SELF CONSENT ESSAY
I have been invited to take part in a research study titled: Impact of patient education about physical activity on glycemic control and overall health status in women with type 2 diabetes.
This study is being conducted by , who can be contacted at:
I understand that my participation is voluntary and that I can refuse to participate or stop taking part at any time without giving any reason and without facing any penalty. Additionally, I have the right to request the return, removal, or destruction of any information relating to me or my participation.
PURPOSE OF STUDY
I understand that the purpose of the study is to: Assess the impact of patient education about physical activity on glycemic control and overall health in women with type 2 diabetes with or without comorbidities.
PROCEDURES
I understand that if I volunteer to take part in this study, I will be asked to: Stick to the group that I will be placed into. I also understand that I may have to participate in educational sessions regarding exercise. I will also, at some point, fill out a questionnaire and have my blood sample taken from my arm and have my blood sugar levels tested. The educational sessions will be twice per week, and the duration of the study will be six months. However, the blood samples will be taken at the beginning and at the end of the study.
BENEFITS
I understand that the benefits I may gain from participation include: An enhanced understanding of type 2 diabetes. Type 2 diabetes is a long-term illness, and by participating in this research, I will be able to acquire knowledge about how to manage this illness and how to prevent its bad outcomes. Additionally, I understand that the study will teach type 2 diabetic patients the recommended type and duration of physical activity. Consequently, by participating in this research, I will be able to learn about self-management practices such as exercise, which are likely to enhance my overall healthcare outcome and the level of control of my diabetes. I also understand that this study is beneficial to healthcare stakeholders, the general public, and the scientific body of knowledge. I understand that the outcomes of this study are beneficial to future nursing and healthcare practice as they will alter the course of patient education on physical activity and tailor it to the needs of diabetic patients. Similarly, through my participation in this research, the findings will be disseminated to the general public, enabling them to learn the necessary level and duration of exercise to enhance their health outcomes. Finally, I understand that the findings of this research, whether good or bad, will contribute to the general scientific body of knowledge by providing an association between patient education about physical activity and healthcare outcomes as well as blood sugar control in type 2 diabetes.
RISKS
I understand that the risks, discomforts, or stresses I may face during participation include:
Changes in the level of HbA1c levels which correlates with the level of my blood sugar control. I also understand that I will experience mild pain when my blood samples are being taken. Additionally, I comprehend that I may be asked to participate in educational sessions and physical activity as well as completing a questionnaire which might cause a little discomfort.
CONFIDENTIALITY
I understand that the only people who will know that I am a research subject are members of the research team. No individually-identifiable information about me, or provided by me during the study will be shared with others except when necessary to protect the rights and welfare of myself and others (for example, if I am injured and need emergency care, if the provided information concerns suicide, homicide, or child abuse, or if revealing the information is required by law).
FURTHER QUESTIONS
I understand that any further questions that I have, now or during the course of the study can be directed to the researcher ( ).
Additionally, I understand that questions or problems regarding my rights as a research participant can be addressed to Dr. Jessica Hillyer, Institutional Review Board Director of Compliance and Training, South University, 7700 W. Parmer Ln., Austin, TX 78729;
jhillyer@southuniversity.edu; 512-516-8779.
My signature below indicates that the researchers have satisfactorily answered all of my current questions about this study and that I understand the purpose, procedures, benefits, and risks described above. I have also been offered a copy of this form to keep for my own records.
Participant Printed Name
Signature of Participant Date (mm/dd/yyyy)
Signature of Principal Investigator Date (mm/dd/yyyy)
WEEK 9 MIDWEEK ASSIGNMENT
Informed Consent Form
By the due date assigned, submit the Informed Consent Letter to the Submissions Area (please note that this is only an example and no data may be collected).
Informed Consent Letter
- Procedure section is clear, described in detail, specific, and all inclusive. Written in lay language (as documented by reading level score). Includes risks and benefits relevant to study. Address assent (if applicable).
- Informed Consent Letter Example (see file attached)
- IRB Application (see file attached )
ORDER A PLAGIARISM-FREE PAPER HERE
Criteria | No Submission
0 points |
Emerging (F through D Range)
0 points |
Satisfactory (C Range)
0 points |
Proficient (B Range)
0 points |
Exemplary (A Range)
5 points |
Criterion Score |
Completed IRB Application | Student did not submit the form | 5 Points Submitted form | Score of Completed IRB Application,
/ 5 |
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Criteria | No Submission
0 points |
Emerging (F through D Range) (1-10)
10 points |
Satisfactory (C Range)
11 points |
Proficient (B Range)(12-13)
13 points |
Exemplary (A Range) (14-15)
15 points |
Criterion Score |
Clearly identifies informed consent procedure section in clear, descriptive detail, specific, and all inclusive. | Student did not submit assignment | Student provided a under-developed description of the informed consent procedure section in clear, descriptive detail, specific, and all-inclusive with little or no analysis of concepts and related issues. | Student provided a minimally developed description of the informed consent procedure section in clear, descriptive detail, specific, and all-inclusive with limited analysis of concepts and related issues. | Student provided a developed description of the informed consent procedure section in clear, descriptive detail, specific, and all-inclusive with reasonable analysis of concepts and related issues. | Student provided a fully developed description of the informed consent procedure section in clear, descriptive detail, specific, and all-inclusive with insightful analysis of concepts and related issues. | Score of Clearly identifies informed consent procedure section in clear, descriptive detail, specific, and all inclusive.,
/ 15 |
Criteria | No Submission
0 points |
Emerging (F through D Range) (1-6)
6 points |
Satisfactory (C Range)
7 points |
Proficient (B Range)
8 points |
Exemplary (A Range) (9-10)
10 points |
Criterion Score |
Required Content “Writing in lay language (as documented by reading level score).” | Student did not submit assignment | Student provided a under-developed description of Writing in lay language (as documented by reading level score with little or no analysis of concepts and related issues. | Student provided a minimally developed description of Writing in lay language (as documented by reading level score with limited analysis of concepts and related issues. | Student provided a developed description of Writing in lay language (as documented by reading level score with reasonable analysis of concepts and related issues. | Student provided a fully developed description of Writing in lay language (as documented by reading level score with insightful analysis of concepts and related issues. | Score of Required Content “Writing in lay language (as documented by reading level score).”,
/ 10 |
Includes risks and benefits relevant to study and addresses consent if applicable. | Student did not submit assignment | Student provided an under-developed description of risks and benefits relevant to study and addresses consent if applicable with little or no analysis of supportive evidence for the problem identified. | Student provided a minimally developed description of risks and benefits relevant to study and addresses consent if applicable with limited analysis of supportive evidence for the problem identified. | Student provided a developed description of risks and benefits relevant to study and addresses consent if applicable with insightful analysis of concepts and related issues. | Student provided a fully developed description of risks and benefits relevant to study and addresses consent if applicable and supported with evidence with insightful analysis and identified. | Score of Includes risks and benefits relevant to study and addresses consent if applicable.,
/ 10 |
Criteria | No Submission
0 points |
Emerging (F through D Range) (1-6)
6 points |
Satisfactory (C Range)
7 points |
Proficient (B Range)
8 points |
Exemplary (A Range) (9-10)
10 points |
Criterion Score |
Academic Writing Expectations (incudes APA) “Displays sentence and paragraph skills: Constructs simple, complex and compound sentences. Writes without spelling, grammatical or syntax errors. Writes without sentence fragments or run on sentences. | Student did not submit assignment | Demonstrates limited sentence, paragraph, and essay level skills. Has limited use of evidence with few or no sources to support the content. Does not meet the graduate level of writing and does not meet the minimum requirement. Demonstrates limited APA formatting with multiple formatting errors. | Demonstrates minimally developed sentence, paragraph, and essay level skills. Minimally meets the graduate level with several writing issues and meets the minimum reference requirement. Demonstrates minimally developed APA formatting with several formatting errors. | Demonstrates developed sentence, paragraph, and essay level skills. Meets the graduate level with minimal writing issues and exceeds the minimum reference requirement. Demonstrates developed APA formatting with minimal formatting errors. | Demonstrates fully developed sentence, paragraph and essay level skills. Meets the graduate level with no writing issues and exceeds the minimum reference requirement. Demonstrates fully developed APA formatting with no errors. | Score of Academic Writing Expectations (incudes APA) “Displays sentence and paragraph skills: Constructs simple, complex and compound sentences. Writes without spelling, grammatical or syntax errors. Writes without sentence fragments or run on sentences.,
/ 10 |
Total 50 / 50