NSG 6101 Week 9 Informed Consent Letter 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). NSG 6101 Week 9 Informed Consent Letter Assignment.
- Informed Consent Letter Example
- IRB Application
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Part I: Information Sheet
Introduction
My name is Ram Pander, a student at South University. I am researching immunization and vaccination. I would like to invite you to participate in this study. Feel free to discuss with anyone you are comfortable with on matters of this research. You may take your time before making the final decision on participating in this study. This consent form may contain words and phrases that you may not understand, feel free to stop me and inquire as we go through the information. If any questions may arise, feel free to ask me. NSG 6101 Week 9 Informed Consent Letter Assignment.
Purpose of the research
Immunization and vaccination are vital for a healthy life. We want to determine the level of acceptance to different types of vaccinations while identifying the challenges faced by those that were not vaccinated.
Type of Research Intervention
This research will involve your participation in half hour a twenty minutes interview.
Participant Selection
You are being invited to take part in this research because we feel that your experience as a medical practitioner, victim of lack of vaccination, well-immunized adult or parent can contribute much to our understanding and knowledge of immunization and vaccination. NSG 6101 Week 9 Informed Consent Letter Assignment.
Voluntary Participation
Your participation in this research is entirely voluntary. It is your choice whether to participate or not. If you choose not to participate in all the services you receive at this Centre will continue and nothing will change.
Risks
You do not have to answer any question that makes you feel uncomfortable. You do not have to justify not having a response to other questions. NSG 6101 Week 9 Informed Consent Letter Assignment.
Benefits
There will be no direct benefit to you, but your participation is likely to help us find out more about how to increase the rate of immunization and help those that have not been immunized in the community.
Reimbursements
You will not be provided an incentive to take part in the research.
Confidentiality
We will not be sharing information about you to anyone outside of the research team. The information that we collect from this research project will be kept private. Any information about you will have a number on it instead of your name. Only the researchers will know what your number is and we will lock that information up with a lock and key. NSG 6101 Week 9 Informed Consent Letter Assignment.
Right to Refuse or Withdraw
You do not have to take part in this research if you do not wish to do so. You may stop participating in the interview at any time that you wish. I will give you an opportunity at the end of the interview to review your remarks, and you can ask to modify or remove portions of those, if you do not agree with my notes or if I did not understand you correctly. NSG 6101 Week 9 Informed Consent Letter Assignment.
Who to Contact
If you have any questions, you can ask them now or later. If you wish to ask questions later, you may contact me.
This proposal has been reviewed and approved by [name of the local IRB], which is a committee whose task it is to make sure that research participants are protected from harm.
Part II: Certificate of Consent
I have read the preceding information, or it has been read to me. I have had the opportunity to ask questions about it, and any questions I have been asked have been answered to my satisfaction. I consent voluntarily to be a participant in this study
Print Name of Participant__________________
Signature of Participant ___________________
Date ___________________________
Day/month/year
NSG 6101 Week 9 Informed Consent Letter Assignment.
If illiterate [1]
I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.
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NSG 6101 Week 9 Informed Consent Letter Assignment.
Print name of witness____________ Thumb print of participant
Signature of witness _____________
Date ________________________
Day/month/year
Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands what is contained
I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.
NSG 6101 Week 9 Informed Consent Letter Assignment.
A copy of this ICF has been provided to the participant.
Print Name of Researcher/person taking the consent________________________
Signature of Researcher /person taking the consent__________________________
Date ___________________________
Day/month/year
[1] A literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team). Illiterate participants should include their thumbprint as well.
| For Official Use Only | |
| Date received: | |
| Date reviewed: | |
| End date: | |
| File #: | |
SELF CONSENT
NSG 6101 Week 9 Informed Consent Letter Assignment.
I have been invited to take part in a research study titled:
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 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:
PROCEDURES
I understand that if I volunteer to take part in this study, I will be asked to:
BENEFITS
I understand that the benefits I may gain from participation include:
RISKS
I understand that the risks, discomforts, or stresses I may face during participation include:
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
NSG 6101 Week 9 Informed Consent Letter Assignment.
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.
NSG 6101 Week 9 Informed Consent Letter Assignment.
Participant Printed Name
Signature of Participant Date (mm/dd/yyyy)
Signature of Principal Investigator Date (mm/dd/yyyy)
NSG 6101 Week 9 Informed Consent Letter Assignment.
Introduction
Immunization is a process whereby an individual, especially a young child below the age of six, is made resistant against infectious diseases. Immunization is usually done through the administration of some medicine commonly known as vaccines. Vaccines are administered in an individual's body through several means such as oral and injection. Vaccines are of great importance in that they boost the body's immunity thus preventing the individual from being infected with the disease later in life. NSG 6101 Week 9 Informed Consent Letter Assignment.
Immunization is one of the tools that have been proven to reduce the number of deaths in the world drastically. Approximately two million deaths have been avoided annually because parents are informed about the necessities of immunizing their children (Russel, 1998). This number is projected to have increased over the years. Thus, with effective medical support from organizations such as the World Health Organization (WHO), the immunization processes can reach the majority of the population even the hard-to-access group of people in the society. With improved medical services brought about by improved infrastructure, WHO has an aim to ensure each person receives proper immunization during childhood. Proper immunization will reduce infant mortality rates due to proper health service. NSG 6101 Week 9 Informed Consent Letter Assignment.
The most important part of the research is to understand the relationship between vaccination and immunization of young children with the improvement in the quality of a healthy life. There is a need to understand other factors surrounding the immunization and lack of immunization of children below the age of six years. In this study, various literature will be studied to enable the development of a hypothesis and its validity tested by the procedures of the research. From the literature review, it clearly shows that immunized children have reduced medical health problems compared to those that have not been immunized. Lack of immunization among the children can lead to the contract of diseases which can easily cause infant mortality. NSG 6101 Week 9 Informed Consent Letter Assignment.
Statement of problem
There is some great relationship between the rate of survival in immunized children and mortality rates due to diseases caused by a lack of immunization. Immunization has led to increased chances of survival in children. However, there are still some children who cannot fully access vaccines due to certain factors that affect them. The factors that affect them from accessing vaccines provide some base for research to be carried out. NSG 6101 Week 9 Informed Consent Letter Assignment.
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Objectives
The objectives of this research include:
- To determine the reason why some people still do not want their children to undergo immunization.
- To not only understand the political problems but also the economic and philosophical difficulties the unimmunized children undergo later in life.
- To clearly understand the importance and benefits of parents ensuring their children are immunized
Null hypothesis
- There are no reasons to explain why some people still do not want their children to undergo immunization.
- The political, economic and philosophical difficulties faced by unimmunized children undergo later in life cannot be understood.
- The importance and benefits of parents ensuring their children are immunized cannot be clearly understood. NSG 6101 Week 9 Informed Consent Letter Assignment.
Research Questions
- How important is immunization
- What are the repercussions of escaping the immunization process to an individual?
Theoretical framework
Research shows that effective vaccination and immunization of children in the whole population will lead to an improved health life of an individual. With the presence of modern statistical programs used for analysis such as STATA, there will be an efficient analysis of variables available in this research. NSG 6101 Week 9 Informed Consent Letter Assignment.
Literature Review
Immunizations and vaccines are considered to be the most cost-effective intervention when it comes to child survival (Prinja et al., 2018). However, coverage and access differ from country to country. This creates large disparities when it comes to children and immunization across the globe. The Effective Vaccine Management (EVM) initiative has the main duty of providing materials that monitor the supply of vaccines. The process must be monitored because with time there has been a rise in the cost of vaccines. Therefore, the stock level must be kept at minimum levels as planned by the medical department without wastage pf resources so that it can be sufficient for the population. NSG 6101 Week 9 Informed Consent Letter Assignment.
Logical support has to ensure that there is a supply of high-quality equipment and vaccines (Markowitz et al., 2007) A well-managed logistics support program will ensure that there are reduced cases of adverse side effects brought about by the vaccines. WHO should also come up with methods aimed at improving the lives of those that have not been vaccinated. The organization should also come up with programs which will be used as a platform for educating those individuals against immunization. The following consists of a literature review of the differences and similarities in the world immunization systems for three countries: Nigeria, India, and Switzerland. NSG 6101 Week 9 Informed Consent Letter Assignment.
Nigeria
Nigeria has one of the highest percentages of vaccine-preventable diseases including measles, poliomyelitis, tuberculosis, diphtheria, and tetanus. According to Oku et al. (2017), only one-fourth of children receive full vaccinations. The country is ranked 2nd when it comes to mortality rates from vaccine-preventable diseases among children. When it comes to economic development, Nigeria outperforms lower-middle-income countries but has the lowest immunization coverage rates in the world. NSG 6101 Week 9 Informed Consent Letter Assignment.. Burroway and Hargrove (2018) investigated the community and individual-level factors that influence whether a child is vaccinated in Nigeria. Researchers found women’s education level to have the largest association with childhood vaccinations. The reasons associated with low immunizations throughout Nigeria consists of: concerns about immunization safety, lack of knowledge regarding vaccinations, and long distances to health facilities (Oku et al., 2017) NSG 6101 Week 9 Informed Consent Letter Assignment.
In 1979, Nigeria launched the Expanded Programs on Immunizations (EPI) to provide routine vaccinations to all children under the age of one, as well as pregnant women. However, Nigeria is one of only three countries where polio remains an endemic (Prinja et al., 2018). In October 2012, Nigeria restructured its polio program and created the Polio Emergency Operation Centre. The country also uses supplementary immunization activities (SIAs) to help eliminate polio. NSG 6101 Week 9 Informed Consent Letter Assignment.. During an SIA, healthcare workers provide all children under the age of five with oral polio vaccine (OPV). These campaigns are usually conducted house-to-house; however, it is difficult for healthcare workers to reach all children due to incomplete household maps and vaccine refusals (Oku et al., 2017). Even with the campaign and programs, there are still currently a substantial amount of children in Nigeria who have not received vaccinations. NSG 6101 Week 9 Informed Consent Letter Assignment.
India
Approximately 62% of children in India have full immunization. A 2015-2016 National Family Health Survey (NFHS) showed large disparities when it came to different doses of the BCG, DPT, polio and measles vaccines across all districts of India. Over the past decade, child vaccination coverage throughout the country has substantially increased. However, currently, one-third of children in India have not received immunizations. While donor and government-funded programs have improved childhood immunizations throughout central and northern India, there is little focus on the north-eastern region. NSG 6101 Week 9 Informed Consent Letter Assignment.. According to Khan, Shil and Prakash (2018), there are state or regional-level inequalities in immunizations throughout India due to the differential healthcare facility and socio-economic factors consisting wealth status, gender preference, place of residence and health infrastructure. The researchers found that women's education was positively correlated with vaccination. They also discovered a positive correlation between childhood immunizations and institutional deliveries, birth registration and having an MCP card (Khan, Shil & Prakash, 2018). NSG 6101 Week 9 Informed Consent Letter Assignment.
Nigeria and India have opposite trends regarding the DPT3 vaccine between 2007 and 2017. In 2007, 3.3 million Nigerian children and 9.3 million children in India did not receive the DPT series. During the same period, the population eligible for the vaccine increased by 23% in Nigeria and decreased by 6% in India. Nigeria surpassed India in 2014 as the country with the most children without the DPT3 vaccine (VanderEnde et al., 2018). NSG 6101 Week 9 Informed Consent Letter Assignment.
Switzerland
Unlike the other two countries, Switzerland is a developed country. After several years of low incidence rates each year, there has been a measles epidemic since 2006. As a result, coverage rates for MMR doses have increased to 86%. However, the number of children who are vaccinated in Switzerland is greatly impacted by parental perception. In Switzerland, all immunization costs are covered, but whether a child is vaccinated depends on the parent's initiative to take them to a pediatrician. Despite the national and international efforts of health authorities, immunizations in high-income countries have adversely impacted by a parent's choice to decline childhood vaccination (Gross et al., 2015). NSG 6101 Week 9 Informed Consent Letter Assignment.
Switzerland has the highest rates of measles in Europe. According to Gross et al. (2015), parents in Switzerland believe childhood diseases are a natural process of gaining immunity and not necessarily a threat to a child's health. This has created problems for the country in regards to measles. The MMR vaccination currently has suboptimal coverage, and as a result, measles is still a local endemic in Switzerland. According to a Swiss Federal Office of Public Health (FOPH), only 86% of children under the age of two have received two doses of MMR. This is lower than the 95% global goal when it comes to vaccination (Gross et al., 2015). NSG 6101 Week 9 Informed Consent Letter Assignment.
Methodology
Research design
The study will utilize questionnaires in the collection of information for this research. The questions will be a combination of both open-ended questions and closed questions. Therefore, this research would focus hugely on descriptive research design. The presence of participants who are used in this study shows that they are variables of the research. NSG 6101 Week 9 Informed Consent Letter Assignment.
Research context
The context of this research involves the detailed study of difficulties faced by individuals who do not access vaccination facilities. The context, therefore, elaborates how vaccination facilities can reach those who do not access them and even those who are against the use of vaccines. The context also shows the improvement of healthy life in individuals who access vaccination services while young. WHO aims of reaching every person is also a research context that is present in the study. NSG 6101 Week 9 Informed Consent Letter Assignment.
Procedure
Participants
The study will utilize two types of participants: those that have been immunized and those that have not been immunized. The presence of the two types of individuals is necessary as it clearly shows the effect of being immunized and not being immunized. It also gives an insight towards the level of acceptance among parents for the immunization process to be carried out on their children. NSG 6101 Week 9 Informed Consent Letter Assignment.
Materials
Questionnaires will be included in the collection of the primary data necessary for this research. The researchers need to be physically available to give guidelines and offer assistance to the interviewees in addition to the instructions provided for at the beginning of the questionnaire. Analytical programs such as STATA and SAS will be highly required in the analysis of the findings. NSG 6101 Week 9 Informed Consent Letter Assignment.
Variables.
The dependent variables in this study will be the level of acceptance of the different types of immunizations. The independent variables will be the participants who will be interviewed for the purpose of collecting data for this study.
Methods of data collection
Several methods will be used in the collection of data. Such means include the use of questionnaires and the use of medical records. Use of questionnaires will take place from ward-based records to ensure easier responding from the respondents. Use of medical records will be limited to medical practitioners since they are the ones with the primary data of information. Information received will later be sent through email to enhance faster transfer of information. NSG 6101 Week 9 Informed Consent Letter Assignment.
Methods of data analysis
STATA will be used in the analysis of data received from the research. The use of STATA makes it easy in making comparisons and determining the associations between variables (Friese et al., 2008). One can develop some regression analysis between variables while using STATA thus making it quite useful in the analysis of data
Ethical Considerations
The questionnaire should provide for confidentiality and protection of the participant's identity. NSG 6101 Week 9 Informed Consent Letter Assignment.
The researchers should also get the necessary approval from the University’s ethics board before carrying out the research
They should also get written consent from the participants to avoid future legal issues.
The significance of the proposed research
The proposed research is going to be useful in finding a solution for individuals who did not undergo vaccination during their childhood. It also finds a solution to how the general population can access medical services after birth with reduced payments. This research would also be an addition to the improvement of medical services in the medical department. NSG 6101 Week 9 Informed Consent Letter Assignment.
Research limitations
This research about vaccination and the lack of vaccination comes along with several limitations. Some of its limitations include computation of a large amount of data, inadequate supply of funds and the lack of seriousness when it comes to vaccination programs. The analysis of this research involves the computation of data from different health organizations thus becomes difficult and tiresome to analyze the data effectively. Secondly, there has been enough supply of resources, especially funds. The available money raised by the government is allocated to other sectors thus resulting to less amount of money being allocated to the health services with the aim of ensuring the whole population receives vaccination (Peyle et al., 2009). Even after undergoing education programs on the importance of vaccination, there are still many individuals who cannot stand their children being immunized.
NSG 6101 Week 9 Informed Consent Letter Assignment.
References
Burroway, R., & Hargrove, A. (2018). Education is the antidote: Individual-and community-level effects of maternal education on child immunizations in Nigeria. Social Science & Medicine, 213, 63-71.
Friese, C. R., Lake, E. T., Aiken, L. H., Silber, J. H., & Sochalski, J. (2008). Hospital nurse practice environments and outcomes for surgical oncology patients. Health services research, 43(4), 1145-1163.
Gross, K., Hartmann, K., Zemp, E., & Merten, S. (2015). ‘I know it has worked for millions of years’: the role of the ‘natural’in parental reasoning against child immunization in a qualitative study in Switzerland. BMC public health, 15(1), 373. NSG 6101 Week 9 Informed Consent Letter Assignment.
Khan, J., Shil, A., & Prakash, R. (2018). Exploring the spatial heterogeneity in different doses of vaccination coverage in India. PloS one, 13(11), e0207209.
Markowitz, L. E., Dunne, E. F., Saraiya, M., Chesson, H. W., Curtis, C. R., Gee, J., ... & Unger, E. R. (2014). Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report: Recommendations and Reports, 63(5), 1-30.
Murphy, T. V., White, K. E., Pastor, P., Gabriel, L., Medley, F., Granoff, D. M., & Osterholm, M. T. (1993). Declining incidence of Haemophilus influenzae type b disease since introduction of vaccination. Jama, 269(2), 246-248.
NSG 6101 Week 9 Informed Consent Letter Assignment.