Research Methods

Which of the following is an example of how the Principle of Justice can be applied to a study involving human subjects?

Ensuring that the selection of subjects includes people from all segments of the population

The Council of International Organizations of Medical Sciences (CIOMS) put forward guidelines for the ethical conduct of research in developing countries. Of the list below, three of the items describe components of CIOMS guidelines. Which item is not a part of the CIOMS guidelines?

that researchers secure access to health care for participants who don't have it

The United States has regulations that govern the ethical conduct of research with human subjects. The US regulations require that

every ethics committee includes at least one non-scientist

Ethics codes governing research with humans require that informed consent be obtained from participants because:

informed consent assures that potential participants understand that the decision to enroll in research is theirs

As part of the consent process a researcher should:

provide translators for eligible subjects who speak a different language from the researcher

You are doing a study on a particular medical condition. You have already enrolled several participants. A family member of a one of your participants has the same medical condition that is being studied. The family member says that he doesn't need to hear details about the study - he just wants to join. What should you do?

require the family member to go through the informed consent process if he wants to join the study

After a flood, half of Dr. Sharma's research records are destroyed. What should she do?

submit a protocol amendment to the ethics committee

The consent form approved by the Ethics Committee must contain:

A statement about why the study is being done

An individual has agreed to join a research study and has signed an informed consent form. Under which one of the following conditions can this individual withdraw from the study?

At any time; the individual is not bound to complete the study

An investigator fails to examine existing drug safety data before testing a new drug in human subjects. Which of the following best describes the research ethics principle violated?

Beneficence

A researcher is conducting a study of trends in laboratory results. To conduct the study, research assistants abstract health clinic laboratory reports and enter the data into case report research forms. During an internal quality assurance check, the researcher discovers a discrepancy between a lab value noted on a case report research form and the laboratory report. Which of the following is the best action for the researcher to take?

Consider the value on the lab report to be correct, make a correction to the case report research form including his initials and the date the change was made

A research project focusing on behaviorally challenged children plans to also conduct a focus group discussion with the children's parents to examine their own experiences being disciplined as children. Which of the following is the most important thing for the researchers to do to protect the privacy and confidentiality of the parents who participate in the focus groups?

Explain to the subjects that the confidentiality of focus group discussions cannot be guaranteed

Individuals who enroll in research must receive benefit

False

Beneficence is a core ethical principle for research. How is the principle of beneficence best described?

Minimize harm and maximize benefits

You are a staff physician in a local hospital preparing to conduct a study on care received by cardiac patients. Participation in the research may be considered anonymous if

No names or identifiers are ever collected

You are orienting a new postdoctoral fellow to your research group. You get her started on a research project in which you will take an active role. Which of the following scenarios is the most appropriate with respect to your postdoc's prospective role as a co-author in a publication that might emerge from the project?

Tell her that if her work is an important part of the total project, she will be listed as a co-author

Commonly agreed upon strategies to improve a research subject's understanding of a consent form include all of the following, except:

attaching the research proposal to the consent form

The Belmont Report described three ethical principles for research. Of the lists below, which list contains the three ethical principles contained in the Belmont Report?

Respect for Person, Beneficence, Justice

Which of the following circumstances would be adequate to justify scientifically the exclusion of potential human subjects from a study?

The investigators are studying the acquisition of English as a second language, so native English speakers are excluded

What statement about risks in social and behavioral sciences research is most accurate?

The level of risk may vary by culture and context

A colleague has written a textbook for a first-year graduate course in epidemiology. You discover that at least 15% of the paragraphs in the first three chapters, which review the evolution of epidemiology as a field, are identical, word for word, with a manuscript published in the 1970s, and no attribution is made to that source. Which of the following is the most accurate statement?

This could be considered plagiarism because the book uses the words of another scholar without attribution

All scientific research should be designed to benefit society

True

Informed consent forms used in clinical research trials must include contact information for the study's ethics committee

True

A group of retired government employees with lung cancer is approached to consider participation in a study testing an experimental cancer treatment. The study involves more than minimal risk, but offers significant financial reward equivalent to two months of pension benefits. Which concern is most likely to be raised by an ethics committee when reviewing this proposal?

Undue influence of subjects

When is it ethically acceptable to conduct a randomized trial of Drug A vs. Drug B?

When it is unknown whether Drug A is any better than Drug B

If a physician is planning to approach her own patients to consider enrollment in her own research, the ethics committee should evaluate:

whether the patients will feel free to say no