Acute Pain for Postoperative Patients in Kuwait - Essay Example

I have looked at your work and attached the ethics application form with comments. Generally, the ethics application form is much improved, and you have justified the research design, sampling and rationale well. There are a couple of minor changes that you need to make, after which the application form will be ready to submit. You do, however need to concentrate on developing the following documents as they all need to be submitted with your application: 1: You will need to submit a participant information sheet that details the project and what is expected of the participants. There should be one for the patients and one for the nurses. I have attached a copy of the participant information sheet which you are expected to use and which you will need to amend to reflect your study 2: you will need to include a standard consent form. I have attached a copy for you to amend 3: You still need to include the interview schedules – there should be one for the patient and one for the nurses. These should detail the questions you will use to guide your semi-structured interview Acute Pain for Postoperative Patients in Kuwait: A Study of How Surgical Nurses Assess Postoperative Pain Research Participant Consent Form Title of Project: RGEC Name of Researcher: (Delete as appropriate) I confirm that I have read and understood the information sheet for the above study titled “Acute Pain for Postoperative Patients in Kuwait: A Study of How Surgical Nurses Assess Postoperative Pain” and what my contribution will be. Yes No I have been given the opportunity to ask questions through the use of an interview guide Yes No I agree to take part in the interview Yes No NA I agree to the interview being tape recorded Yes No NA I understand that my participation is voluntary and that I can withdraw from the research at any time without giving any reason Yes No I agree to take part in the above study Yes No Name of participant …………………………………………………………………………… Signature ……………………………………………………………………………. Date ………………………………. Name of researcher taking consent …………………………………………………………… Researchers e-mail address …………………………………………………………… Example Participant Information Sheet Study Title “Acute Pain for Postoperative Patients in Kuwait: A Study of How Surgical Nurses Assess Postoperative Pain” Invitation paragraph I deem it a great privilege to seek your invitation to be part of the present research study. It is crucial that you understand the purpose of the research and what your role would be as a participant. I therefore ask that you make time to critically study the information provided below. Please feel free to ask any questions if any portion of the information appears unclear to you. Finally, you are free to decide whether or not to be part of the study. What is the purpose of the study? It is good to note that the research seeks to fulfil three major health related purposes which include the need investigate what the knowledge of nurses are on pain assessment; outline the various perceptions that nurses and patients hold on pain assessment; and find out what the risk factors associated with patients response to post-operative pain are. Why have I been invited? Patient The major reason for including you as a participant for the current study is for you to provide experience based data on your experiences with pain as a patient who has gone through surgical operation in a Kuwait medical setting before. The major line of data that will be needed from you will include your experience with pain and how you assessed pain, before and after the operation. Nurse The major reason for including you as a participant for the current research is for you to provide evidence based data on your experiences with patients cases of pain as you supervised their operation sections as a nurse in a Kuwait medical setting before. The major line of data that will be needed from you will include your experience with assessing the pain of patients and the provision of necessary support in times of need. Do I have to take part? It will be kind to note that the choice of participation is up to you to decide. There will be detail outline of all information you need to help you make this decision. After considering all of these, you will be asked to sign a consent form if you so please to be part of the study. At any point while taking part in the study, you are free to withdraw from it. There is however a guarantee that your withdrawal will not affect the quality of care you receive. What will happen to me if I take part? The data collection will last for a period of 10 working days The entire research is being conducted over a period of 90 days Within the 10 working days, there will be two major face to face meetings with the researcher but this will happen at different days within the 10 days The first meeting is a conference with all participants and is expected to last for a maximum for 2 hours. The subsequent meeting will be an interview and will last for not more than one hour. The interview section will be audio tape recorded together with the use of an interview guide, which will help in the easy coding of responses. There is however the assurance of maximum confidentiality as the names of participants or personal information pertaining to their location will not be collected at any time during the interview section. The tape recordings will also be kept in a safe where it is guaranteed that an third person will not have access to. Expenses and payments? You should explain if any expenses (for example travel, meals, child-care, compensation for loss of earning etc.) are available. You should consider whether any gifts or vouchers which you intent as a thank-you should be detailed in the information sheet. What will I have to do? Set down briefly and clearly what you will expect from the research subjects, such as lifestyle, medical health or dietary restrictions, attending scheduled visits, keeping diaries, filling out questionnaires etc. What are the possible disadvantages and risks of taking part? Any risks, discomfort or inconvenience should be briefly outlined. You should consider carefully how to explain any risks involved in your study, as this can be difficult. Risks may include possible side effects from medication, potential injury from exercise trials, or the use of additional ionising radiation within x-rays, or distress from recollecting unpleasant memories and feelings. \For example if you are discussing or exploring sensitive issues with a participant that could upset them then you need to identify this so the participant is fully aware. After the research is completed make appropriate support services available for the participant to access if further support is required. What are the possible benefits of taking part? Explain these, but where there is no intended benefit for the participant, this should be stated clearly. It is important to not exaggerate the possible benefits. It would be reasonable to say something similar to: We cannot promise the study will help you but the information we get from the study will help to improve the treatment of people with (name of condition) Or We cannot promise the study will help you but the information we get from the study will help to increase the understanding of (name the focus of the research) What if there is a problem? You should inform participants who to go to if they have a complaint about the research study, their experience, and/or the researcher. A contact number should be given. This may be the researcher in the first instance, who can try to resolve the problem. However a participant may not wish to complain to the researcher if he/she is the object of the complaint, and may wish to make a more formal complaint for example: If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions (contact number). If you remain unhappy and wish to complain formally you can do this through… (add appropriate contact details of NHS, Private facility, University complaints procedure). You need to identify the appropriate complaints procedure and provide the contact details/location of where this can found, for example: NHS Complaints Procedure (or Private Institution), University Complaints Procedure, Supervisors name and contact details etc. For University-based projects, if the participant does not wish to discuss their complaint with the researcher, they should be directed to the supervisor in the first instance and then to the College Research and Innovation (R&I) Manager. In addition to identifying a clear complaints procedure you need to identify appropriate redress and/or compensation that would be available if the research participant came to any harm as a result of the research study. As a student of the University and/or NHS employee you need to fully explore the compensation arrangements. If there are no such compensation/insurance/indemnity schemes in place then this needs to be clearly explained. Will my taking part in the study be kept confidential? You should tell the participant how their confidentiality will be safeguarded during and after the study. You may wish to tell the participants how your procedures for handling, processing, storage and destruction of their data match the Cadicott principles and/or Data Protection Act 1998. The participant should be told: how their data will be collected. that it will be stored safely, giving the custodian and level of identification, for example: individual participant research data, such questionnaires/interviews/samples/ x-rays will be anonymous and given a research code, known only to the researcher A master list identifying participants to the research codes data will be held on a password protected computer accessed only by the researcher hard paper/taped data will be stored in a locked cabinet, within locked office, accessed only by researcher electronic data will be stored on a password protected computer known only by researcher What it will be used for. For example it must be clear if the data is to be used for future studies and whether further RGEC approval will be sought. Who will access to view identifiable data (authorised persons such as researchers within the team, supervisors, sponsors and for monitoring the quality, regulatory authorities /R&D audit). How long will it be retained and that is will be disposed of securely (the College RGEC recommends a minimum of 3 years) Example introductory statement includes: All information which is collected about you during the course of the research will be kept strictly confidential, and any information about you which leaves the hospital/surgery/university will have your name and address removed so that you cannot be recognised. Involvement of the General Practitioner/Family Doctor (GP) Some studies require that the research participant’s GP be informed if they are involved in studies that may affect their normal health status. You need to explain to the research participant if their GP needs to be contacted and seek their consent to do this. You should clearly explain what information will be exchanged. There are other studies/circumstances which may not impact on the health of the participant therefore it would not be appropriate for you to contact their GP, or in some cases it may not be possible. What will happen if I don’t carry on with the study? There are different positions to take on what will happen if a participant withdraws from a study and it up to the researcher to determine what is applicable to their study and ensure that this is clearly communicated to the participant prior to them agreeing to take part. Three possible scenarios include: If you withdraw from the study all the information and data collected from you, to date, will be destroyed and you name removed from all the study files. Or If you withdraw from the study we will destroy all your identifiable samples/ tape recorded interviews, but we will need to use the data collected up to your withdrawal. Or You can withdraw from the study/treatment but keep in contact with us to let us know your progress. Information collected may still be used. Any stored blood/tissue samples or taped interviews that can still be identified as yours will be destroyed if you wish. What will happen to the results of the research study? Participants often want to know the results of the study in which they were involved. You should tell participants what will happen to the results, whether they will be published and how the results will be made available to them. You should add that they will not be identified in any report/publication unless they have given their consent. Who is organising or sponsoring the research? The answer should include the organisation or company sponsoring the research and funding the research if these are different (e.g. Research Charity, academic institution, NHS employee). Further information and contact details: The additional information that participants require can sometimes be divided into the following four categories. You need to identify where to locate additional information or who to contact to address the different enquires. 1. General information about research (e.g. list relevant documents or websites) 2. Specific information about this research project (e.g. contact details of researcher) 3. Advice as to whether they should participate (e.g. contact details of a different health care professional who can provide impartial advice) 4. Who they should approach if unhappy with the study (e.g. contact details of complaints procedure if not listed earlier) 5. A minimum prerequisite in this section is that the contact details of the researcher (email address) should be clearly identified. Read More