Summary of Proposed Research for Operations Leaders

Summary of Proposed Research for Operations Leaders

Summary of Proposed Research for Operations Leaders

Principal Investigator:Medical StaffNon-Medical Staff
Short Title of Study:
Name of Primary Contact for the Research:
Email: / Telephone or Pager:
1. Indicate the area(s) of the Heart Centre in which the study will be carried out:
Cardiac Cath Labs/Cardiac Short Stay Unit/Cardiac Procedure Room
Clinics Heart Function PACH Heart Transplant Atrial Fib
Pacemaker/Device Cardiac/Obstetrical TAVI
CICU Cardiology Step-down (5A) Echocardiography (also complete Echo form)
CSICU Cardiac Surgery Step-down (5B) Cardiology Lab (also complete Card. Lab form)
Other (PLEASE SPECIFY)
Summary of Research as in Box 5.1.B of REB application (do not exceed 250 words)
Proposed Process for Obtaining Consent:
Expected start date: Expected end date:
Expected number of study participants (at this site):

Staff Impact

  1. Are any of the study procedures planned for times outside of daytime hours (0700-1600, Monday to Friday)?

No Yes  Indicate days of week, times and expected frequency

  1. Will Heart Centre employees be required to collect any data beyond that collected for routine clinical care?

No Yes  Indicate Total amount of estimated time:

  1. Will Heart Centre employees be required to enter data into study databases?

No Yes  Indicate Total amount of estimated time:

  1. List other tasks required of Heart Centre employees for this study:
  1. Are nurses or other Heart Centre employeessubjects in the study?

No Yes

  1. Does the research protocol require any nursing or allied health services? (indicate all that apply)

Type of Nursing/Allied Health Care or Service / Estimated Frequency/Duration / N/A
Increased vital signs, monitoring (e.g. prolonged telemetry, increased blood glucose monitoring), prep for tests(specify)
Obtaining specimens, administering study medication
Prolonged length of stay
Other unit/clinic resources that may be impacted by the study
  1. Outline how you will provide information to nursing or other unit staff about their role in the study. Consulting the clinical area leader is recommended for more complex protocols.

Impact on Resources

The Program will determine if the required services necessitate recovery from the study budget to offset costs. The Program leader will provide investigators with the cost of these services.

  1. Is the study funded? No Yes If Yes, source of funds:
  1. Will study will result in additional costs to the program/unit, e.g. equipment, supplies, personnel. No Yes
  1. Will we need to purchase additional supplies? No Yes
  1. Are those costs covered by the study? No Yes If no, who will pay for the supplies?

Ifthe time commitment is greater than initially anticipated, we reserve the right to review our continued involvement and the need for the study budget to provide resources to the program/unit.

The Operations Leader will strive to process the request or contact the investigator within 2 wks of receiving this summary.

AGREEMENT

All operational and clinical issues have been reviewed and resolved to my satisfaction, and I agree that ______(study) may proceed in the clinical areastarting on (date) pending receipt of the Certificate of Ethical Approval and the PHC Institutional Certificate of Final Approval. The investigator is responsible for providing the Operations Leader with copies of both certificates of approval.

Operations Leader (Print Name)Date

______

Operations Leader (Signature)Date

Areas of Responsibility (Please list units)

Please email or mail this form to:

Heart Centre Administrative Assistant

St. Paul’s Hospital,

Rm B-443, 1081 Burrard St.

Vancouver, BC V6Z 1Y6

Summary Form: Human Subject Research: Clinical Areas: Aug 2014

Page 1 of 3