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This will be a written assignment for my ethics class regarding a mock IRB proposal for my dissertation topic (effect of daily vs. weekly check-ins for adherence in an online fitness & nutrition coaching program ). The course textbooks are McNamee, M. J., Olivier, S., & Wainwright, P. (2006). Research ethics in exercise, health and sports sciences. Routledge. & Steneck, N. H. (2007). Introduction to the responsible conduct of research (pp. 84-101). Washington, DC.
For this assignment, you will be completing parts of a sample CUC Institutional Review Board (IRB) Proposal Form for my dissertation topic (effect of daily vs. weekly check-ins for adherence in an online fitness & nutrition coaching program). IRB approval must be gained before any research or data collection occurs, and the course modules should have provided you with a strong foundation for consuming and conducting responsible and ethical research. This assignment is strictly a mock exercise to help you become familiar with the ethical considerations that must be addressed when seeking IRB approval.
Final Assignment Requirements:
1) Review the CUC IRB Form. Do not complete this actual IRB form.
2) Include in your final assignment ONLY the following IRB sections 1-12, extracted from the CUC IRB Form. Your paper will be organized in Section 1 and Section II but should be submitted as one document.
Section I (1-2 Pages)
Section I may be presented in a list format, with subheadings, and not in paragraph form:
1. Potential study title –
2. Potential research site(s) (Brief Descriiption) –
3. Purposes/Objectives of the study (Brief Descriiption) –
4. Potential methodology and design of the study (Brief descriiption for this assignment, such as Qualitative, Quantitative, Mixed Methods) –
5. Descriiption of potential study participants (Briefly describe the inclusion/exclusion criteria for participants, including gender, other demographics, and health/treatment status. Include a rationale for the involvement of any special groups such as, children, prisoners, pregnant women, individuals with cognitive impairments, etc.) –
6. Descriiption of potential recruitment procedures. (Briefly please describe the procedures for the identification, recruitment, and selection of participant)s –
7. List and briefly describe each potential data collection tool (ex: interview protocol, observation protocol, survey, etc.) –
8. Potential plan to obtain informed consent (Briefly describe the procedures you will use to deliver consent materials, explain those materials to participants, and collect/store signed documents. Written informed consent is required from all participants. If minors will be included, both parent permission and child assent forms should be used. If children 7 years and under are included, a procedure for obtaining oral consent must be used.) –
Section II (7-9 pages)
The main focus of this final assignment is answering the IRB questions 9-12 below, in a singular combined narrative essay format. You will not answer these questions individually, but in Section II, you will be writing an APA scholarly based essay with citations. Current scholarly literature and citations should be integrated throughout the entire paper vs. opinion-based writing. Your APA formatted paper should include a clear introduction with your purpose, subheadings, and a conclusion that reiterates the salient points already shared.
You should use the course concepts and ethical principles learned throughout the course to explain how you will fully address each of these ethical considerations that are applicable to your potential research topic. Section II should include concepts learned in the CITI trainings, course modules, and from your own peer reviewed findings. Your paper should be a comprehensive presentation of how your potential research plan will meet these IRB application requirements, using scholarly based ethical best practice standards.
Your entire final paper (Sections 1 and II) should be 8-11 pages, not including the required Cover Page or Reference page(s).
IRB Questions 9-12 to be addressed in Section II:
9. Potential risks for human participants. (All studies have a level of risk to participants, even if it is mild [example, fatigue from interviewing]. Please fully describe each risk, and how you will minimize each risk, supported by course concepts and the scholarly based literature).
10. Are there any potential conflicts of interest/coercion in this study? (A conflict of interest is any circumstance or relationship that could result in the perception that undue influence, bias, or coercion might occur in the context of your study. Conflicts of interest can be financial, personal, or organizational. Conflicts of interest exist when there is the potential for undue influence, bias, or coercion.) i. Are you doing research at your place of employment? If yes, describe the conflict management plan
ii. Are any participants students, employees, colleagues, or subordinates where grades, incentives, evaluations, or any appearances of authority over participants might coerce, convince or skew participation? If yes, describe the conflict management plan –
iii. Do you have any sort of relationship related to the research or research site, regardless of compensation? If yes, describe the conflict management plan –
iv. Are you doing research on a technology, process, or product, where there is a potential for personal financial gain, patentable invention, or trademark? If yes, describe the conflict management plan –
v. Are you doing research on a technology, process, or product owned by a business in which you or a family member holds a financial interest? If yes, describe the conflict management plan –
vi. Other potential conflicts not addressed above? Please fully explain each potential conflict and describe your conflict management plan, supported by course
concepts and the scholarly based literature.
11. Does the research include deception or manipulation? If yes, explain why it is necessary and describe how and when participants will be debriefed –
12. Confirm how you will protect the confidentiality of your participants in the following areas, continuing in paragraph form, with scholarly based literature and citations: i. All data collection tools will be free of names or numeric identifiers.
ii. All data will be stored in a locked file cabinet, password-protected computer file, or other secure mechanism.
iii. Only the researcher and their advisor (if applicable) have access to the data.
iv. All data will be coded using numbers or pseudonyms.
v. All data will be kept a minimum of 3 years before being destroyed.
vi. If you are conducting a focus group, measures will be taken to ensure confidentiality, such as instructing participants to address each other only by numbers or pseudonyms.
vii. If you are retaining any personal identifiers (names, medical record numbers) following data collection, all identifiers will be removed as soon as possible.
Add any additional potential ethical issues that were not addressed by questions 9-12, and include your scholarly based plan to manage these concerns.
I have attached previous discussions and assignments written for this topic and recommended resources to elaborate on the assignment expectations. Make sure to provide substantial evidence from scholarly resources and refrain from making generalized statements. Textbooks, blogs, magazine or internet articles, book chapters, or special reports, do not count toward scholarly resources.
Here are the places that you should be getting your peer-reviewed sources from:
Journal of Ethics
Journal of Medical Ethics
Kennedy Institute of Ethics Journal
Journal of Ethics and Social Philosophy
Journal of Empirical Research on Human Research Ethics
Ethics and International Affairs
Ethical Theory and Moral Practice
Public Health Ethics
American Journal of Bioethics
The Journal of Law, Medicine & Ethics
Journal of Information Ethics
Journal of Applied Philosophy
Narrative Inquiry in Bioethics
Perspectives in Biology and Medicine
Cambridge Quarterly of Healthcare Ethics
Ethics and Information Technology
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