Answer keys for Assignment 19: Ethical framework for health research
(The correct answer is underlined in bold text)
1. In the middle of a clinical trial, one participant decides to withdraw from the trial. But, the
investigator pressurizes the participant to continue in the study till it completes. Which of the
following ethical principles does the investigator violate?
a. Justice
b. Autonomy
c. Beneficence
d. Non-Maleficence
2. “Do no harm” concept was emphasized in which of the following ethical principles?
a. Justice
b. Autonomy
c. Beneficence
d. Non- Maleficence
3. In which of the following guidelines, discussion on rationale and justification of risk benefit
analysis of research and voluntary consent in research was initiated?
a. Belmont report
b. Helsinki declaration
c. Nuremberg code
d. CIOMS guidelines
4. In which type of the following study/studies is informed consent not necessary?
a. Investigation of an outbreak
b. Analysis of mortality data of 2001-2010
c. Using verbal autopsy to determine the cause of death
d. All of the above
5. In which of the following type of research, ethical review is mandatory?
a. Prevalence of HIV infection using blood investigation
b. Awareness about diabetes using questionnaire only
c. Calculate out of pocket expenditure using secondary data
d. All of the above
6. Which of the following is not important in the context of an informed consent document?
a. Detailed description of study procedures
b. Budget of the study
c. Details regarding compensation and post trial access to care
d. Contact details of the Principal Investigator
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7. Which of the following are not ethical practices in health research?
a. Taking informed consent from participants prior to study participation
b. Giving lot of money to induce study participation
c. Lack of adherence to study protocol
d. ‘b’ and ‘c’
8. In a clinical research, the researcher knowingly excludes recruitment of female participants
without any compelling indications. Which of the following ethical principle does the
investigator violates?
a. Justice
b. Autonomy
c. Beneficence
d. Non-Maleficence
9. Genetic research that involves human beings and conducted by a private research institute
should follow
a. ICMR Guidelines
b. Genome Policy and Genetic Research [2000]
c. Both ‘a’ and b’
d. None
10. Which of the following aspects are NOT examined during regulatory review?
a. Data from pre-clinical studies
b. Specifications regarding protection of Intellectual Property Rights
c. Implications on environment in case of genetically engineered products
d. Investigators competence and safeguards for human participant protection
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Answer keys for Assignment 20: Conducting clinical trials
(The correct answer is underlined in bold text)
1. Bodies like Drug Controller General of India, Health Ministry Screening Committee are
concerned with
a. Regulatory review
b. Scientific review
c. Ethics review
d. All of the above
2. In a clinical trial, Independent Monitoring committee is appointed by the following
a. Sponsors
b. Investigators
c. Participants
d. Regulatory authorities
3. Informed consent is more than just a signature on a form; it is process of information
exchange
a. True
b. False
4. The primary responsibilities of the Data Safety Monitoring Body (DSMB) are to
a. Periodically review and evaluate the accumulated study data for participant safety, study
conduct and progress of trial
b. Periodically review and evaluate the accumulated study data for participant safety,
study conduct and progress and make recommendations concerning the
continuation, modification, or termination of the trial
c. Periodically make recommendations concerning the continuation, modification, or
termination of the trial
d. None
5. Which of the following best describes the advantages of conducting a Randomized
controlled trial?
a. It is the only effective design for overcoming selection bias of participants
b. The results can be readily generalized
c. It is a simple, uncomplicated and non-regulated study design
d. It requires small sample size
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6. A study design that randomly assigns participants into an experimental group or a control
group is called as
a. Cohort study
b. Case-control study
c. Randomized controlled trials
d. Cross-sectional study
7. To ensure that safety and welfare of the research participants is adequately protected, it is
important that the clinical trial protocol is critically reviewed for the following
a. Scientific content
b. Ethical issues
c. Regulatory norms
d. All of the above
8. Which of the following are monitored in a clinical trial?
a. Adherence to Good clinical practice
b. Documentation of informed consent, randomization and study product administration
c. Adverse events reporting
d. All of the above
9. When is the Informed consent obtained from the subjects in a clinical trial?
a. Prior to participation in the trial
b. Just after the trial has started
c. At any point during the conduct of a trial
d. At the end of the trial
10. Investigators are required to report adverse events occurring during a clinical trial to which of
the following agencies?
a. Regulatory authority
b. Sponsor
c. Institutional Ethics Committee
d. All of the above