The Neurological Patient Database (NPD)

NEUROLOGICAL PATIENT DATABASE (NPD)
POLICIES AND PROCEDURES FOR THE RESEARCHER, (pdf)

The following guidelines will outline the policies and procedures which govern the usage and maintenance of the 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 and Tri-Hospital Board of Ethics (if needed). A photocopy of final ethics clearance should be made available to the NPD project coordinator (Currently: Nadine Quehl, PAS 4041; ext 37224).

Please read this document in full and complete the attached forms.

2.0 NEUROLOGICAL PATIENT RECRUITMENT

2.1 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.

2.2 Recruitment of Patients for Specific Research Studies (Primary Investigators, Students, Research Assistants, etc.)
Upon approval of ethics from the ORE, 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;
a) The investigator will identify him/herself to the patient as being a researcher with the Neurological Patient Database.
b) An explanation (in lay terms) of the study and what the patient would be asked to complete.
c) Should a patient wish to continue with the proposed project, the investigator will set up a time and meeting place with them.
d) 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.
d) 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

3.1 General Guidelines for All Patient Testing
ORE 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.

3.2 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 website: http://www.grhosp.on.ca/visitors 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.

3.3 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).

Remuneration Guidelines

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

(A) 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.
(B) 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
(C) 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

Office of Research Ethics (ORE), University of Waterloo
http://iris.uwaterloo.ca/ethics/human/index.htm

Tri-Hospital Research Ethics Board
http://www.grhosp.on.ca/Tri-HospitalResearchEthicsBoard

Grand River Hospital, general website
http://www.grhosp.on.ca

Tri-Council Policy on Ethical Conduct for Research Involving Humans
http://www.pre.ethics.gc.ca/english/policystatement/introduction.cfm

The Interagency Advisory Panel on Research Ethics released an online tutorial in 2004 as an educational resource for the Tri-council Policy Statement: Ethical Conduct for Research Involving Humans
http://www.pre.ethics.gc.ca/english/tutorial/

You will also be required to complete the online Grand River Hospital Privacy and Confidentiality Course:

All Users Instructions via the internet website:
1.         Go to the hospital’s website http://www.grhosp.on.ca
2.         Click on the Organizational Development/ Staff Education link in left hand column
3.         Select Learning Management System
4.         Click where it says “Click Here” at bottom of paragraph describing the LMS
5.         If staff, click “Sign-in” in top right corner; if you are a guest, click on Catalogue tab, top left
6.         Search for Privacy & Confidentiality Course in All Courses
7.         Click Select this Course
8.         Click Take Course Now
9.         If you are a guest, print off the last page to display completion and forward it to the Privacy Office along with the signed Confidentiality Agreement

FORMS

Please complete the attached forms and hand them into the NPD Project Coordinator. The Project Coordinator at this time is;

Nadine Quehl
Department of Psychology, PAS 4041
(519) 885-1211 ext. 37224
nquehl@uwaterloo.ca

Feel free to contact the project coordinator if you have any questions or concerns regarding the NPD.

Request for Patient Participants
Name of Project: ___________________________________________________________

Principal Investigator: ___________________________________________________________

Collaborators/Students            email                                             ext. ______________________     __________________________      ________
______________________     __________________________      ________
______________________     __________________________      ________
______________________     __________________________      ________
______________________     __________________________      ________
(If more space is needed, please continue on the back of this page)

ORE Clearance number: __________________ Clearance date: __________
THREB Approval number (if needed): ________________________

Type of study (behavioral, electrophysiological, etc):__________________
Location of testing:______________________________________________
Number of sessions required with patient: ____________
Anticipated duration of study- per session (minutes): _____________
Anticipated completion date: __________________________

⁭ Brief description of proposed project (as found in ORE 101) attached
⁭ Feedback page attached
⁭ Photocopy of ORE and THREB approval attached
⁭ Non-Disclosure Statement Form for all those working on this project attached

I agree to hold any personal information about potential patient participants in the strictest confidence. I agree to contact these participants for the purposes of the study described above, and I agree to notify the NPD Project Coordinator as soon as I no longer require these participants for the purposes of this study. I will not contact potential participants that I know personally, or whose names are familiar to me – instead, I will notify the Project Coordinator of this conflict of interest immediately, and additional names will be provided to me in order to replace the ones that I recognize.
I HAVE READ AND AGREE TO ABIDE BY THE NPD POLICIES AND PROCEDURES.

Signed: ________________________________ Date: ________________________

Signature of Principal Investigator: ______________________________________

Non-Disclosure Statement Form

All those who will be in contact with any participants, their information, as well as the data collected from these patients must sign this form. Duplicate this form as needed and attach to the completed Request for Participants form.

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I agree to hold any personal information about potential patient participants in the strictest confidence. I agree to contact these participants for the purposes of the study described above, and I agree to notify the NPD Project Coordinator as soon as the participants have completed their involvement in the study. I will not contact potential participants that I know personally, or whose names are familiar to me – instead, I will notify the Project Coordinator of this conflict of interest immediately, and additional names will be provided to me in order to replace the ones that I recognize.
I HAVE READ AND AGREE TO ABIDE BY THE NPD POLICIES AND PROCEDURES

Print Name:______________________________

Signed: ________________________________ Date: ________________________

Print Name:______________________________

Signed: ________________________________ Date: ________________________

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I agree to hold any personal information about potential patient participants in the strictest confidence. I agree to contact these participants for the purposes of the study described above, and I agree to notify the NPD Project Coordinator as soon as the participants have completed their involvement in the study. I will not contact potential participants that I know personally, or whose names are familiar to me – instead, I will notify the Project Coordinator of this conflict of interest immediately, and additional names will be provided to me in order to replace the ones that I recognize
I HAVE READ AND AGREE TO ABIDE BY THE NPD POLICIES AND PROCEDURES.

Print Name:______________________________

Signed: ________________________________ Date: ________________________
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Policies and Procedures