For this assignment, you will complete an informed consent document. Use this Informed Consent Template (Word) for this assignment. You will edit the Informed Consent template to make it about your proposed research project. The language you use to complete the template should be professional, objective, and clear. It should be grammatically correct and free of spelling and punctuation errors. For the purposes of this assignment, you are the Primary Investigator (PI) in the study. 

  

Informed Consent Template

This informed consent template has been adopted by the Regis IRB to assist researchers in developing easy-to-read consent documents. The format may be expanded, but the consent form must contain all the elements below. The brackets [ ] contain additional instructions and areas for customizing the form according to the purpose and procedure of your study. 

For studies involving adult participants (ages 18 and older), you must obtain written informed consent. If your study involves participants ages 7-17, you must obtain written assent from the child and written informed consent from a parent or legal guardian. For participants ages 6 or younger, you must obtain oral assent from the child and written informed consent from a parent or legal guardian. 

Consent cannot truly be called “informed” unless the participant understands the terms of his or her participation in the study. It is the researcher’s responsibility to ensure that the consent documents are comprehensible to the participants. The Regis IRB requires researchers to assess the readability of their forms using the Flesch-Kincaid Grade Level score which is calculated based on the average sentence length and the average number of syllables per word. A grade of 7.0 would indicate that a seventh grader would likely understand the document. The Regis IRB also requires that an informed consent document for an adult (age 18 or over) not exceed a score of 7.0. To test your document’s grade level score in Microsoft Word:

· Click the “File” tab, and then click “Options.” 

· Click “Proofing.” 

· Under “When correcting spelling and grammar in Word” make sure the “Check grammar with spelling” box is selected. 

· Select “Show readability statistics.” 

After you enable this feature, check the document’s spelling (Click the “Review” tab; click “Spelling & Grammar”). When Word finishes checking the spelling and grammar, it displays information about the reading level of the document. 

If the score is too high, try the following: 

· Minimize the use of colons, semicolons, and punctuation other than standard periods and question marks.

· Use short, concise sentences. Long, complex sentences can often be divided into shorter ones to reduce the readability level.

· Use a thesaurus to find synonyms that are more comprehensible to the participants. 

· People are often unfamiliar with terms commonly used in academic fields. Use lay terms, and avoid academic jargon. 

· Write as if you are speaking directly with a person. 

Sometimes, this process can be a bit frustrating. Try to remember that appropriate readability is at the core of fully informing research participants about their rights and what they will experience. In other words, informed consent is a vital element in conducting ethical research.
 

Regis College [school or department name]

Informed Consent to be in [title of study]

Researcher: [name of principal investigator (PI)]

Introduction

Please read this form carefully. You are being asked to be in a research study of [Insert a general statement about the study.]. You were selected to be in this study because [List inclusion criteria.]. You are not eligible to participate if [List exclusion criteria.]. Please ask any questions you may have before you agree to be in the study. You will receive copy of this consent form.

Purpose of the Study

The purpose of this study is [Explain the research question and purpose in lay language.]. 

What Will Happen in the Study

If you agree to be in this study, we would ask you to [Explain procedures and tasks. Identify any procedures that are experimental. Describe the length of time for participation, frequency, and duration of procedures, etc. For example, if participants will be interviewed during the study you would describe: how many interviews, the length of each interview, and/or where the interview will take place.]. 

Benefits of Being in this Study

The benefits of being in this study are [State the anticipated benefits the research will produce for society and/or the participants. If there are no expected benefits, state as such.].

Risks and Discomforts of Being in this Study

The study has the following risks. First [Explain the first risk, its likelihood, and how it will be minimized.]. Second, [Explain the second risk, its likelihood, and how it will be minimized.]. Third, . . . [If there are no foreseeable risks, state there are no expected risks.].

Payments

You will receive the following payment for being in the study: [Explain the amount of payment or other reimbursement information (e.g., class points, tokens, donations, etc.), as well as when payment and/or reimbursement will occur and in what cases payment will not occur, if any]. 

[If there is no payment, state: There is no payment for being in this study.]

Cost

There is no cost to you for being in this research study.

Choosing to Be in the Study and Choosing to Quit the Study

It is your choice to be in this study. If you choose not to be in this study, it will not affect your current or future relations with Regis. You are free to decline to answer questions or quit at any time, for any reason. There is no penalty for not taking part or for quitting. [If you are using students, you must include a statement that participating or not participating in the study will have no impact on their academic status. If you are using employees, you must state that participating or not participating in the study will have no impact on their employment status. Explain consequences (e.g., adjusted monetary benefits) of early withdrawal, if any.]

Getting Dismissed from the Study

The researcher may dismiss you from the study at any time for the following reasons: [Include the reasons, for example, “(1) it is in your best interests (e.g., side effects or distress), (2) you have not followed the study rules, or (3) the study sponsor decided to end the study.”].

Privacy 

The records of this study will be kept private. [Explain how information about the participants will be protected, for example, “Research records will be kept in a locked file” or “All electronic information will be coded and secured using a password-protected file.” Explain who will have access to the study records, and when and how they will be destroyed. Responses are anonymous when the researcher does not know the identity or any identifying information about who wrote them. If you are keeping a list connecting participants’ names to ID numbers, explain how you will keep that information protected and separate from your data analysis. If applicable, state that the responses are meant to be combined with other participants’ data and are not meant to gather information about specific individuals.] No published reports will include any information that will make it possible to identify you. 

Contacts and Questions

The researcher conducting this study is: [PI’s name]. The researcher will be available to answer any questions about the study at: [phone number and email address]. If you have questions or concerns about your rights, you may contact the Regis Institutional Review Board Chair:

Dr. Margaret Oot-Hayes, PhD, RN

781-768-7163

[email protected] 

Statement of Consent [Choose only one statement according to the type of consent form.]

[Adult Participant Informed Consent]

I have read this form (or have had it read to me). I have been encouraged to ask questions. I have received answers to my questions. I give my consent to be in this study. I have received (or will receive) a copy of this form. I understand the risks and discomforts associated with the above study and understand that I may quit the study at any time without penalty.

[Parent/Guardian Informed Consent for Participants Ages 17 and Younger]

I have read this form (or have had it read to me). I have been encouraged to ask questions. I have received answers to my questions. I give my consent for my child to be in this study. I have received (or will receive) a copy of this form. I understand the risks and discomforts associated with the above study and understand that my child may quit the study at any time without penalty.

Signature(s)/Date [Delete any that do not apply to your protocol.]

[Adult Participant Informed Consent]

Participant Printed Name: ___________________________________

Participant Signature: ___________________________________ Date: __________

[Parent/Guardian Informed Consent for Participants Ages 17 and Younger]

Study Participant Printed Name: ___________________________________

Parent/Guardian Printed Name: ___________________________________

Parent/Guardian Signature: ___________________________________ Date: __________

[Interpreter for Non-English-Speaking Participants]

Interpreter Printed Name: ___________________________________

Interpreter Signature: ___________________________________ Date: __________

[Participant’s Legal Representative]

Participant Printed Name: ___________________________________

Legal Representative Printed Name: ___________________________________

Legal Representative Signature: ________________________________ Date: __________

Witness Printed Name: ___________________________________ 

Witness Signature: ___________________________________ Date: __________

  

Answer the following questions in three well-developed paragraphs (450–500 words) using APA formatting, integrating two evidence-based resources to include clinical practice guidelines 

RR is 48-year-old woman who comes to see you at the V. A. homeless clinic. The major complaint is a six-day history of worsening cough, productive of green sputum. There have been fever and chills with complaints of pain in the right mid-back with deep breathing or coughing. Further history reveals a history of tobacco use of one pack of cigarettes a day for 30 years. There is an inconsistent health history as a result of PTSD and homelessness. On examination, the skin is warm and clammy, pale; RR appears to not feel well; the temperature is 100.5° F; respiratory rate is 24 breaths per minute; pulse is 98 beats per minute; blood pressure is 120/75 mm Hg; and saturation of oxygen is 96 percent on room air by pulse oximetry.

Auscultation of the lungs reveals rales in the right lower-posterior lung field. The remainder of the examination is within normal limits.

1. What organism(s) do you most      suspect and why?
2. What antibiotic would you      recommend to treat RR with and why?
3. What is the mechanism of action      of this antibiotic?
4. Do you have any counseling points      for RR ?

In Huston’s (2010) brief, but impressive article (required reading this week), the author outlines several leadership competencies that EVERY nurse leader will need for 2020. That year is not too far in the future, is it?

1. Select one of the eight leadership competencies Huston described and relate it to your own leadership of nurses and nursing. This should promote a robust discussion as we come from different clinical and nonclinical perspectives.
2. Discuss how the BSN-prepared nurse can assist a nurse leader in the budgeting process by contributing data readily available to the staff nurse.

Huston, C. (2010). What skills will the nurse leaders of 2020 need? (2010). Kai Tiaki Nursing New Zealand, 16(6), 14–15. 

***The leadership competency I choose is better use of technology to connect people.***

350 words with reference and in text citation

  In your reply posts, incorporate challenges you would anticipate for the proposals, as well as arguments to overcome those challenges. Each reply should be 200  :

 Today, I believe most of the money being spent on healthcare should be used on educating patients on possible lifestyle modifications that can be made for many different disease preventions. Diet is one of the most modifiable factors for numerous diseases that the majority of the population suffers from, such as diabetes and hypertension. “The Dietary Approach to Stop Hypertension (DASH) diet, a dietary pattern, currently receiving much attention, was originally designed to reduce blood pressure13; this diet emphasizes intakes of fruits, vegetables, whole grains, nuts, legumes, moderate amounts of low-fat dairy; and underscores reduced intakes of red or processed meats, sodium, and sweetened beverages( Hossein, 2019) ” Here the author stresses the importance of DASH diet and how it can manage hypertension apart from using prescription drugs. With the stress of education on patients, they would be able to manage hypertension and save money on costs such as insurance premiums, and copays. “and higher adherence to DASH diet score was related with lower odds of metabolically unhealthy normal weight phenotype in comparison to metabolically healthy normal weight younger adults ( Hossein, 2019) “ Here, the population can avoid metabolic syndrome by following the DASH diet, which is proven to be a modifying factor. The avoidance of liquor is also a large modifying risk factor in the role of hypertension.
Other modifying factors include exercise. It has been proven that 30 mins of exercise at least 3 times a week reduces blood pressure levels. Diet and exercise have great impact in the prevention of hypertension and diabetes ( type 2) “ brings attention to the importance of healthy aging. Adoption of healthy lifestyle activities such as participating in physical activity on a daily basis is key to maintaining physical and mental health. (Norma, 2020).” Here, we can even use education to involve the elderly population to prevent any extra complications of aging. “he results indicated that the exercise intervention contributed to significant improvements in the older adults’ health-related variables for the EG when contrasted with the control group ( Norma, 2020 )” So, you see the Dash diet, and even exercise is useful at any age so this would be a modifiable factor. This method has also proved to be effective in reducing diastolic, systolic blood pressures, cholesterol, blood lipids, and even depressive symptoms. Money that is given to insurance companies should be spread out to other healthcare branches in order to spread knowledge. Health companies would be putting money towards prevention. Money should also be going towards mandatory screening of preventable diseases. Offices need to be constantly reminded of annual blood work up, lung cancer screening, and even regular blood pressure work up. As far as end of life care goes, money would be spent naturally less on chronic treatments and even procedures because of better health maintenance and wellness which was added earlier in life. In regard to policy utilizing this information we can install schools to have only healthy food option in order to prevent diabetes. The cost of diabetes is a lifelong commitment to insulin, blood checks, and doctor visits if not controlled early on. There should be no sodas, fresh squeezed juices, and more gym time. I hope to see a future that focus more on wellness to eliminate the prognosis of diseases and money spent on these diseases. A lot of diseases can be prevented by exercise, proper eating, and being active with screening. We should educate regrading things like the DASH diet to promote wellness. There should be strict polices in regards to foods in children’s school’s, and free screenings.