MCQs

Choose one correct answer of the following MCQs;
Q1) the ethical theory which suggests that an action is right if it promotes the best consequences is:
1. Virtue ethics 2. Utilitarianism 3. Deontology 4. Consequentialism
Q2) immanuel Kant is primarily associated with the ethical theory:
1. Consequentialism 2. Utilitarianism 3. Virtue ethics 4. Deontology
Q3) the principle of medical ethics that requires that researchers engaged in medical research on human subjects should avoid any harm to

the subject is known as:
1. Autonomy 2. Beneficence 3. Non-maleficence 4. Justice
Q4) choose an answer that most accurately describes one of the 32 declarations listed in the Declaration of Helsinski:
1. Research subjects should ask not what the research will do for them but, rather, what their participation will do to benefit

society
2. In medical research on human subjects, considerations related to the well- being of the human subject should take precedence over

the interests of science and society
3. Individuals have a moral obligation to participate in research that benefits society
4. The primary obligation of a researcher is to promote the advancement of science
Q5) the responsibility for the conformity of medical devices to the Medical Device Directive 93/42/EEC is by:
1. The Notified Body 2. The Manufacturer 3. The Competent Authority 4. All of the above
Q6) research that tests the efficacy and side effects of the drug on a small number of people suffering from the relevant condition is

described as a:
1. Phase I clinical trial 2. Phase II clinical trial 3. Phase III clinical trial 4. Phase IV clinical trial
Q7) which of the following is NOT a role of a Research Ethics Committee:
1. To provide independent ethical review of research proposals
2. To protect the welfare and dignity of research subjects
3. To provide funding for research projects
4. To review the information to be provided to potential research subjects
Q8) which statement best describes the term equipoise:
1. A situation where researchers are uncertain which group in a clinical trial will receive the best treatment
2. A dummy treatment designed to looks like the test treatment, so that the research subject doesn’t know which is being taken
3. A proposition to be tested by the research project
4. The results obtained when a clinical trial is performed
Q10) the Medical Devices Directive (MDD) 93/42/EEC
1. is a national Law in each member state
2. instructs the member states to transpose the Directive into National Law
3. provides a framework for member states to operate within
4. provides a framework for member states to transpose the Directive into National Law
Q11) the information sheet provided to a research subject should:
1. Include only the information that a reasonable person would want to know to decide whether to participate in the research
2. Include all the scientific references for work leading up to the trial
3. Describe all conceivable events and risks that a subject could encounter from participation in the research
4. Emphasise the potential advantages of the drug or device being tested
Q13) which of the following is a requirement for valid consent for a research subject:
1. That information is provided in writing 2. That the subject is over 18 years of age
3. That consent is provided in writing 4. That the subject is competent
Q14) the term used to describe the liability standard for defective products under the Consumer Protection Act 1987 is
1. Proportionate liability 2. Negligence 3. Strict liability 4. Duty of care
Q15) for the purposes of the Consumer Protection Act, a product has a “defect” if:
1. It causes personal injury, loss or damage when used in accordance with its instructions for use
2. Its safety is not such as persons generally are entitled to expect
3. It fails to fulfil its intended purpose due to manufacturing and/or design deficiency
4. It fails to meet the state of the art for products of its type and description at the time it was produced
Q16) who may be liable under the Consumer Protection Act?
1. The producer of the product
2. The importer of the product into a member State from outside the member States
3. A person who by putting his name to the product has held himself out to be the producer of the product
4. All of the above
Q17) which of the following is NOT covered under the Human Tissue Act 2004:
1) Human embryonic stem cells 2. Human blood3. Human lung tissue4. Human skin
Q18) the purpose of risk management in the development of a medical device is to
1. Eliminate ALL risks introduced through the use of the device
2. Reduce the risks involved in using the device to an acceptable level
3. Formally record ALL the risks introduced through the use of the device
4. Record the highest risks associated with the use of the device
Q19) which of the following is NOT a requirement for a project licence to be granted under the Animal (Scientific Procedures) Act 1986 to

perform research involving the implantation of a new biomaterial into a large animal such as a sheep:
1. The minimum number of animals will be used
2. The biomaterial will have already been tested using a small animal, such as mice
3. The procedures will cause the minimum distress or suffering to the animals
4. Anaesthetic will be used during implantation
Q21) a post-market clinical trial of a class 3 medical device would be undertaken because
1. The manufacturer would like to find out how well their product is performing
2. the manufacturer is required to within the CE approval process
3. Post market surveillance has been advised by the Notified Body
4. It is a way to ensure the device is taken up by the healthcare professionals
Q22) which type of clinical study, sponsored by a manufacturer, would NOT require notification to the Medicines and Healthcare products

Regulatory Agency (MHRA):
1. A pilot clinical study on a new type of medical device
2. A clinical study on a CE Marked medical device being used for its intended purpose
3. A clinical study on a CE Marked medical device being used for a new intended purpose
4. A clinical study on a new type of medical device to determine its safety and performance
Q23) If a manufacturer decides that a pre-market clinical investigation for a new device is required, which type of evidence is

UNNECESSARY for regulatory approval to obtain the CE Mark:
1. Evidence of cost effectiveness 2. Evidence of clinical performance
3. Evidence of user safety 4. Evidence of patient safety
Q24)which of the following statements best reflects the legal position of a child aged 16 or 17 in the United Kingdom in relation to

consent to medical treatment:
1. The child is presumed not to have the capacity to consent.
2. The child is presumed to have the capacity to consent.
3. The child should never be a subject in a research trial.
4. The child is always able to consent.
Q25) which of the following CANNOT be authorised by the Human Fertilisation and Embryology Authority:
1. Replacing the nucleus of an oocyte with the nucleus taken from another cell.
2. Creating a human embryo in vitro.
3. Replacing the nucleus of an embryo with the nucleus taken from another cell.
4. Using a human embryo for the treatment of infertility.
Q26) which of the following has been discussed as a moral rule which ought to govern nanotechnology research?
1. The Asilomar principles. 2. The precautionary principle.
3. The principle of utility. 4. The Declaration of Helsinki.
Q27) in the context of animal research what are the 3Rs:
1. Research, Regulation and Re-evaluation.2. Replacement, Reduction and Refinement.
3. Rodents, Rats and Rabbits. 4. Reallocation, Redefinition and Recognition.
Q28) research involving which animal species is NOT covered by the Animal (Scientific Procedures) Act 1986:
1. Mouse.2 Human. 3. Cat. 4. Common octopus.
Q29) the abbreviation FDA stands for:
1.Federal Drug Authority. 2. Federal Device Authority.
3. Federal Drug Administration. 4. Food and Drug Administration.
Q30) which type of clinical study, sponsored by a manufacturer, would NOT require notification to the Medicines and Healthcare products

Regulatory Agency:
1. A pilot clinical study on a new type of medical device.
2. A clinical study on a CE Marked medical device being used for its intended purpose.
3. A clinical study on a CE Marked medical device being used for a new intended purpose.
4. A clinical study on a new type of medical device to determine its safety and performance.
Q31) under medical device vigilance requirements, which adverse events arising in a post market clinical follow-up study must be reported

to the Medicines and Healthcare products Regulatory Agency as adverse incidents:
1. All adverse events. 2. All serious adverse events.
3. All adverse device effects. 4. All serious adverse device effects.
Q32) what is the definition of the clinical evaluation that is required in connection with CE Marking:
1. The assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance

of the device.
2. A randomised controlled clinical trial carried out before CE marking.
3. A post market clinical follow-up study carried out after CE marking.
4. An informal clinical assessment of a medical device by a user.
Q33) an implantable drug pump is regulated in Europe under which EC legislation:
1. In-vitro Diagnostics Directive. 2. Medical Device Directive.
3. Active Implantable Medical Device Directive. 4. Medicinal Products Directive.
Q34) ‘The greatest happiness of the greatest number’ best describes which ethical theory:
1. Utilitarianism. 2.Consequentialism. 3. Deontology. 4. Justice
Q35) this principle of medical ethics requires that researchers engaged in medical research on human subjects respect the opinion and

independence of the research subject:
1. Autonomy. 2. Beneficence. 3. Justice. 4. Non-maleficence.
Q36) research that tests a new drug on a small number of healthy volunteers to assess safety is described as a:
1.Phase I clinical trial. 2.Phase II clinical trial. 3. Phase III clinical trial. 4. Phase IV clinical trial.
Q37) which of the following statements best reflects the legal position of a child aged 16 or 17 in the United Kingdom in relation to

consent to medical treatment?
1. The child is presumed to have the capacity to consent.
2. The child is presumed not to have the capacity to consent.
3. The child is always able to consent.
4. The child should never be a subject in a research trial.
Q38) research involving the derivation and use of human embryonic stem cells is completely prohibited in which country:
1. United States of America. 2. United Kingdom. 3. Republic of Ireland. 4. Germany.
Q39) the official UK body responsible for regulating gene therapy in humans is:
1. The Nuffield Council on Bioethics 2. The Gene Therapy Advisory Committee
2. The Human Genetics Commission 4. The Human Fertilisation and Embryology Authority
Q40) the abbreviation PGD stands for:
1. Pre-embryo Gene Destruction. 2. Postnatal Genetic Detection.
3. Preimplantation Genetic Diagnosis. 4. Permanent Gene Deletion.
Q41) which of the following is covered under the Human Tissue Act 2004?
Human embryonic stem cells. Human mucus. Human hair. Human cell lines
Q42) which of the following is covered under the Human Tissue Act 2004:
1. Human embryonic stem cells. 2. Human mucus.3. Human hair. 4. Human cell lines.
Q43) what principle controls the inclusion of people lacking mental capacity to consent in research?
1.The best interests principle. 2.Theprecautionaryprinciple. 3.Theprincipleofautonomy. 
4.The solidarity principle.
Q44) Which statement best describes the role of a Research Ethics Committee?
1.The primary purpose of a Research Ethics Committee is to protect the welfare and dignity of research subjects.
2. Research Ethics Committees should protect vulnerable people by excluding them from participation in research.
3. AResearchEthicsCommitteeshouldensurethataresearchsubjectwillneverbeharmed.
4. To assess the commercial value of a research project.
Q45) the term Gillick competence refers to:
1. The situation where an adult with parental responsibility provides consent for medical treatment for a child.
2. Thesituationwhereanadultwithdiminishedmentalcapacitycanconsenttocertaintypes of treatment.
3. Achildwhoisconsideredtohavethecapacitytoconsenttoalltypesofmedicaltreatment.
4. A child who is considered to have the capacity to consent in a specific situation.
Q46) the information sheet provided to a research subject should:
A. Include only the information that a reasonable person would want to know to decide whether to participate in the research
B. Include all the scientific references for work leading up to the trial
C. Describe all conceivable events and risks that a subject could encounter from participation in the research
D. Emphasise the potential advantages of the drug or device being tested
Q47) that kinds of payments are permissible to healthy volunteers in medical research?
A. Payment conditional on completing the study.
B. Travelandotherexpensesoccurredinthecourseofparticipatingintheresearch.
C. Paymentperhourbasedonthenationalminimumwage.
D. Nothing at all
Q48) which of the following is NOT a requirement for valid consent for an adult research subject?
1. That the subject is competent.
 2. Thatthesubjectisprovidedwithsufficientinformation.
3. Thatthesubjectmaywithdrawfromtheresearchatanytime. 4. That consent is provided in writing.
Q49) which of the following international bodies has issued ethical guidance on nanotechnology?
1. The European Group on Ethics. 
2. The Council of Europe.
3.TheWorldHealthOrganization. 
4. The European Parliament.
Q50) which of the following types of research that might be undertaken using a human embryo is NOT listed in either the Human

Fertilisation and Embryology Acts 1990/2008 or the Human Fertilisation and Embryology (Research Purposes) Regulations 2001:
1. Increasing knowledge about serious disease.
 2. Developingmoreeffectivetechniquesofcontraception.
3. Promotingadvancesinthetreatmentofinfertility.
4.Isolating embryonic stem cells.
Q51) which of the following is NOT a requirement for a project licence to be granted under the Animal (Scientific Procedures) Act 1986 to

perform research involving the implantation of a new biomaterial into a large animal such as a sheep:
1. The minimum number of animals will be used
2. The biomaterial will have already been tested using a small animal, such as mice
3. The procedures will cause the minimum distress or suffering to the animals
4. Anaesthetic will be used during implantation
Q52) approximately what percentage of animals used in scientific procedures in the United Kingdom are non-human primates:
1. 0.1%. 2. 1%. 3. 5%. 4. 10%.
Q53) how soon should a death or serious injury associated with a CE Marked medical device be reported to the national Competent Authority:
1.Immediately, or within two days. 
2.Immediately,orwithinfivedays.
3.Immediately,orwithintendays. 
4.Within thirty days.
Q54) which of the following activities requires a licence from the Human Tissue Authority under the Human Tissue Act 2004?
1. Using tissue sample for diagnosis.
2. Storing human tissue samples for a specific research project that has been approved by a Local Research Ethics Committee.
3. Conductingresearchusinganestablishedhumancellline.
4. Storing tissue samples for more than 48 hours.
Q55) the Human Tissue Act 2004 does not apply to the storage and use of ‘historic material’. How many years must have elapsed following

the death of the donor for the material to be considered historic?
1. 50 years. 2. 100years. 3. 150years. 4. 200 years.
Q66) which of the following is not of the 35statements listed in the Declaration of Helsinski as revised in 2008?
1. Medical research involving human subjects may only be conducted if the importance.
2. Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.
3. Without exception the benefits, risks, burdens and effectiveness of a new intervention must be tasted against those of the best current

proven intervention.
4. The physician must inform the patient which aspects of their care are to the research.
Q67) when is it ethically unacceptable to use a placebo in a research trial?
1.When there is no risk of serious harm if the subjects receive a placebo when compared to an existing treatment.
2. When the medical condition is minor, such as a headache.
3. when there is no alternative treatment available.
4. when an effective existing treatment exists for a serious medical condition.
Q68) the steering committee of the UK Stem Cell Bank will grand access to embryonic steam cell lines for specific purposes. Which of the

following purposes is not covered I the code of practice for the use of human stem cell lines?
1.The development of cell based therapies for clinical trails in respect of serious human diseases.
2. Research which increases the knowledge about the development of embryos.
3. Research that has the long term goal of helping to increase knowledge about serious diseases and their treatment.
4. Research aimed at developing more effective techniques of contraception.
Q69) approximately how many research procedures involving animals were performed in the UK in 2012 under licence associated with the

Animal(Scientific Procedures) Act 1986
1. 3.2 Million 2. 3.7 Million 3. 4.1 Million 4. 4.5 Million
Q70) under the Medical Devices Directive, the manufacturer is required to assess the conformity of a new medical device to the essential

requirements for safety and performance based on clinical data. This assessment must be based on:
1. Only a critical evaluation of the results of clinical investigation on the device and a critical evaluation of the relevant scientific

literature on an existing device where there is a demonstration of equivalence to the new device.
2. Only a critical evaluation of the results of clinical investigation on the device.
3. only a critical evaluation of the relevant scientific literature on an existing device where there is a demonstration of equivalence to

the new device.
4. A or B or C.
Q71) which of the following serious adverse events must be reported to the Medicine and Healthcare Products Regulatory Agency (MHRA)?
1. A patient receives a CE Marked total hip prosthesis and subsequently requires a revision surgery after 1 year because the hip becomes

infected.
2. A patient receives a novel hip prosthesis in a premarket clinical investigation and subsequently requires revision surgery after 1 year

because the hip becomes infected.
3. A patient receives a CE marked total hip prosthesis and subsequently requires revision surgery after 1 year because of dislocation

following a road traffic accident.
4. A patient receives a CE Marked total hip prosthesis and the product’s Information for Use cautions against vigorous sports-relate use.

The patient runs several marathons and subsequently requires revision surgery after 2 years as the prosthesis has loosened due to

significant wear.
Q72) Levels of evidence are hierarchical rating systems for classifying study quality. In the five-level evidence rating system, which of

the following clinical study designs are incorrectly rated?
1. A well conducted randomized controlled trail is Level I evidence.
2. A retrospective non-randomized comparative study is Level II evidence.
3. A prospective case serious is Level IV evidence.
4. A retrospective case series is Level IV evidence.

WE ACCEPT