Appendix A

Application for a Full Ethics Review by the Research Ethics Board

Please submit eight (8) (collated copies) of the documents required (see checklist on page 7) and one (1) electronic version via email (REB-CER@hc-sc.gc.ca) to the Research Ethics Board (REB) Secretariat, Holland Cross Building, Tower A, Room 511 on 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: Identification

Project Title

Principal Investigator

• Name:
• Position:
• Branch:
• Department/Agency:

• Address:
• Telephone:
• Facsimile:

• E-Mail:

Co-Investigator(s)

• Name:
• Position:
• Branch:
• Department/Agency:

• Signature:
• Date:

• Name:
• Position:
• Branch:
• Department/Agency:

• Signature:
• Date:

• Name:
• Position:
• Branch:
• Department/Agency:

• Signature:
• Date:

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

• Pilot Study
• Chart Review
• Basic Research
• Epidemiological
• Social Science
• Focus Group
• Genetics
• Descriptive Analysis
• Surveillance
• Observational
• Supplemental Services
• Quality Assurance
• Cohort Study
• Survey
• Telephone Interviews
• Health Services
• Natural Health Products
• Use of secondary data
• Use of an Existing Databank
• Creation of a Databank
• Other:

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

• Capable Adults
• Minors
• Children
• Newborns
• Pregnant Women
• Students
• Prisoners
• Ethnic Groups
• 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?

• Contractor
• Research collaborator
• Co-investigator
• Funder
• Other, please specify:

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

• Anonymous/unidentified samples
• Anonymized/unlinked samples
• Identifiable/coded samples
• 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
• No

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)

• Destruction of samples after the completion of this project
• Storage 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?
• Future 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?

• A co-author
• Acknowledgement of participation
• Other, please specify:
  
  

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

• Name:
• Position:
• Branch:
• Department/Agency:

• Signature:
• Date:

Section 5: Departmental Approval (Health Canada or PHAC)

• Name:
• Position:

• *Signature:
• Date:

*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

• Enclosed
• Not 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 General or Assistant Deputy Minister's signature to ensure that the project is scientifically sound as proposed:

• *Signature:
• Date:

*Health Canada or the Public Health Agency of Canada

Section 7: Funding

Available:  Yes  No

Amount $:

Funding Source: for example:

• Internal Funding
• Canadian Institutes of Health Research (CIHR),
• National First Nations Environmental Contaminants Program (NFNECP)
• Other source:

• Requested From:
• Funding Source:
• Amount $:
• Deadline:

• Not Required:

Study Budget Sheet enclosed:  Yes  No

Section 8: Proposed Protocol

1. Objectives of the study
2. Background and rationale
3. Methods
4. Control Group
5. Recruitment
   1. Participants
   2. Controls
   3. Proportional Representations
   4. Duration
6. Analysis
7. Sub-group
8. Interventions
9. Potential harm, discomforts and inconveniences to
10. Potential benefits to: (must be described in simple lay terms)
11. Questionnaire
12. Proposed monitoring

Section 9: Steps to be taken to ensure security and confidentiality of data (please check all that apply)

1. Identifying information scrambled / de-linked / anonymous

Method:

• Participant /numbers coded
• Other (specify):

2. Records / computers secured

Method:

• Participant coded
• Files/Folders password protected
• Computer password protected
  (Please provide name of password software)
• Computer in locked office only
• Other (specify):

Chart/Computer Access limited to research team

Method:

• Cabinet/Office keys only with research personnel
• Computer passwords only with research team
• Other (specify):

Section 10: Privacy Legislation
Are you aware of your obligations under the Privacy Act for obtaining?

1. Personal Information Bank  Yes  No
2. Privacy Impact Assessment  Yes  No

Section 11: Third party implications
Are there any third parties being identified in your research documentation?  Yes  No

If yes, name the party:

Section 12: Legal advice
Have you sought legal advice on the project in question?   Yes   No

Section 13: Contract Information
Has a contract been issued for this study/project?  Yes   No

(If available, please provide a signed copy)

Conflict of Interest: Please confirm with your signature below that any conflict of interest (actual, apparent, perceived, or potential) relating to this project is 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 Investigator:
• Date:

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

Note to Researchers

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

Documentation: The documentation required for a thorough and complete ethics review of 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;
• 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 Health Canada 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 humans at Health Canada or PHAC must be reviewed and approved by the Research Ethics Board. 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
Holland Cross Building, Tower A
11 Holland Avenue,
Suite 511, Address Locator #3005B
Ottawa, Ontario, K1A 0K9
Phone number: 613-941-5199
Fax: 613-948-6781

Email: REB-CER@hc-sc.gc.ca