reliability and validity of test instruments

A list of publications that the researcher has had in the last ten years

45. means that the participant's identity, although known to the researcher is not revealed to anyone outside of the researcher and his or her staff.

Anonymity

Confidentiality

Falsification

Plagiarism

46. Which of the following is not true?

Misrepresenting and creating fraudulent data is dishonesty

Misrepresenting data is very easy to detect

Misrepresenting data can be difficult to detect

Breaking confidentiality is not a problem

47. Which term refers to publishing several articles from the data collected in one large study?

Duplicate publication

Partial publication

Triplicate publication

None of these

48. Which of the following is a right of each participant in a clinical trial or study involving human subjects

Deception

Utilitarianism

Freedom to withdraw

Participants have no rights

49. Concerning "authorship" in educational research, intellectual ownership is predominantly a function of a

Effort expended

Creative contribution

Professional position

Level of higher education

50. Which of the following approaches says that ethical issues should be judged on the basis of some universal code?

Deontological

Ethical skepticism

Utilitarianism

All of the above

Write short notes on any four of the following in about 200 -300 words:

51. Drugs and Cosmetics Act.

52. Digital Divide.

53. Nuffield Council of Bioethics.

54. Misconduct in Research.

55. Institutional Ethics Committee.

56. Helisnki Declaration.