Control Cohort: Healthy Donor Samples For Medical Research
What is this cohort?
It is a cohort of various samples from healthy people aged 18 and over
Why are we collecting this cohort?
The reasons are actually many fold but in a nutshell it is to allow us to have real samples to use as control samples for medical research method workups and for use in creating reference ranges for the normal population and also for use as control samples in normal testing processes. We can’t get these samples from anywhere else and it is important that we do get a good cross section of the normal population. Without this information we will be unable to conduct quality medical research and understand what is normal in the general population.
Can I donate samples?
If you are age 18 or over and are otherwise healthy, you can donate samples to our cohort. This is obligation free and we ask to keep your information on file as a potential donator of the samples you could provide. When we need samples of the type you may have agreed to provide we will contact you using the methods you tell us we can use. You are at all times free to decline when we ask, and you will be unable to donate a sample if you have been ill in the previous 6 weeks. To enquire about becoming a sample donor please contact the Study Manager: A.Prof. Mark Watson, Medical Genomics and Facility Manager, Health Futures Institute, Building 390 Discovery Way, Murdoch University on 9360 1367. You may enrol in person, via mail or on line (see below). We encourage you to read the information below before you consider enrolling .
What happens to samples I donate?
Below is a detailed description of what would happen to samples you donate. Essentially they are used immediately or they are stored for our future use. You are able to select if you would like your samples to stored or not stored for future use. If we store your samples you may at any time ask for us to remove then from storage and destroy them.
Approved Study information is described below here:
This study has been approved by the Murdoch University Human Research Ethics Committee (Approval 2020/053 and amendments) ——————————————————————————————————————————————————
Aim: To provide samples for research methodology control, development and validations at Murdoch University
Please take time to read the following information carefully. If any part of the information is not clear to you, or if you would like more information do not hesitate to ask us to explain it more fully. Make certain you do this before you sign the consent form to participate in this process.
Project Title: Healthy donor samples for medical research.
Study Manager: A. Prof. Mark Watson, Health Futures Institute, Building 390 Discovery Way, Murdoch University. mark.watson@murdoch.edu.au 93601381
Do I have to participate in this study?
No. Participation in this study is completely voluntary.
What do you require from me?
We ask that you allow us to add your name to our sample donor registry so that we are able to contact you in the future to donate samples you are willing and able to provide.
Why have I been approached to participate?
It is important that we obtain a good cross section of samples to understand the variances in the general population as they may apply to the assays we are developing. Participation in this study is unrestricted with the only criteria for exclusion from the study at enrolment being;
· that you must be over 18 years of age
· You are otherwise and to the best of your knowledge in good health
Each time you are asked to donate a sample we will ask you questions relating to your current health status. You must also meet the following criteria at the time of donation
· You must not be currently unwell and or have been unwell in the preceding six weeks
· You are otherwise and to the best of your knowledge in good health.
What is the purpose of collecting samples for this study?
Research worldwide suffers from a lack of reproducibility due to a lack of standardisation of methods and samples. The Murdoch University Health Futures Institute aim to produce the most reproducible research data worldwide. We are doing this by attaining national and international accreditation for the research work we do. This requires a great deal of effort to workup and validate the assays we perform to bring them under our accredited quality workflows umbrella. Such workup and validation require “real-word samples” to evaluate the sensitivity, specificity and reference ranges for the workflows we develop. The samples that we are seeking from you will enable us to perform these incredibly important steps to ensure our research outputs are of the highest international standards.
Normal reference ranges are equally as important as samples from persons with disease and while obtaining samples from affected individuals is relatively easy getting a suitable comparison data set for what is “normal” is often extremely difficult and where this project hopes to help in allowing data to be available for direct comparison from a normal population.
The assays your sample could be used in vary greatly in their scope but are broadly focused across all aspects of health and nutrition..
There will be no benefit to you directly by participating in this study. The benefit to reproducibility in scientific medical research and improved research quality is great. Your choice to participate is entirely yours.
What will I be asked to do?
Initially, you will be asked to consent to being on a list of people we could approach when we are in need of control / workup / validation samples. This allows us to keep a record of who we can approach for a particular type of sample in the future. You will be asked to indicate what type of samples you would be willing to donate. At a later date, we may contact you to ask if you would still be willing and able to provide a sample. You will always be able to decline even if you have agreed to provide a sample previously. The provision of any sample at any time is purely your own decision and will not affect your ability to donate a sample in the future in any way.
What is the process for me to be involved?
Once the purpose of the study has been carefully explained to you and you have decided to participate, we require you to consent in writing to be included in this study. The consent can be conducted in person or online.
How frequently will I be asked to provide a sample?
The frequency of the request is unknown and will be depended upon the size of the donor registry and the laboratory needs. It is unlikely you would be asked to provide samples more than a few times annually and you would always have the option to decline without prejudicing your future provision of samples. You may at any time withdraw from the process or change the types of samples you have previously agreed to donate.
What will happen to my sample after I provide it?
Once you have donated your sample it will be sent to the Health Futures Institute at Murdoch University. Your sample will usually be used immediately for control / workup and validation of assays. Your sample may also be stored for future use for control or validation purposes. On each occasion when you provide samples you are able to select during the consent process whether in addition to having your samples used immediately you are also willing to consent for them to be stored for future use. As our process involves the use of confidential codes on all samples, we will not be able to identify you from your samples regardless of whether they are stored or used immediately. Your samples may be pooled with other samples to make a population super sample with each individual being indistinguishable in that super sample. This process involves adding your sample to other samples of the same type before we do anything with the samples, this has the effect of averaging out the levels of things we measure in the pooled sample and reflects the average for the normal population.
Will all information about me, including my test results, be kept confidential?
Trained research staff will ensure that your data is handled in strict confidence and in compliance with privacy laws. Your samples will be deidentified with a unique code that will be coded to your samples and any data generated from them. Only the Study Manager and their authorised delegates will have access to the coded donor registry.
Who is funding this study?
Murdoch University are providing support for this study.
If I have any questions about this research who can I contact?
You are welcome at any time to contact the Study Manager (as details above ) who is independent from the researchers who will be involved with the samples.
Who do I contact if I have any concerns or complaints?
This study has received the approval of the Murdoch University Ethics Committee. If you have any concerns about the conduct of the study or your rights as a study participant, you may contact:
Human Research Ethics Officer, Murdoch University, Chancellery Building Room 1.006, South Street, Murdoch, Western Australia 6150
Phone: +61-8 9360 6677
Email: Ethics@murdoch.edu.au
How can I find out more about the research work my samples will have helped support?
The work we will perform with your samples is not directed toward any specific research project. Instead, it will support a great many projects worldwide by enabling the development and validation of workflows used in the Heath Futures Institute to improve the health of people world-wide. Outcomes of the work conducted by the Institute are published on the Murdoch University web site http://iiid.murdoch.edu.au/Research/
We are happy to discuss with you our recent developments and how samples you may provide have or will support cutting edge research for the benefit of all. Please contact the Study Manager for more information.
Sincerely,
Asc. Prof. Mark Watson
This study has been approved by the Murdoch University Human Research Ethics Committee (Approval 2020/053). If you have any reservation or complaint about the ethical conduct of this research, and wish to talk with an independent person, you may contact Murdoch University’s Research Ethics & Integrity on Tel. 08 9360 6677 (+61 8 9360 6677 for overseas studies) or e‐mail ethics@murdoch.edu.au. Any issues you raise will be treated in confidence and investigated fully, and you will be informed of the outcome
How can I enrol?
You can enrol by contacting the study manager and requesting a study pack or you can complete an enrolment on line. Please contact the study manager to obtain the on line link.
