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 | June, 2016 | |
| City, State | new delhi, |
Question Paper
1. When a participant withdraws from the study due to medical reasons he/ she receives:
Benefit for full participation
Amount equal to the amount of participation
No compensation
None of the above
2. Conflict of interest is
A disagreement between the investigators conducting the study
Business interest with a company developing the product
Both of the above
None of the above
3. Non-Vulnerable study group includes:
economically disadvantaged people
pregnant mothers
geriatric population
lactating mothers
4. Helsinki declaration stated about post trial access in the following years:
2000, 2004, 2008
2001, 2005, 2007
2000, 2008, 2006
None of the above
5. Informed consent refers to
voluntary but uninformed decision making
principle of autonomy
voluntary decision made by competent individuals after understanding the information
none of the above
6. Re-consent is obtained from participants when
study extensions are planned
change in the method of treatment
both of the above
none of the above
7. Conflict of interest should be informed to
Journals
Research participants
IEC
All of the above
8. In Research ethics, professional judgement should be concerning which of the following?
Welfare of the patient
Academic and financial benefits
Primary and secondary interest
None of the above
9. Latest Helsinki declaration is
6th declaration -2008
5th declaration -2007
8th declaration -2010
10th declaration -2012
10. ICMR updated its guidelines in the year:
2000
1998
2001
2005
11. The number of principles laid down by ICMR for ethical guidelines for "Biomedical research with human participants" is
16
14
12
10
12. Experimental research should be conducted in a
Fair, honest, partial and transparent manner
Biased, honest, impartial and transparent mam1er
Fair, honest, impartial and transparent manner
Biased, dishonest, partial and selective manner
13. Along with investigators and sponsors who should own responsibility of a study about all issues concerning it
IEC and institution
Participants
Institution and participants
None of the above
14. When was Nuremberg code formulated?
1948
1943
1957
1947
15. Participants rights and dignity is protected by
Distributive justice
Confidentiality
Informed consent
All of the above
16. The four ethical principles for research involving human participants are:
Autonomy, Beneficence, Justice, Non-maleficence
Confidentiality, Beneficence, Justice and Autonomy
Non-maleficence, Anonymity, Justice and Confidentiality
None of the above
17. ICMR 2006 revisions include
HIV/ AIDS and genetics
Molecular studies, HIV and STD
Cancer and genetics
STDs and genetics
18. Misconduct in Research is
Plagiarism
Taking credit for other's work
Fragmentation of data and republishing it as several articles
All of the above
19. What is the compensation that participants receive?
Ancillary care
Free medication
Treatment for physical injury related to the study
and
20. The principle which states that research should be conducted in a "fair, honest, impartial and transparent manner" is
Principle of Accountability and Transparency
Non-exploitation
Professional competence
Compliance
21. Declaration made in 1948 pertaining to essentiality of volunteers in informed consent:
UNESCO
Helsinki declaration
Universal declaration of Human Research
International convenant on civil and political rights
22. ClOMS released the proposed International ethical guidelines for Biomedical Research involving Human subjects in the year:
1993
1991
1982
1990
23. Mature minor is a person:
Around 16 years of age
Takes independent decisions
Can reject or choose health care treatment
All of the above
24. A child has the right to express his/her way freely in all matters affecting the child. Which article in UN convention states this?
Article 12
Article 22
Article 14
Article 11
25. Proxy consent from guardian can be obtained
Prisoners, Terminally ill
Pregnant women, Nursing women, geriatric population
All of the above
None of the above
26. The advantages of informed consent include:
Protection of Research group and institution
Privacy and confidentiality
Protection of right of participant
and
27. Who decides that proposal can be exempted from review?
IEC
ICMR
Legal expert
Investigator
28. Collection of Biological specimens for Research purpose for prospective study should be by:
Invasive means
Co-ercive means
Disfiguring means
Non-invasive means
29. AAHRPP stands for:
Acadamic Alliance for Healthcare Providers and Research Protection Program
Association of Accreditation of Human Research Protection Program
Accreditation Association of Human Research Participation Program
None of the above
30. Undue compensation is
Free Medication
Insurance for unrelated condition
Free Transport for any investigations unrelated to the study
All of the above
31. CIOMS stands for:
Council for International Organisations of Medical Science
Council for International Organisation of Molecular Science
Council of Indian Organisations of Medical Science
None of the above
32. An example for unethical practice is
Unethical to coerce children to participate in research without parental approval
You cannot participate in a study as you are a student of a university
If few results in a research are different you can delete the different ones
It is okay to conduct research of students under the age of 18 years but first obtain parental approval
33. Which of the following is unethical when conducting research with humans
Getting consent from participant
Telling participants that they must continue till the study has been completed
Maintaining anonymity of the participants
Telling them that they can withdraw at any time
34. The theory of would state that if an act produces more good than bad that act is ethically correct.
Justice
Autonomy
Beneficence
Rightfulness
35. Helsinki declaration is a document of
American Medical Association
World Medical Association
World Health Organisation
Helsinki Medical Association
36. IEC is an acronym for:
Institutional Ethics Comnittee
Informational and Educational Committee
Internal Ethics Comnittee
All of the above
37. Helsinki declaration has been revised:
5
7
10
8
38. SIDCER stands for:
Society of International Development Code for Ethics and Research
Strategic Initiative for Developing Capacity in Ethical Review
Social Initiative for Development of Codes in Ethical Research
None of the above
39. Composition of IEC should be
Multi-disciplinary
Multi-sectoral
Both of the above
None of the above
40. A review which involves re-examination of a proposal already examined by IEC which should be brought to IEe's attention
Interim review
Periodical review
Partial review
Continuing review
41. IEC decisions can be kept pending for:
12 months
1 month
3 months
No time limit
42. DSMB stands for
Data Safety Monitoring Board
Documentation Safety Monitoring Board
Digital Services and Monitoring Board
None of the above
43. IEC members should be upto date with all National and International developments in Ethics:
Training in Ethics related to human protection
Orientation Causes on all life science
Good Clinical practice for clinical trial
All of the above
44. Principal investigator should:
Observant of right and welfare of the participants
Comply with scientific, legal and ethical requirements of study
Be competent in Biomedical research methodology
All of the above
45. Any study testing a new drug in children should be conducted after:
Animal trials
Phase I trials in humans
Phase II trials in animals
Phase III in humans
46. A legally acceptable/authorized representative can be
Relative/Caretaker
Research member
Unrelated witness
None of the above
47. Components of Informed consent
Information, Comprehension, Voluntariness
Comprehension, Non-exploitation, Compensation
Compensation, Information, Autonomy
None of the above
48. When is research children are justified as study subject
With minimal risk
Direct benefit to the child in case of greater risk
Research devised only for children
All of the above
49. Emancipated Minor refers to
14 years
Working teenager
Married
and
50. Proposals are categorised into:
Exemption from review, expedited, full review
High risk, full review, expedited
Partial, high risk, full review
Expedited, partial, high risk
Write short notes on any four of the following in 200 to 300 words. 5 marks. Each question carries
Informal Consent
Third Party Reproduction
Expedited Review
IEC and its Role in Research
Ethical Principles in Human Participant Research
Helsinki Declaration
Benefit for full participation
Amount equal to the amount of participation
No compensation
None of the above
2. Conflict of interest is
A disagreement between the investigators conducting the study
Business interest with a company developing the product
Both of the above
None of the above
3. Non-Vulnerable study group includes:
economically disadvantaged people
pregnant mothers
geriatric population
lactating mothers
4. Helsinki declaration stated about post trial access in the following years:
2000, 2004, 2008
2001, 2005, 2007
2000, 2008, 2006
None of the above
5. Informed consent refers to
voluntary but uninformed decision making
principle of autonomy
voluntary decision made by competent individuals after understanding the information
none of the above
6. Re-consent is obtained from participants when
study extensions are planned
change in the method of treatment
both of the above
none of the above
7. Conflict of interest should be informed to
Journals
Research participants
IEC
All of the above
8. In Research ethics, professional judgement should be concerning which of the following?
Welfare of the patient
Academic and financial benefits
Primary and secondary interest
None of the above
9. Latest Helsinki declaration is
6th declaration -2008
5th declaration -2007
8th declaration -2010
10th declaration -2012
10. ICMR updated its guidelines in the year:
2000
1998
2001
2005
11. The number of principles laid down by ICMR for ethical guidelines for "Biomedical research with human participants" is
16
14
12
10
12. Experimental research should be conducted in a
Fair, honest, partial and transparent manner
Biased, honest, impartial and transparent mam1er
Fair, honest, impartial and transparent manner
Biased, dishonest, partial and selective manner
13. Along with investigators and sponsors who should own responsibility of a study about all issues concerning it
IEC and institution
Participants
Institution and participants
None of the above
14. When was Nuremberg code formulated?
1948
1943
1957
1947
15. Participants rights and dignity is protected by
Distributive justice
Confidentiality
Informed consent
All of the above
16. The four ethical principles for research involving human participants are:
Autonomy, Beneficence, Justice, Non-maleficence
Confidentiality, Beneficence, Justice and Autonomy
Non-maleficence, Anonymity, Justice and Confidentiality
None of the above
17. ICMR 2006 revisions include
HIV/ AIDS and genetics
Molecular studies, HIV and STD
Cancer and genetics
STDs and genetics
18. Misconduct in Research is
Plagiarism
Taking credit for other's work
Fragmentation of data and republishing it as several articles
All of the above
19. What is the compensation that participants receive?
Ancillary care
Free medication
Treatment for physical injury related to the study
and
20. The principle which states that research should be conducted in a "fair, honest, impartial and transparent manner" is
Principle of Accountability and Transparency
Non-exploitation
Professional competence
Compliance
21. Declaration made in 1948 pertaining to essentiality of volunteers in informed consent:
UNESCO
Helsinki declaration
Universal declaration of Human Research
International convenant on civil and political rights
22. ClOMS released the proposed International ethical guidelines for Biomedical Research involving Human subjects in the year:
1993
1991
1982
1990
23. Mature minor is a person:
Around 16 years of age
Takes independent decisions
Can reject or choose health care treatment
All of the above
24. A child has the right to express his/her way freely in all matters affecting the child. Which article in UN convention states this?
Article 12
Article 22
Article 14
Article 11
25. Proxy consent from guardian can be obtained
Prisoners, Terminally ill
Pregnant women, Nursing women, geriatric population
All of the above
None of the above
26. The advantages of informed consent include:
Protection of Research group and institution
Privacy and confidentiality
Protection of right of participant
and
27. Who decides that proposal can be exempted from review?
IEC
ICMR
Legal expert
Investigator
28. Collection of Biological specimens for Research purpose for prospective study should be by:
Invasive means
Co-ercive means
Disfiguring means
Non-invasive means
29. AAHRPP stands for:
Acadamic Alliance for Healthcare Providers and Research Protection Program
Association of Accreditation of Human Research Protection Program
Accreditation Association of Human Research Participation Program
None of the above
30. Undue compensation is
Free Medication
Insurance for unrelated condition
Free Transport for any investigations unrelated to the study
All of the above
31. CIOMS stands for:
Council for International Organisations of Medical Science
Council for International Organisation of Molecular Science
Council of Indian Organisations of Medical Science
None of the above
32. An example for unethical practice is
Unethical to coerce children to participate in research without parental approval
You cannot participate in a study as you are a student of a university
If few results in a research are different you can delete the different ones
It is okay to conduct research of students under the age of 18 years but first obtain parental approval
33. Which of the following is unethical when conducting research with humans
Getting consent from participant
Telling participants that they must continue till the study has been completed
Maintaining anonymity of the participants
Telling them that they can withdraw at any time
34. The theory of would state that if an act produces more good than bad that act is ethically correct.
Justice
Autonomy
Beneficence
Rightfulness
35. Helsinki declaration is a document of
American Medical Association
World Medical Association
World Health Organisation
Helsinki Medical Association
36. IEC is an acronym for:
Institutional Ethics Comnittee
Informational and Educational Committee
Internal Ethics Comnittee
All of the above
37. Helsinki declaration has been revised:
5
7
10
8
38. SIDCER stands for:
Society of International Development Code for Ethics and Research
Strategic Initiative for Developing Capacity in Ethical Review
Social Initiative for Development of Codes in Ethical Research
None of the above
39. Composition of IEC should be
Multi-disciplinary
Multi-sectoral
Both of the above
None of the above
40. A review which involves re-examination of a proposal already examined by IEC which should be brought to IEe's attention
Interim review
Periodical review
Partial review
Continuing review
41. IEC decisions can be kept pending for:
12 months
1 month
3 months
No time limit
42. DSMB stands for
Data Safety Monitoring Board
Documentation Safety Monitoring Board
Digital Services and Monitoring Board
None of the above
43. IEC members should be upto date with all National and International developments in Ethics:
Training in Ethics related to human protection
Orientation Causes on all life science
Good Clinical practice for clinical trial
All of the above
44. Principal investigator should:
Observant of right and welfare of the participants
Comply with scientific, legal and ethical requirements of study
Be competent in Biomedical research methodology
All of the above
45. Any study testing a new drug in children should be conducted after:
Animal trials
Phase I trials in humans
Phase II trials in animals
Phase III in humans
46. A legally acceptable/authorized representative can be
Relative/Caretaker
Research member
Unrelated witness
None of the above
47. Components of Informed consent
Information, Comprehension, Voluntariness
Comprehension, Non-exploitation, Compensation
Compensation, Information, Autonomy
None of the above
48. When is research children are justified as study subject
With minimal risk
Direct benefit to the child in case of greater risk
Research devised only for children
All of the above
49. Emancipated Minor refers to
14 years
Working teenager
Married
and
50. Proposals are categorised into:
Exemption from review, expedited, full review
High risk, full review, expedited
Partial, high risk, full review
Expedited, partial, high risk
Write short notes on any four of the following in 200 to 300 words. 5 marks. Each question carries
Informal Consent
Third Party Reproduction
Expedited Review
IEC and its Role in Research
Ethical Principles in Human Participant Research
Helsinki Declaration
Other Question Papers
Departments
- Centre for Corporate Education, Training & Consultancy (CCETC)
- Centre for Corporate Education, Training & Consultancy (CCETC)
- National Centre for Disability Studies (NCDS)
- School of Agriculture (SOA)
- School of Computer and Information Sciences (SOCIS)
- School of Continuing Education (SOCE)
- School of Education (SOE)
- School of Engineering & Technology (SOET)
- School of Extension and Development Studies (SOEDS)
- School of Foreign Languages (SOFL)
- School of Gender Development Studies(SOGDS)
- School of Health Science (SOHS)
- School of Humanities (SOH)
- School of Interdisciplinary and Trans-Disciplinary Studies (SOITDS)
- School of Journalism and New Media Studies (SOJNMS)
- School of Law (SOL)
- School of Management Studies (SOMS)
- School of Performing Arts and Visual Arts (SOPVA)
- School of Performing Arts and Visual Arts(SOPVA)
- School of Sciences (SOS)
- School of Social Sciences (SOSS)
- School of Social Work (SOSW)
- School of Tourism & Hospitality Service Sectoral SOMS (SOTHSM)
- School of Tourism &Hospitality Service Sectoral SOMS (SOTHSSM)
- School of Translation Studies and Training (SOTST)
- School of Vocational Education and Training (SOVET)
- Staff Training & Research in Distance Education (STRIDE)
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