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NSG 6101 Week 9 Informed Consent Letter Paper.

NSG 6101 Week 9 Informed Consent Letter Paper. NSG 6101 Week 9 Informed Consent Letter Paper.Informed Consent FormBy 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 LetterProcedure 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 ExampleIRB ApplicationPart 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.ORDER A PLAGIARISM-FREE PAPER HEREPurpose 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.NSG 6101 Week 9 Informed Consent Letter Paper.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.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.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.NSG 6101 Week 9 Informed Consent Letter Paper.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. 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.Who to ContactIf 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. NSG 6101 Week 9 Informed Consent Letter Paper.Part II: Certificate of ConsentI 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 If illiterate 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. NSG 6101 Week 9 Informed Consent Letter Paper.Print name of witness____________ Thumb print of participantSignature of witness _____________Date ________________________ Day/month/year Statement by the researcher/person taking consentI 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 containedI 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.  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/yearInformed Consent Form for IntervieweesNSG 6101 Week 9 Informed Consent Letter Paper.� 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. THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S INFORMED CONSENT LETTER AND IS ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101 .For Official Use OnlyDate received: Date reviewed: End date: File #:   SELF CONSENT I have been invited to take part in a research study titled: NSG 6101 Week 9 Informed Consent Letter Paper.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). NSG 6101 Week 9 Informed Consent Letter Paper.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) THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101 .INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCHThis form is to be used for requesting IRB review for exempt, expedited and full board studiesPlease note that handwritten and/or incomplete forms will be returned to you. NSG 6101 Week 9 Informed Consent Letter Paper. CHECKLIST FOR IRB APPLICATION SUBMISSION (to be completed by PI before submission to IRB) FORMCHECKBOX Application Form with Signatures/ Confidentiality AgreementsFORMCHECKBOX NIH Training Certificate(s)FORMCHECKBOX Protocol or Attached Research Proposal and/ or Contract/ GrantFORMCHECKBOX Solicitation Announcements/Recruitment FlyersFORMCHECKBOX Data Collection Instruments/Research Questions/Questionnaires/SurveysFORMCHECKBOX Informed Consent DocumentsFORMCHECKBOX Parental/Legal Guardian Permission Form (if applicable)FORMCHECKBOX Child Assent Form (if applicable)FORMCHECKBOX Approval from Study Sites (if applicable)FORMCHECKBOX Medical Screening Instrument (if applicable)FORMCHECKBOX Debriefing Plan (if applicable)FORMCHECKBOX Student as Principal Investigator Worksheet (if applicable)Project Title   PART I – INVESTIGATOR and RESEARCH PERSONNEL 1) PRINCIPAL INVESTIGATOR (Undergraduate students cannot serve as Principal Investigator, but may be listed as a Co-Investigator.) Name:     FORMCHECKBOX Dr. FORMCHECKBOX Mr. FORMCHECKBOX Ms. FORMCHECKBOX ProfessorHighest Degree Completed:      Investigator Status:FORMCHECKBOX Faculty FORMCHECKBOX Graduate Student FORMCHECKBOX StaffE-mail Address:     NSG 6101 Week 9 Informed Consent Letter Paper.College/Department:     Campus Mailing Address:     Daytime Phone:     2) CO-INVESTIGATOR – 1 (if applicable)Name:     FORMCHECKBOX Dr. FORMCHECKBOX Mr. FORMCHECKBOX Ms. FORMCHECKBOX ProfessorHighest Degree Completed:      Investigator Status: FORMCHECKBOX Faculty FORMCHECKBOX Graduate Student FORMCHECKBOX Other      FORMCHECKBOX Undergraduate FORMCHECKBOX StaffE-mail Address:     College/Department:     Campus Mailing Address:     Daytime Phone:     3) CO-INVESTIGATOR – 2 (if applicable)Name:     FORMCHECKBOX Dr. FORMCHECKBOX Mr. FORMCHECKBOX Ms. FORMCHECKBOX ProfessorHighest Degree Completed:      Investigator Status: FORMCHECKBOX Faculty FORMCHECKBOX Graduate Student FORMCHECKBOX Other      FORMCHECKBOX Undergraduate FORMCHECKBOX StaffE-mail Address:     College/Department:     Campus Mailing Address:     NSG 6101 Week 9 Informed Consent Letter Paper.Daytime Phone:     4) FACULTY SPONSOR (if applicable)Name:     FORMCHECKBOX Dr. FORMCHECKBOX Mr. FORMCHECKBOX Ms. FORMCHECKBOX ProfessorHighest Degree Completed:      E-mail Address:     College/Department:     Campus Mailing Address:     Daytime Phone:     5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS (if applicable)Name:     E-mail:     Phone:     Name:     E-mail:     Phone:     Name:     E-mail:     Phone:     Name:     E-mail:     Phone:     Name:     E-mail:     Phone:      PART II – FUNDING INFORMATION 1) Check all of the appropriate boxes for funding sources for this research. Include pending funding source(s).FORMCHECKBOX ExtramuralFORMCHECKBOX CollegeFORMCHECKBOX Department FORMCHECKBOX Other: P.I. of Grant or Contract:     Sponsor:     NSG 6101 Week 9 Informed Consent Letter Paper.Contract/Grant No.(if available):      Contract/Grant Title:     ***Please provide one complete copy of the proposal submitted to the sponsor with this application. Please note that submission of your grant application is a regulatory requirement and will be maintained for the record with your application. The IRB will not utilize the grant during the review process other than to confirm that the grant proposal is consistent with the IRB proposal. You must submit all necessary documentation for the application in addition to the copy of the grant. PART III – EDUCATION AND TRAINING All research personnel (faculty, staff, graduate students working on a thesis or dissertation, anyone using data for purposes of independent research, students involved in data collection, faculty sponsors, persons receiving grant monies for human subject research or those personnel with management responsibilities) must complete this section.NSG 6101 Week 9 Informed Consent Letter Paper.1) Have all key research personnel completed the required NIH training? No FORMCHECKBOX Yes FORMCHECKBOX ***If No, DO NOT submit this application . Your application will not be considered until you have completed the IRB training and can provide a copy of your NIH course completion certificate. (Please include a copy/copies of all certificate(s) with each application.) ***Please note that this NIH training is a mandatory requirement to be completed every three years. ***If you have not completed the NIH training, but have completed a comparable course (e.g. CITI training), please include documentation of those courses.2) If other necessary training/education is required for completion of this study, please attach copies of certificates or other documentation (e.g., HIPAA training, phlebotomy training). PART IV – INVESTIGATOR ASSURANCE 1) Institutional Review Board Policy Compliance Agreement· I certify that the information provided in this application is complete and correct.· I understand that as Principal Investigator, I have the responsibility for the conduct of the study, the ethical performance of the project and the protection of the rights and welfare of human participants.· I agree to comply and to assure that all affiliated personnel comply with all South University IRB policies and procedures, as well as with all applicable federal, state and local laws regarding the protection of human participants in research.· I agree that I have the appropriate expertise to conduct this study.NSG 6101 Week 9 Informed Consent Letter Paper.· I assure that this study is performed by qualified personnel adhering to the South University IRB approved protocol. Student PI’s must attach student PI worksheet (see appendix A).· I assure that no modification to the approved protocol and consent materials will be made without first submitting for review and approval by the South University IRB an amendment to the approved protocol.· I agree to obtain legally effective informed consent from the research participants as applicable to this research and as prescribed in the approved protocol.· I will promptly report unanticipated problems to the South University IRB by using the Notification Form provided on the IRB website.· I will adhere to all requirements for continuing review and will complete a Continuance Request form if my research extends beyond one year.· I will advise the South University IRB of any change of address or contact information as long as this protocol remains active.· I assure that I have obtained all necessary approvals from entities other than South University IRB that are necessary to conduct this research (e.g., cooperation letters or approvals from other institutions).My signature below certifies that I am knowledgeable about the regulations and policies governing research with human subjects and have sufficient training and experience to conduct this particular study in accordance with the research protocol.NSG 6101 Week 9 Informed Consent Letter Paper.Principal InvestigatorDate (mm/dd/yyyy)Co-InvestigatorDate (mm/dd/yyyy)Faculty SponsorDate (mm/dd/yyyy)2) Confidentiality Agreement· I have agreed to assist with the research project described in this application.· I agree not to discuss or disclose any of the content or personal information contained within the data, tapes, transcriptions, or other research records with anyone other than the Principal Investigator, Co-Investigator, or in the context of the research team.· I agree to maintain confidentiality at all times and to abide by the South University IRB Policy and Procedures Manual.· If I am aware of any breach in confidentiality, I am required to report violations of confidentiality to the IRB Committee Director, who will report this information to the College Dean and the Vice Chancellor of Academic Affairs.Principal InvestigatorDate (mm/dd/yyyy)Co-InvestigatorDate (mm/dd/yyyy)Faculty SponsorDate (mm/dd/yyyy)Student InvestigatorDate (mm/dd/yyyy)Student InvestigatorDate (mm/dd/yyyy)Student InvestigatorDate (mm/dd/yyyy) PART V – ADMINISTRATIVE DATA 1) Proposed duration of data collection/analysisStart date:       End date:      ***South University IRB policy dictates that project approvals may be granted for a maximum of one year, although the exact approval term will be determined based on the level of participant risk inherent in the proposal. Should the PIs need an extension beyond the proposed duration, they can apply by completing the Continuance Request Form.NSG 6101 Week 9 Informed Consent Letter Paper.2) If this research will result in a thesis or dissertation, please check the appropriate box.FORMCHECKBOX Undergraduate Level Project FORMCHECKBOX Masters Level Project FORMCHECKBOX Doctoral Level Project(Thesis, Capstone) (Thesis, Capstone) (Dissertation, Capstone)3) Conflict of InterestIs there any potential or perceived conflict of interest between the researcher, sponsor and/or South University associated with this study? No FORMCHECKBOX Yes FORMCHECKBOX***If yes, please explain, including any and all possible conflicts:   4) Study populationa. Maximum Number of Participants Proposed:      b. Age Range:       to       (include low/high age range)c. Gender: FORMCHECKBOX Males FORMCHECKBOX Femalesd. Site of Subject Recruitment:***Please note that if recruitment will be conducted at any physical site other than South University, you will need to include a letter from management of the proposed site indicating their approval of your use of the facility.e. Will medical clearance or medical screening be necessary for participants to participate because of tissue or blood sampling, administration of substances such as food or drugs, or physical exercise conditioning?No FORMCHECKBOX Yes FORMCHECKBOX***If yes, explain how clearance will be obtained. If a screening instrument will be used, please attach a copy to the application.   NSG 6101 Week 9 Informed Consent Letter Paper.5) Potentially Vulnerable Populations. Please check any groups included in the study.FORMCHECKBOX Children (under 18 years of age)FORMCHECKBOX Pregnant WomenFORMCHECKBOX Elderly (65 & older)FORMCHECKBOX Psychologically ImpairedFORMCHECKBOX Cognitively ImpairedFORMCHECKBOX PrisonersFORMCHECKBOX Native American Tribes and/or Tribal OrganizationsFORMCHECKBOX Students currently enrolled in a class instructed by the investigator*** If you checked any of the above groups, your proposal will require full board review. 6) Study Site:***Please note that if research will be conducted at any physical site other than South University, you will need to include a letter from management of the proposed site indicating their approval of your use of the facility. PART VI – SUMMARY OF STUDY ACTIVITIES ***Submission of a copy of a grant application or project proposal does not replace completion of this form. If additional space is required, you may attach a separate document, but please respond to each item in this section and label your responses accordingly. Incomplete proposals will be returned to you. 1) Provide background information for the study including the objective of the proposed research, purpose, research question, hypothesis and other information deemed relevant.  NSG 6101 Week 9 Informed Consent Letter Paper.2) Describe the research design of the study (i.e., state whether the study is correlational, experimental, etc. and define the variables).  3) Describe the tasks that participants will be asked to perform including a step‑by‑step description of the procedures you plan to use with your subjects. Provide the approximate duration of subject participation for each procedure/ instrument and the frequency and setting of each administration. Identify any personnel who will assist with data collection.***You must submit a copy of each study instrument, including all questionnaires, surveys, protocols for interviews, etc.***If someone will be assisting with data collection, but is not indicated as a co-investigator or research assistant in this application (i.e. they will be accessing archival data for you) you must submit a letter of approval indicating that they are willing and capable to assist.NSG 6101 Week 9 Informed Consent Letter Paper.  4) Describe the recruitment procedures. Explain who will approach potential participants and take part in the research study and what will be done to protect the individual’s privacy in this process.***You must submit a copy of any material used to recruit subjects (e.g., informed consent forms, advertisement, flyers, telephone scripts, verbal recruitment scripts, cover letters, etc.)   5) Describe how participants will be debriefed.***If deception is used, the principal investigator should offer the participant the opportunity to withdraw his/her data after being debriefed, and this information should be included in the debriefing script.   PART VII – PRIVACY PROCEDURES 1) Will data be recorded by audiotape? No FORMCHECKBOX Yes FORMCHECKBOXWill data be recorded by videotape? No FORMCHECKBOX Yes FORMCHECKBOXWill photographs be taken? No FORMCHECKBOX Yes FORMCHECKBOXa. How will subjects be identified in these recordings?  b. Explain your plan for disposal of tapes/photographs/negatives, including when this disposal will occur (i.e. after transcription/development or at the conclusion of the study).***If you wish to retain the tapes/photographs/negatives beyond transcription/development, you must provide justification. ***Subjects must be informed of the collection and disposal of the tapes/photographs/negatives via the informed consent process.   2) Will you record any direct identifiers (e.g.,, names, social security numbers, addresses, telephone numbers, etc)? No FORMCHECKBOX Yes FORMCHECKBOXa. Explain why it is necessary to record these identifiers.  b. Describe the coding system you will use to protect against disclosure of these identifiers.  c. Describe how subject identifiers will be maintained or destroyed after the study is completed.***If you will retain a link between the study code numbers and direct identifiers after the data collection is complete, explain why this is necessary and state how long you will keep this link.  d. Will you provide a link or identifier to anyone outside the research team? No FORMCHECKBOX Yes FORMCHECKBOX***If yes, explain why and to whom.  NSG 6101 Week 9 Informed Consent Letter Paper.3) Where, how long, and in what format (such as paper, digital or electronic media, video, audio or photographic) will data be kept? In addition, describe what security provisions will be taken to protect these data (password protection, encryption, etc).  4) Will you place a copy of the consent form or other research study information in the participant’s record such as medical, personal or educational record? No FORMCHECKBOX Yes FORMCHECKBOX***If yes, explain why this is necessary. ***This information should be clearly explained in the consent document and/or process.   5) Will any record of the subject’s participation in this study be made available to his or her supervisor, teacher, or employer? No FORMCHECKBOX Yes FORMCHECKBOX***If yes, please explain why this is necessary .   6) Will you obtain a Federal Certificate of Confidentiality for this research? No FORMCHECKBOX Yes FORMCHECKBOX***If yes, submit documentation of application (and a copy of the Certificate of Confidentiality award if granted) with this application form. If the data collected contain information about illegal behavior, visit the NIH Certificates of Confidentiality Kiosk http://grants1.nih.gov/grants/policy/coc for information about obtaining a Federal Certificate of Confidentiality. PART VIII – INFORMED CONSENT INFORMATION 1) Informed Consent: Please attach, as an appendix, an informed consent document to this application. South University IRB requires that all activity involving human subjects be carried out only AFTER obtaining proper consent from the participants of the research. Thus an information sheet or cover letter that contains all required elements of informed consent must be attached to this application. You may access a template for this form on the South University IRB website. (Please attach an assent form for children/youth participation and permission forms for parents/legal guardians; or consent forms for adult participation).2) Request for Waiver of Informed Consent: Are you requesting a waiver of informed consent?NSG 6101 Week 9 Informed Consent Letter Paper.No FORMCHECKBOX Yes FORMCHECKBOX***If yes, provide a written justification for a waiver of informed consent according to Section 46.116 of 45 CFR 46 ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116 ).  3) Request for Waiver of Documentation of Consent (applies to studies that do not wish to have signatures of the participants, i.e. internet research): Are you requesting a waiver of documentation of consent?No FORMCHECKBOX Yes FORMCHECKBOX***If yes, provide a written justification for a waiver of documentation of consent according to Section 46.117 of 45 CFR 46 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117).   PART IX – RISKS AND BENEFITS 1) Does the research involve any of the possible risks or harms to subjects listed below?No FORMCHECKBOX Yes FORMCHECKBOX***If Yes, independent scientific review may be required to determine if scientific merit justifies this risk. Check all that apply: FORMCHECKBOX Use of deception***If deception is used, describe in detail here, including the debriefing process and script. ***If deception is used, the principal investigator should offer the participant the opportunity to withdraw his/her data after being debriefed, and this information should be included in the debriefing script.   FORMCHECKBOX Use of confidential records (e.g. educational or medical records)FORMCHECKBOX Manipulation of psychological or social variables such as sensory deprivation, social isolation, psychological stressorsFORMCHECKBOX Presentation of materials which subjects might consider sensitive, offensive,threatening or degradingFORMCHECKBOX Possible invasion of privacy of subject or familyFORMCHECKBOX Social, legal, or economic riskFORMCHECKBOX Employment/occupational riskFORMCHECKBOX Students of the researcherFORMCHECKBOX Subordinates and colleagues of the researcherFORMCHECKBOX Residents of any facility (i.e., prison)NSG 6101 Week 9 Informed Consent Letter Paper.FORMCHECKBOX Pregnant womenFORMCHECKBOX Children and minorsFORMCHECKBOX Elderly subjects (65+ years of age)FORMCHECKBOX Wards of the stateFORMCHECKBOX Mentally and emotionally disabilityFORMCHECKBOX Individuals who are not fluent in EnglishFORMCHECKBOX Other risks (specify):    2) Describe the nature and degree of the risk or harm checked above.***The described risks/harms must be disclosed in the consent form.   3) Explain what steps will be taken to minimize risks or harms and to protect subjects’ welfare. If the research include protected populations (See Part V, Item 5 above), please identify each group and answer this question for each group.  4) Describe the anticipated benefits of this research for individual participants in each subject group. If none, state “none”.  5) Describe the anticipated benefits of this research for society, and explain how the benefits outweigh the risks.    PART X – COMPENSATION INFORMATION 1) Will any compensation or inducements, i.e. course credit, be offered to the subjects for their participation? No FORMCHECKBOX Yes FORMCHECKBOXIf yes, describe those inducements and include a statement in the informed consent document explaining how compensation will be handled in the event the participant withdraws from the study. NSG 6101 Week 9 Informed Consent Letter Paper. ***If yes, describe those inducements.***The informed consent document must include a statement explaining how compensation will be handled in the event that the participant withdraws from the study.   Appendix A: Student as Principal Investigator WorksheetLevel: FORMCHECKBOX Masters FORMCHECKBOX Doctorate This project has been reviewed to determine that the scope, anticipated risks and benefits, and methodology are appropriate for this research by: FORMCHECKBOX Approval of thesis/dissertation proposal by faculty committeeFORMCHECKBOX My personal review and approval of research proposal FORMCHECKBOX Other:      The student researcher is qualified to conduct independent research based on the following credentials (check all that apply):FORMCHECKBOX has completed a graduate research methods courseFORMCHECKBOX has experience as an independent or closely supervised research assistant FORMCHECKBOX has completed NIH training FORMCHECKBOX Other:      FACULTY SPONSOR’S ASSURANCE By my signature as sponsor on this research application, I certify that the student is knowledgeable about the regulations and policies governing research with human subjects and has sufficient training and experience to conduct this particular study in accordance with the research protocol. Additionally,· I hereby confirm that I have thoroughly reviewed this IRB application, including the protocol narrative, and deem it ready for submission.NSG 6101 Week 9 Informed Consent Letter Paper.· I agree to meet with the investigator on a regular basis to monitor study progress.· I agree to be available, personally, to assist the investigator in solving problems, should they arise during the course of the study.· I assure that the investigator will promptly report unanticipated problems and will adhere to all requirements for continuing review.· If I am unavailable, e.g. sabbatical leave, vacation, or resignation, I will arrange for an alternate faculty sponsor to assume responsibility during my absence, and I will advise the South University IRB, in writing, of such changes.· The research is appropriate in design.Print Faculty Sponsor NameFaculty Sponsor Signature       Date (mm/dd/yyyy)Print PI NamePI Signature     Date (mm/dd/yyyy)PAGEIntroductionImmunization 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 Paper.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 Paper.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 Paper.Statement of problemThere 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.ObjectivesThe objectives of this research include:a.) To determine the reason why some people still do not want their children to undergo immunization.b.) To not only understand the political problems but also the economic and philosophical difficulties the unimmunized children undergo later in life.c.) To clearly understand the importance and benefits of parents ensuring their children are immunizedNull hypothesisa.) There are no reasons to explain why some people still do not want their children to undergo immunization.b.) The political, economic and philosophical difficulties faced by unimmunized children undergo later in life cannot be understood.NSG 6101 Week 9 Informed Consent Letter Paper.c.) The importance and benefits of parents ensuring their children are immunized cannot be clearly understood.Research Questionsa.) How important is immunizationb.) What are the repercussions of escaping the immunization process to an individual?Theoretical frameworkResearch 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.Literature ReviewImmunizations 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 Paper.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 Paper.NigeriaNigeria 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. 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 Paper.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. 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 Paper.IndiaApproximately 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. 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 Paper.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 Paper.SwitzerlandUnlike 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 Paper.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 Paper.MethodologyResearch designThe 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.Research contextThe 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 Paper.ProcedureParticipantsThe 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 Paper.MaterialsQuestionnaires 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.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 collectionSeveral 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 Paper.Methods of data analysisSTATA 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)NSG 6101 Week 9 Informed Consent Letter Paper.. One can develop some regression analysis between variables while using STATA thus making it quite useful in the analysis of dataEthical ConsiderationsThe questionnaire should provide for confidentiality and protection of the participant’s identity.The researchers should also get the necessary approval from the University’s ethics board before carrying out the researchThey should also get written consent from the participants to avoid future legal issues.The significance of the proposed researchThe 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 Paper.Research limitationsThis 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 Paper.   ReferencesBurroway, 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.Khan, J., Shil, A., & Prakash, R. (2018). Exploring the spatial heterogeneity in different doses of vaccination coverage in India. PloS one, 13(11), e0207209.NSG 6101 Week 9 Informed Consent Letter Paper.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.Oku, A., Oyo-Ita, A., Glenton, C., Fretheim, A., Ames, H., Muloliwa, A., … & Bosch-Capblanch, X. (2016). Communication strategies to promote the uptake of childhood vaccination in Nigeria: a systematic map. Global health action, 9(1), 30337.NSG 6101 Week 9 Informed Consent Letter Paper.Peyre, M., Samaha, H., Makonnen, Y. J., Saad, A., Abd-Elnabi, A., Galal, S., … & Domenech, J. (2009). Avian influenza vaccination in Egypt: limitations of the current strategy. Journal of molecular and genetic medicine: an international journal of biomedical research, 3(2), 198.NSG 6101 Week 9 Informed Consent Letter Paper.Prinja, S., Monga, D., Rana, S. K., Sharma, A., Dalpath, S., Bahuguna, P., … & Aggarwal, A. K. (2018). District level analysis of routine immunization in Haryana State: Implications for mission indradhanush under universal immunization programme. Indian journal of community medicine: official publication of Indian Association of Preventive & Social Medicine, 43(3), 209.Russell, D. G., & Alexander, J. (1988). Effective immunization against cutaneous leishmaniasis with defined membrane antigens reconstituted into liposomes. The Journal of Immunology, 140(4), 1274-1279.VanderEnde, K., Gacic-Dobo, M., Diallo, M. S., Conklin, L. M., & Wallace, A. S. (2018). Global Routine Vaccination Coverage—2017. Morbidity and Mortality Weekly Report, 67(45), 1261. NSG 6101 Week 9 Informed Consent Letter Paper.

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