Version date: August 2014

Appendix I

PREVIOUSLY APPROVED BY

AN EXTERNAL RESEARCH ETHICS BOARD

Please submiteight (8) (collated copies) of the documents required (see checklist on page 7) and one (1) electronic copy via email () to the Research Ethics Board (REB) Secretariat, Brooke Claxton Building, 9th Floor, Room 941Con the submission deadline date. The office is open between 7:30 am and 5:00 pm. All submissions will be accepted on a first come first serve basis. A maximum of ten (10) protocols will be accepted by the deadline date. For additional information, please contact the REB Secretariat at (613) 941-5199.

Section 1:Previously reviewed by another REB

Name of the outside REB:

Decision of the REB:

Please provide a copy of the Letter of Decision communicated by the outside REB, as well as a copy of all the documentation provided to the outside REB for an ethical review.

Section 2:Identification

Project Title

Principal Investigator

Name:

Position:

Branch:

Department/Agency:

Address:
Telephone:

Facsimile:

E-mail:

Co-Investigator(s)

Name:

Position:

Branch:

Department/Agency:

______

SignatureDate

Section 2:Type of Study(please check all that apply)

GPilot StudyGChart ReviewG Basic Research

GEpidemiologicalG Social ScienceG Focus Group

G GeneticsG Descriptive AnalysisG Surveillance

G ObservationalG Supplemental ServicesG Quality Assurance

G Cohort StudyG SurveyG Telephone Interviews

G Health Services G Natural Health ProductsG Use of secondary data

GUse of an Existing DatabankG Creation of a Databank

G Other:

Section 3:Study Population(please check all that apply)

G Capable AdultsG Minors G Children

G NewbornsG Pregnant WomenG Students

G PrisonersG Ethnic GroupsG Other vulnerable populations

Section 4: Health Canada/Public Health Agency of Canada (PHAC) Involvement

4a.Role of Health Canada/PHAC in the project

What is the Health Canada/PHAC official’s role in this project?

GContractor

GResearch collaborator

GCo-investigator

GFunder

GOther, please specify:

4b.How will the samples be submitted to Health Canada/PHAC? (Please check all that apply.)

GAnonymous/unidentified samples

GAnonymized/unlinked samples

GIdentifiable/coded samples

G Identified samples

4c.What specific services to the research project has Health Canada/PHAC been asked to provide?

4d.Was informed consent of participants obtained for the specific activity to be carried out by Health Canada/PHAC prior to the collection of the samples?

Yes G No G

If not, please specify why not:

If yes, please enclose a copy of the consent form.

4e.Retention / Disposition

How long will the data or samples collected for the project be maintained? (Please check all that apply.)
GDestruction of samples after the completion of this project

GStorage of samples

  • Who will keep the samples?
  • How long will the samples be stored?
  • Where will the samples be stored?
  • Will you have access to the stored samples?

GFuture research on the samples

Please specify:

4f.Publication

How will Health Canada/PHAC’s participation on this project be recognized in any publications resulting from this activity?

GA co-author

GAcknowledgement of participation

G Other, please specify:

4g.Departmental Official (when different from the Principal Investigator)

Name:

Position:

Branch:

Department/Agency:

______

SignatureDate

Section 5:Departmental Approval (Health Canada or PHAC)

Name:

Position:

______

*SignatureDate

*Division heads cannot sign-off on their own protocol. If this is the case, the signature of the Health Canada or the Public Health Agency of Canada’s Director General or the Assistant Deputy Minister is required.

Section 6:Scientific Peer Review

GEnclosed

GNot applicable, give reason:

Rationale:

Note: If no scientific peer review has been undertaken for the proposed project, the Principal Investigator must obtain his/her Director / Director General or Assistant Deputy Minister’s signature to ensure that the project is scientifically sound as proposed:

______

*SignatureDate

* Health Canada or the Public Health Agency of Canada Official’s signature

Section 7:Funding

Available:Yes GNo G

Amount $______

1

Funding Source: for example:

GInternal Funding

GCanadian Institutes of Health Research (CIHR),

GNational First Nations Environmental Contaminants Program (NFNECP)

GOther source:

Requested From:______

Funding Source:______

Amount $:______

Deadline:______

Not Required:G

Study Budget Sheet enclosed:Yes GNo G

Section 8:Protocol

  1. Objectives of the Study
  2. Background
  3. Hypotheses or Questions
  4. Methods
  5. Statistical Analysis
  6. Proposed number of Research Participants
  7. Sample Timeframe

Section 9: Sensitive Issues

Are any sensitive issues raised in this study or its publication,(for example: HIV status, mental health status, participants identifiable for example: pedigrees and other)

Yes G No G

Section 10:Consent

Have you sought participant consent?

Yes GNo G

If no, why not

Section 11:Data Collection

Attach data collection form or list of fields, please note that the content of the form should be adequate to answer the research questions(s)

Section 12:If you are planning on extracting sociodemographic information,for example: race or ethnicity, please provide justification.

Section 13:What participant information data source are you accessing?

GHealth Records

GClinic/Office Files

Specify which

GElectronic Database

Specify which

GOther

Specify which

Section 14:Security and Confidentiality

Steps to be taken to ensure Security and Confidentiality of data (please check all that

apply)

1) Identifying information scrambled / de-linked
Method:GParticipant names/numbers coded

G Other (specify):

2) Records / computers secured

Method:G Participant coded

G Files/Folders password protected

G Computer password protected

(Please provide name of password software)

G Computer in locked office only

G Other (specify):

3) Chart/Computer Access limited to research team

Method:G Cabinet/Office keys only with researchpersonnel

G Computer passwords only withresearch team

G Other (specify):

Section 15:Privacy Legislation (Health Canada/PHAC employees)

Are you aware of your obligations under the Privacy Act for obtaining?

1) Personal Information Bank

Yes GNo G

2) Privacy Impact Assessment

Yes GNo G

Section 16:Third Party Implications

Are there any third parties being identified in your research documentation?

Yes G No G

If yes, name of identified party:

Section 17:Legal Advice

Have you sought legal advice on the project in question?

Yes GNo G

Conflict of Interest: Please confirm with your signature below that any conflicts of interests (actual, apparent, perceived, or potential) relating to this project are disclosed in this application for the Research Ethics Board’s review.

I certify that the above declaration is accurate and is/will be in force at the time data is collected.

______

Signature, Principal InvestigatorDate

Please include a copy of your resume, dated and signed.

Note to Researchers:

Health Canada and PHAC are responsible for the ethical conduct of research undertaken within or for the institution regardless of the location where the research is conducted. If the ethics review and decision was carried out by an outside REB, the researcher from Health Canada or PHACis still required to submit an application to the REB for an ethics review/approval, in addition to the decision communicated by the outside REB.

Documentation: The documentation required for a thorough and complete ethics reviewof the proposed research to be submitted by the applicant, may include:

  • signed and dated application form;
  • a completed and signed scientific peer review and all correspondence pertaining to the review;
  • the protocol of the proposed research (clearly identified and dated) together with supporting documents and annexes;
  • a summary (in non-technical language) synopsis, or diagrammatic representation (flowchart) of the protocol;
  • a description (usually included in the protocol) of the ethical considerations involved in the research;
  • case report forms, diary cards and other questionnaires intended for research participants.
  • material to be used (including advertisements) for the recruitment of potential research participants;
  • a description of the process used to obtain and document consent;
  • written and other forms of information for potential research participants (clearly identified and dated) in the language(s) understood by the potential research participants and, when required, in other languages;
  • informed consent form (clearly identified and dated) in the language(s) understood by the potential research participants;
  • a statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants;
  • all significant previous decisions (for example, those leading to a negative decision or modified protocol) by other REBs or regulatory authorities for the proposed study (whether in the same location or elsewhere) and an indication of the modification(s) to the protocol made on that account. The reasons for previous negative decisions should be provided;
  • a statement of agreement to comply with ethical principles set out in relevant guidelines; and
  • investigator’s(s) curriculum vitae (updated, signed and dated).

Research Involving Aboriginal People

The Canadian Institutes of Health Research (CIHR), in conjunction with its Institute of Aboriginal Peoples' Health, have recently released the Guidelines for Health Research Involving Aboriginal People. These Guidelines have been produced to assist researchers and institutions in carrying out ethical and culturally competent research involving Aboriginal people.

The intent is to promote health through research that is in keeping with Aboriginal values and traditions. The Guidelines will assist in developing research partnerships that will facilitate and encourage mutually beneficial and culturally competent research. The Guidelines will also promote ethics review that enables and facilitates rather than suppresses or obstructs research.

There is a need for researchers to involve Aboriginal communities when doing research involving Aboriginal people.

  • The researcher needs to ensure the involvement of Aboriginal communities in the development of the proposed research project;
  • The Principal Investigator, when submitting an application for an ethics review to the REB, should include the following:
  • The results of the consultation undertaken with the Aboriginal communities and a copy of the exchange of correspondence with these communities;
  • The recruitment processes to be undertaken in these communities;
  • The consent processes for obtaining informed consent from both these communities and the individuals;
  • The communication of the report of findings to these communities and the individuals.

All research involving human subjects at Health Canadaor PHAC must be reviewed and approved by the REB. Approval must be obtained in writing before the research begins.

The Application and all supportive documents should be forwarded to:

Manager, Research Ethics Board Secretariat

70 Colombine Driveway

9th Floor, Room 941C

Brooke Claxton Building, Postal Locator: 0909C

Tunney’s Pasture

Ottawa, Ontario, K1A 0K9

Phone number (613) 941-5199

Fax (613) 941-9093

Email:

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