Research Ethics

PPAL 6200-3.08-9 February, 2011 Part 2

Introduction

• Why?• Regulatory Framework• Administration of the Framework here at York• Practical Advice

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

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

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 (TCPS2).

What does TCPS2 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)

• 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)

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

Administration of the Framework @ York• TCPS2 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

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.

Practical Advice• You can find the forms you need by clicking on

the link marked “Guidelines, Policies and Forms” on the MPPAL 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!

The Difference between a Guideline and a Regulation

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.