Week6 008

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Week 6 - Assignment: Manage Ethical Dilemmas

Instructions

This week, you became familiar with the ethical dilemmas a researcher may face. As a

scholarly and ethical researcher, you must anticipate the problem and address it. In the

following three scenarios, you will identify what the ethical issues are and determine how to

address them.

Scenario 1:

Each year, the International Agency for the Research of Cancer (IARC)—which is part of the

World Health Organization (WHO)—assembles expert working groups from across the globe

to investigate evidence related to the carcinogenicity of specific exposures. During their

2018 meeting, the IARC (2018, June) classified ingested nitrates and nitrite ions as likely

carcinogenic (cancer-causing) to humans. Based on these findings, Dr. M. is studying the

relationship between colon cancer and nitrate exposure from the dietary consumption of

certain types of vegetables. Dr. M. conducts tests on stored pathology samples and extracts

data from medical records from patients diagnosed with colon cancer. Since Dr. M’s research

requires a large sample size and some of the patients may be deceased, obtaining informed

consent for each cancer patient is problematic. To address this issue, Dr. M. has requested to

conduct the study with a waiver of informed consent. All data would be recorded without

names or other identifying information.

1. Is it ethically permissible to bypass individual consent in this type of study? Why or

why not?

2. What conditions would Dr. M’s study have to meet to qualify for a waiver of consent

under the Common Rule?

3. What concerns do the waiver of consent raise?

Scenario 2:

Dr. D. is conducting a study comparing a new beta-blocking agent to an existing drug. Beta-

blockers are prescribed medications that lower blood pressure, protect against heart attacks,

and can improve the quality of life for people with heart failure (Nordqvist, 2017, June 30).

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Two days per week, Dr. D. works at a Federally Qualified Health Center (FQHC) providing

care to low-income, rural patients, many of whom are minorities. Dr. D. also works two days

per week at the Inner-City Health Center (ICHC), serving uninsured and underserved

suburban patients. Dr. D. proposes to recruit subjects from the FQHC and ICHC to

participate in his study. The IRB defers the protocol primarily because they are concerned

with fairness in subject recruitment. They believe that Dr. D. will be taking advantage of a

poor, predominantly minority population, many of whom will not likely be able to afford

beta-blockers outside the study. In addition, the IRB expressed concern with access to care

for the study subjects following the 36-week trial.

1. Should the IRB be concerned with fairness in Dr. D’s subject selection in this study?

Why or why not?

2. What measures, if any, should be taken to ensure post-trial access to care?

3. Are there concerns associated with conducting studies only in better-off patients?

Explain. What concerns does recruitment from a primarily poor population raise?

Scenario 3:

A graduate student files a formal complaint to the university, stating that their mentor, a

tenured professor, falsified data in a recently published study. The student’s complaint

indicates that the study does not accurately reflect the data that was collected. The

university’s Office of Research Integrity and Assurance (ORIA) inquired about the situation

and found that 160 of the 200 reports accurately represented participant data, while the

other 40 reports contained a number of errors, including several that failed to support the

hypothesis proposed in the study. The ORIA inquiry concluded that, although the researcher

showed a high level of carelessness in extracting participant data, there was no substantiated

evidence indicating that the data was intentionally falsified (Shamoo & Resnik, 2009).

1. Does this situation constitute research misconduct? Why or why not?

2. Does the university have an obligation to require that the researcher collect data in an

appropriate manner in the future? Why or why not?

3. Should the published report be rescinded even though the researcher was not found

guilty of misconduct? Explain your rationale.

References

International Agency for the Research of Cancer. (2018, June). Ingested nitrate and nitrite.

Nordqvist, C. (2017, June 30). What you need to know about beta-blockers.

Shamoo, A., & Resnik, D. (2009). Responsible conduct of research (2nd ed.). New York:

Oxford University Press

10/9/2019

https://ncuone.ncu.edu/d2l/le/content/168767/viewContent/1591489/View 3/3

Upload Choose Existing

Length: 5-7 pages, not including title and reference pages

References: Include a minimum of 5 scholarly and/or professional references

Your paper should demonstrate thoughtful consideration of the ideas and concepts that are

presented in the course and provide new thoughts and insights relating directly to this topic.

Your response should reflect graduate-level writing and APA standards.

Record