Department of Evaluation and Research Services
#400, 13450 102nd Avenue, Surrey, BC V3T 0H1
Phone: 604.587.4436 Fax: 604.930.5425
APPLICATION FOR INITIAL ETHICAL REVIEW
The ethical review process is governed by the FH Policy: “The Ethical Conduct of Research and Other Studies Involving Human Subjects”
INSTRUCTIONS FOR COMPLETION
1) Complete this form with reference to the current FHREB Guidance Notes (GN) for Initial Applications at http://research.fraserhealth.ca/media/FHGN_Initial-Application-for-Ethical-Review.pdf
2) All questions must be answered. Please indicate “Not Applicable” if necessary.
INSTRUCTIONS FOR SUBMISSION
Delegated Review / Full Board Review
· Submit for delegated review if project meets all of the following criteria: (double click to check)
Minimal risk – refer to Guidance Notes for definition
Does not have any corporate (i.e. industry/for profit) sponsorship (industry grants-in-aid are DR)
Does not involve subjects incapable of full consent unless for retrospective chart review or observational data collection only
Does not deviate from standard clinical practices or from normal procurement of tissue/blood / · Submit for full board review if project meets any of the following criteria: (double click to check)
Does have any corporate (i.e. industry/for profit) sponsorship
Does require a waiver of consent – refer to page 9.
Does involve subjects incapable of full consent unless for retrospective chart review or observational data collection only.
Does deviate from standard clinical practices or from normal procurement of tissue/blood
Does involve linkage of subject personal information to non-FHA databases/registries
Email all documents to
· Obtain electronic/digital signatures or fax application’s signature page to 604-953-5137 at same time as electronic submission.
· All approved consent form(s) will be stamped with approval date and returned with the initial ethics approval certificate.
· List all documents submitted with this application; indicate n/a if not applicable.
· Incomplete submissions will be returned.
· Use the attached Appendix 1, Page 10, for additional information or to complete the application boxes.
Document Type: * Always Required with Submission
Version # and/or Date MUST be included for applicable documents. INCLUDE DATE AS YYYY MM DD
Application Form-Principal Investigator Signature
Date / Participant Consent Form
Version # Date
Principal Investigator C.V.
Date / Normal/Control Consent Form
Version # Date
Protocol
Version # Date / Optional Consent Form (e.g. biobanking, genetic, biomarker)
Version # Date
Investigator’s Brochure (Clinical Drug Trials only)
Version # Date / Assent Form
Version # Date
Questionnaires, Tests, Interview Scripts, Focus Group Guides, etc. Use Appendix 1 to append a separate list. / Other Consent Form
Version # Date
Peer Review Reports
Date / Data Collection Tools/Case Report Form. A list of ALL variables to be collected must be submitted for quantitative studies.
Version # Date
1. Title of Research Proposal
2. Main Contact Information
All correspondence including the initial Certificate of Ethical Approval will be emailed to the address given here.
Surname / Title / Mailing Address
First Name / Email Address / City/Province
Postal Code
3. Key Words (key words may include the disease, the intervention, the topic/category of study etc.)
1. 2. 3. 4. 5.
4. Has/will this study been/be submitted to/approved by another Research Ethics Board?
Yes No If yes, provide the name of the REB(s)
5. Principal Investigator
Check only one as applicable:
FH Principal Investigator
Must be FH employee or physician with privileges at the FH Site(s) for this study. / Academic Affiliated Principal Investigator
Must be a non-FHA researcher who has been granted ‘affiliated’ status with FHA.
Affiliated Researchers must include a memo signed by their FHA co-Investigator that describes their responsibilities for this study.
Submitted Pending
Surname / FHA Department/Division
FHA Site
IF AFFILATED ONLY
Faculty/University
Email Address
Mailing Address
First Name
Title
Address
Mailing
Address
Discipline (e.g. medicine, nursing)
FHA Program (if applicable)
6. If this Research is required for completion of an Academic Program, specify:
Name of University and type of degree Program:
Masters Doctorate Residency Other:
7. SIGNATURES
PRINCIPAL INVESTIGATOR [PI]:
By signing this page, I certify that I have read this application and that the information provided is accurate and complete. I will conduct the proposed research in accordance with the FHA policy on the “Ethical Conduct of Research and Other Studies Involving Human Subjects”, the Tri-Council Policy for “Ethical Conduct for Research Involving Human Subjects” and all other applicable laws, regulations and guidelines. /
PI Signature Date
ADMINISTRATIVE SUPERVISOR:
[this person cannot be a co-investigator]
I confirm that the Principal Investigator has the qualifications, experience and resources to carry out this research. /
Supervisor Signature Date
Supervisor Printed Name
Supervisor Title Site
8. Co-Investigators List all Co-investigators (insert appendix if necessary)
FH Co-I: / Non-FH Co-I: / Full Name: / Email Address:
FH Co-I: / Non-FH Co-I: / Full Name: / Email Address:
FH Co-I: / Non-FH Co-I: / Full Name: / Email Address:
FH Co-I: / Non-FH Co-I: / Full Name: / Email Address:
FH Co-I: / Non-FH Co-I: / Full Name: / Email Address:
FH Co-I: / Non-FH Co-I: / Full Name: / Email Address:
9. Type of Research
Please check the box which most closely describes the type of research for this study:
Biomedical
Clinical
Health Services
Population Health
/ Research on human subjects that is not diagnostic or therapeutic.
Research on or for the treatment of patients.
Research on how to improve efficiency/effectiveness of the health care system.
Research on factors affecting health status.
Ethical review is NOT conducted for evaluation/quality improvement.
10. FH Sites Where Research will be Conducted
ARHCC BH CGH DH ERH FCH LMH PAH RCH RMH SMH JPOCSC
Physician’s Private Office Community Site(s), please specify:
Other:
10a. Is this proposal closely linked to any other proposal submitted to the FHREB? / Yes / No
10b. If Yes, Describe the relationship of this proposal to this primary study:
10c. If Yes, provide the FHREB File Number of Primary study:
11. Department Agreement for Providing Research-Related Services [DAR] Form
The DAR Form must be completed for any studies that require access to information or services required to complete the study and that are NOT standard of care. Submit by email or fax as above. For details, refer to http://research.fraserhealth.ca/approvals_%26_ethics/forms-and-guidance-notes/
11a. Is a DAR Form Required? If YES, indicate the department (s) providing
service(s) for this study. / Yes / No
Anatomical Pathology
Biomedical Engineering
Communicable Diseases/Public Health / Diagnostic Imaging
Health Records (Electronic) Health Records (Paper) / Health &
Business Analytics
Information Management / Laboratory
Pharmacy
Patient Care/Surgical Suites
12. Funding Information: Please complete as applicable.
12a. Industry Sponsored
Directly*
Grant-In-Aid / Name of Sponsor:
Please indicate the status of the Clinical Trial Agreement (CTA) for any study funded directly or indirectly by a grant-in-aid from an industry/for profit sponsor:
CTA Submitted for Review / CTA Submission Pending
Please indicate where the funds for the study will be held:
Fraser Health Cost Centre Physician Held Account
Are there any restrictions regarding the disclosure of information to research subjects (during or at the end of the study) that the sponsor has placed on investigators, including those related to the publication of results? If yes provide details below: / Yes / No
*For Direct Sponsorship ONLY: FHREB Fee of $4,000.00 is required, payable to the ‘Fraser Health Authority’. Please submit with the application as payment is required to issue the ‘Letter of Authorization to Conduct Research’.
12b. Grant Funded Awarded Pending
Name of Granting Agency:
Name of Grant Awardee:
* Fraser Health Grant Award Recipients must include the Notification of Award Letter with this application* Notification of Award Letter attached
Name of Institution Administering Grant: / Fraser Health? Yes No Note: If yes, DERS will request that a FH cost centre to be created
If No, Name Other Institution
For studies funded by a grant held by a non-FH institution, is an agreement between FH and the institution/PI required?
Please confirm the need for an agreement with the non-FH institution. / Yes / No
If Yes, Submitted for Review Submission Pending
If Yes, will funds be transferred to FH? Yes No
12c. Other / Please specify:
12d. Unfunded
For Funded Research ONLY: Is the researcher or research group paid by the funder for each subject enrolled? / Yes / No
If Yes, state amount (Please refer to TCPS Article 7.3): / $
Will any research-related costs be billed to the health care system? If yes, provide details: / Yes / No
13. Financial Conflict of Interest
If any of the following are true for the PI, PI’S family, please provide details in the space provided below:
Has a financial interest in the research with value that cannot be readily determined (for example, stock that is not publicly traded);
Has a financial interest in the research with value that exceeds $10,000 other than payments for conducting the trial as outlined in the clinical trials agreement;
Has a financial interest in the research with value that exceeds 5% ownership;
Has received or will receive compensation with value that may be affected by the outcome of the study;
Has a proprietary interest in the research, such as a patent, trademark, copyright, or licensing agreement;
Has received or will receive payments other than payment for the conduct of clinical research form the sponsor that exceeds $10,000 in the last 365 days;
Is an employee of the agency or company sponsoring the research;
Is on the board of directors of the sponsor;
Has a financial interest that requires disclosure to the sponsor or funding source; or
Has any other financial interest that the investigator believes may interfere with his or her ability to protect subjects.
Provide details if any of the above are checked:
14. Clinical Trial Registration
All Prospective clinical trials which include an intervention and comparison group MUST be registered at one of the following. Please check which applies: Not Applicable
www.ClinicalTrials.gov / www.Controlled-trials.com / Registration No.:
15. Regulated Research
Is this study a clinical trial regulated by Health Canada? / Yes Complete the following as applicable: / No
15a. Name the investigational drug(s):
15b. Name any marketed drug(s) used outside of its approved indication:
15c. Name and describe any new investigational device(s):
15d. Name and describe any marketed device to be used experimentally:
15e. Has the Letter of No Objection [LNO] been obtained from Health Canada for this study? / Yes / No
If Yes, Date of Approval: / Is Letter attached? or Is Letter Pending?
15f. If No, has the request for approval been submitted to Health Canada?
LNO must be submitted BEFORE the Letter of Approval to Conduct Research (LOA) is issued. / Yes / No
15g. Is there a requirement for this research to comply with United States regulations under 45CRF46? (i.e. any U.S. government funded research) / Yes / No
15h. Is there a requirement for this research to comply with United States regulations under 21CFR56? (i.e. any research regulated by the Food and Drug Administration) / Yes / No
16. Peer Review
16a. Has this research proposal received independent scientific/methodological peer review? / Yes / No
If Yes, External Review Internal Review (FH or Hospital)
16b. Provide details: (i.e. include the names of committees or individuals involved in the review or explain why no independent review has taken place):
17. Participant Enrollment
17a. Is this a Multi-Centre Study? (i.e. also being conducted outside of FHA) / Yes / No
17b. For all studies, what is the total number of expected research participants? This includes the use of individual record level data obtained for secondary research (e.g. how many charts).
17c. For studies that involve an experimental intervention, how many - participants will be in the experimental arm? AND
be in the control/normal/placebo arm?
18. Procedures
18a. Please indicate which of the following procedures are involved in this study and if they are:
Standard Care [SC] or Investigational [I]. Please check all that apply.
SC or I Drug administration
SC or I Surgical procedures
SC or I Experimental medical devices
SC or I Imaging procedures (e.g., X-ray, MRI)
SC or I Collection of blood
SC or I Collection of other tissue – use of identifiers must be in consent if sent off site
SC or I Other Interventions, e.g. psychological; eHealth, rehabilitation / SC or I Questionnaires/surveys
SC or I Analysis of tissue only
SC or I Analysis of data only
SC or I Individual interview
SC or I Focus Groups
SC or I Home visits / SC or I Video/Audio Recording
SC or I Secondary use of previously
collected data (i.e. health
records) (e.g. retrospective chart review)
SC or I Database Linkage
SC or I Prospective data collection
None of these Methods
19. Privacy, Confidentiality and Data Security [Complete Appendix 2]
*Please note that if the study requires access to patient personal information that is collected and held by FH that the information provided in Appendix 2 will be forwarded to the FH Privacy Office for review and approval of the security requirements. The Privacy Office may determine that a Privacy Impact Assessment is necessary.
This is a survey and does not require written consent as consent is implied with survey completion. Yes No
If Yes, please ensure that the invitation to complete the survey meets standard requirements. Refer to the survey template at http://research.fraserhealth.ca/approvals_%26_ethics/forms-and-guidance-notes/
N.B. This does not apply to Consent To Contact databases.
20. Use of Study Results
20a. Describe any plans for using the results of the research.
20b. Are there plans to publish the results of the research? / Yes / No
20c. Are there plans to present the results of the research? / Yes / No
20d. Are there plans to implement the results of the research into practice at FHA? / Yes / No
21. Retention of Research Records
21a. Research records will be maintained for 25 years for regulated clinical trials
Research records will be maintained for 5 years
22. Research Harms Not Applicable
· Describe what is known about the risks of harm of the proposed research. Include any information about discomfort or incapacity that the participants are likely to endure as a result of the research procedure(s), along with the details of any known side effects/harms which may result from the research procedure(s).
· For clinical and non-clinical research, please attach a separate page using the table format as outlined below.
· For clinical research, ensure that all measurable side effects are quantified.
· For non-clinical research, use qualitative measures to assess severity, if quantitative measures do not apply.
· Refer to the Consent Form template and Guidance Notes for Initial Ethical Review
Template for Completion of Risks of Proposed Research