The following guidelines will outline the policies and procedures which govern the usage and maintenance of the Neurological Patient Database (NPD). These policies and procedures are in place to ensure consistency and to protect those who have volunteered at a delicate time in their lives. These guidelines apply to all researchers (including scientists, postdoctoral fellows, students, and research assistants) who have ethics clearance through the necessary institutions and wish to use the NPD.
1.0 To begin usage of the NPD
Only researchers who are members of the NPD project and their collaborators/students will be allowed access to the NPD. The study must have ethics clearance from the ORE (Office of Research Ethics) and Tri-Hospital Board of Ethics (if needed). A photocopy of final ethics clearance should be made available to the NPD project coordinator.
Please read this document in full and complete the attached forms.
2.0 Neurological patient recruitment
Original recruitment of patients by NPD project coordinator
The NPD project coordinator will recruit neurological patients with the help of the health care professionals at Grand River Hospital and their affiliations. The hospital will be visited weekly to interview new neurological patients. The reason for the visit will be explained to the patient and, upon written consent, paper and pencil assessment tests will be administered to identify their particular symptoms of stroke. The patient will be given specific database information as well as this policies booklet to read over and share with their family. This will contain the contact information for the project coordinator and Principal investigators and chairs for both the Office of Research Ethics at University of Waterloo and the Tri-Hospital Research Ethics Board.
Upon written consent to being added to the database, the patient will be asked for their contact information and information regarding their stroke. Whether or not they choose to participate will be kept confidential in order to ensure the patient that there will be no effect on the medical care depending on their decision.
Recruitment of patients for specific research studies (Primary Investigators, Students, Research Assistants, etc.)
Upon approval of ethics from the ORE (Office of Research Ethics), Researchers wishing to obtain patient participants for their studies must first complete the necessary forms in order to receive access to the NPD (see section 4.0 for these forms). Once these primary steps have been met, the investigators will be allowed to request patient information via the project coordinator. The contact and recruitment of neurological patients will be completed by the approved investigators via phone. Patient recruitment should include the following;
- The investigator will identify him/herself to the patient as being a researcher with the Neurological Patient Database.
- An explanation (in lay terms) of the study and what the patient would be asked to complete.
- Should a patient wish to continue with the proposed project, the investigator will set up a time and meeting place with them.
- Patient transportation should be offered- if needed- via taxi service (at the cost of the researcher), and the amount of remuneration for the patient’s time should be clear.
- The investigators’ (primary and other) name and contact information will be given to the patient in case of confusion or cancellation.
3.0 Patient treatment
General guidelines for all patient testing
ORE (Office of Research Ethics) approval and Tri-Hospital Ethics approval, if needed, as well as patient’s written consent must be obtained before conducting any studies. All participant tracking and additions to the database will be done solely by the NPD project coordinator.
All materials pertaining to patient information should remain confidential and only be seen by those who are approved under the ORE. Patient personal information (address, phone number, etc) should be discarded after use. The labs involved in the NPD should not retain information for a creation of their own database.
The comfort of the patient and their family is our priority, and it is important to maintain this comfort in any way possible. For the patient participant, this may include breaking up a longer study into smaller sections or shortening an existing study that is presently being completed by healthy participants to accommodate those patients who do not have the energy to complete longer tasks. Always have a feedback page as well as any contact information available for family members who wish to be more informed of your study. Remember that hospitalization of one patient will be difficult on all members of their family, and to keep their interests and feelings in mind while visiting a patient participant.
Within hospital studies (acute patients)
All studies that are to be done within the hospitals must respect the wishes of the hospitals and their staff, including the visitor limit (please see the Grand River Hospital website for more information).
All studies must be arranged ahead of time with the patient and must not interfere with rehabilitation or treatment time. When a patient is visited for a study, the patient will be verbally ensured that if at any time they wish to discontinue the study, there will be no problem and full remuneration will be given regardless of task completion.
Patients with language deficits
Patients who have left hemisphere damage may be subject to language deficits. Those who request these patients must have the proper training to understand how to communicate with the patient under these circumstances. This training will be determined by their supervisor (Principal Investigator).
While volunteerism is encouraged, the Tri-Council Policy Statement acknowledges that nominal remuneration in recognition of participant’s time may sometimes be appropriate. It is not implied that all volunteers receive payment for participation in research studies, but in some circumstances it may be warranted. These guidelines are here to promote consistency across studies.
Guidelines for remuneration
- Reimbursements of Out-Of-Pocket Expenses.
Local Travel: GRT fare or University of Waterloo parking will be reimbursed at the current rates. Where taxi or long distance travel (ie. gas or mileage costs) is involved, arrangements must be approved beforehand by the primary investigator.
Lunch: A maximum of $10 will be provided, if testing exceeds 4 hours or can only be scheduled over a lunch period.
- Nominal remuneration in recognition of time.
Note: this does NOT imply that volunteer participants must be paid for their time.
Suggested rate is $10 per hour.
- Processing of remuneration
Out-of-pocket expenses will be reimbursed in cash on the day on which they are incurred.
Payments in recognition of time will be paid in cash at the completion of each participant's time commitment. In cases where a participant withdraws from a study, payment may be pro-rated according to the amount of time completed.
It is the responsibility of the researcher to pay participants from his/her own research grants.
Where appropriate, reimbursement of expenses or nominal payment for initial testing and information gathering may be drawn from centrally-held funds (ie. a group grant).
4.0 Useful websites
Grand River Hospital privacy and confidentiality course
You will also be required to complete the online Grand River Hospital privacy and confidentiality course. Instructions for all users via the internet website:
- Go to the Grand River Hospital website.
- Click on the Careers link at the top.
- Select Wellness and Organizational Development (just below Careers).
- Scroll down to "Learning Management System" and click where it says Login Now.
- Click on Catalogue tab, top left.
- Search for REQD 102 in key words
- Go to Online Course REQD 102: Privacy & Confidentiality and click Select This Item.
- Click Take Course Now.
- When you get to the "Congratulations" page, print it off to display completion and forward it to Karly Neath-Tavares along with the signed Confidentiality Agreement. (you will need to click the link to get to the Grand River Hospital Confidentiality Agreement)
View the NPD policies, procedures, and forms for the researcher (PDF) for access to the NPD policies, procedures, and forms.