Topic: ethics in research
Order Description
Assessment 4: Ethics Application
•Marks Allocated: 50% (35% Ethics Application + 15% Participant Information Statement
.2 DOCUMENTS TO HELP WITH THIS ASSIGNMENT.
RESEARCH PROPOSAL
PROPOSED SURVEY.
magine you are the chief investigator for this project. You are required to apply for ethics approval to conduct this research. . This assignment is in two parts: a mock ethics application (completing a pdf form), and a Participant Information Statement (prepare a separate Word document).
Part A: Mock Ethics Application
Referring to the information provided in the research proposal, prepare a mock ethics application using:
•the ‘La Trobe University Low Risk Application Form – Human Research Ethics’ (file attached)
For guidance on completing this application you will need to read and apply the guidelines presented in:
•the ‘La Trobe University Low Risk Application Form – Completion Guidelines’ (file attached)
For the purposes of this assignment, use your own name as chief investigator. You do not need to get any sections signed – this is a mock application only. You will be assessed on how you explain the proposed research, and how you identify ethical issues (if any), including risk management strategies.
Part B: Participant Information Statement
Using the information provided in the research proposal, and referring to the guidelines:
•La Trobe University Participant Information Statement and Consent Form Guidelines (file attached)
draft a Participant Information Statement to inform potential participants about your research proposal.
Prepare your Participant Information Statement as a Word document, following the requirements of the Guidelines. For the purposes of this assignment, use your own name as the Chief Investigator. You do not need to include letterhead for this example
participant information
The information and details to be included in the Participant Information Statement (PIS) and the Consent Form is set out in the points below. The format and content should not normally vary from what is set out in these Guidelines. If this model is inappropriate for your group of participants, alternative models will be considered by the University Human Ethics Committee (UHEC) or College Human Ethics SubCommittee (CHESC). It is advisable to discuss alternate models with either the Secretary or a member of the UHEC or CHESC.
The Participant Information Statement (PIS) must be a separate document from the Consent Form. Forms must be titled ‘Participant Information Statement’ and ‘Consent Form’. A separate PIS and Consent Form should be prepared for, and retained by, each participant or his/her guardian, or organisation.
Where the PIS is presented as an introduction to an on-line survey data gathering instrument and the participant has not already received a copy, then it must contain instructions on how to save and/or print a copy of the document.
A PIS must comply with all of the instructions below and contain all of the following details:
1. La Trobe University School/Department/Centre letterhead should appear at the top of the page. When the research is conducted through an external agency, it may also be appropriate for the agency’s logo to be used or letterhead to be included.
2. The title of the project written in block letters.
3. Names, affiliations and convenient contact details of all researchers (University staff and students as well as external investigators). For reasons of individual safety, the inclusion of personal telephone numbers on PIS and Consent Forms are not recommended. Similarly, phone numbers for administrative staff who are not involved with the project should not be given. Where an undergraduate, Honours or postgraduate student is to conduct the project, state the name of the course of study for which the research is being conducted and who is supervising the research.
4. A description in lay language of the aims of the project and how the participant has been identified and recruited and any requirements to be met by participants, for example, “In order to participate you must be aged 18 years or older.
5. If applicable, a declaration of any personal, professional or institutional conflicts of interest by the researcher or their institution or the name(s) of commercial companies that have provided funding or sponsorship for the project.
6. A description of the research procedures including the anticipated time commitment expected of the participant, the information you will be obtaining, how that information will be collected, and a description of any actual physical interventions.
7. A statement of any risks, discomforts or harms which may result from participation in the project. Include an explanation of how any such risks or harms will be minimised and a statement of who would not be eligible to participate, such as pregnant women, asthmatics, children under a particular age, etc.
8. A statement which details the use of the data. This must be explained in sufficient detail so that a participant is able to give informed consent about the actual use of their data. This statement must include:
(a) procedures to be followed to ensure security and confidentiality of data
(b) circumstances under which the confidentiality of the participant cannot be guaranteed, for example, as authorised or required by law or where the investigators believe that disclosure is necessary to lessen or prevent a serious threat to public health or public safety
(c) how and in what format, such as hard copy and/or electronic, the data will be maintained and used for reporting and publications, including publication of interview transcripts or written narratives prepared by participants
(d) that the participant may request a copy of their personal data collected in the course of the research, if applicable
(e) that participants will be provided with an opportunity to review transcript(s) of their interview(s) prior to submission of a thesis or publication of reports or papers, if applicable
(f) that participants will be provided with a summary of the results of the research, if applicable
(g) when, how, and for what purpose the data might be preserved for possible future use in another project
(h) who might be given access to data preserved for possible future use in another project
(i) when and how the raw data will be disposed of
9. In the case of postal surveys, a statement explaining any follow-up procedures, such as reminders to complete questionnaires, use of coded envelopes or questionnaires
10. A statement of the benefits of the project to the participant or lack thereof and to society in general.
11. A statement that explains that there are no disadvantages, penalties or adverse consequences for not participating or for withdrawing from the research. This is particularly important where participants are in a dependent relationship with the researchers or their professional associates who are providing continuing treatment or care to the participant or where the participants are students of the investigators.
12. Where deception is used, the following statement should be incorporated:
“It is sometimes essential for the validity of research results not to disclose the true purpose of the research to participants. If this occurs participants will be debriefed as soon as possible and at that time given the opportunity to withdraw from the research and have data arising from their participation not used in the research project.”
13. An offer to answer any questions the participant has regarding the project, as follows:
“Any questions regarding this project may be directed to the Investigator(s)
(name(s)), of the School of (name) on telephone number (details).”
For contact numbers, it is recommended to not provide personal telephone numbers or phone numbers of administrative staff who are not involved with the project.
14. A separate statement advising the method of complaint/concerns must be included. You are advised to copy and paste the following statement:
If you have any complaints or concerns about your participation in the study that the researcher has not been able to answer to your satisfaction, you may contact the Senior Human Ethics Officer, Ethics and Integrity, Research Office, La Trobe University, Victoria, 3086 (P: 03 9479 1443, E: humanethics@latrobe.edu.au) . Please quote the application reference number _______.
15. A withdrawal of consent declaration, explaining that the participant is free to withdraw consent and discontinue participation in the research at any point during their immediate involvement in the research and following their involvement in the research. In certain cases it is appropriate to distinguish between the right of a participant to withdraw from active participation in a project and the right to demand that no data arising from their participation is used. Participants may request data to be destroyed, in instances where a participant has a right to request this.
When focus groups are conducted, it is important to explain that it may not be possible to withdraw an individual’s data from that collected from the focus group session, depending on how the data is captured.
When anonymous surveys are conducted, it is important to explain that it will not be possible to withdraw an individual’s data from that collected.
Following a participant’s involvement in the research, a written withdrawal of consent form and request to remove a participant’s data should be provided. Researchers must retain evidence of all submitted requests for withdrawal of consent and removal of a participant’s data. Consent forms may include a time limit on a request for the withdrawal of data as long as the time limit specified is not less than four weeks following the completion of data collection. An example of the suggested wording for withdrawal follows:
“You have the right to withdraw from active participation in this project at any time. You may also request that data arising from your participation are not used in the research project provided that this right is exercised within four weeks of the completion of your participation in the project. You are asked to complete the “Withdrawal of Consent Form” or to notify the researcher by email or telephone that you wish to withdraw your consent for your data to be used in this research project.”
The Consent Form should contain the following information:
1. La Trobe University School / Department / Centre letterhead must appear at the top of the page. When the research is conducted through an external agency, it may also be appropriate for the agency’s logo to be used or letterhead to be included.
2. Title of the project (Block Letters).
3. A signed statement of agreement to participate, as follows:
“I (the participant) have read (or, where appropriate, have had read to me) and understood the participant information statement and consent form, and any questions I have asked have been answered to my satisfaction. I agree to participate in the project, realising that I may withdraw at any time. I agree that research data provided by me or with my permission during the project may be included in a thesis, presented at conferences and published in journals on the condition that neither my name nor any other identifying information is used.”
Or, if a sunset clause is to be used:
“I (the participant) have read (or, where appropriate, have had read to me) and understood the participant information statement and consent form, and any questions I have asked have been answered to my satisfaction. I understand that even though I agree to be involved in this project, I can withdraw from the study at any time, and can withdraw my data up to four weeks following the completion of my participation in the research. Further, in withdrawing from the study, I can request that no information from my involvement be used. I agree that research data provided by me or with my permission during the project may be included in a thesis, presented at conferences and published in journals on the condition that neither my name nor any other identifying information is used.”
4. If photographs or audio or video recordings are being taken, the consent form needs to request specific permission for these to occur, usually by providing a ‘yes’/‘no’ tick box option.
5. Provisions for signatures of the participant (or authorised representative) and the senior investigator:
Name of Participant (block letters):
Signature: Date
*Name of Authorised Representative (block letters):
Signature: Date
Name of Investigator (block letters):
Signature: Date
**Name of Student Supervisor (block letters): Date:
*Use this signature block only in such cases where the participant is not capable of providing his/her own informed consent.
**To be used when the researcher is either an undergraduate or postgraduate student.
RESEARCH PROPOSAL
CVC Insertion and Management practices in Australia and New Zealand in the NICU Investigators: Blac J., McDonald, S.
Contact: Jac.blac@students.laatrobe.edu.au
BACKGROUND
Central venous catheters (CVCs) are commonly used in the neonatal intensive care unit (NICU) for intravenous nutrition, administration of medications and monitoring(1). For preterm and extremely ill infants these devices are lifesaving; however they are not without complications, infection being the most prevalent (2).
A central line is defined as “an intravascular catheter that terminates at or close to the heart or in one of the great vessels such as the aorta, pulmonary artery, superior vena cava, inferior vena cava, brachiocephalic veins, internal jugular veins, subclavian veins, external iliac veins, common iliac veins, femoral veins, and in neonates, the umbilical artery/veins” (2).
They are further classified by the location of skin entry, peripherally inserted central catheter (PICCs) where the entry point is in a limb, or centrally inserted, where the entry point is on the trunk. Centrally inserted lines are then further described as non--tunnelled, tunnelled or implanted (3).
The terms used to describe intravascular infections are often used interchangeably and inaccurately. Catheter related blood stream infection (CRBSI) is the clinical term used to describe formally confirmed blood stream infection associated to the central catheter (2). Central line associated blood stream infection (CLABSI) is the term used to describe blood stream infections where the catheter is the most likely source(4). CLABSI is used for surveillance purposes and may overestimate actual CRBSI(2).
CLABSI for infants weighing 750g or less are 3.1/1000 catheter days decreasing to 1.4/1000 per catheter days for infants greater than > 1501g (5). Other studies show infection rates ranging from 0--29% of catheters placed, and from 2--49/1000 catheter days (6--12). Stoll et al., (2002) retrospective study of 6215 infants demonstrated that occurrence of late--onset sepsis is directly related to a prolonged hospital stay, increase in morbidity and mortality than those infant’s without nosocomial infection (13). The incidence of infection was inversely proportional to gestational age and birth weight but directly proportional to length of days ventilated and with CVC in situ. Other studies support this, particularly with very low birth weight infants with CRBSI, having a higher risk of mortality with attributable mortality ranging from 4 to 20% (14) and a range of important morbidities including the need for intensive care, mechanical ventilation, bronchopulmonary dysplasia, necrotising enterocolitis, retinopathy of prematurity and prolonged hospitalisation(14--17).
Catheter related blood stream infection (CRBSI) occurs when micro--organisms adhere to the intraluminal or extraluminal surface of the catheter. Micro--organisms can enter the catheter from colonisation of the catheter ports (hubs) and insertion sites, contaminated intravenous fluids and injection devices and from hematogenous dissemination from other sources of infection (18). Once they have entered the catheter, they can adhere and become incorporated into a biofilm made up of extracellular polymers.
There are numerous strategies on prevention and treatment of CRBSI in CVCs and there are extensive recommendations for practice produced by the Centres for Disease Control and Prevention (CDC) (2). These include education, hand hygiene, maximal barrier precaution during insertion, selection of catheter and site, skin preparation, dressings, antibiotic usage, line set replacement, usage of intravascular devices and performance improvement. However, there are limitations to the recommendations for infants < 2months old. Moreover although there are recommendations on the cleaning solution used to access the port there is limited advice from the CDC on length of time these access ports should be clean for. Furthermore, there are no recommendations on the use of in--line filters to reduce infection rates. There is increasing evidence from temporal studies that incorporating a ‘bundle’ of strongly recommended prevention strategies lead to a decrease in infection rates (19--23).
Practice variations may occur between the NICUs in Australia and New Zealand but this has not been previously studied. This survey is a start towards identifying practices in the level 3 neonatal units than make up the ANZNN.
AIMS
1) To ascertain if current evidence based recommendations for the prevention of infection in CVCs are practiced in the clinical setting in Australian and New Zealand Neonatal Intensive Care Units.
2) To establish if there any major variations in clinical practice for the prevention of infection in CVCs in Australian and New Zealand Neonatal Intensive Care Units.
3) To develop a clinical trial, informed by the survey, to improve CVC practices and reduce infection.
METHODS
Design
A prospective, cross--sectional, descriptive study utilising a survey methodology.
This design is the most appropriate to ascertain current clinical practices in the neonatal units in Australia and New Zealand.
The survey will be separated into two; one focusing on insertion practices and one on maintenance. Insertion is a medical procedure and maintenance is nursing, therefore separating them will enable more accurate answers.
The surveys will utilise a questionnaire format, using partial closed ended questions with areas for the participant to comment further. The surveys do contain medical terminology, however every effort has been made to define terms and give working examples to reduce ambiguity. The surveys will be piloted using appropriate personnel prior to distribution, to ensure the questions are appropriately worded.
The surveys will be distributed on--line using the tool ‘Survey Monkey’. Survey Monkey is an on-line tool that enables the user to create surveys, distribute, collect responses and analyse data. It maintains confidentiality; however Survey Monkey can follow up non--responders without the surveyors knowing who has not responded.
Participants
Purposive sampling will be utilised to ensure accurate representation of the Level 3 Neonatal
Intensive Care Units in Australia and New Zealand (28 in total). The Nurse Unit manager and Medical Director will be contacted and each asked to complete the relevant survey or nominate an appropriate representative (see below). The clinical leads are ultimately responsible for clinical practice and will have the best understanding of what the unit’s expectations are; or who is most suitable to answer the questions. A limitation of this is that individual
medical/nurse practice may vary, however there is also an expectation that individuals follow the protocols/guidelines and therefore minimising individual variations.
The target group consists of 56 persons in total (2 from each neonatal unit) consisting of:
• One senior nursing (Nurse Unit Manager, Clinical Nurse Educator or Clinical Nurse Consultant) who has key involvement in CVC maintenance
• One senior medical representative (Consultant or Fellow) whose responsibility it is to insert CVCs. An initial introduction letter explaining the survey and its purpose will be e--mailed to the Nurse Unit Manager and the Medical Director followed by the survey; non--respondents will be followed up by email a week later.
Consent
Informed consent will be obtained from each participant. Each participant will be provided with a letter explaining that completion of the survey is voluntary and also the purposes of the survey and the expected duration of completion. The participants will also be provided with an explanation of confidentiality and that responses will not be identifiable. No personal data will be collected. Completion of the survey will imply consent.
Data Analysis
Analysis of data will be performed utilising the analysis software in Survey Monkey. Where this is not possible analysis will be performed using the Statistical Package for the Social Sciences (SPSS®). Categorical data will be analysed using percentages. Continuous data will be calculated using mean and standard deviation.
Data Protection
No personal data will be collected in the survey. Responses and completed surveys will be password protected within Survey Monkey, once downloaded data will be stored electronically on a password protected hard drive within the investigators office. Data will be kept for a minimum of seven years, after which all data will be deleted.
proposed survey.
Insertion Survey:
Web link: https://www.surveymonkey.com/s/W9YRGBG
Completion by the Medical Director or their nominee who’s responsibility it is to insert CVCs
1. Position held:
a. Neonatal consultant,
b. Neonatal fellow,
c. Neonatal nurse practitioner,
d. Other (please specify)
2. Which types of CVC do you use in your unit? (select all that apply)
a. UVC (umbilical venous catheter),
b. PICC (peripherally inserted central catheters or long line or PCVC), c. Femoral,
d. Tunnelled (Broviac, Hickmans),
e. Other (please specify)
3. Do you have a unit protocol/ procedure/guideline on CVC insertion for the following? a. PICC YES/NO/N/A
b. UVC YES/NO/N/A
c. Femoral YES/NO /N/A
d. Other (please specify)
4. Do you have a dedicated team for CVC insertion?
YES/NO
5. Do you have a trolley designated for CVC insertion/management? YES/NO
6. Is there a preference for the site of insertion, such as upper limb or lower limb?
YES/NO
If you answered yes please specify?
7. How is hand hygiene performed prior to CVC insertion?
a. Site palpated, then hands washed immediately prior to applying gloves
b. Site palpated, then alcohol hand rub immediately prior to applying gloves
c. Hands washed, then site palpated, gloves applied
d. Hands cleaned with alcohol rub, then site palpated, gloves applied
e. Hands washed, gloves applied, then site palpated
f. Hands cleaned with alcohol rub, gloves applied, then site palpated
g. Other (please specify)
8. Which of the following are used during CVC insertion? (select all that apply) a. Sterile glove (single)
b. Sterile glove (double)
c. Non--sterile glove
d. Surgical Hat/Cap
e. Surgical gown
f. Surgical mask
g. Full body sterile drapes
h. Dressing trolley
i. Sterile dressing pack / sterile tray / sterile designated CVC set
j. Insertion checklist to observe for adherence to practice
k. Observer to watch for breech in maintaining sterility
l. Other (please specify)
9. In a non--emergent setting is CVC insertion always stopped if there is a breach in infection control practices?
YES/NO/No designated observer to watch or stop procedure
10. Which cleaning solution is usually used to prep the skin prior to insertion? a. 70% alcohol / Alcohol swab
b. > 0.5% Chlorhexidine gluconate with alcohol
c. Tincture of iodine
d. Povidone--iodine
e. Other (please specify)
11. Is it practice to allow the skin preparation to dry prior to inserting the catheter? YES/NO
12. Which type of catheter is most commonly used?
a. Polytetrafluoroethylene
b. Polyurethane
c. Polyethylene
d. Polyvinyl chloride
e. Silastic
f. Other (Please specify)
13. Do you use antimicrobial/Antiseptic impregnated catheters and cuffs, such as
Chlorhexidine/silver sulfadiazine catheters or Micocycline/Rifampin catheters to prevent infections?
Routinely / Never / Occasionally
If you occasionally use please specify when?
14. Which type of impregnated catheters do you use?
a. Chlorhexidine/silver sulfadiazine catheters
b. Micocycline/Rifampin catheters
c. Other (Please specify)
15. What is used to dress the catheter site for PICC lines? (Select all that apply) a. Sterile gauze
b. Steri--strips
c. Sutures
d. Transparent semipermeable dressing ( i.e. Tegaderm, Opsite) e. Non--sterile tape
f. Other (please name)
16. What is used to dress the catheter site for femoral lines? (Select all that apply) a. Sterile gauze
b. Steri--strips
c. Sutures
d. Transparent semipermeable dressing ( i.e. Tegaderm, Opsite) e. Non--sterile tape
f. Other (please name)
17. What is used to dress the catheter site for tunnelled lines? (Select all that apply) a. Sterile gauze
b. Steri--strips
c. Sutures
d. Transparent semipermeable dressing ( i.e. Tegaderm, Opsite) e. Non--sterile tape
f. Other (please name)
18. Do you routinely use chlorhexidine--impregnated sponge dressing for short term catheters (PICC) YES/NO/Depends on gestation and /or weight (please specify)
19. Do your infants routinely, with CVCs in situ, receive systemic antimicrobial prophylaxis before or during use to prevent infection?
YES/NO
20. Do you use prophylactic antimicrobial lock solution in patients with long term catheters (i.e. femoral lines, tunnelled catheters)
YES/NO/Sometimes
If you answered sometimes can you please state when prophylactic antimicrobial solution would be used?
21. Do you use prophylactic antimicrobial lock solution in patients with PICC catheters?
YES/NO/Sometimes
If you answered sometimes can you please state when prophylactic antimicrobial lock solution would be used?
22. Do you use antimicrobial lock solution in patients with suspected or proven line infection?
YES/NO/Sometimes If you answered sometimes can you please state when an antimicrobial lock solution would be used?
23. Do you routinely use low dose heparin to fluid infused through:
a. UVC (YES/NO)
b. UAC (YES/NO)
c. PICC (YES/NO)
d. Femoral catheters (YES/NO)
e. Tunnelled catheters (YES/NO)
24. When using multi--lumen CVCs which lumen do you heparinise? a. None
b. All of them (when possible)
c. The proximal
d. The distal
e. The medium
25. How do you ascertain correct position of a CVC?
a. X--ray without contrast
b. X--ray with contrast
c. Ultrasound
d. Other
26. Are CVCs discussed daily on the medical round? YES/NO
If you answered yes what is discussed?
27. How frequently do the medical team assess the CVC insertion site? (Check all that apply) a. When the nurse asks the doctor to look
b. Daily
c. Not routinely assessed
d. 2nd daily
e. Weekly
f. Other (please specify)
28. What is the policy on line removal with proven or strongly suspected CRBSI?
a. Remove CVC immediately, regardless of type of infective microorganism
b. A trial of IV antibiotics and removal of line based on type of microorganism
c. A trial of IV antibiotics to eradicate line infection, regardless of type of infective microorganism
How long are UVC usually left in situ?
d. < 7 days
e. 7--10 days
f. 11--14 days
g. < 14 days
h. 15 – 21 days
i. 22--28 days
29. Do you routinely remove PICC after a specified time?
YES/NO
If you answered yes please specify?
30. Do you routinely prescribe antibiotics for CVC removal?
YES/NO
31. Do staff involved in catheter insertion receive annual education on CVC insertion, including prevention of infection?
YES/NO
32. Do staff involved in catheter insertion have their knowledge assessed on CVC insertion, including preventing infection during insertion?
YES/NO
33. Does all medical staff receive feedback on the number of catheter related blood stream infections?
YES/NO
Maintenance Survey
(web link: https://www.surveymonkey.com/s/WBQ9RWR )
Completion by the Nurse Manager or their nominee
34. Position held:
a. Nurse Unit Manager
b. Nurse Educator
c. Nurse consultant
d. Other (please specify)
35. Do you have a Unit protocol/ procedure/guideline on the management of the following
CVCs?
a. UVC (umbilical venous catheter), YES/NO/Don’t use
b. PICC (peripherally inserted central catheters or long line or PCVC), YES/NO/Don’t use c. Femoral, YES/NO/Don’t use
d. Tunnelled (Broviac, Hickmans) YES/NO/Don’t use
e. Other (please specify)
36. Has your unit adopted the principles of ANTT (Aseptic Non Touch Technique) when handling CVCs?
a. Yes
b. NO
37. Which of the following are used when accessing a UVC (e.g. for medications)? (select all that apply)
a. Sterile glove
b. Non--sterile gloves
c. Hat
d. Gown
e. Mask
f. Full body sterile drapes
g. Dressing trolley
h. Sterile dressing pack / tray
i. Unsterile tray
j. Checklist to observe for adherence to practice
k. Observer to watch for breech in maintaining sterility
l. Other (please specify)
38. Which of the following are used when accessing a PICC (e.g. for medications)? (select all that apply)
a. Sterile glove
b. Non--sterile gloves
c. Hat
d. Gown
e. Mask
f. Full body sterile drapes
g. Dressing trolley
h. Sterile dressing pack / tray
i. Unsterile tray
j. Checklist to observe for adherence to practice
k. Observer to watch for breech in maintaining sterility
l. Other (please specify)
39. Which of the following are used when accessing a femoral catheter (e.g. for medications)?
(select all that apply)
a. Sterile glove
b. Non--sterile gloves
c. Hat
d. Gown
e. Mask
f. Full body sterile drapes
g. Dressing trolley
h. Sterile dressing pack / tray
i. Unsterile tray
j. Checklist to observe for adherence to practice
k. Observer to watch for breech in maintaining sterility
l. Other (please specify)
40. Which of the following are used when accessing a Tunnelled catheter for medications?
(select all that apply)
a. Sterile glove
b. Non--sterile gloves
c. Hat
d. Gown
e. Mask
f. Full body sterile drapes
g. Dressing trolley
h. Sterile dressing pack / tray
i. Unsterile tray
j. Insertion checklist to observe for adherence to practice
k. Observer to watch for breech in maintaining sterility
l. Other (please specify)
41. When accessing the CVC which solution is used to clean the access point? a. 70% alcohol / Alcohol swab
b. > 0.5% Chlorhexidine gluconate with alcohol
c. Tincture of iodine
d. Povidone--iodine
e. Other (please specify)
42. Which technique is used to clean the access point?
a. Wipe gently for a period of time or rubs
b. Vigorous rubbing for a period of time or rubs
c. Other (please specify)
43. What is the duration of time the access point is cleaned for? a. < 5 seconds
b. <10 seconds
c. 11-- 14 seconds
d. > 15 seconds
e. Not timed
44. How many rubs of the access point is performed?
a. <5
b. <10
c. 11--19
d. > 20
e. Not counted
45. Is it practice to allow the access point to dry prior to accessing the catheter?
YES/NO
46. Do you routinely use in--line filters for clear fluids?
YES/NO
47. Do you routinely use in--line filters for Lipids?
YES/NO
48. How often are the following infusion lines changed?
a. lipid / fat emulsion lines (daily, 48 hourly, 72 hourly, 96 hourly, weekly)
b. TPN (excluding lipid) (daily, 48 hourly, 72 hourly, 96 hourly, weekly)
c. Clear fluids daily (48 hourly, 72 hourly, 96 hourly, weekly)
d. Blood / blood products (daily, 48 hourly, 72 hourly, 96 hourly, weekly, after infusion)
49. How often are the following fluids changed?
a. Pre--package with no additives (i.e. 10% Dextrose) (daily, 48 hourly, 72 hourly, 96 hourly, weekly)
b. Pre--package with additives added on the ward (i.e. extra sodium chloride) (daily, 48 hourly, 72 hourly, 96 hourly, weekly)
c. Pharmacy prepared (i.e. TPN) (daily, 48 hourly, 72 hourly, 96 hourly, weekly)
d. Lipid / fat emulsion (daily, 48 hourly, 72 hourly, 96 hourly, weekly)
50. What time are fluids and lines routinely changed?
a. Between 0800--1200
b. Between 1200--1600
c. Between 1600--2100
d. Between 2100--0000
e. Between 0000--0600
f. No set time
g. Other (please specify)
51. Are stopcocks (three way taps) routinely used?
YES/NO
52. Are multi lumen extension tubing’s (octopus systems) routinely used? YES/NO
53. When using stopcocks (3 way taps) on CVC’s how are they capped when not in use? a. Left open
b. A needle--less access point is attached
c. A cap
d. Never use
54. Are needle--less intravascular devices ( e.g. Smart Site) routinely used on all access points? YES/NO
55. How often are needle--less intravascular devices changed? a. Daily
b. 48 hourly
c. 72 hourly
d. 96 hourly
e. Weekly
f. Not routinely changed
g. Don’t use
56. How often are dressings changed on the following? (select all that apply)
a. PICC lines (long line) (not routinely, daily,2nd daily, weekly, visibly soiled or loose)
b. Femoral lines (not routinely, daily,2nd daily, weekly, visibly soiled or loose)
c. Tunnelled catheters (unhealed insertion site) (i.e. Broviac / Hickman) (not routinely, daily,2nd daily, weekly, visibly soiled or loose)
d. Tunnelled catheters (healed insertion site) (i.e. Broviac / Hickman) (not routinely, daily,2nd daily, weekly, visibly soiled or loose, dressing not used)
57. Which of the following are used when accessing a CVC to change a dressings? (select all that
apply)
a. Sterile glove
b. Non--sterile gloves
c. Hat
d. Gown
e. Mask
f. Full body sterile drapes
g. Dressing trolley
h. Sterile dressing pack / tray
i. Unsterile tray
j. Checklist to observe for adherence to practice
k. Observer to watch for breech in maintaining sterility
l. Other (please specify)
58. Do you use positive pressure displacement valves (e.g. CLC) on the follow CVCs? a. PICC (YES/NO)
b. UVC (YES/NO)
c. Femoral catheters (YES/NO)
d. Tunnelled catheters (YES/NO)
59. How often is the insertion site physically examined by the nurse? a. Hourly
b. At care times
c. Each shift
d. Daily
e. Other (please specify)
60. Do nursing staff responsible for CVC management receive annual education on CVC management, including infection prevention?
YES/NO
61. Do nursing staff responsible for CVC management have their knowledge assessed on CVC management, including infection prevention? YES/NO
62. Do nursing staff receive feedback on the number of catheter related blood stream infections?
LOW RISK APPLICATION FORM-HUMAN RESEARCH ETHICS.
Please do not print this form. To complete this application form, save a blank copy to your computer and open the form in the
free Adobe Reader software (version 9.0 or later). Complete the form, save it and attach it to an email from your La Trobe
University email account addressed to the relevant Faculty Human Ethics Committee (FHEC) Secretary.
If you do not have this software installed, or are using an older version of Adobe Reader, the latest version can be downloaded
from the Adobe website.
Please be advised that expedited review does not absolve the researcher(s) from adherence to acceptable ethical standards as
outlined in the NHMRC National Statement and the La Trobe University Human Research Ethics Guidelines.
Please note that this application needs to be submitted with the following supporting documentation:
· Participant Information Statement
· Consent Form
· Withdrawal of Consent Form (use the template provided on the La Trobe University Human Research Ethics website).
· Other documents related to your project including advertisements, flyers, questionnaires, interview schedules etc
Section 1. Project Details
1.1 Core Project Details
Project Title
Title/Full Name of Chief Investigator/
Supervisor
Must be an academic staff member of La
Trobe University or affiliated institute
School/Institute Phone
Position Staff ID
Email
Title/Full Name of Principal Research
Student (if applicable)
Enter contact details in Section 12
Proposed commencement date Proposed conclusion date
Please provide a summary in lay terms
of what this research project involves
with particular reference to the
participants
(Please ensure the description is 50
words or less and in plain language)
1.2 Type of Project
Research by Academic Staff Member Postgraduate Research Contract Research
Masters by Coursework Undergraduate Research Honours Research
Clinical Trial
Other
1.3 Is this project part of a larger project?
No Yes
1.4 Does this project involve multi-centre research?
No Yes
1.5 Project Description
Aims
Research design / approach
Methodology / data
collection techniques &
analysis
Section 2. Participant Details
Does your research project involve:
Human participants
Use of data banks only
Section 3. Research Using Existing Databases
Please refer to the Victorian Privacy Impact Assessment Guide.
https://www.privacy.vic.gov.au/privacy/web2.nsf/files/privacy-impact-assessments-guide
3.1 If the research involves access to existing database provided by an institution(s), please indicate:
Source(s) and number of records
Whether data to be used will be de-identified,
potentially identifiable (e.g. coded), or identified
Whether permission has been granted by donors
to use these data for research purposes
Whether formal permission/clearance has been
sought or obtained from the relevant institution(s)
(see also Section 5 below)
Updated December 2013 Page 3 of 7
Section 4. Location of Study
4.1 Please identify the precise location of the study
If permission is required to use the location, indicate how permission will be obtained. See also Section 5.
Section 5. External Approvals
If a project requires approval from other institutions or ethics committees, next of kin or guardian, or representative or authority in the
case of special groups, copies of such approvals must be provided to the UHEC at the time of application or be made available as soon as
possible thereafter.
Please indicate as appropriate if formal clearance/permission has been sought or obtained.
5.1 Institutional
Name(s) of institution/ethics committee/authority:
Yes, details below Yes, to follow (estimate when likely to be obtained below) No, please explain below N/A
Section 6. Informed Consent
6.1 How will consent be obtained?
Written consent form Other – explain below how consent will be recorded
6.2 How will competence to give consent be determined and who will make this determination?
Please provide details below:
6.3 Will Participant Information Statement and Consent Forms be used?
Yes (copies attached) No (please explain below) An alternative method of obtaining consent
will be used (please specify below)
6.4 Will Participant Information Statement and Consent Forms be translated into the participants’ first language?
Yes (please provide copies of translations) No (please explain below) N/A
Updated December 2013 Page 4 of 7
6.5 Will all participants have the capacity to give voluntary and informed consent?
Yes No
Section 7. Description of Procedures
7.1 Describe in detail below exactly what you will be asking of participants and emphasise anything that may have
adverse consequences.
7.2 Will questionnaire(s) (including those that are published or commercially available) be used in the project?
Please attach a copy to this application.
No Yes (please attach a copy to this application)
7.3 If interviews or focus groups are to be held, please indicate the kinds of questions to be asked below or attach
the interview schedule in the case of structured interviews.
7.4 Will participants at any time be photographed, video recorded, or audio recorded?
No Yes
Section 8. Risk and Indemnity
8.1 Is there any risk of physical, psychological, social, legal or financial and/or community, employment and/or
professional harm to the participant or organisation?
No Yes
Section 9. Recording and Security of Project Documentation
9.1 How will data be recorded? (e.g. written questionnaires, interview notes, photographs, audio/video recording,
direct electronic data entry)
9.2 How will confidentiality of results be maintained?
If you cannot ensure the confidentiality of results, your project may be above low risk and require full ethical review.
Updated December 2013 Page 5 of 7
9.3 Indicate how the security of project documentation will be maintained and specify the precise location of the
storage place(s):
9.3.1 During the study
9.3.2 Following completion of the study
Project documentation should be stored in secure, lockable locations, preferably on campus. Computer files should be password protected. Data, de-identified
where appropriate, and consent forms should normally be kept for a period consistent with the Public Records Office of Victoria Standard (02/01) (normally 5 years
for non clinical trial data and 15 years for clinical trial data following publication).
9.4 Will any data (including samples) be preserved for possible future use in another project either by yourself or
another researcher?
No Yes
Section 10. Dissemination of Results
10.1 Will participants be informed that results from the study may appear in publications, be included in a thesis or
report, or be presented at conferences? (If relevant, this information should be included in the Participant
Information Statement and given to participants prior to obtaining informed consent).
No Yes
Please provide details
10.2 Will participants be informed that results from the study will be available to them on request? (If relevant, this
information should be included in the Participant Information Statement and given to participants prior to
obtaining informed consent).
No Yes
10.3 Will participants be informed that their personal data collected in the course of the research will be available to
them on request? (If relevant, this information should be included in the Participant Information Statement and
given to participants prior to obtaining informed consent).
No Yes
Please explain
Section 11. Potential Conflict of Interest
11.1 Is there any personal or affiliated benefit, in particular a financial benefit, for researchers in this study, or its
outcomes or any circumstances which might represent a perceived, potential or actual conflict of interest?
No Yes
[If you have declared a potential conflict of interest, you should include an appropriate comment on the Participant Information Statement and Consent
Form]
Section 12. Co-Investigator Details
Co-Investigator
For database purposes please ensure that all details are up to date and correct
Title/Full Name Phone
Updated December 2013 Page 6 of 7
Position Staff ID
School/Institute Student ID
Email
Position / Other Affiliations Relevant to this Application
If Student, provide Details on Level and Course of Study
Co-Investigator
For database purposes please ensure that all details are up to date and correct
Title/Full Name Phone
Position Staff ID
School/Institute Student ID
Email
Position / Other Affiliations Relevant to this Application
If Student, provide Details on Level and Course of Study
Section 13. Certification
By submitting this application(1) , I, the Chief Investigator, declare that I :
have obtained agreement from all co-investigators listed on this application and will retain evidence of this agreement(2)
1 The application must be submitted by the Chief Investigator from a password-protected computer issued by La Trobe University.
2 This evidence may consist of a hard-copy signed document or an email from the co-investigator agreeing to participate as described in the application.
By submitting this application, we, the La Trobe University co-investigators declare that we:
have read and agree to abide by the La Trobe University Human Research Ethics Guidelines.
have read and agree to abide by the conditions and constraints of the National Statement on Ethical Conduct in Human Research
(2007) and any other relevant University and / or statutory requirements;
abide by the terms and conditions set by the University Human Ethics Committee;
will ensure that the qualifications and / or experience of all La Trobe University personnel involved with the project are
appropriate to the procedures performed;
will ensure that any permits from external organisations or agencies will be obtained and that any imposed conditions will be
observed;
understand that the information contained in this application is given on the basis that it remains confidential in accordance
with relevant University and statutory requirements.
certify that the information contained in this application is true and accurate;
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