Topic for capstone
patients with a serious mental illness (SMI) hospitalized in inpatient psychiatric hospitals are a challenging safety problem. Early identification of aggressive behaviors is vital to helping nursing staff develop proactive interventions that focus on prevention. Structured risk assessments identify the level of risk and allow for early interventions.
The purpose of the doctoral capstone project was to: (a) provide education to nursing staff on implementing a structured risk assessment tool in order to identify risk for imminent aggression, manage risk for imminent aggressive behaviors
Write a 6-8 page double-spaced paper with an additional template in which you analyze potential ethical considerations that may arise from your doctoral project. Determine strategies to address these ethical considerations.
Introduction
Ethical researchers act in honest ways. Ethics are conduct norms or standards that distinguish between right and wrong and acceptable and unacceptable behaviors. Ethical considerations matter because they guard against the fabrication or falsification of data. They promote the pursuit of knowledge and truth, research’s primary goal. Ethical behavior is also crucial for collaborative work because it encourages an environment of trust, accountability, and mutual respect among team members. Likewise, researchers must adhere to ethical standards for the public to support and believe in the research. Although most quality improvement and evidence based practice projects pose minimal risk to human subjects, an IRB screening process for your capstone project is required to ensure the project is meeting the appropriate ethical standards.
The Nuremberg Code (1947) protects human rights and is the leading code for conducting ethical research. It focuses on:
Voluntary informed consent.
Freedom to withdraw from research.
Protection from physical and mental harm.
Protection from suffering and death.
It also emphasizes the risk-benefit balance of conducting research. The Declaration of Helsinki (1964) underscored the importance of protecting subjects in research and strongly proclaimed that individuals’ well-being takes precedence over scientific and social interests.
Good research is well planned, appropriately designed, and ethically approved. Developing and following a research protocol helps to ensure this. Research needs to seek to answer specific questions rather than just collect data. Researchers must obtain approval from the Institutional Review Board or Ethics Committee. Researchers also need to pay special attention to vulnerable subjects to avoid breech of ethical codes. Although most quality improvement and evidence based practice projects pose minimal risk to human subjects, an IRB screening process for your capstone project is required to ensure the project is meeting the appropriate ethical standards.
The major ethical issues in conducting research usually involve:
Informed consent.
Beneficence—do no harm.
Respect for anonymity and confidentiality.
Respect for privacy.
You are responsible to ensure your project is conducted ethically and responsibly from planning to publication. Be familiar with ethical principles and follow them strictly. Discuss openly with the project team any potential ethical issues. If in doubt, consult the Institutional Review Board (IRB) for expert opinion and direction.
In this assessment, you will apply what you have learned from the CITI training and from your independent research on ethics to your doctoral project. In a 6- to 8-page paper plus a template, you will identify ethical considerations that may arise as part of your doctoral project. You will also identify strategies to address these ethical considerations.
Reference
World Medical Association General Assembly (2004). World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. International Journal of Bioethics, 15(1), 124–9.
Demonstration of Proficiency
By successfully completing this assessment, you will demonstrate your proficiency in the course competencies through the following assessment scoring guide criteria:
Competency 2: Apply strategies to maintain a climate of mutual respect and shared values.
Apply historical ethical principles to analyze potential ethical concerns related to your doctoral project.
Determine vulnerability or possible concerns for identified project participants.
Create strategies to address potential ethical risks related to the doctoral project.
Describe the IRB processes to be completed prior to starting the data collection process.
Describe possible future changes to your doctoral project that would require IRB approval and the process to follow to obtain this approval.
Competency 4: Address assessment purpose in a well-organized text, incorporating appropriate evidence and tone in grammatically sound sentences.
Create a clear, well-organized, succinct, professional ethics analysis paper that uses appropriate tone and is generally free from errors in grammar, punctuation, and spelling.
Integrate relevant sources to support arguments, correctly formatting citations and references using APA style.
Preparation
To successfully prepare for this assessment, you will need to conduct independent research on ethics related to research studies. You will be asked to supply a minimum of five references in your ethics analysis paper over and above those provided under suggested resources.
Rather than researching the importance of ethical practice (which of course is very important), focus your research efforts on other research studies that have been conducted that are similar to your proposed research. For example:
Can you locate other studies that took place in a setting similar to yours?
What other studies exist that used participants similar to yours?
What studies can you find that address a problem similar to yours?
Do other studies exist that used research tools similar to yours, such as surveys, questionnaires, health behavior models, performance improvement plans, et cetera?
Examine current resources available through peer-reviewed articles and professional and government websites. These guides can help you identify scholarly and authoritative sources:
Instructions
For this assessment, you will write a 6- to 8-page ethics analysis paper. Include the following headings in your paper and be sure to address the bullets underneath each heading:
Introduction
In brief, what is your project about?
Who are the major stakeholders involved?
History of Research Ethics
What are the major principles in the history of research ethics?
How do autonomy, beneficence, malfeasance, and distributive justice specifically apply to your project?
Human Subjects/Participants
What human subjects/participants, if any, will be part of your project?
What are the exclusion and inclusion criteria for any people who are part of your study?
Potential Ethical Risks and Action Plans Template
As a researcher, you must take steps to minimize potential risks. Potential risks fall into these five categories: physical, psychological, socio-economic, loss of confidentiality, and legal. Weighing the potential risks of research against the potential benefits are part of the IRB review process.
Complete the following tables to determine any ethical risks your research study may pose to participants. For all ‘yes’ answers, determine strategies to minimize the potential risk. Be sure to remove all bolded, italicized instructional text before submitting your template.
Table 1. Physical Risks
Physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research.
Ethical Risk Type
Yes
No
Strategy(ies) to Minimize Risk
Does your research involve physical stimuli, such as noise, electric shock, heat, cold, electric magnetic or gravitational fields?
[Describe the specific physical stimuli involved.]
Does your research involve engaging a subject in a social situation which could involve violence?
[Provide specifics.]
Does your research involve other physical risks to study participants?
[Specify these risks below. Add table rows as needed.]
[Other risk]
[Other risk]
[Other risk]
Table 2. Psychological Risks
The production of negative affective states, such as anxiety, depression, guilt, shock, loss of self-esteem, and altered behavior.
Ethical Risk Type
Yes
No
Strategy(ies) to Minimize Risk
Does your research result in negative affective states for study participants? Consider anxiety, depression, guilt, shock, and altered behavior.
[Describe the specific negative affective state(s) involved.]
Does your study involve sensory or sleep deprivation, use of hypnosis, deception, or mental stresses?
[Provide specifics.]
Does your research involve other psychological risks to study participants?
[Specify these risks below. Add table rows as needed.]
[Other risk]
[Other risk]
[Other risk]
Table 3. Socio-Economic Risks
Alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling a subject in a way that will have negative consequences, or in some way diminish those opportunities and powers a person has by virtue of relationships with others. Economic risks involve negative financial outcomes for study participants.
Ethical Risk Type
Yes
No
Strategy(ies) to Minimize Risk
Does your study result in subjects experiencing alterations in their relationships with others that are to the disadvantage of the subject? These alterations may include embarrassment, loss of respect of others, labeling a subject in that will have negative consequences, or in some way diminish those opportunities and powers a person has by virtue of relationships with others.
[Describe the specific detrimental relationship alterations involved.]
Does your research involve payments by subjects for procedures that are not otherwise necessary?
[Provide specifics.]
Does your research result in subjects losing wages or other income?
[Provide specifics.]
Does your research result in other financial costs for subjects, such as damage to the subject’s employability due to project participation?
[Please specify.]
Does your study pose other socio-economic risks to study participants?
[Specify these risks below. Add table rows as needed.]
[Other risk]
[Other risk]
Table 4. Loss of Confidentiality Risks
Negative consequences that result from an invasion of privacy or breach of confidentiality. Confidentiality of identifiable information is presumed and must be maintained in research involving human subjects, unless the researcher has obtained subjects’ express permission to do otherwise. Subjects have the right to be protected against injury or illegal invasions of their privacy and to preservation of their personal dignity. The more sensitive the research material, the greater the care researchers must exercise in obtaining, handling, and storing data.
Ethical Risk Type
Yes
No
Strategy(ies) to Minimize Risk
Does your study collect personal information from subjects that is not essential to the research?
[Specify what non-essential personal information was obtained and why.]
Do others besides the researcher and other authorized staff have access to personal data about study participants?
[Specify who has access to this data and why. Also specify what personal data others besides the researcher and other authorized staff have access to.]
Have the identities of individual subjects been released without the express consent of these subjects?
[Specify the circumstances of this release of information.]
Has the study used the data it collected for other purposes without obtaining subjects’ consent for the data’s new use?
[Explain why the subjects’ consent was not obtained.]
Does your study pose other loss of confidentiality risks to study participants?
[Specify these risks below. Add table rows as needed.]
[Other risk]
[Other risk]
[Other risk]
Table 5. Legal Risks
Research methods result in study subjects or others being liable for violations of the law.
Ethical Risk Type
Yes
No
Strategy(ies) to Minimize Risk
Does your study reveal that subjects or others have or will engage in conduct for which they may be criminally or civilly liable?
[Provide the specifics involved.]
Does your study require subjects or others to engage in activities for which they may be criminally or civilly liable?
[Provide specifics.]
Does your study pose other legal risks to study participants or others?
[Specify these risks below. Add table rows as needed.]
[Other risk]
[Other risk]
[Other risk]
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