Ethical Issues in Research and Methodology Section of a Research Proposal

Part 1
The purpose of this part of assignment is to increase awareness of the ethical issues related to research. There are multiple ethical principles that must be considered when conduction a research study. In this assignment participant. protection is primary to understand. This goes beyond HIPPA as HIPPA related to patient medical issues and medical record privacy. A research proposal requires multiple other issues of privacy.

1.   Write a 2 – 4-pages that includes the following:

a.   Explanation of the informed consent process for your research proposal. Even if your proposal qualifies for expedited review, you still must address informed consent specifically for your proposal.

b.   Description of how you will protect participant privacy. HIPPA is insufficient for a research proposal. Address protection of data and confidentiality

c.   Review of the IRB process for your proposal.

d.   The risk benefit ratio for the participant in your proposed study.

Part 2
The purpose of this part of assignment is to develop your understanding of how the process portion of a research proposal is constructed. In this assignment you will focus on the following elements: study setting, sampling, and data collection. For the study setting, a description of where the study will take place. This description will need to be very specific. The sampling and data collection sections should be congruent with the research design that was chosen and explained in the research design section.

Instructions
1.   This section of paper includes 
a.   Study setting 
b.   Sampling processes and procedures 
c.   Data collection
2.   Write a 3 – 5-pages

Study Setting 
Describe where the study will take place, i. e., institution, geographical location, population, etc. For example, if your study setting is a unit in the hospital, you would briefly describe the institution, patient population, acuity level, and so on.  Avoid use of proper names when discussing setting or specific information that would allow identification of the identity of participants. Sample and Sampling Procedure Describe what kind of sample will be obtained with the sampling procedure. How will you obtain subjects including how you plan to access subjects, the projected number of participants needed for the study and the sample type (convenience, cluster probability etc.). Do you need a power analysis? Inclusion/exclusion criteria must be addressed as well. What criteria subjects must meet in order considered to be included in the study. For example, should the participants be nurses with 2 years or less experience between the ages of 22 – 30, or those patients who have had coronary bypass surgery in the ICU? The exclusion criteria would be nurses who did not fit those parameters or patients in the ICU who did not have coronary bypass surgery. You determine the inclusion/exclusion criteria for your study based on the research question and design. For a qualitative study, describe how you will recruit participants. For example, will you use snowball technique, or focus groups?

Methodology Section of a Research Proposal

Data Collection
The data you propose to collect is the information you need to answer your research question or to test/support your research hypothesis. Provide a description of the type of measurement data you will be using. The variables in the study need to be measured. The type of measure is determined in part by the type of study (qualitative vs quantitative) How you will measure your variables? Are you proposing to study depression in children? There are number of scales or measures of depression such as the Beck Depression Inventory. This is a quantitative measure. If you use a scale or questionnaire include a copy in the appendix if possible. Some scales require purchase. You are not required to purchase a scale. You will need to provide the link for the scale in the paper. You could also develop your own scale. If so, this would need to be included in the appendix. However, for most research proposals for this class, measures that is already developed and testes is usually best. The last issue related to measurement is reliability and validity. Are these addressed with the scale you are using? You would not have a questionnaire or scale in a qualitative study. But you must describe how you will be collecting data. Will this be done in focus groups, one to one interviews or observation. This will need to be explicit. You will not identify variables in a qualitative study. How will you collect the data? Discuss methods and your procedures for collecting data. For example, if you plan to send out a mailed questionnaire, will you include a self-addressed stamped envelope? How much time will you allow subjects to respond?  If you are using patients what is the procedure for collecting data from them? This is especially true if you are using biological measures such as blood pressure, weights, lab information (blood sugar, A1C,) etc. 

Part 3
This assignment continues the development of the methodology section of the research proposal.  The analysis of data will be dependent on the type of data you are collecting. A decision matrix is present in your reading. The data analysis description should be specific and detailed. The last sections are based on this assignment and the past assignments. The “anticipated results” is your assessment of what you think the data will show you. This is speculation on your part. Then you will analysis the strength and weaknesses of your study. The final step is to propose what future research should be done.

Study Setting

Instructions
1.   This part of paper includes:
 a.   Data analysis, 
b.   Anticipated results (based on previous research and own clinical knowledge). Since this study is only a proposal and will not be done, a reasoned outcome should be provided. It is acknowledged that this proposed outcome may be in error or faulty.
c.   Strengths and weaknesses of the proposed study
d.   Suggestions for future research

2.   Write a 3 – 5-page paper, excluding the title and reference pages, 3 Include a minimum of 2 – 3 scholarly references 

Data Analysis
In this section you will describe how you will analyze the data. This information needs to be very specific. It is insufficient to just describe the statistical software package you will be using like SPSS. The analysis of data includes description of (a) preparation of the data for analysis, (b) description of the sample, (c) testing the reliability of the measurement (d) level of significance. In addition, quantitative data always uses descriptive statistics (analysis of the sample) as well as analysis of variables.  A rationale should be provided to support the choice of statistical analysis.  A full description of the statistical procedures that are used to analyze the variables to be done should be given. If you have chosen to do a qualitative proposal, a full description of how you would analyze this data should be done. Qualitative data does not use inferential statistics. The analysis of data would also include description of (a) preparation of the data for analysis, (b) description of the sample as well as a full analysis of the data itself. 

Anticipated Results Based on previous research and your clinical experience, what would be the possible anticipated result of the study if it were done?  Try to be as specific as possible based on the research question, relationship between variables, and the statistical analysis.  What would be your rationale for this outcome? As previously stated, “Since this study is only a proposal and will not be done, a reasoned outcome should be provided. It is acknowledged that this proposed outcome may be in error or faulty.” 

Strengths and Weaknesses
Discuss the strengths and weaknesses of your proposed study. Review your research question and literature. Consider your sampling procedure, sample, sample size, type of research design, extraneous variables, data collection tool used, etc. Also discuss external validity (generalizability) of your proposed study. 

Suggestions for Further Research 
What would be the next steps in the research of this topic or these variables. Is there a new direction the research should go? Should there be replication studies? Where does the research go from here? 

Part 4
1.   This paper includes:
a.   The research question and design.
b.   The Literature Review.

You will need to take the information from the literature review matrix and convert it to a narrative format. This should be a cohesive and organized flow of information. Your references must be integrated throughout the body of your review, not listed independently like an annotated bibliography. Instead, they must flow in a way that supports your research question by providing the research findings of other scientists and building your case for the study you are proposing. There must be very few instances of copying and pasting large quotes from your sources. Instead, you must articulate the findings accurately using your own words. Make sure you cite your sources appropriately. The literature review section needs to end with a summary paragraph that leads into your proposed research question or hypothesis. For example, “In light of the studies reviewed, there is a need to conduct further studies that...” would serve as a good start to a summary paragraph.