Exam Details
| Subject | Research Ethics - I | |
| Paper | ||
| Exam / Course | Post Graduate Diploma In Bioethics | |
| Department | School of Health Science (SOHS) | |
| Organization | indira gandhi national open university | |
| Position | ||
| Exam Date | December, 2016 | |
| City, State | new delhi, |
Question Paper
1. Expedited review happens in
High risk studies
Minimal risk studies
Emergency situations
All of the above
2. The minimal risk proposals exempted from review include
Instructional techniques
Interview procedures
Behavioural studies
All of the above
3. According to the ICMR, how long should IEC records be maintained after the completion of the study?
Minimum 3 years
Maximum 3 years
Minimum 3 months
Maximum 6 months
4. SOP stands for
System Operation Protocol
Standard Operating Protocol
Scientific Operational Protocol
System Operating Programme
5. Which of the following is necessary for an IEC to function smoothly and efficiently?
Full time secretariat
Record keeping space
Members to be compensated for their time
Fund allocation by all institutions under IEC
6. Kasturba Manipal Hospital is accredited for research and-clinical trial by
AAHRPP
SIDCER
Both and
Neither of the above
7. The areas of research which do not require special considerations by IEC are
Children
Pregnant and nursing women
International Collaborative Research
Geriatric Population/Senior citizens
8. A proposal was submitted on November 1st, 2012 and reviewed on July 2nd, 2013. Ideally, which month should it have been reviewed?
May 2013
June 2013
August 2013
November 2013
9. An ongoing project should be reviewed
At regular intervals of 6 months year
Once in 3 months
Once-in 2 years
No need for review upon approval
10. If an IEC member has conflict of interest in a project, he/she should withdraw from IEC
While the project is being discussed
Anytime during the project
During completion of the project
of the above
11. In an international collaborative study, what is the requirement for exchange of biological material
Review of HMSC and DCGI
Details of funding agent
Memorandum of Understanding between collaborative partners
All of the above
l2. Which of the following does the study protocol include in the application to IEC?
Details of research participants
Curriculum vitae of investigators with inclusion of qualification and experience
Inclusion and exclusion criteria for entry of participants
Both and
13. IEC has
Quorum of 8 -12 members
Subject experts
Research team
Both and
14. Terms of appointment of IEC members include
Policy of removal
Replacement
Duration of term
All of the above
15. IEC members are trained through
Human protection ethics training
Relevant orientation course
Clinical practice for drug trial review
All of the above
16. Proposals are categorised into
Exemption from review, expedited, full review
High risk, full, expedited
Partial, high risk, full review
Expedited, partial, high risk
17. Qualities of a principal investigator is
Competent in biomedical research methodology
Observant of rights and welfare of the participants
Comply with the scientific, legal and ethical requirements of study
All of the above
18. IEC can choose to waive the consent
For left-over sample after clinical investigation
If participants' privacy is breached
In situations with no available surrogate consent
All of the above
19. If a participant withdraws from a study, then he/she receives
Benefit of full compensation
Half of the benefits/compensation
No compensation
None of the above
20. Undue compensation includes
Free medication
Insurance for unrelated conditions
Both the above
None of the above
21. Vulnerable study group means
Lactating mothers
Economically disadvantaged people
Geriatric population
Pregnant women
22. The investigator can inform the media about
Preliminary findings
Selective information that might bring about fear to the public
Assure clinical application for human use, while in mid trial
None of the above
23. A legally acceptable/authorized representative can be
A relative/A care taker
An investigator
An unrelated witness
Any adult person
24. Mutat is Mutandis means
Change only what needs to be changed
Do not make any changes
Change what can be changed
None of the above
25. The ICMR Code has certain general and specific principles which specifically pertain to
Epidemiology, clinical trials, gynaecology and transplantation
STD, HIV/AIDS, genetics and clinical trials
Interventional clinical trials, epidemiology, genetics, transplantation and ART
None of the above
26. The Supreme Court's opinion on confidentiality about HIV/AIDS in India is
Right to privacy not absolute, individual with HIV should tell his/her sex partner
Right to privacy absolute, individual's wish whether or not to disclose the status to his/her partners
No opinion on confidentiality
None of the above
27. Nuremberg Code was formulated in
1947
1948
1949
1950
28. The ICMR principle which highlights autonomy is
Principle of maximization of public, interest and distributive justice
Principle of voluntariness, informed consent and community agreement
Principle of non-exploitation
None of the above
29. From children between 2 years of age
Assent should be obtained from children and consent from parent/legally authorized/acceptable representatives
Consent from parent should be obtained
Consent from children should be obtained
None of the above
30. How many components constitute the Informed consent document?
2
3
4
5
31. Informed consent should be obtained preferably
On the day of the trial
One or more days before the trial begins
6 months before
1 year before
32. Independence and competence are the hallmarks of wbich scientific body?
ICMR
IEC
AAHRPP
All of the above
33. Conflict of interest is
Business interest with a company developing the product
A disagreement between the investigators of a study
Both the above
None of the above
34. Post trial access is stated in Helsinki Declaration in which of these years
2000,2006,2008
2001,2010,2011
2000,2004,2008
None of-the above
35. Latest Helsinki Declaration is the
6th declaration 2008
5th declaration 2007
8th declaration 2008
10th declaration 2012
36. ICMR updated its guidelines in
2000
1998
2001
2005
37. Conflict of interest should be informed to
Journals
Research participants
IEC
All of the above
38. ICMR 2006 revisions include
HIV/AIDS and genetics
Molecular studies and HIV/STD
Cancer and genetics
STD and genetics
39. Who decides the exemption of a proposal from review?
IEC
ICMR
Legal expert
Investigator
40. Collection of a biological specimen for research purpose for prospective study should be
Invasive
Coercive
Disfiguring
Non-invasive
41. Helsinki Declaration has been revised
5 times
8 times
7 times
11 times
42. IEC should be
Multidisciplinary
Multisectorial
Both and
None of the above
43. DSMB means
Data Safety Monitoring Board
Documentation Safety Monitoring Board
Digital Safety Monitoring Board
None of the above
44. A study testing a drug in children should be conducted after
Animal trials
Phase-IT trials in humans
Phase-III trials in humans
Phase-I trials in animals
45. Components of an Informed consent are
Information, compensation and autonomy
Comprehension, information and voluntariness
Compensation, voluntariness and autonomy
Information, comprehension and autonomy
46. Helsinki Declaration is a document of
American Medical Association
World Medical Association
World Health Organisation
Helsinki Medical Association
47. IEC is an acronym for
Information and Ethical Committee
Institutional Ethics Committee
Indian Ethics Committee
Internal Ethics Committee
48. SIDCER stands for
Strategic Initiative for Developing Capacity in Ethical Review
Society for International Development Code for Ethics and Research
Social Institute for Development of Codes in Ethics and Research
None of the above
49. Experimental Research should be conducted in a
Fair, honest, impartial and transparent manner
Fair, dishonest, partial and transparent manner
Biased, honest, partial and selective manner
Honest, impartial and transparent manner
50. The rights and dignity is protected by
Distributive justice
Confidentiality
Informed consent
All of the above
Write short notes on any four of the following in 200 -300 words each.
51. Designer Babies
52. Records to be maintained by IEC and their Monitoring Methods
53. Are Scientists playing God Comment.
54. Vulnerable Populations in a Research
55. Three-parent Reproduction
56. Nuremberg Code
High risk studies
Minimal risk studies
Emergency situations
All of the above
2. The minimal risk proposals exempted from review include
Instructional techniques
Interview procedures
Behavioural studies
All of the above
3. According to the ICMR, how long should IEC records be maintained after the completion of the study?
Minimum 3 years
Maximum 3 years
Minimum 3 months
Maximum 6 months
4. SOP stands for
System Operation Protocol
Standard Operating Protocol
Scientific Operational Protocol
System Operating Programme
5. Which of the following is necessary for an IEC to function smoothly and efficiently?
Full time secretariat
Record keeping space
Members to be compensated for their time
Fund allocation by all institutions under IEC
6. Kasturba Manipal Hospital is accredited for research and-clinical trial by
AAHRPP
SIDCER
Both and
Neither of the above
7. The areas of research which do not require special considerations by IEC are
Children
Pregnant and nursing women
International Collaborative Research
Geriatric Population/Senior citizens
8. A proposal was submitted on November 1st, 2012 and reviewed on July 2nd, 2013. Ideally, which month should it have been reviewed?
May 2013
June 2013
August 2013
November 2013
9. An ongoing project should be reviewed
At regular intervals of 6 months year
Once in 3 months
Once-in 2 years
No need for review upon approval
10. If an IEC member has conflict of interest in a project, he/she should withdraw from IEC
While the project is being discussed
Anytime during the project
During completion of the project
of the above
11. In an international collaborative study, what is the requirement for exchange of biological material
Review of HMSC and DCGI
Details of funding agent
Memorandum of Understanding between collaborative partners
All of the above
l2. Which of the following does the study protocol include in the application to IEC?
Details of research participants
Curriculum vitae of investigators with inclusion of qualification and experience
Inclusion and exclusion criteria for entry of participants
Both and
13. IEC has
Quorum of 8 -12 members
Subject experts
Research team
Both and
14. Terms of appointment of IEC members include
Policy of removal
Replacement
Duration of term
All of the above
15. IEC members are trained through
Human protection ethics training
Relevant orientation course
Clinical practice for drug trial review
All of the above
16. Proposals are categorised into
Exemption from review, expedited, full review
High risk, full, expedited
Partial, high risk, full review
Expedited, partial, high risk
17. Qualities of a principal investigator is
Competent in biomedical research methodology
Observant of rights and welfare of the participants
Comply with the scientific, legal and ethical requirements of study
All of the above
18. IEC can choose to waive the consent
For left-over sample after clinical investigation
If participants' privacy is breached
In situations with no available surrogate consent
All of the above
19. If a participant withdraws from a study, then he/she receives
Benefit of full compensation
Half of the benefits/compensation
No compensation
None of the above
20. Undue compensation includes
Free medication
Insurance for unrelated conditions
Both the above
None of the above
21. Vulnerable study group means
Lactating mothers
Economically disadvantaged people
Geriatric population
Pregnant women
22. The investigator can inform the media about
Preliminary findings
Selective information that might bring about fear to the public
Assure clinical application for human use, while in mid trial
None of the above
23. A legally acceptable/authorized representative can be
A relative/A care taker
An investigator
An unrelated witness
Any adult person
24. Mutat is Mutandis means
Change only what needs to be changed
Do not make any changes
Change what can be changed
None of the above
25. The ICMR Code has certain general and specific principles which specifically pertain to
Epidemiology, clinical trials, gynaecology and transplantation
STD, HIV/AIDS, genetics and clinical trials
Interventional clinical trials, epidemiology, genetics, transplantation and ART
None of the above
26. The Supreme Court's opinion on confidentiality about HIV/AIDS in India is
Right to privacy not absolute, individual with HIV should tell his/her sex partner
Right to privacy absolute, individual's wish whether or not to disclose the status to his/her partners
No opinion on confidentiality
None of the above
27. Nuremberg Code was formulated in
1947
1948
1949
1950
28. The ICMR principle which highlights autonomy is
Principle of maximization of public, interest and distributive justice
Principle of voluntariness, informed consent and community agreement
Principle of non-exploitation
None of the above
29. From children between 2 years of age
Assent should be obtained from children and consent from parent/legally authorized/acceptable representatives
Consent from parent should be obtained
Consent from children should be obtained
None of the above
30. How many components constitute the Informed consent document?
2
3
4
5
31. Informed consent should be obtained preferably
On the day of the trial
One or more days before the trial begins
6 months before
1 year before
32. Independence and competence are the hallmarks of wbich scientific body?
ICMR
IEC
AAHRPP
All of the above
33. Conflict of interest is
Business interest with a company developing the product
A disagreement between the investigators of a study
Both the above
None of the above
34. Post trial access is stated in Helsinki Declaration in which of these years
2000,2006,2008
2001,2010,2011
2000,2004,2008
None of-the above
35. Latest Helsinki Declaration is the
6th declaration 2008
5th declaration 2007
8th declaration 2008
10th declaration 2012
36. ICMR updated its guidelines in
2000
1998
2001
2005
37. Conflict of interest should be informed to
Journals
Research participants
IEC
All of the above
38. ICMR 2006 revisions include
HIV/AIDS and genetics
Molecular studies and HIV/STD
Cancer and genetics
STD and genetics
39. Who decides the exemption of a proposal from review?
IEC
ICMR
Legal expert
Investigator
40. Collection of a biological specimen for research purpose for prospective study should be
Invasive
Coercive
Disfiguring
Non-invasive
41. Helsinki Declaration has been revised
5 times
8 times
7 times
11 times
42. IEC should be
Multidisciplinary
Multisectorial
Both and
None of the above
43. DSMB means
Data Safety Monitoring Board
Documentation Safety Monitoring Board
Digital Safety Monitoring Board
None of the above
44. A study testing a drug in children should be conducted after
Animal trials
Phase-IT trials in humans
Phase-III trials in humans
Phase-I trials in animals
45. Components of an Informed consent are
Information, compensation and autonomy
Comprehension, information and voluntariness
Compensation, voluntariness and autonomy
Information, comprehension and autonomy
46. Helsinki Declaration is a document of
American Medical Association
World Medical Association
World Health Organisation
Helsinki Medical Association
47. IEC is an acronym for
Information and Ethical Committee
Institutional Ethics Committee
Indian Ethics Committee
Internal Ethics Committee
48. SIDCER stands for
Strategic Initiative for Developing Capacity in Ethical Review
Society for International Development Code for Ethics and Research
Social Institute for Development of Codes in Ethics and Research
None of the above
49. Experimental Research should be conducted in a
Fair, honest, impartial and transparent manner
Fair, dishonest, partial and transparent manner
Biased, honest, partial and selective manner
Honest, impartial and transparent manner
50. The rights and dignity is protected by
Distributive justice
Confidentiality
Informed consent
All of the above
Write short notes on any four of the following in 200 -300 words each.
51. Designer Babies
52. Records to be maintained by IEC and their Monitoring Methods
53. Are Scientists playing God Comment.
54. Vulnerable Populations in a Research
55. Three-parent Reproduction
56. Nuremberg Code
Other Question Papers
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Subjects
- Bioethics And Law
- Clinical Ethics
- Educational Technology And Communication
- Introduction To Bioethics
- Research Ethics - I
- Research Ethics-Ii
- Research Methodology
- Social Science Research Related To Health
- Special Issues In Research Ethics