c/o Ethics Services
Saint John Regional Hospital, 2nd Floor
400 University Avenue / PO Box 2100,
Saint John, N.B., Canada E2L 4L2
Tel: (506) 648-6094 Fax: (506) 648-7734
RESEARCH STUDY APPLICATION for Non-Clinical Trials
Please ensure that the application is signed by both the Principal Investigator and the Department Head. Incomplete forms will not be reviewed.
1. RESEARCH STUDY/PROTOCOLFull Title:
Protocol #: / Version Number: / Version Date:
RS # assigned by the Horizon Health Network REB (Research Ethics Office use only):
Has this Study been approved at other Horizon Health Network Sites? Yes No (If yes, where?)
Is the Principal Investigator a trainee or Non-Horizon Health Network staff (I.e., student, post-grad, fellow)?
If yes, please complete both 2a and 2b below. / Yes
No
2a. PRINCIPAL INVESTIGATOR (Horizon Health Network staff member)
Name: / Department:
Mailing Address: / Division/Program:
Telephone:
Fax:
Pager:
E-mail:
Institutional Appointments: / SJRH / DECH / Moncton Hospital / Miramichi Hospital
UNB SJ/Fredericton / Université de Moncton / Dalhousie
DMNB / Other (please specify)
2b. PRINCIPAL INVESTIGATOR (NON- Horizon Health Network1 Staff Member)
1If not a Horizon Health Network staff member, please identify a Horizon Health Network staff member in box 3a who is an associate or Co-Investigator who will accept overall clinical and supervisory responsibility during the conduct of this study.
Name: / Department:
Mailing Address: / Division/Program:
Telephone:
Fax:
Pager:
E-mail:
Institutional Appointments: / SJRH / DECH / Moncton Hospital / Miramichi Hospital
UNB SJ/Fredericton / Université de Moncton / Dalhousie
DMNB / Other (please specify):
3. CO-INVESTIGATOR(S)
2 Signature(s) confirm the co-investigator(s) have read the protocol and the Principal Investigator has fully explained the co-investigator role in the study. The co-investigator(s) agree to conduct the study following all applicable standards. (I.e., Horizon Health policies and procedures, Tri-Council policy Statement: Ethical Conduct for Research Involving Humans).
Name / Signature2 / Name / Signature2
4. ADMINISTRATIVE CONTACT FOR STUDY
4.1 / The Principal Investigator (PI) is the administrative contact
The Research Coordinator (RC) is the administrative contact / Name:
The Study Coordinator (SC) is the administrative contact / Name:
Other: Name:
Telephone: / Fax: / Email:
4.2 / To whom is REB correspondence to be mailed? / Name:
Mailing Address:
5. RESEARCH COORDINATOR (if applicable)
Name: / E-mail:
Telephone: / Fax: / Pager:
6. POTENTIAL CONFLICTS OF INTEREST
Is there a Conflict of Interest? Yes No
(If yes, please explain)
7. REVIEW FROM OTHER REGULATORY AUTHORITIES or REB
Has this study been peer reviewed?
Yes / No / Pending / Reviewed by:
Has this study been reviewed by an REB other than the Horizon Health REB?
Yes / No / Pending / Reviewed by:
For studies that have been reviewed by another REB or regulatory authority:
Please enclose all significant previous decisions (e.g., those leading to a negative decision or a modified protocol) by other REBs or regulatory authorities for the proposed protocol/study (whether in the same location or elsewhere), an indication of modification(s) to the protocol/a study made on that account, and the reasons for previous negative decisions.
There has been no significant previous decisions by an REB or regulatory authority
Significant previous decisions are enclosed. (e.g., those leading to a negative decision or modified protocol)
8. REB FEES
REB Fee Structure (Effective January 1, 2010):
$ 2,500 for Initial Project Submission
$ 500 for Amendments
$ 500 for Annual Study Reapprovals
All projects/submissions are subject to the above stated REB Fees. A waiver of REB Fees may be granted for various submissions. A request for a waiver of REB Fees will be processed before the REB meets to review the submission that you are seeking the waiver for.
If you are requesting a waiver, please proceed as follows:
1) Email your request for a waiver to the REB Administration () detailing the reason(s) REB review fees should be waived.
2) The REB will review the request and provide a response within 2 business days of receipt.
3) Have you been granted a waiver of REB fees? Yes No
REB FEES: INVOICE INFORMATION
Please Note: The Clinical Trial Agreement along with any Cost Impact Agreements (CIAs) and their related documents are processed by Research Services. Please submit these documents directly to Research Services. (Zone 2 Only. Other zones, please contact your Research Services Office for instructions on how these documents are to be processed).
Please consult the Clinical Trial Agreement (CTA) or Grant to assist with completion of the following information. (Alternatively, you may copy and submit those pages of the CTA which contain the information requested below). If you are submitting copies, please ensure that ALL the information requested below is provided within those copies.
The Clinical Trial Agreement or Grant states or implies that REB review fees are to be paid directly by the Investigator. The Clinical Trial Agreement or Grant states that REB review fees are to be paid directly by the Sponsor or an Agent of the Sponsor (Ie. CRO)
Many contracts have very specific procedures that are to be followed in order to receive payment. (For example, a reference number or Purchase Order (PO) number must be included on the invoice). Please include this information if applicable. Failure to include this information on the invoice may result in a non payment to the REB.
Sponsor Billing Information
Sponsor Name:
Billing contact name:
If a CRO, Name of CRO
Tel: Fax: Email:
Billing Address:
9. FUNDING
Grant / Granting Organization Name:
Per Patient Amt.: / Total Grant Value:
Non-funded
10. RESEARCH PROTOCOL INFORMATION
10.1 / Planned start date locally (MM/DD/YYYY):
10.2 / Planned end date locally (MM/DD/YYYY):
10.3 / Number of participants locally: / 10.4 Number of participants overall:
10.5 / Number of sites in Horizon:
(List locations)
10.6 / Number of sites outside Horizon:
(List locations)
10.7 / Provide the rationale for any exclusion criteria that appear to violate the principle of inclusion (Ex. Upper or lower age limits, exclusion of women). Not applicable
10.8 / Does the protocol or contract limit your ability to notify research subjects, other investigators, physicians, the REB, regulatory agencies or the scientific community of newly identified risk during the conduct of the study? / Yes / No
10.9 / Are there any restrictions on publication or dissemination of results? / Yes / No
10.10 / If yes, what are they?
10.11 / Have you included your protocol? Yes No
11. STUDY POPULATION AND SITE LOCATION (Physical)
Population / Location
Inpatient
Outpatient
Other :
Specify: / Horizon Health Network Facilities
Physician’s Office
Other,
specify: / Physical Site Location address:
(where you will see patients and/or keep the study files/documents)
12. DEPARTMENTAL SUPPORT AND AWARENESS
Does this study require the support of any department, nursing unit, or clinic? Yes No
Is there a cross analysis agreement (for Moncton sites only)? Yes No
Which department(s)?
Is your letter of support attached? Yes No
13. INFORMED CONSENT PROCESS
13.1 Are you seeking a waiver of consent for secondary use of identifiable information or identifiable human biological materials?
Yes No
If a researcher satisfies all the conditions in (a) to (f), the REB may approve the research without requiring consent from the individuals to whom the information relates. (TCPS2 Article 5.5 and Article 12.3)
If yes, please answer the following:
(a) identifiable information is essential to the research;
(b) the waiver is unlikely to adversely affect the welfare of individuals to whom the information relates;
(c) the researchers will take appropriate measures to protect the privacy of individuals and to safeguard the identifiable information;
(d) the researchers will comply with any known preferences previously expressed by individuals about uses of their information;
(e) it is impossible or impracticable to seek consent from individuals to whom the information relates; and
(f) The researchers have obtained any other necessary (e.g. legal) permission for secondary use of information for research purposes.
13.2 If no, have you included a copy of your consent form? Yes No
13.3 How will potential subjects be identified? Who will initially contact subjects regarding study participation? Patients should not be approached by “strangers” who are aware of their health care situation). Who will be involved in the consenting process?
13.4 Does the study require any deception or lack of disclosure?
Yes No
If “yes”, please describe.
14. PRIVACY AND CONFIDENTIALITY
14.1 / Collection, Use and Disclosure
14.1.1 What type of personal information will be collected during the study? (For example: name, address, telephone number, diagnostic history, full patient record, etc…).
14.1.2 How will the personal information be collected? (From the patient themselves, databases, forms, etc…)
14.2 / Security and Access
14.2.1 Where, how and for how long will this information be stored? (For example: central data repository, electronically on user terminals, physical location, etc…)
14.2.2 Who will have access to the personal information?
14.3 / Maintaining Personal Information
14.3.1 Please provide details on the duration of retention for the personal information collected and the methods of destruction of the personal information.
14.4 / Access to Personal Information
14.4.1 Will the study participants be given the right to access his or her personal information? If so, please describe any limitations on access:
15. RESEARCH SUMMARY
15.1 Population (What is the Patient Population you plan to use for your study?)
15.2 Intervention (What type of intervention?)
15.3 Comparison (What is the comparison?)
15.4 Outcome (What is the outcome to be measured?)
16. APPLICATION CHECKLIST
Copies / N/A / Yes / No / Explanation/Comment
Research Study Application (one with original signatures) / 3
Study Protocol (signed by PI) / 3 / Version & Date:
Horizon Health Network Consent Form / 3 / Version & Date:
Data Collection Forms / 1 / Version & Date:
Questionnaires/Diaries / 3 / Version & Date:
Advertisements (indicate where they will be posted) / 3 / Version & Date:
Letter(s) of Support (If applicable). / 1 / List:
PI: CV, and
Current N.B. Medical License (If applicable)
PI Only: CV - 1 original & 1 copy signed/dated
NB License: Submit with application and annually thereafter / 2 / PI Name:
CV Date:
16b Additional Documentation
Document Name / Copies / Description/Comment
17. PRINCIPAL INVESTIGATOR’S AGREEMENT AND ATTESTATION (see section 2a)
As Principal Investigator, I certify that all information on this form is accurate and that the Co-investigators (if applicable) listed have approved the content of this protocol. I, my co-investigator(s), and supporting staff have the appropriate qualifications, experience and facilities to conduct the research set out in the attached application, and to deal with any emergencies and contingencies that may arise. I understand that projects may not be undertaken until I have received FINAL written approval through the Horizon Health Network REB and the local Research Services Office. During the conduct of the study, I agree to:
(1) Comply with ICH GCP, and the Tri-Council Policy Statement.
(2) Ensure that all persons assisting with the study are adequately informed, trained on protocol procedures, the investigational product(s), and their trial related duties and functions.
(3) Recruit participants through ethical means by conforming with regulations and policies relating to disclosure of personal information and confidentiality.
(4) Obtain informed consent using the most current version of the Horizon Health Network REB approved informed consent form(s).
(5) Provide the Horizon Health Network REB with any new information affecting the risk/benefit ratio, any interim analysis results or data safety monitoring reports.
(6) Obtain Horizon Health Network REB approval prior to instituting any amendments/revisions to the protocol, informed consent, advertisements, and change in recruitment strategy.
(7) Submit a study Change-In-Status form with any changes in recruitment activity (use – Ethics Services “Study Change-In-Status” template).
(8) Submit Annual Re-approval two months prior to initial Horizon Health Network REB review date and annually thereafter (use – Ethics Services “Annual Study Re-Approval” template).
(9) Submit a comprehensive final report as soon as it becomes available.
(10) Arrange for the retention of study records after the completion of the study (5-7 - contact your local Research Office).
______
Principal Investigator (Print) Signature Date
18. CLINICAL DEPARTMENT HEAD / HORIZON HEALTH NETWORK STAFF MEMBER* SIGNATURE
I have reviewed the research study to be submitted and certify that it has appropriate benefit for our patients, and that the applicant has the required expertise and departmental support.
______
Department Head /Staff Member (Print) Signature Date
Version Date: Version Date: September 2015 / © Horizon Health Network - Ethics Services
Internal Working Document / Page 1 of 8