Appendix N

Supplemental Services - Health Canada's Component of Research

This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to submit a form, you must use only the Microsoft Word Version.

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

---

Questionnaire

Health Canada is responsible for the ethical conduct of research undertaken within or for the institution regardless of the location where the research is conducted and of its nature.

Health Canada and/or the Public Health Agency of Canada (PHAC) officers, due to their highly specialized expertise, are often requested to provide analytical services to a project by a Principal Investigator (PI) from another institution. The following circumstance can be contemplated as such a service, for example, the Health Canada/PHAC officer analyzes anonymous or anonymized human biological material samples, without engaging in their collection, and will not be a co-author in publications resulting from the project.

The PI must have obtained an ethics review from his/her own institution's Research Ethics Board (REB), before the research begins. Once the PI has obtained approval to proceed by his/her institution's REB, then the Health Canada/PHAC officer is required to obtain an ethics review by the Health Canada REB, prior to performing these analytical services. Health Canada REB approval must be obtained in writing before the Health Canada/PHAC official takes possession of the data or biological samples and begins the analysis thereof.

The purpose of this questionnaire is to have the Health Canada REB screen the general parameters of the project that has received an approval by an outside REB. The Health Canada/PHAC officer should submit the following documentation to the REB Secretariat:

• PI to complete this questionnaire
• To provide a copy of the PI's application to his/her REB
• A copy of the PI's REB letter of approval, and
• Investigator's(s) curriculum vitae (updated, signed and dated).

Note to Researchers

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

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 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:

Senior Secretariat Officer
Research Ethics Board Secretariat
Health Canada
Holland Cross Building, Tower B
1600 Scott Street
Room 410, Address Locator #3104A
Ottawa, Ontario, K1A 0K9
Phone number: 613-941-5199
Fax: 613-948-6781

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

The Research Ethics Board (REB) aims to adhere to the principles and practices stated in the Canadian Tri-Council Policy Statement (1998) and the Declaration of Helsinki.

1. Project Title
2. Principal Investigator
   
   Name:
   Position:
   Branch:
   Department/Agency:
   
   Address:
   Phone:
   Fax:
   E-Mail:
3. Departmental Official
   
   Name:
   Position:
   Department/Agency:
   
   Signature
   
   Date
4. Departmental Approval
   
   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.
5. Previously approved by an outside REB
   Yes    No
   
   If yes, what type of ethics review was done by the outside REB?
   Full review
   Expedited review
   N/A
   
   Name of the outside REB:
   
   Please provide copy of the entire application submitted to the outside REB as well
   as a copy of their Letter of Approval.
   Enclosed    Not applicable
   
   If not applicable, please provide the reason why.
6. 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
   Other, please specify:
   
   If applicable, please attach a copy of the Memorandum of Understanding or contract for the services that will be provided by Health Canada/PHAC in this project.
7. How will the samples be submitted to you? (Please check all that apply.)
   Anonymous/unidentified samples
   Anonymized/unlinked samples
   Identifiable/coded samples
   Identified samples
8. What specific services to the research project has Health Canada/PHAC been asked to provide?
9. Informed Consent
   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.
10. Identifiable communities / Groups
    Are there any possibilities of identifying communities or groups from the
    collected sample?
    Yes No
    
    If yes, please specify:
11. 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:
12. 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:
13. Conflicts of Interest
    Is there any conflict of interest (actual, apparent, perceived or potential) arising from your work in Health Canada/PHAC?
    Yes    No
    
    If yes, please specify:

I certify that the above declaration is accurate. If any changes are done to the above declaration, I certify that I will immediately contact the REB Secretariat.

Principal Investigator's Signature

Date