Read Chapter 13 in the textbook and review the websites to supplement your understanding of the consent process and look at actual university IRB forms to prepare for this assignment.
You are to prepare a consent form for your clinical project proposal. You may obtain your facility’s Informed consent form, or you may inspect the university IRB (institutional review board, also known as an independent ethics committee) forms that are listed for your review. Create you own consent form, including all of the following points:
The name of the study and the researchers
Why any individuals are being asked to participate
Brief rationale for study and participation
Brief explanation of study purpose
Brief explanation of the study procedures and the nature of the participants’ activities and time commitment
The benefits (any payment/compensation) (Be realistic: if you are paying participants, explain where will you obtain the money.)
Risks of participation (including any fees)
That participation is voluntary, with no negative consequences if they choose not to participate, as well as alternatives to participation
Individuals may withdraw at any time, without negative consequences
Confidentiality
Who to contact if they have questions/problems/injury
Signature block for participant and consenter
This consent should not exceed two pages, reference is only required if you have used an agency’s form
Review the following websites to prepare for this lesson’s assignment on creating a consent form.
Institutional Review Board (IRB) – Palm Beach State CollegeLinks to an external site. (download both the application and the booklet– the sample IRB consent form is located in the booklet)
What is Ethics in Research & Why is it Important?Links to an external site.
NIH Clinical Center: Ethics in Clinical ResearchLinks to an external site.
Institutional Review Board: University of PortlandLinks to an external site.
Use the student presentation grading rubric to guide your writing.
References:
Bonnel, W. & Smith, K. (2013). Proposal Writing for Nursing Capstones and Clinical Projects. New York, NY: Springer Publishing Company.
What is Ethics in Research & Why is it Important? (2015, December 1). Retrieved October 16, 2018 from https://www.niehs.nih.gov/research/resources/bioethics/whatis/
NIH Clinical Center: Ethics in Clinical Research (2018, September 4). Retrieved October 16, 2018 from https://clinicalcenter.nih.gov/recruit/ethics.html
Institutional Review Board: University of Portland (2018). Retrieved October 16, 2018 from https://www.up.edu/irb/
Institutional Review Board (IRB) – Palm Beach State College (2018). Retrieved October 16, 2018 from https://www.palmbeachstate.edu/ire/irb.aspx
Read Chapter 13 in the textbook and review the websites to supplement your under
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