NUR 550 Week 2 Discussion question

NUR 550 Week 2 Discussion question

NUR 550 Week 2 Discussion question

DQ1 You attend a local health fair organized by several health care research companies. You notice that a company is distributing a trial drug to other attendees at one of the booths. When you approach one of the researchers, you are offered a waiver to sign for participation in the trial.

What ethical or legal parameters should the researchers have considered prior to distributing the trial drug at the health fair? If you were on the translational research team, what steps would you have taken to maintain ethical and legal guidelines?

DQ2 In nursing research, how are respect for the persons, potential benefits and burdens of the research, and justice kept in balance? Provide examples of how you would ensure this balance in your research.

Conducting a research project can be time-consuming and stressful, tempting some busy nurse researchers to cut corners. They might obtain consent signatures, but not take the time to ensure that patients fully comprehend the project. Or perhaps they neglect to weigh a patient prior to administering a medication that calculates dosing by weight and instead rely on information in the patient’s chart. The ramifications could be minor or catastrophic. Either way, it’s a violation of research ethics.

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“When you conduct a research study, the work doesn’t end with approval from the Institutional Review Board (IRB),” says Linda Lewicki, PhD, RN, Senior Nurse Researcher at Cleveland Clinic and Vice-Chair of the IRB. “You have to comply with federal regulations and keep in mind the ethical principles of the Belmont Report. They should carry through all research activity, up to and including reporting your research results.”

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Adhering to governmental guidelines

As a member of the IRB, Dr. Lewicki says her stance on research ethics has one primary goal – to protect enrolled subjects. “It’s imperative to design a study that minimizes risks to participants, meets the parameters approved by the IRB and honors the three principles of the Belmont Report,” she says.

Released in 1979 by the U.S. Department of Health and Human Services, the Belmont Report presents three basic ethical principles that should underlie biomedical and behavioral research involving human subjects:

1. Respect for persons – Individuals should be treated as autonomous, and those with diminished autonomy (due to illness, dementia, etc.) are entitled to protection.
2. Beneficence – People should be treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.
3. Justice – This relates to receiving the benefits of research or bearing its burdens. An injustice occurs when a person is denied without good reason some benefit to which they are entitled or when some burden is unduly imposed.

In addition, researchers must adhere to the Federal Policy for Protection of Human Subjects, also known as the Common Rule. Published in 1991, it sets forth the baseline standard of ethics for government-funded research in the U.S.

Minimizing potential research risks

When applying the Common Rule and principles from the Belmont Report, Dr. Lewicki says breaches in research ethics typically occur in one of three main areas: protocol development, study implementation, and data analysis and reporting.

A sound study design is at the heart of protocol development, says Dr. Lewicki. “You need a clearly defined aim, purpose and hypothesis,” she says. To ensure risks are minimized during protocol development, she offers the following advice:

• Ensure that the data you plan to collect will very specifically address your research question.
• Use valid tools and instruments to collect data.
• Make sure your sample size and statistical analysis are justified and reasonable.
• Choose a study team with appropriate expertise and experience or seek a mentor.
• Eliminate or manage any conflicts of interest.
• Carefully consider the inclusion and exclusion criteria for enrolling subjects.
• Conduct a risk-benefit analysis, examining physical, psychological, social, legal and economic risks.
• Confirm that there is either a direct benefit to participants or a societal benefit of the research.

One of the biggest factors related to study implementation is the consent of subjects. The written form must contain all the required elements, including information on the research, risks and discomforts, benefits, alternative procedures of treatment, confidentiality, research-related injuries, costs and the subject’s signature. The person conducting the consent interview must be knowledgeable about the protocol and have received human subject protection education. In addition, the interview must be done in a manner and setting that allows potential participants to process the information, ask questions and seek more information, if necessary.

Name:  NUR 550 Week 2 Discussion question Assignment Rubric

		Excellent	Good	Fair	Poor
Summarize your interpretation of the frequency data provided in the output for respondent’s age, highest school grade completed, and family income from prior month.		32 (32%) – 35 (35%) The response accurately and clearly explains, in detail, a summary of the frequency distributions for the variables presented. The response accurately and clearly explains, in detail, the number of times the value occurs in the data. The response accurately and clearly explains, in detail, the appearance of the data, the range of data values, and an explanation of extreme values in describing intervals that sufficiently provides an analysis that fully supports the categorization of each variable value. The response includes relevant, specific, and appropriate examples that fully support the explanations provided for each of the areas described.	28 (28%) – 31 (31%) The response accurately summarizes the frequency distributions for the variables presented. The response accurately explains the number of times the value occurs in the data. The response accurately explains the appearance of the data, the range of data values, and explains extreme values in describing intervals that provides an analysis which supports the categorization of each variable value. The response includes relevant, specific, and accurate examples that support the explanations provided for each of the areas described.	25 (25%) – 27 (27%) The response inaccurately or vaguely summarizes the frequency distributions for the variables presented. The response inaccurately or vaguely explains the number of times the value occurs in the data. The response inaccurately or vaguely explains the appearance of the data, the range of data values, and inaccurately or vaguely explains extreme values. An analysis that may support the categorization of each variable value is inaccurate or vague. The response includes inaccurate and irrelevant examples that may support the explanations provided for each of the areas described.	0 (0%) – 24 (24%) The response inaccurately and vaguely summarizes the frequency distributions for the variables presented, or it is missing. The response inaccurately and vaguely explains the number of times the value occurs in the data, or it is missing. The response inaccurately and vaguely explains the appearance of the data, the range of data values, and an explanation of extreme values, or it is missing. An analysis that does not support the categorization of each variable values is provided, or it is missing. The response includes inaccurate and vague examples that do not support the explanations provided for each of the areas described, or it is missing.
Summarize your interpretation of the descriptive statistics provided in the output for respondent’s age, highest school grade completed, race and ethnicity, currently employed, and family income from prior month.		45 (45%) – 50 (50%) The response accurately and clearly summarizes in detail the interpretation of the descriptive statistics provided. The response accurately and clearly evaluates in detail each of the variables presented, including an accurate and complete description of the sample size, the mean, the median, standard deviation, and the size and spread of the data.	40 (40%) – 44 (44%) The response accurately summarizes the interpretation of the descriptive statistics provided. The response accurately explains evaluates each of the variables presented, including an accurate description of the sample size, the mean, the median, standard deviation, and the size and spread of the data.	35 (35%) – 39 (39%) The response inaccurately or vaguely summarizes the interpretation of the descriptive statistics provided. The response inaccurately or vaguely evaluates each of the variables presented, including an inaccurate or vague description of the sample size, the mean, the median, the standard deviation, and the size and spread of the data.	0 (0%) – 34 (34%) The response inaccurately and vaguely summarizes the interpretation of the descriptive statistics provided, or it is missing. The response inaccurately and vaguely evaluates each of the variables presented, including an inaccurate and vague description of the sample size, the mean, the median, the standard deviation, and the size and spread of the data, or it is missing.
Written Expression and Formatting – Paragraph Development and Organization: Paragraphs make clear points that support well-developed ideas, flow logically, and demonstrate continuity of ideas. Sentences are carefully focused—neither long and rambling nor short and lacking substance. A clear and comprehensive purpose statement and introduction is provided which delineates all required criteria.		5 (5%) – 5 (5%) Paragraphs and sentences follow writing standards for flow, continuity, and clarity. A clear and comprehensive purpose statement, introduction, and conclusion is provided which delineates all required criteria.	4 (4%) – 4 (4%) Paragraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time. Purpose, introduction, and conclusion of the assignment is stated, yet is brief and not descriptive.	3 (3%) – 3 (3%) Paragraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time. Purpose, introduction, and conclusion of the assignment is vague or off topic.	0 (0%) – 2 (2%) Paragraphs and sentences follow writing standards for flow, continuity, and clarity < 60% of the time. No purpose statement, introduction, or conclusion was provided.
Written Expression and Formatting – English writing standards: Correct grammar, mechanics, and proper punctuation		5 (5%) – 5 (5%) Uses correct grammar, spelling, and punctuation with no errors.	4 (4%) – 4 (4%) Contains a few (1 or 2) grammar, spelling, and punctuation errors.	3 (3%) – 3 (3%) Contains several (3 or 4) grammar, spelling, and punctuation errors.	0 (0%) – 2 (2%) Contains many (≥ 5) grammar, spelling, and punctuation errors that interfere with the reader’s understanding.
Written Expression and Formatting – The paper follows correct APA format for title page, headings, font, spacing, margins, indentations, page numbers, parenthetical/in-text citations, and reference list.		5 (5%) – 5 (5%) Uses correct APA format with no errors.	4 (4%) – 4 (4%) Contains a few (1 or 2) APA format errors.	3 (3%) – 3 (3%) Contains several (3 or 4) APA format errors.	0 (0%) – 2 (2%) Contains many (≥ 5) APA format errors.
Total Points: 100

Name:  Assignment Rubric