Advance Nursing Research: Informed Consent Form

Informed Consent Form.

For this assignment, you will complete an informed consent document. Use the attached “Informed Consent Template Form” for this assignment. 

You will edit the Informed Consent template to make it about your proposed research project (see “my proposed research project” on the attachment section). 

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.

Free of Plagiarism.

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:

————

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: __________

Revised 08/03/15

Participant’s Initials _______

Running Head: EVIDENCE-BASED PRACTICE PROJECT
1

RESEARCH 2

Advance Nursing Research

Mental Health

Mental health is crucial in every stage of life. It is defined as the state of psychological well-being whereby the individual realizes a satisfactory integration instinctual drive acceptable to both oneself and his or her social setting (Ritchie & Roser, 2018). The status of mental health influences physical health, relationships, and most importantly day-to-day life. Mental health problems arise when there is a disruption in mental well-being.

The risk factors to mental health problems are not limited and therefore everyone is entitled to the problem irrespective of gender, economic status, and ethnic group. For example, data shows that in America one out of five individuals experience mental health problems annually, with mental disorders being recognized as the leading cause of disability not only in the United States but also globally (Ritchie & Roser, 2018). Mental health disorders are seen to be complex and of many forms such as anxiety, mood, and schizophrenia, among others.

Data shows that in 2017 about seven hundred and ninety-two million people lived with a mental disorder. Challenges have been identified with data presentation since mental health disorders are under-reported worldwide (Ritchie & Roser, 2018). World health organization data shows that mental health disorders are not only determined by one’s ability to manage their thoughts, behavior and interaction with others but also economic, environmental and social factors. For example, the on-going global financial crisis creates a macroeconomic phenomenon that provides a significant opportunity for mental health consequences with an increased rate of suicide and harmful substance use.

Most research studies have shown that there exist many gaps in relation to mental health problems. The gap ranges from treatment interventions and effective use of the available tools to reduce the issues of mental health. For example, there exists a research gap on the interventions meant to reduce and eradicate stigma which has been recognized as a determinant of mental health problems and this spiked my interest.

Therefore, in order to fill this gap such question as a) What is the association between stigma towards mental health patients and help-seeking? b) To what extent does stigma constitute a barrier to the search for help among mental health patients? And c) Are there populations that are more deterred from seeking help due to stigma? Have to be answered through research to get the intended purpose.

References

Ritchie, H., & Roser, M. (2018, April). Mental Health. Retrieved from https://ourworldindata.org/mental-health

W.H.O. (2020). Mental Health. Retrieved from https://www.who.int/mental_health/en/

Running Head: ADVANCE NURSING RESEARCH
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ADVANCE NURSING RESEARCH 2

The Details of Your EBP Project.

EBP Project Proposal Draft

Research topic

To assess the role of stigma towards mental health patients in help seeking.

Research problem

Most studies have shown that stigmatization towards mental health patients have been present throughout history and even despite the evolution in modern medicine and advanced treatment. Stigmatization have resulted from the belief that those with mental problem are aggressive and dangerous creating a social distance (Szeto et al., 2017). Also, mental health-related stigma has become of major concern as it creates crucial barriers to access treatment and quality care since it not only influences the behaviour of the patients but also the attitude of the providers hence impacting help-seeking. Most studies have identified stigma as a barrier that is of significance to care or help seeking while the extent to which it still remains a barrier have not been reviewed deeply. Therefore, this study will assess the role contributed by stigma in help seeking in depth.

Research purpose

The intention of the research study is to review the association between stigma, mental illness and help seeking in order to assess in depth the role that mental-health stigma contribute in help seeking.

Research objectives

a) To review the background history of mental-health related stigma and mental problem or illness

b) To explore the impacts of stigma

c) To assess an association between the contributing factors of stigma to help seeking

d) To assess the extent in which these factors of stigma contribute to help seeking.

e) To assess the risk factors influencing help seeking with regard to stigma

Research questions

a) What is the association between stigma towards mental health patients and help-seeking?

b) To what degree does stigma constitute a barrier to the search for help among mental health patients?

c) Are there populations that are more deterred from seeking help due to stigma?

Research Hypothesis

Ho: stigma towards mental health patients have a significant role in influencing help seeking

Ha: the extent to which stigma influences help seeking is not significant

Theoretical framework

Stigma has been described as a negative effect of a label and the product of disgrace that makes a person to be apart from others (Henderson et al., 2013). It is built upon distinct constructs prejudice, discrimination, and stereotypes (Henderson et al., 2013). For example, believing that those people diagnosed with mental illness is stereotype. Also, agreeing with the fact that those with mental problem are indeed dangerous with a resultant fear or anger is prejudice while discrimination is the total avoidance to those with mental conditions as a result of prejudice and stereotype. Mental problem or illness is a condition that distorts an individual’s capability to relate to others, thinking, mood feeling and also daily functioning (Szeto et al., 2017).

Many studies have reported an existence of negative attitudes with regard to mental health problem and social distance (Henderson et al., 2013). This is because those persons with mental problem are regarded as dangerous, a public nuisance and aggressive. Some of the contributing factors include the media which influences the society’s view, public perception which is influenced by the level of understanding towards mental health problems and the illness itself and also reluctance to seek help which contribute to further stigmatization. Stigma is therefore seen as barrier since it inhibits a person from seeking help hence resulting to a treatment gap and advancement in medical programs meant to reduce cases of medical care (Szeto et al., 2017). Therefore, mental health-related stigma is seen to influence help seeking by creating a general pattern of behavior and attitudes.

References

Henderson, C., Evans-Lacko, S., & Thornicroft, G. (2013). Mental Illness Stigma, Help Seeking, and Public Health Programs. American Journal of Public Health, 103(5), 777-780. doi:10.2105/ajph.2012.301056

Knaak, S., Mantler, E., & Szeto, A. (2017). Mental illness-related stigma in healthcare. Healthcare Management Forum, 30(2), 111-116. doi:10.1177/0840470416679413

Running Head: ADVANCED NURSING RESEARCH
1

ADVANCED NURSING RESEARCH
4

Advanced Nursing Research (Research Study)

Student Name

Institution-Affiliated

Different Parts of a Research Study

Research topic

A systematic review of the association between stigma and or on help-seeking among mental health patients.

Research Problem

Stigma or the process of labelling, discrimination and prejudice towards individuals suffering from mental health problems is considered to have numerous adverse consequences compared to the health conditions themselves according to Thornicroft, Mehta, Clement, Evans-Lacko, Doherty, Rose & Henderson, (2016). In addition, research has found stigma to be responsible for the failure of numerous individuals suffering from mental health to seek help from both their close relatives or trusted individuals and from healthcare providers (Clement, Schauman, Graham, Maggioni, Evans-Lacko, Bezborodovs, Thornicroft, 2015).

Given an increase in mental health disorders and the challenges that such disorders pose to both individuals and society, numerous studies have been conducted to examine the association between stigma and help-seeking among mental health patients. However, research has largely focused on the attitudes that constitute stigma towards mental health patients and little on the interventions required to reduce or eradicate stigma. Moreover, since the failure to reduce stigma prevents mental health patients from seeking help and hence worsening their conditions, there is need for further studies regarding the association between stigma and help-seeking and the need to reduce stigma making the study not only relevant but significant.

Research purpose

The purpose of this paper is to explore the association between stigma and help-seeking among mental health patients and to identify proven strategies or actionable recommendation for reducing stigma.

Research objectives

The objective of the study will be to (1) Explore the extent to which stigma posses a barrier to help-seeking among mental health patients, (2) Identify whether stigma affects certain populations more than others and (3) propose strategies that can help reduce stigma.

Research question

The study will aim to answer the following questions (1) What is the association between stigma towards mental health patients and help-seeking? (2) To what extent does stigma constitute a barrier to the search for help among mental health patients and (3) Are there populations that are more deterred from seeking help due to stigma?

Research hypothesis

Ho: Stigma towards mental health patients deters them from seeking help

Ha: There is no association between stigma and the search for help among mental health patients.

In addition, the study hypothesizes that a reduction in stigma would result in increased help-seeking among mental health patients.

References

Clement, S., Schauman, O., Graham, T., Maggioni, F., Evans-Lacko, S., Bezborodovs, N., … & Thornicroft, G. (2015). What is the impact of mental health-related stigma on help-seeking? A systematic review of quantitative and qualitative studies. Psychological medicine, 45(1), 11-27.

Thornicroft, G., Mehta, N., Clement, S., Evans-Lacko, S., Doherty, M., Rose, D., … & Henderson, C. (2016). Evidence for effective interventions to reduce mental-health-related stigma and discrimination. The Lancet, 387(10023), 1123-1132.