Week 7 Assignment 1 Informed Consent Form

NU 631 Week 7 Assignment 1: Informed Consent Form

Value: Complete at 100 points/Incomplete at 0 points

Due: Day 7

Grading Category: Assignments

Instructions

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.

Please refer to the Grading Rubric for details on how this activity will be graded.

To Submit Your Assignment:

Select the Add Submissions button.
Drag or upload your file to the File Picker.
Select Save Changes.

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.

Important information for writing discussion questions and participation

Welcome to class

Hello class and welcome to the class and I will be your instructor for this course. This is a -week course and requires a lot of time commitment, organization, and a high level of dedication. Please use the class syllabus to guide you through all the assignments required for the course. I have also attached the classroom policies to this announcement to know your expectations for this course. Please review this document carefully and ask me any questions if you do. You could email me at any time or send me a message via the “message” icon in halo if you need to contact me. I check my email regularly, so you should get a response within 24 hours. If you have not heard from me within 24 hours and need to contact me urgently, please send a follow up text to

I strongly encourage that you do not wait until the very last minute to complete your assignments. Your assignments in weeks 4 and 5 require early planning as you would need to present a teaching plan and interview a community health provider. I advise you look at the requirements for these assignments at the beginning of the course and plan accordingly. I have posted the YouTube link that explains all the class assignments in detail. It is required that you watch this 32-minute video as the assignments from week 3 through 5 require that you follow the instructions to the letter to succeed. Failure to complete these assignments according to instructions might lead to a zero. After watching the video, please schedule a one-on-one with me to discuss your topic for your project by the second week of class. Use this link to schedule a 15-minute session. Please, call me at the time of your appointment on my number. Please note that I will NOT call you.

Please, be advised I do NOT accept any assignments by email. If you are having technical issues with uploading an assignment, contact the technical department and inform me of the issue. If you have any issues that would prevent you from getting your assignments to me by the deadline, please inform me to request a possible extension. Note that working fulltime or overtime is no excuse for late assignments. There is a 5%-point deduction for every day your assignment is late. This only applies to approved extensions. Late assignments will not be accepted.

If you think you would be needing accommodations due to any reasons, please contact the appropriate department to request accommodations.

Plagiarism is highly prohibited. Please ensure you are citing your sources correctly using APA 7th edition. All assignments including discussion posts should be formatted in APA with the appropriate spacing, font, margin, and indents. Any papers not well formatted would be returned back to you, hence, I advise you review APA formatting style. I have attached a sample paper in APA format and will also post sample discussion responses in subsequent announcements.

Your initial discussion post should be a minimum of 200 words and response posts should be a minimum of 150 words. Be advised that I grade based on quality and not necessarily the number of words you post. A minimum of TWO references should be used for your initial post. For your response post, you do not need references as personal experiences would count as response posts. If you however cite anything from the literature for your response post, it is required that you cite your reference. You should include a minimum of THREE references for papers in this course. Please note that references should be no more than 5 years old except recommended as a resource for the class. Furthermore, for each discussion board question, you need ONE initial substantive response and TWO substantive responses to either your classmates or your instructor for a total of THREE responses. There are TWO discussion questions each week, hence, you need a total minimum of SIX discussion posts for each week. I usually post a discussion question each week. You could also respond to these as it would count towards your required SIX discussion posts for the week.

I understand this is a lot of information to cover in 5 weeks, however, the Bible says in Philippians 4:13 that we can do all things through Christ that strengthens us. Even in times like this, we are encouraged by God’s word that we have that ability in us to succeed with His strength. I pray that each and every one of you receives strength for this course and life generally as we navigate through this pandemic that is shaking our world today. Relax and enjoy the course!

Hi Class,

Please read through the following information on writing a Discussion question response and participation posts.

Contact me if you have any questions.

Important information on Writing a Discussion Question

Your response needs to be a minimum of 150 words (not including your list of references)
There needs to be at least TWO references with ONE being a peer reviewed professional journal article.
Include in-text citations in your response
Do not include quotes—instead summarize and paraphrase the information
Follow APA-7th edition
Points will be deducted if the above is not followed

Participation –replies to your classmates or instructor

A minimum of 6 responses per week, on at least 3 days of the week.
Each response needs at least ONE reference with citations—best if it is a peer reviewed journal article
Each response needs to be at least 75 words in length (does not include your list of references)
Responses need to be substantive by bringing information to the discussion or further enhance the discussion. Responses of “I agree” or “great post” does not count for the word count.
Follow APA 7th edition
Points will be deducted if the above is not followed

Remember to use and follow APA-7th edition for all weekly assignments, discussion questions, and participation points.
Here are some helpful links
Student paper example
Citing Sources
The Writing Center is a great resource

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.].

Week 7 Assignment 1 Informed Consent Form

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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

margaret.oot-hayes@regiscollege.edu

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]