1. Research Ethics PPAL 6200-3.0 8-9 February, 2011 Part 2

2. Introduction Why? Regulatory Framework Administration of the Framework here at York Practical Advice

3. Why? The University Setting Academic Freedom comes with Social Responsibility Academic Freedom does not mean freedom from Peer Review Ethics Review can improve Research Design

4. Why? The Public Service Setting The Charter of Rights and Freedoms Freedom of Information and Protection of Privacy Legislation Obligations arising out of Common Law The Court of Public Opinion

5. Basic Regulatory Framework in Canadian Research Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri- Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2010 (TCPS 2 ).

6. What does TCPS 2 Apply To All researchers and research conducted in an academic setting in Canada involving human subjects Most research otherwise funded by the federal government involving human subjects is regulated by rules largely based on the TCPS regime (see for example Health Canada)Health Canada Most research otherwise regulated by the federal government involving human subjects is regulated by rules largely based on the TCPS regime (see Sec 9.25 of Canada’s Research Based Pharmaceutical Companies 2010 Code of Ethics)2010 Code of Ethics

7. Basic Principles of Ethical Research: Respect for Human Dignity Respect for Persons – Autonomy and Informed Consent Concern for Welfare – Protection of Research Subjects and in some research Promotion of their Wellbeing – Protecting the Wellbeing of Communities and Society as a Whole Justice – Treating People Fairly and Equitably Recruitment Process issues Power Imbalance between Researchers and Subjects

8. Administration of the Framework @ York TCPS 2 Requires each institution that receives Tri-Council Funding (like York) to review proposed research projects, supervise on-going ones and generally ensure compliance with the policy (generically called a Research Ethics Board or REB). Additionally, REBs often take on other functions as well. Basic Administrative Principles of any REB in Canada – Administer the Policy at Arms-Length from University Administration – Predominantly academics with community membership – Proportionate Review: Research that poses greater risks to the subject ought to receive more thorough review and more careful monitoring Minimal Risk Threshold: Applications screened to determine if cross this threshold: Does the proposed research pose no greater risk to participant than what they would face in their daily life. If cannot say Yes to this question, the research is NOT minimal risk. – Confidentiality and Right of Appeal

9. Senate Policy: Ethics Review Process for Research Involving Human Participants Policy Human Participants Review Committee (HPRC) which ensures review and supervision for all research involving human subjects Office of Research Ethics (ORE) which administratively assists the committee Delegation of supervision for student projects involving minimal risk. – As a graduate student you have a separate process to apply for permission that begins with your MRP supervisor (Who must sign off on your proposal) and the Research Committee in SPPA – If the Research Committee deems your project to be minimal-risk they have the authority to approve it on behalf of the HPRC.

10. Practical Advice You can find the forms you need by clicking on the link marked “Guidelines, Policies and Forms” on the MPPAL Website.Guidelines, Policies and FormsMPPAL Website Using an informed consent document signed by each participant is the norm. – If you deviate from this you need a good reason. Anonymity of research participants is the norm. – If you deviate from this you will definitely need a signed consent form where participants acknowledge they will be named in the research The “its their job” guideline The “I got this info through my job” warning If you do not know, ASK!

11. The Difference between a Guideline and a Regulation

12. The policies governing Research Ethics are Regulations not Guidelines Violations of the policies governing research ethics are dealt with very harshly by both York and our funder/regulators in Ottawa. Punishments for even first offences can be serious. Depending on the offence you may also face repercussions from your employer But there is really no reason to run afoul of these policies as the rules are pretty obvious and straightforward. Compliance does however take a bit of time, thought and planning. It is well worth the effort.