Please ensure that you have identified Covenant Health as a site under the Health Research Ethics Board (HREB) - REMO application form under 1.6 “Study Locations
and Sites”, 2.0. OR the Health Research Ethics Board of Alberta (HREBA) IRISS application; this allows our office personnel to access your file and all relevant
documents to support your application. If a protocol and sponsor agreement is not included in your REB application, please submit those documents along with this
application.
All documents can be submitted via email to: research@covenanthealth.ca. If you have questions, please contact the Covenant Health Research Centre (CHRC) for
assistance at 780.735.2274.
For the purposes of this application only, “Covenant Health” will include Covenant Health, Covenant Care and Covenant Living.
POLICY AND ETHICS - All researchers doing research at Covenant Health, Covenant Care and/or Covenant Living are expected to
comply with the following:
1) The Tri-Council Policy Statement, Version 2 (TCPS)
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
2) The Health Information Act (HIA)
http://www.oipc.ab.ca/pages/HIA/ReadAct.aspx
3) Freedom of Information and Protection of Privacy Act (FOIP)
http://www.oipc.ab.ca/pages/FOIP/ReadAct.aspx
4) The Health Ethics Guide (For a copy of the Guide, please contact the CHRC office)
http://www.chac.ca/resources/ethics/ethicsguide_e.php
5) The Covenant Health Research Policy No. III-10
Policy III-10 2011May or visit Compassion Net at: http://compassionnet.ca/Policies.asp
LOGO - The Covenant Health logo has been provided to you for use within study documents - those already vetted through the
approval process at both the HREB and further, through the CHRC as part of our approval process. Should you require the use of the
logo for any additional documents not already approved through the HREB and CHRC, please contact the CHRC as prior approval of
logo use is required.
MEDIA - Should your study become the subject of media attention or report, please provide Covenant Health with prior notice in order
to prepare for any resulting media questions or statements.
KNOWLEDGE TRANSFER (KT) - It is important that you provide a copy of a final research report and any corresponding
publications/articles to the CHRC upon completion of the study, both for us to complete our files and to have the opportunity to
incorporate your important research project in our knowledge transfer initiatives. You are eligible to submit a paper, article or abstract
for inclusion in the “Covenant Health Research” publication. You are also eligible to provide a presentation in various formats and for
various ongoing events, including a lecture or poster presentation as part of the annual Covenant Health “Research Day”. If you
require assistance with Knowledge Transfer planning – developing pre-study and/or post-study KT, or if you are interested in
participating in one of our ongoing events with your study, please contact the CHRC office.
The CHRC may reference your name, study name, and location of study in various Covenant Health research publications, reports,
sessions or internal/external website, unless you advise us to the contrary in writing.
Your signature indicates that you have read and understand the implications for your study
(electronic signature is acceptable):
______________________________________
Signature
____________________________________
Date Signed
1.
Full Long Title of Study:
2.
Study reviewed by:
Conjoint Health Research Ethics Board (CHREB);
Health Research Ethics Board (HREB);
Health Research Ethics Board of
Alberta (HREBA);
3.
Name of Principal Investigator:
Mailing Address:
4.
Specify Research Coordinator and/or Research Assistant(s) who will be involved with this study:
Phone Number:
Fax Number:
Email:
Name:
Mailing Address:
5.
Phone Number:
Fax Number:
Email:
Locations participating in the study: (For a listing of patient populations served within each location, please reference
http://www.covenanthealth.ca/facilities.html)
Banff:
Mineral Springs Hospital (MSH)
Beaumont:
Chateau Vitaline (CV) – Covenant Care facility
Bonnyville:
Bonnyville Health Centre (BHC)
Calgary:
Holy Cross Manor (HCM) – Covenant Care facility
St. Marguerite Manor (SMM) – Covenant Care facility
Camrose:
St. Mary’s Hospital (SMH)
Castor:
Our Lady of the Rosary Hospital (OLRH)
Edmonton:
Edmonton General Continuing Care Centre (EGCCC)
Grey Nuns Community Hospital (GNCH)
Misericordia Community Hospital (MCH)
Villa Caritas (VC)
St. Joseph’s Auxiliary Hospital (SJAH)
Centre de santé St-Thomas (CSST) – Covenant Care facility
6.
Killam:
Killam Health Centre (KHC)
Lethbridge:
St. Michael’s Health Centre (SMHC)
St. Therese Villa (STV)
Martha’s House (MH) – Covenant Living facility
Medicine Hat:
St. Joseph’s Home for the Aged (SJHA)
Mundare:
Mary Immaculate Hospital (MIH)
Red Deer:
Villa Marie (VM) – Covenant Care facility
St. Albert:
Youville Home (YH)
Trochu:
St. Mary’s Health Care Centre (SMHCC)
Vegreville:
St. Joseph’s General Hospital (SJGH)
Alberta Health Services (AHS) Locations:
List all departments/units that will be impacted by the study and how they will be impacted (i.e. Health Records – charts
pulled…; Family Medicine Clinic – patients recruited…; )
Depts/impact: Lab
-
|
Pharmacy
-
|
-
Diagnostic Imaging
|
-
7.
Estimated duration of project:
8.
List all databases you will be using as part of your research
study:
|
Start Date:
If Chart Review:
Who will be reviewing the charts (name &
phone number if other than P.I.):
-
|
plus
-
|
-
Completion Date:
Please note that you cannot recruit patients from these systems without use of
an intermediary. Separate database agreements may also be required. A
navigator will advise you accordingly.
9.
Ethics board study # (i.e. Pro00001234):
Netcare
eClinician
Other (specify)
Number of charts to be reviewed:
Diagnoses or Procedures:
Time period for patient chart review: From
Date
to
Pax
10. For Database purposes, please complete the following sections by indicating the appropriate elements that best represent
your study.
Chart Review - A retrospective method of collecting data that involves
Type of study: (mark at least one from each
reviewing
medical records
column, and all that apply)
Sequel (study#)
Clinical Trial - Any investigation in human subjects intended to discover or verify the
clinical, pharmacological, and/or other pharmaco-dynamic effects of an investigational
Interventional Research - Any research
product, and/or to identify any adverse reactions to an investigational product(s), and/or
project that prospectively assigns human subjects
study absorption, distribution, metabolism, and excretion of an investigational product(s)
to intervention and comparison groups to study the
with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical
cause-and-effect relationship between a medical
study are synonymous
intervention and a health outcome.
Epidemiological Study - A study of the patterns of determinants and antecedents of
Observational Research - A type of study in
disease in human populations utilizing biology, clinical medicine, and statistics in an effort to
which individuals are observed or certain outcomes
understand the etiology (causes) of illness and/or disease.
are measured. No attempt is made to affect the
outcome (for example, no treatment is given).
Multi-centre Trial - A single trial conducted according to a single protocol but at
more than one site
Excerpt from HREB Guideline document:
“In a clinical context, it is sometimes difficult to
determine which data-collection projects need
research ethics review. Ordinarily, quality
improvement projects do not require review. Use the
following questions as a guide to decide whether
your project must be submitted for research ethics
review:
*Is your project designed to test a specific hypothesis
or answer a specific research question?
*Will the information be collected by someone who
does not normally have access to clinical records or
patient names?
*Are you comparing different groups or treatments
methods, or is there random assignment to groups?
*Do you want to present the results at a conference or
in written form as research findings?
If you are unsure whether or not your project should
be reviewed, contact the HREB office at: (780)
492.0459
Pilot Study - a small scale preliminary study conducted before the main
research, in order to check the feasibility or to improve the design of the
research.
Qualitative Study - Investigative methodologies described as ethnographic,
naturalistic, anthropological, field, or participant observer research. It emphasizes the
importance of looking at variables in the natural setting in which they are found. This differs
from quantitative research which attempts to gather data by objective methods to provide
information about relations, comparisons, and predictions and attempts to remove the
investigator from the investigation.
Technology Assessment/Development - Technology assessment is hereby
defined as any clinical research studying or evaluating new technologies (for example;
medical equipment, biologic specimen/sample or testing with no direct patient contact).
Biologic specimens and samples are/can be obtained from human subjects.
Other (specify)
11. Indicate the research
context for your research:
Urban
Rural
All
12. Indicate the research focus
from a strategic
perspective:
Capacity Building
Professional Practice
Patient-centered
Systems-centered
Prevention
Innovation
Sub-acute
Palliative
CC or DAL or AL
Rehab
13. Indicate the Covenant
Health service area:
Acute
Community Service
(respite)
14. Indicate the appropriate Therapeutic Department and corresponding Section:
Department*:
Addictions and
Mental Health
Anesthesia
Cardiac Sciences
Section*:
Psychiatry (Child)
Other, specify
Psychiatry (Adult)
Psychiatry (Geriatric)
Anesthesia
Cardiology/Vascular Diseases – Diseases having to do with the structure and function of the heart and blood vessels. Studies in these areas include: heart failure, coronary
artery disease, high cholesterol, blood clots, circulation disorders, and others*
Child Health
Pediatrics
Dental/Oral Health
Dental & Oral Health
Devices
Cardiology
Speech Pathology & Audiology
Diagnostic Imaging
Radiology Diagnostic
Nuclear Medicine
Family Health
Family Practice
Patient-centered Health Team (PCHT)
Endocrinology & Metabolism
Palliative Care (Family Health)
Obstetrics & Gynecology
Anesthesia
Geriatrics
Geriatrics (Family Health)
Geriatric Medicine
ICU
Critical Care Medicine
Laboratory
Pathology, General
Pathology, Anatomical
Laboratory Medicine General
Medicine
Infectious Diseases
Nephrology/Urology – The studies and the
Internal Medicine
Neurology
Endocrinology & Metabolism – Field relating to
treatment of diseases of the kidney and the urinary tract.
Studies in these areas include: bladder cancer, impotence,
kidney disease, kidney stones, mastectomy, nocturia, renal
cell carcinoma, urinary tract infections, and others*
Respiratory/Pulmonary
Clinical Immunology & Allergy
Neonatal-Perinatal Medicine
hormone-manufacturing glands such as the pituitary, thyroid,
parathyroid, and adrenal glands, as well as the ovary and
testis, the placenta, and the pancreas. Studies in this area
include: diabetes and diabetes-related disorders, diet and
nutrition, hormone-replacement therapy, menopause, obesity,
and others*
Other, specify
Emergency Medicine
Family Practice with Obstetrics
Infectious Diseases
Hematopathology
Gastroenterology – The study of
gastrointestinal organs and diseases relating to them.
This includes any part of the digestive tract from mouth
to anus, liver, biliary tract, and the pancreas. Studies in
this area include: constipation, Crohn’s diseases,
diarrhea, gall bladder disease, heartburn, hemorrhoids,
irritable Bowel Syndrome (IBS), ulcers, liver disease,
stomach cancer, and others*
Rheumatology
Physical Medicine & Rehab
Palliative Care
Palliative Care
Podiatry
Podiatry
Practice
Physicians
Other, specify
Nursing
Allied Health
Surgery
Urology
Otolaryngology – Also known as ENT (ears, nose,
Surgery, General
Maxillofacial Prosthodontics (Dent.)
Surgery, Plastic – Fields concerned with skin
Surgery, Vascular
Surgery, Orthopedic
Obstetrics & Gynecology
and throat); this is the study of diseases involving the ears
and the larynx. Studies in this area include: allergy, ear
infections, pneumonia, rhinitis, sinus infections, strep throat,
and others*
Oral & Maxillofacial (Dent.) – Surgery relating
to the teeth, jaw, face and its structures. Studies in these
areas include: acute and chronic dental pain, oral cavity
cancer, oral facial pain, oral medicine, and saliva and
salivary gland dysfunction*
Genetics
disorders and reconstruction or replacement of deformed,
damaged, or lost parts of the body. Also concerns cosmetic
surgery. Studies in these areas include: acne, congenital skin
diseases, genital herpes, genital warts, liposuction, psoriasis,
skin wounds, athlete’s foot, venous leg ulcers, and others*
Podiatry
Women’s Health
Obstetrics & Gynecology – Research pertaining
to the care of women during pregnancy and childbirth, as
well as to the study of the women’s reproductive system in
general. Studies in these areas include: contraception,
hormone-replacement therapy, menopause, menstrual
disorders, ovarian cysts, PMS, pregnancy/labor/delivery,
yeast infections, and other*.
Urogynecology
*Definitions obtained from CentreWatch
15. For Database Purposes - Multi-disciplinary Teams (please list all disciplines participating as part of your study team, i.e. nursing,
respiratory therapy, etc.)
16.
Please indicate which strategic directions your study impacts at Covenant Health (check all that apply)
SERVE: Strengthen our
mission and live our
values to meet the
needs of those we
serve through
excellence in care, an
engaged team and wise
use of our resources.
S1 Attract, engage, develop
S2 Provide excellence in
and retain Mission driven
care and service by exceeding
employees, physicians and
performance expectations in
volunteers and support them in quality and safety.
discovering and deepening
their own call.
S3 Utilize and enhance
our information,
infrastructure and financial
resources to their fullest
capacity
GROW: Seek out and
respond to the needs
of our communities,
especially vulnerable
and marginalized
populations.
G1 Expand service and
capacity in acute care to
respond to a growing
population and changing
demographics.
G2 Expand our capacity to
care for seniors and those with
addiction and mental illness.
G3 Expand into
community care to address
gaps in service delivery.
C2 Partner with patients,
residents, families,
communities and key
contributors to achieve health
and healing.
C3 Leverage the legacy
and strength of Catholic
health care in order to be of
better service to Albertans.
CONTRIBUTE: Leverage
C1 Give voice to those who
our legacy to maximize are vulnerable or voiceless
the strategic
through public engagement
contribution of Catholic and advocacy.
health care.
C4 Deepen the
understanding of the strategic
contribution of Catholic health
care in Alberta and across
Canada.
TRANSFORM: Create
systems of care that
enable people and
communities to be
healthy.
T1 Design, implement and
share high performing systems
of care and service based on
integration, innovation and
evidence.
T4 Be leaders in robust
palliative and end of life care
and advocate for it as an
essential part of the health
system.
T2 Enable seniors to live to
T3 Create opportunities
the fullness of their capacity as to enable those with
active and connected members addiction and mental illness
of their communities.
to live and participate in
community with dignity and
hope.