Ethical Approval for Post-Graduates - Essay Example

College Ethics Panel Ethical Approval Form for Post-Graduates 1a. of proposed research project Acute Pain for Postoperative Patients in Kuwait: A Study of How Surgical Nurses Assess Postoperative Pain 1b. Is this Project Purely literature based? NO 2. Project focus No research has been conducted on the status of pain assessment by nurses in the hospital setting in Kuwait .Hence; The aim of this study is to explore the surgical nurses’ approaches to pain assessment for post-operative patients in a Kuwait hospital setting and to discover how nurses know that their patients are in pain. his study will explore the surgical nurses assessment of the postoperative patients with the patients recorded experience of pain. Any difference or conflict between the patients experience and nurses assessment of the pain will be used to help formulate a better pain assessment strategy. 3. Project objectives To explore nurse’s knowledge of pain assessment; To analyse the perceptions of nurses and patients of pain assessment in a Kuwait medical surgical setting; To identify potential factors that could affect how the patients respond to post-operative pain. 4. Research strategy (For example, outline of research methodology, what information/data collection strategies will you use, where will you recruit participants and what approach you intend to take to the analysis of information / data generated) Due to the subjectivity of pain experience a qualitative method will be used for this study, which seeks to provide a perception of how or why things are as they are. Data will be collected through a face-to-face semi-structured interview of nurses and patients. This is only fitting considering that Hancock (1998) relates that data collection in a qualitative research involves direct encounters with individuals through one to one interviews. In-depth interview allows intensive exploration of a topic with someone who has had related experiences. Open-ended questions will be used during the interview. This is in contrast with close-ended questions which may limit further exploration of the participants’ experiences. Purposive sampling will be used in this study. Typically the recommended sample for grounded theory is about 20 to 30 participants (Polit & Beck, 2006). Determining the sample size depends on the quality and richness of the data. This research will aim to involve 20 nurses and 20 patients. Recruitment Once College ethical approval is gained, the researcher will send a formal letter to the hospital administration in Kuwait and to the surgical unit supervisor or manager requesting permission to recruit patients and staff from the hospital. Once the approval is gained the researcher will then proceed to place a notice/poster in the surgical ward which will invite volunteers from among surgical nurses and patients who are willing to take part in the research or those who are readily available to become participants of the research. There is no ethical committee in the Kuwait hospital; therefore organisational approval will be gained from the Manager. Phase one: interviewing the nurses The research will involve registered nurses who work in surgical units. Only those nurses who are currently assigned in the surgical unit of the Kuwait Hospital will be eligible to participate in the study. The questions for nurses covers main areas of interest such as how one is to know when patients are in pain, the parameters or cues that the patients are to use to signal that they are in pain, the most common reactions of patients towards pain, how to assess the pain, and find out if all patients complain about their pain. Phase two: Interviewing the Patients The research will involve post-operative patients in surgical units. All patients are eligible to participate in the study but this will be limited to those patients who have fully recovered from the general anaesthetic. The aim of interviewing the patients is to solicit their views and opinions about their experience of post-operative pain. Ultimately, the researcher seeks to understand the feelings, attitudes and influences related to the pain and the assessment of pain. All participants will be over 18 years old and patient under 18 will be excluded. As in any research, it is often significant to first establish a clear schedule to the participants. Hence, Head nurse has to be informed earlier so that the head nurse can arrange a suitable time and place to allow the nurses and patients to participate in the research. Upon the approval, the interviews will take place during the morning shift in the surgical units office. Because interviews should be conducted in areas free from distractions and at times and locations that are most suitable for participants. The length of interviews varies depending on the researcher and participant. However, on average interviews last 20-45 minutes. Timeline: 01/2013 – 02/2013 Ethical approval from Salford University applied for and awaited. Meet with the hospital director and the head nurse of the surgical units and explain the study purpose and the methods which are going to be used to conduct the research to gain permission to do study. 3/2013- 6/2013 Subject to gaining ethical approval, nurse interviews will be conducted as well as patients’ interviews of pain assessment. The data collection and analysis of data will commence. 6-9/2013 Data analysis will be completed and research findings written up for peer-review. The data from the qualitative interviews will be analysed using Strauss and Corbin’s (1998) approach. This involves three types of coding: open, axial and selective coding (p.217). Open coding relies on the comparison of the differences and similarities. It tags portions of data depending on their content (Strauss and Corbin, 1998, p.217). In axial coding, the researcher sub-categorizes the data under broader headings by seeking the relationship between the codes (Strauss and Corbin, 1998, p.217). Selective coding focuses on incorporating and filtering the findings (Strauss and Corbin, 1998, p.217). It concentrates its attention on just the core codes, which are the codes emerged from open and axial coding (Strauss and Corbin, 1998, p.217). Other groups may come to light during analysis such as grouping nurse participants’ responses by their number of years in service as nurse. Ultimately, this analytic process will enable categories to emerge from the data which may be used later to develop understanding about the assessment and management of pain. 5. What is the rationale which led to this project? (For example, previous work – give references where appropriate. Any seminal works must be cited) Suboptimal pain management can lead to the development of harmful effects including worsening of pain that impairs the patient’s quality of life and social determinants (for example, affecting relationships and employment capacity); continuous pain leading to depression, anxiety and suicidal tendencies; and, constant pain that prolongs the body’s stress responses which can at times lead to health complications (such as suppressed immune functions, increased cardiac risk, increased susceptibility to hormonal imbalance) (Wells, Pasero & McCaffery, 2008; Pasero, 2009; Wood, 2010; Marmo & Fowler, 2010). It is proposed that pain assessment is difficult and it is affected by a number of variables (for instance, knowledge of pain cues, consistent tools for pain assessment, and competency in pain assessment) that the nursing practice needs to understand the process more fully to be able to progress practice going forward. It becomes problematic since pain is subjective and all the other aspects that influence pain assessment are varied such as age, gender, medications, previous pain, culture, and so on (Carr et al., 2010; Khan et al., 2011), Therefore, appropriate assessment and management of pain are essential for good nursing practice to improve their health outcomes (Brunner et al., 2009; Carr et al., 2010). No research has been conducted on the status of pain assessment by nurses in the hospital setting in Kuwait. This research proposes a grounded theory approach which will allow for an exploration of pain assessment strategies undertaken by nurses in a Kuwait hospital setting. The theory that will emerge from this research will provide a great understanding of the standard of pain assessment in Kuwait and how to improve such a standard. 6. If you are going to work within a particular organisation do they have their own procedures for gaining ethical approval (For example, within a hospital or health centre) NO If YES – what are these and how will you ensure you meet their requirements? There is no formal ethical approval process required in Kuwait hospitals. However the researcher seek an authorization from the hospital administration and to the surgical unit 7. Are you going to approach individuals to be involved in your research? YES If YES – please think about key issues – for example, how you will recruit people? How you will deal with issues of confidentiality / anonymity? Then make notes that cover the key issues linked to your study Purposive sampling will be used in this study. The research will involve nurses who work in surgical units and patients in the surgical units. Only those nurses who are currently assigned in the surgical unit of the Kuwait Hospital become eligible to participate in the study. Only registered nurses will be included. Doctors, midwives, pharmacists, nursing aides or nursing students will not be allowed to form part of the sample population. Once the approval is attained, the researchers will then proceed to place a notice/poster in the surgical ward which will invite volunteers from among surgical nurses and patients who are willing to take part in the research or those who are readily available to become participants of the research. 8. More specifically, how will you ensure you gain informed consent from anyone involved in the study? Informed consent will be an on-going process rather than a single detached event (NMC 2010). In nursing care, consent is the legal means by which a patient gives a valid authorisation for treatment and care (Caulfield 2005). This NMC declaration can be applied in this case by ensuring that the semi-formal teaching prior to the actual interview as well as the interview it are done in a professional and respectful manner. This is logical because nurses must not expect that the participant is well versed in nursing research. A full and detailed participant information sheet will be provided. All participants will be given at least 24 hours to decide if they want to participate. The client will be given sufficient time to process the information and the opportunity to ask questions if he/she wishes to (NMC 2010). It will also be emphasised that the participant has a right to withdraw from the study at any point, with knowledge that no castigatory actions by the study doctor or coordinator of the study will be carried out if the participant decides to withdraw. There will be contact persons for concerns or questions that come up during the study. Written and verbal consent will be obtained on the day of the interview. 9. How are you going to address any Data Protection issues? See notes for guidance which outline minimum standards for meeting Data Protection issues During the actual interview, the researcher will inform the participant about the purpose of the interview. It is to be done by providing a participant information sheet which utilises appropriate language for the age and comprehension of the participant group thus using options related to the consent form. It is during this stage that the ethical principle of veracity comes into play. Fry and Johnstone (2002) state that the principle of veracity implies the obligation to tell the truth and never deceive people. This means that in educating the participant as to the purpose of the interview, the researcher will disclose all the information related to the research in order for the participant to comprehend fully the nature of the interview. Confidentiality is a vital aspect of professional practice that protects human rights (NMC 2010). The duty of confidence occurs when a client discloses information to a healthcare professional in circumstances where it is reasonable to expect that such information should be held in confidence (NMC 2010). This NMC provision certainly applies to nursing research considering that the researcher is a (student) nurse and it is only reasonable to expect that the information disclosed by the participant during the interview is supposed to be held confidential. During the entire course of the interview until the data analysis, the participant’s identity was strictly kept confidential. An alias was used to refer to her during the analysis of data. Confidentiality will be maintained throughout the study by ensuring that no other persons than the researcher and his instructor will have access to the data collected from the participants. When Nurses’ professional views and opinions is shared to the researcher, the information is not to be traced back to them. Their identities will be kept anonymous by the use of unknown nick names such as ‘alias flower’ without having the need to divulge their true identities. Under this nick naming system, each participant will be given a nick name which will serve as his or her identity throughout the research. This nick names will also help increase recruitment because possible participants know that their identities will be concealed. 10. Are there any other ethical issues that need to be considered? For example - research on animals or research involving people under the age of 18. All participants will be over 18 years old. There are no animals involved in the study. To avoid implications for obtaining informs consent, the first step is to obtain an authorization from the patient before the surgery. Then retake an approval from the patient after the recovery period by signing consent for the research. In the event of bad practice in reveal by participant in the interview, tell the person my professional responsibility is to share that information with the manager of the unit. 12. How many subjects will be recruited/ involved in the study/research? What is the rationale behind this number? Sampling qualitative research usually relies on small numbers with the aim of studying in depth and detail (Miles and Huberman 1994, Patton 1990). Initially, the research sample size was determined based on the research aims and objectives (Ezzy 2002, Reed et al 1996). The aims and objectives for this research are to seek the richness of the data about a pain and pain assessment. Therefore, the sample derived purposefully rather than randomly (Ezzy 2002, Mays and Pope 1995, Reed et al 1996). At this time the decision was made based on Strauss & Corbin recommendations by using the first three or four interviews as a guide to the core of the phenomena which can narrow the focus and reduce the number of interviews (1998). Similarly, the researchers’ knowledge, experience and interviewing skills entail smaller amount of participants as they can guide and encourage them to expose data (Strauss & Corbin, 1998). It therefore becomes reasonable for 20 nurses and 20 patients to offer a significant depth of information on the phenomenon 13. Please state which code of ethics has guided your approach (e.g. from Research Council, Professional Body etc). Please note that in submitting this form you are confirming that you will comply with the requirements of this code. If not applicable please explain why. Since Kuwait does not have any professional bodies that regulate nurses, the RCN guidance on ethics for nurses will be used to support the adherence to ethical processes in this project. INFORMED CONSENT FORM Project Details Project Title: Acute Pain for Postoperative Patients in Kuwait: A Study of How Surgical Nurses Assess Postoperative Pain Organization: Address: Contact Person: Contact Number: Study Period: Study Location: Purpose of This Study To explore nurse’s knowledge of pain assessment; To analyze the perceptions of nurses and patients of pain assessment in a Kuwait medical surgical setting; To identify potential factors that could affect how the patients respond to post-operative pain. Guidelines The research involves 20 patients and 20 nurses who are trained in their profession. All participants must be of 18 years of age or older. All participants will be given at least 24 hours to decide if they want to participate. Once involved in the research you have a right to withdraw from the study at any point, with the knowledge that no castigatory actions by the study doctor or coordinator of the study will be carried out against you. There will be contact persons for concerns or questions that come up during the study. Written and verbal consent will be obtained on the day of the interview. Confidentiality All participants must understand that their information will remain confidential and used solely for the purpose it is collected. Participants will be given nicknames to prevent identities. Authorization I have read and understood this consent form and I place myself as a volunteer for this research study. I voluntarily choose to participate since there seems no risk involved. I have received a copy of this consent form, and I agree to participate in this study. __________________________________________ Participant Name __________________________________________ Signature __________________________________________ Date Organizational Letter Name Title Address Dated: Dear Manager, The research is associated with pain assessment by nurses in a hospital, set up in Kuwait. The study intends to explore the surgical nurses’ approaches to pain assessment for post-operative patients and to discover how nurses know that their patients are in pain. Any difference or conflict between the patients experience and nurses assessment of the pain will be used to help formulate a better pain assessment strategy. In line with these ideas I wish to seek your approval for hiring forty volunteers - twenty patients and twenty surgical nurses – who can work as our sample and help me in devising an effective strategy in our hospital. I hope this request would not be denied. Confidentiality is our utmost priority and all of the collected data will be kept confidential with individual identities being hidden using pseudo names. Additionally, every volunteer will be able to exercise his/her rights and can withdraw at any point of the study without being questionable to the organization. Hereby I request you for an approval for hiring of volunteers from your organization. I assure you our best treatment towards the volunteers and a healthy interaction with your company. Kindly let me know if you have any queries, I will be pleased to respond to them. Regards, [Signature] NAME Participant Information Sheet Patients S. No. Name Age Sex Contact # Address Notes 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Interview Schedule Shift: Morning Location: Surgical Unit’s Office Date Status Details 02/2013 To 03/2013 In Process Apply for moral approval from Salford University. Meet up with the hospital director, as well as head nurse of the surgical units for the study authorization request, explain the research purpose, and the techniques to be utilized to do the study. 03/2013 To 06/2013 Pending Subject to getting ethical authorization, interviews for nurses as well as patients’ will be done for pain assessment. The data gathering and examination of data will begin. 07/2013 To 10/2013 Pending Data examination will be finished and research results written for a peer-review. Read More