GUIDELINES

RESEARCH

Policy Bulletin 176

DEFINITIONS

1. Research is the systematic, controlled investigation into a subject to provide an organized body of knowledge.

2. A Treatment Demonstration Program is a clinical trial or pharmaceutical treatment that is not approved for general use in Canada. Such a program is characterized by the use of a scientifically designed experiment in which control groups, randomization and placebos may be used. It may also include drugs obtained under the Special Access Program of Health Canada.

3. The Special Access Program, which is managed by Health Canada, has the mandate of making drugs that are not approved for use in Canada available on application by a practitioner. These drugs are used to treat patients with a serious or life-threatening illness when conventional therapies have failed or are unsuitable and may include pharmaceutical, biologic and radiopharmaceutical products.

SUBMISSION AND APPROVAL OF RESEARCH PROPOSALS

Internal

4. All research proposals will be governed as outlined in Annex A and be submitted for review and approval as follows:

1. submit projects requiring national participation, directly to the Research Branch at National Headquarters;
2. submit regional projects to the Regional Research Committee for review and recommendation for inclusion in the Annual Research Plan; and
3. projects requiring ethics review must have internal ethics review committee approval in compliance with the Tri-Council's (the Medical Research, Natural Sciences and Engineering Research, and Social Sciences and Humanities Research Councils of Canada) Policy Statement on Ethical Conduct for Research Involving Humans.

External

5. Researchers affiliated with a university, including students and university staff, must obtain approval for proposed research projects from their respective university ethics committees prior to research commencing in compliance with the Tri-Council's (the Medical Research, Natural Sciences and Engineering Research, and Social Sciences and Humanities Research Councils of Canada) Policy Statement on Ethical Conduct for Research Involving Humans. Approval for proposed research projects from the university ethics committees may proceed concurrently to the approval from the CSC.

Women Offenders

6. The Deputy Commissioner for Women must approve any research proposals that involve women offenders.

EMPLOYEE OPINION SURVEY IN THE FEDERAL PUBLIC SERVICE

7. Employee opinion surveys are considered public opinion research and subject to the communications policy of the Government of Canada.

PERSONAL INFORMATION

8. Where personal information that is normally collected by CSC is to be provided to the researcher, an addendum is to be attached to the Research Application and Undertaking form.

9. All researchers who will have access to classified information shall be required to undergo an enhanced reliability assessment.

10. Personal information shall only be given to researchers if one of the two following conditions are met:

1. consent for disclosure from each participant is obtained; or
2. the Assistant Commissioner of Policy, Planning and Coordination, the Senior Deputy Commissioner or the Commissioner determines that the information can be disclosed based upon the provisions of the Privacy Act, paragraph 8 (2) (j):
   1. " is satisfied that the purpose for which the information is disclosed cannot reasonably be accomplished unless the information is provided in a form that would identify the individual to whom it relates, and
   2. obtains from the person or body a written undertaking that no subsequent disclosure of the information will be made in a form that could reasonably be expected to identify the individual to whom it relates."

11. The term "person or body" shall refer to the researcher. The written undertaking shall be CSC's Research Application and Undertaking form.

12. There shall be no subsequent disclosure of personal information unless the participants have consented or the information has been depersonalized in accordance with the undertaking given by the researcher under paragraph 8 (2) (j) of the Privacy Act.

INFORMED CONSENT

13. Where the research involves subjects directly, each participant must give informed and written consent prior to his or her involvement. The consent form will outline the objective of the study, the limits of confidentiality and any implications of participating in the research. It is the responsibility of the researchers to obtain this consent. Support from Parole Officers and/or Aboriginal elders may be helpful.

14. Informed consent for any type of research that involves treatment, including medical interventions, is defined in subsection 88 (2) of the Corrections and Conditional Release Act as follows:

"[…] an inmate's consent to treatment is informed consent only if the inmate has been advised of, and has the capacity to understand,

1. the likelihood and degree of improvement, remission, control or cure as a result of the treatment;
2. any significant risk, and the degree thereof, associated with the treatment;
3. any reasonable alternatives to the treatment;
4. the likely effects of refusing the treatment; and
5. the inmate's right to refuse the treatment or withdraw from the treatment at any time."

15. Experimental treatment shall meet the provisions of subsection 88 (4) of the CCRA:

"Treatment under a treatment demonstration program shall not be given to an offender unless a committee that is independent of the Service has

1. approved the treatment demonstration program as clinically sound and in conformity with accepted ethical standards;
2. reviewed the inmate's consent to the treatment and determined that it was given in accordance with this section."

16. The Treatment Demonstration Program Committee shall be comprised of "equal numbers from the community of lay persons and registered health care professionals with expertise related to the treatment demonstration program." (CCRR, section 115).

17. An offender may volunteer to participate in a medical research study or a Treatment Demonstration Program, for which an ethical review has taken place, only if he or she:

1. has been diagnosed as having a condition which the study addresses;
2. clearly understands the objective of the study and the anticipated benefits and risks in comparison with the current best treatment or no treatment, as outlined by health care professionals who are registered or licensed in Canada;
3. understands and accepts the methods to be used, including the use of controls, placebos, and randomization;
4. has signed a consent form which clearly described the objective of the study, the inmate's understanding of his or her involvement and the implications of his or her consent. The requirements for this consent are contained in subsections 88 (1), (2) and (3) of the CCRA and Commissioner's Directive 803 - Consent to Health Service Assessment, Treatment and Release of Information.

18. The offender's involvement in a medical study or treatment demonstration program shall be discontinued if requested by the researcher, CSC or the offender.

CONDUCTING THE RESEARCH

19. There will be no rewards for inmates participating in research projects. Where participation requires absence from usual work, those hours will be calculated as worked hours.

REVIEW/PUBLICATION OF RESULTS

20. Prior to the publication or release of the report, a review shall be undertaken by the party that sponsored the research. Further, where personal identifiers are used in the report, it shall be reviewed and vetted by the Access to Information and Privacy Division at National Headquarters.

21. In the case of research conducted under contract or otherwise sponsored by the CSC, the sharing of research findings shall be the responsibility of the Service.

22. Copies of all reports resulting from approved research conducted by contractors, other external researchers, or CSC employees shall be forwarded to the Research Branch at National Headquarters for information purposes.

23. Research findings will be shared service-wide through research publications accessible on the Infonet and Internet.

Assistant Commissioner,
Policy, Planning and Coordination

Original signed by :
Cheryl Fraser

Annex A

CSC Research Governance

Table of Contents