operational approval for research ......operational approval for research saskatchewan health...

OPERATIONAL APPROVAL FOR RESEARCH SASKATCHEWAN HEALTH AUTHORITY

REGINA AND AREA

Version 5.1 dated June 22, 2018 of 14

Submit to: Research Approval Coordinator, Saskatchewan Health Authority – Regina and Area Room M-704, Wascana Rehabilitation Centre 2180 - 23rd Avenue, Regina, SK S4S 0A5 [email protected] (306) 766-0893

If you have any questions regarding how to complete this form, please refer to the associated Operational Approval Guidance Notes available at: http://www.rqhealth.ca/department/research-and-performance/operational-approval or contact the Research Approval Coordinator at the coordinates listed above.

Once this form is completed, submit it to [email protected] and the Department of Research and Performance Support, Saskatchewan Health Authority – Regina and Area (formerly Regina Qu’Appelle Health Region), will obtain the appropriate signatures.

PART 1: IDENTIFICATION

1.1 Project Title:

Abbreviated Title (if applicable):

Anticipated Start Date (mm-dd-yyyy): Anticipated End Date (mm-dd-yyyy):

New Project Application to Amend a Previously Approved Project

1.2 Principal Investigator:

Full Name: Telephone Number:

Affiliation: Department:

Mailing Address: Email Address:

1.3 Project Personnel:

Full Name:

Email Address:

Full Name:

Email Address:

Full Name:

Email Address:

Full Name:

Email Address:

Full Name:

Email Address:

Full Name:

Email Address:

mailto:[email protected]

http://www.rqhealth.ca/department/research-and-performance/operational-approval




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PART 2: FUNDING

2.1 Source of Funds*:

Industry (for-profit organization)** National Institute of Health (NIH)

Tri-Council Grant (CIHR, SSHRC, NSERC) Sask. Health Research Foundation (SHRF)

Not-for-Profit Foundation – Please specify:

Internally funded (Saskatchewan Health Region) – Specify Department:

Other – Please specify:

Not Applicable (if there is no financial support being provided for this study, proceed to Part 3. Please

note that studies with no funding that are requesting billable services may be denied Operational Approval)

*Research may be supported internally through the use of departmental resources, facilities, or personnel, however this section refers only to the source of financial support, where funds are transferred to the Principal Investigator for use in a research study. **Note: For-profit organizations will be subject to the Authority’s institutional overhead fee, charged at a rate of 30% of the funds awarded.

2.2 Specify funding source, grant competition, or award:

2.3 Status of Funds: Awarded Pending

*Note: If funds have been awarded, please attach a copy of the Award Letter to this application.

2.4 Name of Sponsor (if different from funding source in 2.2):

2.5 If you are in receipt of funding to support your research, you must open an Research Account to manage your project funds (to administer and manage funds through the Authority).

Please complete a Research Account Application Form and attach it to this application. Link to the form is available at: http://www.rqhealth.ca/department/research-and-performance/operational-approval

PART 3: CONTRACTS

3.1 Will there be a contract associated with this research project?

Yes No – If you checked “No,” proceed to Part 4.

N/A contract already executed with initial application

3.2 Type of contract (check all that apply):

Confidential Disclosure Agreement (CDA) / Non-disclosure Agreement (NDA)

Sub-Site Agreement (SSA)




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Clinical Trial Agreement (CTA) / Clinical Study Agreement (CSA)

Data Sharing Agreement (DSA) / Data Transfer Agreement (DTA)

Funding Agreement Other (please specify):

3.3 If you indicated “yes” to 3.1, please submit the following by email to the Research Contract Specialist ([email protected]) for legal review and contract negotiation:

Research Project Title Contact information for the other party (Principal Investigator/Sponsor and Contracts Office) https://clinicaltrials.gov/ link or protocol number for study (if applicable) Draft agreement provided by Sponsor (or indicate that a new agreement must be drafted)

NOTE: MUST BE IN WORD DOCUMENT FORMAT! (so that changes can be tracked) Copy of study protocol and/or consent form and all relevant appendices (e.g. study budget)

3.4 Contract-related comments for consideration:

PART 4: DEPARTMENTAL IMPACT ASSESSMENT – Resource Utilization

Resource utilization refers to the utilization of Regina Area personnel, facilities, or equipment for tests/ procedures/tasks required for clinical research. This applies to study-specific tests or procedures and includes outpatient and inpatient participants. For more information, please refer to the Operational Approval Guidance Notes available at: http://www.rqhealth.ca/department/research-and-performance/operational-approval.

REDCap Account

REDCap (Research Electronic Data Capture) is a secure web based data collection platform for building and managing online surveys and databases.

4.1. REDCap

Do you intend on using REDCap for this research project?

Yes– If you checked “Yes,” proceed to (insert Hyperlink) and complete REDCap application form

No


https://clinicaltrials.gov/




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ACCESS TO EXISTING HEALTH INFORMATION

*If you are unsure of which data source would be most appropriate, it is recommended that you consult with HIMS and/or IT in order to determine the appropriate source prior to seeking approval.

4.2 HEALTH INFORMATION MANAGEMENT SERVICES (HIMS)

Will you be requiring access to hard-copy patient charts for your research study?

Yes No

Approximately how many charts will you need access to (retrieved by health records)*?

*Note: The fee per chart is $7.10 for on-site charts and $17.70 for charts requiring retrieval from off-site long-term storage. If no external funding is available to cover this fee, a strict limit of 200 charts per study will be imposed. Please refer to the associated Research Costing List available at: http://www.rqhealth.ca/department/research-and-performance/operational-approval for more information.

Will you be requiring the generation of a patient report or data file from an electronic Health Records database for review (either in place of or in addition to the hard-copy patient charts)?

Yes No

Please specify which information you will require in the patient report or data file:



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4.3 INFORMATION TECHNOLOGY (IT) SERVICES

Will you be requiring access to Electronic Patient Records for your research study? (Please note that resources are limited and requests for access/information will be granted in the order that they are received. Please also be aware that there is a high demand for custom developed SCM Reports and we are currently processing a backlog. We recommend getting any reporting requests in the queue as soon as you have defined the requirements to help mitigate the delay.)

Yes* No - If you checked “No,” proceed to Section 4.3.

*If you answered “yes”, you MUST attach a copy of the Data Collection Tool and/or Case Report Form(s) that you will be using to extract your data elements.

Please provide rationale for why you will be requiring access to electronic patient records for your research study:

Please list the study personnel that will be accessing information from the electronic patient records:

Full Name:

Email Address:

Phone number:

Full Name:

Email Address:

Phone number:

Full Name:

Email Address:

Phone number:

Full Name:

Email Address:

Phone number:

What is the time period for which study personnel will require access?

Start Date (mm-dd-yyyy): End Date (mm-dd-yyyy):


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ACCESS TO OTHER HOSPITAL SERVICES

4.4 LABORATORY SERVICES

Will you be requiring Laboratory Services from Regina or the Row Romanow Provincial Lab (previously Saskatchewan Disease Control Lab) for your research study?

Yes No - If you checked “No,” proceed to Section 4.4.

*Note: All research studies requiring Laboratory Services are subject to a $150.00 Lab Utilization Fee. Studies will then be charged on a per sample basis, at a rate dependent on the service being provided. Please refer to the Research Costing List available at: http://www.rqhealth.ca/department/research-and-performance/operational-approval for more information.

What service(s) will you require?

Phlebotomy

Approximate number of samples:

Chemistry


Description of services required:

Hematology



Anatomic Pathology



Laboratory Information System (LIS) Data Extraction



Microbiology





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Specimen Storage



Other



4.5 MEDICAL IMAGING AND NUCLEAR MEDICINE SERVICES

Will you be requiring Medical Imaging and Nuclear Medicine Services for your research study?

Yes No - If you checked “No,” proceed to Section 4.5. Note: Studies will be charged on a per participant basis, at a rate dependent on the service being provided. Please refer to the Research Costing List available at: http://www.rqhealth.ca/department/research-and-performance/operational-approval for more information.

What service(s) will you require?

X-ray

Approximate number of participants:


Modified Barium Swallow



MUGA



CD copy of test



MRI





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CT Scan



Tomogrophy



Ultrasound



Doppler



Other



4.6 PHARMACY SERVICES

Will you be requiring Pharmacy Services for your research study?

Yes No - If you checked “No,” proceed to Section 4.6.

The only Pharmacy Department service currently available to support drug research is storage of Investigational Product which includes availability of monitored refrigerators/freezer if necessary. Please note, this does not include ordering product or maintaining drug inventory logs. This will be the responsibility of study personnel who will be provided access to the Department to perform these functions during Department hours of operation only.

Indicate if you will require the following?

Storage space for Investigational Drug Product


*If reports of 24h temperature logs for Pharmacy Department refrigerators/freezer are required, please contact Facilities Management - Building Automation Technology as needed (RGH -Dan Helmond [email protected] or PH - Elton Preikchat [email protected])




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4.7 AMBULATORY OR OTHER DIAGNOSTIC SERVICES

Will you be requiring any diagnostic services for your research study that were not mentioned above in Sections 4.1 – 4.5?

Yes No - If you checked “No,” proceed to Part 5.

*Note: Additional services may be subject to additional fees. Please refer to the Research Costing List available at: http://www.rqhealth.ca/department/research-and-performance/operational-approval for more information.

What services will you require?

Specify service:



Specify service:



Specify service:



Specify service:






REGINA AND AREA


PART 5: DEPARTMENTAL IMPACT ASSESSMENT – Program/Unit/Facility Utilization

Program utilization refers to access to Regina Area programs for recruitment of study participants (inpatients, outpatients, long term care residents, or staff), or if the study will be taking place within a program or accessing data from a program. This section is intended for the identification of departments/divisions/services whose operations will be affected by your research protocol. This is to ensure that, prior to commencement of the study, these individuals have had an opportunity to assess the impact of the protocol on their area.

Services/resources required?

Department Description of services/resources required

Y N Communications

Y N Critical Care & Cardioscience Units & Medicine Inpatient Units

Y N Emergency & EMS

Y N Library Services (specialized support)

Y N Long-term Care (Urban)

Y N Long-term Care (Rural)

Y N Mental Health & Addictions

Y N Nursing Unit (specify):



Y N Nutrition & Dietetics

Y N Population & Public Health

Y N Primary Health Care (Rural)

Y N Primary Health Care (Urban)

Y N Surgical Services

Y N Rehabilitation

Y N Research (specialized support)

Y N Women’s & Children’s Health

Y N Other:

Y N Other:


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PART 6: DECLARATION BY PRINCIPAL INVESTIGATOR

By signing below, I certify that all information provided herein is accurate and complete. If circumstances should arise that materially affect the accuracy and completeness of the information provided, I will immediately report the new information in writing. I agree to abide to all applicable laws, regulations and international guidelines concerning the conduct of research with humans. I have read, understood and will abide to the Saskatchewan Health Authority – Regina Area, Research Policies and Procedures as outlined at: http://www.rqhealth.ca/department/research-and-performance/research-policies-and-procedures.

PRIVACY AND CONFIDENTIAL INFORMATION DISCLOSURE:

Under the provisions of The Health Information Protection Act (HIPA), The Local Authority Freedom of Information and Protection of Privacy Act (LA FOIP), and other privacy legislation, the Saskatchewan Health Authority (h e r e in ‘ th e Au th or i ty ’ ) is under a duty to establish policies and procedures to protect confidential information which it collects and has under its custody and control. In this respect the Authority must ensure compliance with these Acts by persons providing services to the Authority, including research participation.

As an individual conducting research within the Authority, I understand that I may have access to confidential information in many formats including, without limitation, electronic, printed, or spoken communication. Confidential information may include, but is not limited to, information relating to:

Patients – including Personal Health Information (i.e. medical records, diagnoses, conversations, admittance information);

Employees – including employment records, disciplinary actions;

The authority’s business information – confidential information collected for SHA business purposes as defined in LA FOIP which includes, but is not limited to, financial and statistical records, strategic plans, internal reports, memos, draft documents, contracts, legal advice, vendor proposals, quality assurance reviews, communications, proprietary technology and computer programs, source code, evaluations; and

Information about the Authority’s business partners and service providers. Collectively, the above-mentioned information shall be referred to as “Confidential Information.”

Accordingly, I acknowledge and agree that my right to view, use, and disclose Confidential Information is subject to the following conditions:

1. I will only view, use and disclose Confidential Information on a need-to-know basis to perform my duties as defined by my relationship with SHA or as required by law:

a) I will not view, use or disclose Confidential Information which I have no legitimate need-to-know;

b) I will keep all Confidential Information in the strictest of confidence; c) I will only view and use such Information for the purpose(s) for which I am granted user

rights, and will only disclose that information as permitted by HIPA, LA FOIP, other law and/or the Authority’s policy;

d) I will not view or use databases to access my own personal health information at the SHA;

e) I will not in any way divulge, copy, release, alter, revise, or destroy any Confidential Information except as properly authorized within the scope of my duties with the

http://www.rqhealth.ca/department/research-and-performance/research-policies-and-procedures

http://www.qp.gov.sk.ca/documents/english/Statutes/Statutes/H0-021.pdf

http://www.qp.gov.sk.ca/documents/English/Statutes/Statutes/L27-1.pdf

http://www.qp.gov.sk.ca/documents/English/Statutes/Statutes/L27-1.pdf


REGINA AND AREA


Authority and as permitted by law and any of the Authorities policies regarding the release of Confidential Information; and

f) I understand that it is my responsibility to ensure Confidential Information in my possession is maintained in a physically secure environment.

2. I will safeguard and will not disclose or share with any other person my access code(s) (password), user IDs, access passcards, keys or any other authorization code or device that allows me use to Confidential Information. I accept responsibility for all activities undertaken using my codes and devices:

a) I will log off of computer systems after use; b) I will not log on to a system or access Confidential Information to allow another person to

view that Information or to use that system; c) I will report any suspicion or knowledge that my access code, user ID, access card, key or

other authorization code or device, or any Confidential Information has been lost, misused or disclosed without SHA Regina Area authorization;

d) If I download or transfer computer files containing Confidential Information to any non-SHA authorized computer, data storage device, portable device, mobile device, or other device capable of storing digitized data it shall be done in compliance with HIPA, LA FOIP, any other privacy legislation and the Authorities policies with respect to the treatment of the Confidential Information;

e) I will only print documents containing Confidential Information in a physically secure environment, will not allow other people access to printed Confidential Information, and will store all printed Confidential Information in a physically secure environment; and

f) If I no longer need Confidential Information, I will securely dispose of or destroy the Confidential Information. (Note that physicians may be required to maintain patient files beyond this period for ethical and legal reasons and this is their responsibility).

3. I acknowledge my obligation to report to the SHA Regina Area Privacy Office a n d the R e s e a r ch A pp ro va l Coo r d i na to r any practice by another person that violates these obligations or puts SHA, its personnel, or its patients at risk of improper access, use or disclosure of Confidential Information.

4. I understand that my use of Confidential Information is subject to monitoring and periodic auditing by the SHA.

5. I agree that I have no right or ownership interest in any Confidential Information referred to in this Agreement.

6. I agree to review and comply with all applicable legislation and SHA Regina Area policies respecting privacy, confidentiality and security of which I am specifically advised and provided a copy of or given access to by the SHA, as amended from time to time.

7. I understand that a failure to comply with this Agreement may result in action being taken against me which may include, but is not limited to, the following:

a) Disciplinary action by the SHA which may result in the suspension or revocation of my appointment and privileges, or the termination of my employment;

b) A legal action being brought against me by the SHA or the patient affected by the breach of Confidential Information;

c) A complaint or report about me being made to my professional licensing body by the SHA;

d) A complaint being made to the Privacy Commissioner by the SHA; and/or e) A complaint to a law enforcement agency by the SHA.


REGINA AND AREA


In addition to other remedies available, SHA will not provide any further data to the Researcher if any of the conditions set out in this Agreement have been breached and will seize the data already provided. The terms and conditions of this Agreement will be of indefinite duration. Please Note: Depending on the nature of the research project, a separate Memorandum of Understanding (MOU) between the Regina Qu’Appelle Health Region and the Principal Investigator may be required.

Signature of Principal Investigator:______________________________Date:______________________

Please complete this form and submit it electronically to the Research Approval Coordinator.

The signature page can either be submitted as a scanned PDF page of a hand written signature or as a hard-copy page mailed to the Research Approval Coordinator.

Research Approval Coordinator Contact Information: Research and Performance Support Room M-704, Wascana Rehabilitation Centre 2180 - 23rd Avenue Regina, SK S4S 0A5 [email protected] (306) 766-0893



REGINA AND AREA


PART 7: ATTACHMENTS

Provide a full and accurate listing of all documents submitted with this application.

Document Included? Comments

Funding Award Letter / Notice of Award

*Mandatory for all studies receiving external funds

Yes N/A

Research Account Application

*Mandatory for all studies receiving external funds

Yes N/A

Draft Contract

*Mandatory for all studies involving a research contract

Yes N/A

Data Collection Tool

*Mandatory for all studies requesting

access to Electronic Patient Records

Yes N/A

Other – please specify: Yes N/A



operational approval for research ......operational approval for research saskatchewan health...

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