Research Ethics Sandy Auld Director Research Ethics Office

Research Ethics Sandy Auld Director, Research Ethics Office of Research University Centre 437 X 56606

Tri-Council Policy Statement: Ethical conduct for research involving humans (TCPS 2) � NSERC, SSHRC, CIHR ◦ 1998 – First Edition ◦ 2010 – Second Edition � Memorandum of Understanding (MOU)

Moral Imperative Respect for Human Dignity � Concern for Welfare � Respect for Persons � Justice

Research Ethics �REB-General �REB-Natural, Physical, and Engineering Sciences

Research Ethics: REB-G � Faculty ◦ ◦ CSAHS CME COA OAC representatives � Community members � Legal representative � Graduate Student

Research Ethics: REB-NPES � Faculty ◦ CPES ◦ CBS ◦ OVC representatives � Alternative Health Care Provider � Community members � Legal representative � Medical representative � Graduate Student

Research Ethics � REB-NPES ◦ 10 members � REB-G ◦ 11 members � Monthly meetings � Full board review � Delegated review

Application � Proportionate � Ethics and the Law ◦ Duty to report ◦ Compelled to report � Perspective of the Participant

Research Requiring Ethics Review �living human participants �human biological materials ◦ living or deceased

Research NOT Requiring Ethics Review �Publicly available information. �No expectation of privacy �Quality assurance studies. �Observation in public places �Secondary use of anonymous information �Creative practice

Risk Benefit Ratio �Physical risk �Psychological risks �Social Risks (privacy) �Benefit

Informed Consent – Free and Informed � PROCESS ◦ INITIATE before research begins. ◦ MAINTAIN throughout. ◦ ONGOING � FREE ◦ Undue influence ◦ Conflict of Interest � INFORMED ◦ Consent documents �Information letters �Recruitment �Written consent �scripts

Privacy and Confidentiality � Directly identifying data � Indirectly identifying data � Coded information � Anonymized information � Anonymous information � Maintained “within the extent permitted by ethical principles and the law”

Methodology � E-Surveys � Chapter 9 � Chapter 10 ◦ Observation � Chapter 11

What do I submit? � PROTOCOL ◦ Application to Involve Human Participants ◦ Recruitment documents ◦ Consent Document(s) ◦ Surveys/questionnaires ◦ Debriefing ◦ Permission from external agencies ◦ Signature page.

Tips for Quick Review � Keep it simple. � DO NOT submit your grant proposal, thesis proposal. � Avoid jargon in all documents but particularly those to go to participants. � Read guidance documents beforehand. � Use your Ethics Office – we’re there to help.

How long will it take? � Full Board Review � Delegated Review � Revisions will be required ◦ work with the ethics office ◦ communication

Human Ethics Sandy Auld Director, Research Ethics Office of Research X 56606 sauld@uoguelph. ca