SJHC Research Ethics Board

SJHC Research Ethics Board

Retrospective Chart Review

Instructions and Application Form

Information:

1)  All sections of this form must be completed to be considered for REB review.

2)  Please submit two hard copies of your complete application form along with a cover letter addressed to the REB Chair (Michael Heffer, RPh, MHSc), including any associated documents (e.g. data collection forms). A separate detailed protocol should be included with your submission.

3)  SJHC Departmental Approval signatures are required – this may be from a department head for charts belonging to specific departments or from the Manager of Health Records (Radika Manicks, ). If uncertain who should sign, please contact the REB coordinator with a description of your project and which charts you wish to access.

4)  The Tri-Council Policy Statement (TCPS 2) Tutorial certificate of completion is to be submitted by all investigators and research staff. Go to http://tcps2core.ca/welcome or google “TCPS2 tutorial” and click on the purple box.

5)  Requesting Charts: The SJHC Health Records Department will request verification of REB approval (copy of REB approval letter), the Chart Review Application Form, and individual identification prior to granting access to records. (Contact: Radika Manicks, Manager of Health Records, ).

6)  Amendments: Amendments to your study protocol must be submitted to the REB for approval prior to implementation. Please provide a Change in Personnel Form, found on the REB webpage, to the REB coordinator when reporting changes in study staff.

7)  Please be aware of related policy: SJHC Policy on Information Security and Confidentiality (SE 10-1-1)

Hardcopy submissions go to:

Thereza Dos Santos, REB Coordinator

St. Joseph's Health Centre

30 The Queensway, Room 6S604a

Toronto, ON, M6R 1B5

If you have any questions, please e-mail

REB Study #: (office use only)

Research Ethics Board

Retrospective Chart Review Application Form

Please acknowledge that you are aware that an incomplete or inadequate submission may not be accepted by the REB office. _____ (initial required)

TITLE OF STUDY:

INVESTIGATOR(S):

A. PRINCIPAL INVESTIGATOR:

Title:

/

Name:

/

If, resident (PGY):

Telephone: / Pager: / FAX: / Email:
Institution Name:
Dept/Division: / Program:
Mailing Address:

Is the Principal Investigator considered SJHC staff or do they have privileges at SJHC?

LOCAL STUDY LEAD (SJHC representative) – if above PI is external:

Title:

/

Name:

/

If, resident (PGY):

Telephone: / Pager: / FAX: / Email:
Institution Name:
Dept/Division: / Program:
Mailing Address:

CO-INVESTIGATOR(S) who will be given access to collected data:

(Note: there is a table to list delegates on the signature page)

Not Applicable

Name / PGY
(Yr) / Institution & Program / Contact: Telephone Numbers & e-mail

Study Coordinator or Administrative Contact (if not the PI):

Not Applicable

Name:

Telephone: / Pager: / FAX: / Email:
Institution name:
Mailing Address:

please indicate to whom correspondence should be sent:

PI Admin Contact

Expected Study Duration: Start Date End Date

FUNDING: Is the project funded by a sponsor or organization? NO YES

If yes, name the funding agency:

Internal Research – specify funding source:

SJHC Confidentiality Agreement

Investigator:

I assume full responsibility for the scientific and ethical conduct of the study as described in this application and submitted protocol and agree to adhere to the SJHC Policy on Information Security and Confidentiality (SE 10-1-1), TCPS2, PHIPA and any other relevant laws, regulations or guidelines. I also agree that if I receive any personally identifiable information (including but not limited to PHI and biological samples), I will only use or disclose the information as set out in this application and submitted protocol, the conditions of the REB, the research participant’s consent (unless consent is waived) and the conditions and restrictions imposed by the relevant information guardian who supplies the information. I certify that all researchers and other personnel involved in this project as this institution are qualified or will undergo appropriate training to fulfil their role in this project. If there is more than one principal investigator named, all should sign below.

The Confidentiality policy may be found on the REB webpage by going to: https://stjoestoronto.ca/teaching-and-education/research-ethics-board/

Investigator Name (Print) / Investigator Signature / Date
Investigator Name (Print) / Investigator Signature / Date

Additional Investigators or Delegates Carrying out Chart Review:

(Please note that the above Confidentiality Statement applies to those included below.)

Name (Print) / Study Role / Signature / Contact Info (Email, Telephone)

Faculty Supervisor (for student/fellow/resident research studies):

Not Applicable

Name:

Telephone: / Pager: / FAX: / Email:
Institution Name:
Dept/Division: / Program:
Mailing Address:

SJHC Departmental Approval:

I am aware of this proposal and support its submission for ethics review. I consider it to be feasible and appropriate. I attest that the Principal Investigator responsible for the conduct of this study is qualified by education, training, and experience to perform his/her role in this study.

This section cannot be signed by the Principal Investigator or a Co-Investigator. An alternative approval signature is required.

Department Head (Print) / Department Head (Sign) / Date
Department Head (Print) / Department Head (Sign) / Date

Please respond to questions with sufficient detail so that the reviewer may determine the merit of the study and that sufficient protection is in place to guard the confidentiality and security of patient information.

Study Details:

1. What is the purpose of the study, the study objectives and the research question to be addressed?

2. Risks and Benefits of the proposed study:

a) Briefly describe the anticipated public and scientific benefits of the study.

b) Briefly describe the possible harms/risks to patients and how this will be managed.

3. Please describe or specify the data to be collected and attach all data collection forms:

a) Briefly explain what method of data analysis will be used:

b) Is this a multi-site study? YES NO

If yes, please identify the sites and their approval status:

4 Please identify all sources to be accessed:

Health record/clinical chart (specify source(s)):
o Number of charts in total (across all participating sites):
o Number of charts at this site:
Existing database (specify source(s)):
o Does the Principal Investigator maintain the database? Yes No
o If NO, identify the entity that maintains the database:
o  Has access/use for research purposes been granted? Yes No Yes pending REB approval
NOTE The creation and maintenance of a database for research purposes is a research activity that may require a separate REB application. Please consult with the REB coordinator.

5. Proposed number of research subjects/charts/records:

6. Date range of requested data – month and year. (In order to be considered a retrospective review, dates cannot go beyond the present). (ex. May 2005 – May 2016):

From: To:

7.  What information will be provided when requesting the charts/records?

N/A

8. How will relevant patient charts/records be identified?

9. Will any identifying information be recorded?

YES NO

If YES, please respond to the following:

a)  List all direct and indirect subject identifiers to be recorded on data collection forms (Direct - Names, Addresses, OHIP #, Medical Number; Indirect - Initials, Full DOB, Postal code, etc.).

b)  Please justify the collection of subject identifiers:

c)  Will individual identifiers be removed once the relevant data is collected?

YES NO

If no, please justify.

d)  If multiple sources/databases will be used to access the retrospective data, will the data be linked? YES NO

If YES, explain what data will be linked, how it will be linked and why the linkage is required.

10. Photocopies of chart contents require approval from the Director, Health Records. Will photocopies of chart contents be requested?

YES NO

If YES, how will photocopies be disposed of and when?

11. Security & Confidentiality:

a) Please indicate how data will be stored:

Computerized files

Hard copy

Other (Please specify):

b)  Where and how will hard copy data be physically stored? (Please provide institution name and address).

N/A

c) Who will have access to the location of the stored data?

d) For data storage in computerized files, please specify where the database is located and who will have access. (ie. computer drives, address of institution)

N/A

e) Is the computer password-protected? YES NO

f)  Will there be a transmission of study data?

YES NO

If YES, complete below:

Transmission via: / Sent? / Received?
Fax (describe):
Email (encryption protocol may be required):
Private courier (delivery must be traceable):
Canada Post (Regular mail may not be used)
Memory stick (encryption may be required):
Other:

g)  Describe any security measures in place to protect confidentiality.

h)  What will happen to the data at the end of the study?

Destroyed Irreversibly anonymized (ie. the link between data and the individual’s identity is deleted or destroyed)

Other:

i)  Please specify who will have access to data in the future?

j)  How will security and confidentiality be protected and maintained during long term storage of study records?

N/A

Explain:

12. Will these data be available or distributed to others? If so, specify how confidentiality will be protected.

13. Will the collected data be used now or in the future for commercial purposes?

YES NO

If YES, please describe:

14. Will the data be entered into an ongoing electronic database for future use in another study? (Please note: Any secondary analysis must be approved by the REB prior to implementation).

YES NO

If yes, the following information must be provided:

-  Where exactly the data will be stored (address)

-  who the custodian will be (ie. the person responsible for data storage and integrity)

-  who will have access to the data

-  what are the safeguards

DEFINITIONS

(Source: Tri-Council Policy Statement, unless otherwise specified.)

Personal Health Information (PHI): In this Application, PHI has the meaning ascribed to it in the Personal Health Information Protection Act, 2004 (PHIPA). With limited exceptions, PHI is defined as identifying information about an individual in oral or recorded form, if the information,

a) relates to the physical or mental health of the individual, including information that consists of the health history of the individual's family,

b) relates to the providing of health care to the individual,

c) is a plan of service within the meaning of the Long-Term Care Act, 1994 for the individual,

d) relates to payments or eligibility for health care in respect of the individual,

e) relates to the donation by the individual of any body part or bodily substance of the individual or is derived from the testing or examination of any such body part or bodily substance,

f) is the individual's health number, or

g) identifies a provider of health care to the individual or a substitute decision-maker of the individual.

Identifiable Information: Information that may reasonably be expected to identify an individual, alone, or in combination with other available information. Also referred to as “personal information.”

Directly Identifying Information: The information identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number).

Indirectly Identifying Information: The information can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal characteristic).

Coded Information: Direct identifiers are removed from the information and replaced with a code. Depending on access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a list that links the participants’ code names with their actual name so data can be re-linked if necessary).

Anonymized Information: The information is irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low.

Anonymous Information: The information never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low.

Data Set: A collection of information to be used for research purposes, including human biological materials.

Key Code: A document that links the coded information with the identifying information of the individual. This must be stored separately from the data set.

SJHC REB – Retrospective Chart Review, April, 2017 Page 11 of 11