NR 505 / NR505 INTRODUCTION TO RESEARCH ETHICS QUIZ SUMMARY

1. The ‘conflict of mission’ in research refers to the potential conflict between: 1. preventing harm to an individual, and 2. gaining scientific k… • True Your correct answer • False 2. Which of the following should not be included as part of the research protocol and submitted to the REC (ERC)? • The budget, including sources of funding • Curricula vitae of the Principal Investigator and the core research team • The information sheet and consent form that potential participants will be asked to sign • A section on the ethical aspects of the protocol, and how the investigators are planning to deal with the ethical issues that may arise • If the protocol has also been reviewed elsewhere, a list of the ethics committee members who reviewed the protocol Your correct answer • A description of how data will be kept confidential and private 3. The Secretariat of an ethics committee can overturn the decision of a committee if they find it unreasonable • True • False Your correct answer 4. Following an animated discussion and after much debate, an REC has decided not to approve a research study that is utilizing a placebo control desi… • Explain the Committee’s rationale, and share the detailed comments made by members of the Committee in order to diffuse the situation and provide a better understanding of the REC functioning • Refuse to enter into any discussion with the PI but invite him to share their views with the REC Secretariat, citing confidentiality as a rationale Your correct answer 5. Ethics committee members should consider the following issues when reviewing a protocol: • have research risks have been minimised? • is appropriate information being provided to participants in a comprehensible way? • are there appropriate provisions to protect privacy and confidentiality? • are the proposed inducements for participants to take part in research appropriate? • all of the above Your correct answer 6. It is often said that 'bad science is unethical'. Please choose the best follow-up sentence. • However, research ethics committees are not qualified to judge the science of a protocol and should therefore not consider the science in their protocol reviewHowever, if the protocol has been reviewed and 'approved' by a scientific or technical committee prior to ethical review, the ethics committee should set aside their doubts as experts have already provided input • Ethics review committees should, therefore, consider the science of the protocol where it has an impact on the ethics of the study Your correct answer • However, this statement is false. Science and ethics are completely separate issues and should never be considered by the same committee. This is supported by all WHO guidance 7. Ethical review is necessary if researchers are to: • ensure that the rights and well-being of research participants and communities are protected • comply with guidance and regulation for research • meet the requirements of some funders and journals • all of the above Your correct answer 8. Research is necessary to: • gain generalizable knowledge which may lead to improvements in health Your correct answer • benefit individual research participants 9. The interests of an individual in research can be overridden in research if it is expected to provide significant benefits to society. • True • False Your correct answer 10. Benchmarks of ethical research include: (select all that apply) • fair selection of study populations Your correct answer • favourable risk/benefit ratios in research Your correct answer • ethical review of protocols by funding agencies • respect for participants and communities Your correct answer 11. Ethics committees should consider the sociocultural, economic and political contexts of research when reviewing protocols • True Your correct answer • False 12. Ethical challenges in research in low and middle income settings include: • research participants may have limited literacy and familiarity with research concepts • limited healthcare services may provide significant incentives for participants to take part in research • local researchers may have limited resources and ability to negotiate with international sponsors to ensure that research protocols are amended to make them appropriate for the local research context. • all of the above Your correct answer Principles and Guidelines Quiz Summary Score for this module: 89% 13. An REC should base its decisions about the research that it reviews on a coherent and consistent application of: • ethical principles in international guidance • human rights instruments • relevant regulations • all of the above Your correct answer 14. Benchmarks for ethical research in low and middle income settings include: (select all that apply) • institutional review • respect for recruited participants Your correct answer • fair selection of study populations Your correct answer • social value Your correct answer • scientific validity Your correct answer 15. An REC should be transparent about the specific ethical guidelines it relies on to make decisions and make these available to researchers and the p… • True Your correct answer • False 16. Research can present difficult dilemmas where reasonable people may disagree and guidance may be inconsistent. In such circumstances committees th… • May find it useful to refer back to the principles and benchmarks of research that underpin the guidance to inform their considerations • Will need to be able to clearly articulate how they have reached a decision and the resources they have relied upon to do so • Should seek to ensure that universal ethical principles have appropriately informed the procedures proposed for the specific research context • All of the above Your correct answer 17. Human rights that are not relevant to research include: • the right to freedom from discrimination • the right to freedom of opinion and expression • the right to employment Your correct answer • the right to equal access to public services and medical care 18. Guidelines for the ethical conduct of research always agree. • True • False Your correct answer 19. The following principles to guide the conduct of ethical research have received widespread acceptance: (select all that apply) • respect for persons Your correct answer • justice Correct answer • beneficence Your correct answer • non-maleficence Your correct answer • informed consent 20. Universal ethical principles can be compatible with procedures to ensure that research is appropriately adapted to the context in which it is condu… • True Your correct answer • False 21. Applications of the principle of respect for persons include: (select all that apply) • the need for voluntary and informed consent Your correct answer • the need to use appropriate study designs • requirements to respect privacy and confidentiality Your correct answer • meaningful community engagement in research Your correct answer Understanding Vulnerability Quiz Summary Score for this module: 93% 22. To determine the impact of pre-natal exposure to alcohol, a research team plans to recruit school-going children studying in grades 2 and 3 of sele… • Reject the protocol and recommend that research into such sensitive issues not be carried out. • Reject the submitted protocol and invite the Principal Investigator to consider alternate ways of collecting the required data and sharing it with teachers and parents, while protecting the interests of the children and their mothers. Your correct answer • Accept the protocol as long as the children themselves are allowed to assent. 23. Which of the following statements are consistent with CIOMS guidance on vulnerable persons? (select all that apply) • Special justification is required for inviting vulnerable persons to serve as