Your Homework Assignment

You will be creating a power point presentation that you will be presenting to your site staff addressing an ethical issue that occurred or took place at your site. Review below requirements for further information.

TOPIC – Ethical Principles of Research

For this assignment, you will be required to choose one of the topics below and follow the instructions provided:

● Autonomy ● Respect ● Beneficence ● Exploitation ● Fair Subject Selection ● Informed Consent

REQUIREMENTS:

● Prepare a power point presentation to be presented at a staff meeting at your study site about an issue that does not conform to the ethical principle you chose (as listed above). You should not exceed more than 10 slides, however this does not include your Title slide and Reference slides. Follow the requirements below:

○ Create a hypothetical site issue that does not conform to the ethical issue you chose. (For example, the site is initiating a Phase 1 study for the first time, a recent audit identified a major informed consent problem. In an audit it has been discovered that non-English speaking patients aren’t being approached or considered for a study for which they are eligible. ) Provide relevant background information on topic that relates to the ethical issue you chose. Why is it important?

○ Be sure to present evidence &/or quote sources (citations/references) to support the rationale for the position you take on the topic you chose. These include federal regulations, informed consent requirements, Belmont Report, etc. Explain things fully and clearly. Use one or two brief examples. Just be sure you cover the key points and provide details.

○ At the end of your presentation, discuss why the ethic chosen is important to human research and the site. Refer to how the site failed to meet the ethical conduct. Include specific strategies, a

potential corrective and preventive action plan, your site will implement to correct and prevent the ethical issue.

● You are only expected to submit the PowerPoint presentation as part of this assignment.

● APA ○ Make sure your Title Slide and Reference Slide (s) follow APA for

student paper ○ Make sure to follow APA for all your in-text citations and

references. Be sure to properly cite your references in the body of your presentation (Author[s] Last Name, Year). (If you use a direct quote you must include the page number.)

● Include citations and references from at least three (3) credible sources to support your ideas. Wikipedia is not considered a credible source for academic papers. Credible sources include magazine and journal articles, books, newspapers, interviews, internet (i.e., association websites, databases, blogs), etc.

● Include your reference section at the end of your presentation, in alphabetical order and include a hanging indentation for the second and subsequent lines of each entry. (First line is aligned left and following lines indented.)

● It is strongly recommended you review the online APA guide available at: https://owl.purdue.edu/owl/research_and_citation/apa_style/apa_formatting _and_style_guide/general_format.html

● Links to an external site. ● ● Please review the rubrics for grading scheme. ● All submissions must be done in Canvas, assignments submitted by email

will not be accepted unless you are having difficulty uploading the assignment, as noted above.

Rubric Short Topical Paper

Criteria Ratings Pts

This criterion is linked to a Learning Outcome

APA Formatting

10 to >8.0 pts

Proficient

Less than 3 APA formatting errors and includes 3 references.

8 to >0.0 pts

Competent

Citations and references are formatted per APA style but has greater than 3 errors and/or less than 3 references.

0 pts

Novice

Citations and references are not formatted per APA style.

10 pts

This criterion is linked to a Learning Outcome

Sentence Structure, Grammar & Spelling

10 to >8.0 pts

Proficient

All sentences are well constructed & have varied structure/length. Fewer than 3 errors in grammar &/or spelling.

8 to >0.0 pts

Competent

Most sentences are well constructed & have varied structure/length. Fewer than 15 errors in grammar &/or spelling that do not interfere with understanding.

0 pts

Novice

Sentences sound awkward, are distractingly repetitive, or are difficult to understand. Paper has numerous errors (>15) in grammar &/or spelling that interfere with understanding.

10 pts

This criterion is linked to a Learning Outcome

Coverage of required introduction, strategies for implementatio n, and summary addressing appropriate audience

40 to >30.0 pts

Proficient

Includes a clear and complete introduction of the ethic and related study site issue. Provides a description of the 3 – 4 key elements of the ethic explaining their importance for research and at the study site. Provide one example of each element. Identify specific strategies the site will implement to correct the issues.

30 to >10.0 pts

Competent

Includes a clear and complete introduction of the ethic and related study site issue. Provides a description of the 2 key elements of the ethic explaining their importance for research and at the study site. Provide one example of each element. Identify specific strategies the site will implement to correct the issues.

10 to >0 pts

Novice

Does not meet any of the required content.

40 pts

This criterion is linked to a Learning Outcome

Content is succinct, summarizes the topic and its implication

40 to >30.0 pts

Proficient

Covers topic and meets the intent of the assignment of a maximum of 10 slide limit, in addition to a title slide and reference slides. Content is clear, precise and presents key points directly related to the ethic. Includes regulations, guidance, GCPs supporting the

30 to >10.0 pts

Competent

Does not fully address the topic or intent of the assignment. Includes content not related to the site issue and ethic chosen. Goes over slide limit.

10 to >0 pts

Novice

Submission is off topic and does not meet the intent of the assignment.

40 pts

ethical topic and relevant to the site issue.