Psychology 291 – Lab 4 Ethics October 9, 2012

1. Psychology 291 – Lab 4EthicsOctober 9, 2012

2. Ethics • Ethics are a code of proper action which take into account: • Respect for human dignity • Respect for free and informed consent • Respect for vulnerable persons (& animals) *people need to understand what’s going on • Respect for privacy and confidentiality • Respect for justice and inclusiveness • Balancing harm and benefits

3. Animal and Human Research • Both types of research require clearance from their respective boards • Animal research requires that protocols be cleared through the Animal Care Committee (ACC)(the one on campus)and that all investigators complete the Canadian Council on Animal Care (CCAC)(Canada wide)modules to be able to work with animals • Human Research requires studies/apparatus to be cleared through the Research Ethics Committee (REC)

4. Levels of Clearance for Animal Research • The CCAC outlines its primary ethical concerns according to the three R’s of research:*replacement: try to replace organism with smallest possible form, or even a computer model *reduction: using the smallest amount of animals possible *refinement: minimizing pain/invasiveness • ACC is the “local enforcer” of CCAC requirements • In order to be cleared to work with animals, an investigator must pass ( > 70%) 12 CCAC modules and their protocols must be cleared by the ACC

5. CCAC modules • Guidelines, Legislation & Regulations • Ethics in Animal Experimentation • The Three R’s of Humane Animal Experimentation • Occupational Health & Safety • Research Issues • Basic Animal Care • Environmental Enrichment *making home area as pleasant as possible • Basic Diseases and the Animal Facility • Pain, Distress & Endpoints • Analgesia • Anesthesia • Euthanasia of Experimental Animals

6. Proposing Animal Research • Animal Care Committee (ACC) consists of: • An ACC coordinator *most knowledge about the rules • The ACF manager *work in area animals are kept, runs the facility • Two community members *volunteers from community • Two faculty members that use animals • A faculty member that is not an animal user*often has a background in ethics • A student • A veterinarian *know best about pain and distress etc.

7. Animal Ethics Applications • The ACC must have a clear understanding of: • Purpose/merit of the research • Research design • Distress to animals, Use of controlled substances, Health risks for Animal Care Facilities (ACF) personnel and other animals • Personnel involved • Level of invasiveness of protocol • Validity of the research according to the 3 R’s of CCAC • Experimental endpoints and fate of animals involved • ACF requirements

8. Proposing Human Research • The REC committee consist of: • Dr. John Edwards (Coordinator) • Dr. Ted Wright • Dr. Karen Brebner

9. The REC board must have a clear understanding of: • The purpose of the research • The hypothesis(es) • Research design • Participants • How that population will be accessed • Protection of Participant rights • Risks and how to minimize them • Benefits of the research • Using these criteria, the REC board can clear ethically sound research

10. Completing an Ethics Application There are 5 sections in a complete ethics application:Purpose & DesignParticipantsRisks and BenefitsDeceptionDebriefing Note: All scripts, questionnaires, etc. must be attached as appendices

11. Completing a REC applicationSection 1 • Provide general information • title, supervisor, researchers, start date … • Provide supporting background research to validate hypotheses and purpose • Include citations, but not references • State the hypotheses • Experimental design for collecting data

12. Completing a REC applicationSection 2 • Describe the target participants • How many participants will be recruited? • How will those participants be recruited? • Appendix • Are there any possible conflicts between the researcher and the participants? • Procedure for informed consent • Consent form (Appendix) • Recruitment script (Appendix)

13. Completing a REC applicationSection 3 • Describe any risk to participants • Apparatus • Risk of non – confidentiality • Describe any benefits to the participants • Will they be compensated ($, Psych 100 credit …)

14. Completing a REC applicationSection 4 • Deception • Justify why deception is necessary if it will be used • Private Speech • Introducing confounds and extraneous variables • If deception is used, informed consent has not been obtained, :. a new consent form must be signed after complete debriefing has occurred.

15. Completing a REC applicationSection 5 • Debriefing • Verbal and/or written • Should include: • statement of appreciation • details about the purpose and hypotheses of the study • statement that the research has received ethics clearance from the Research Ethics Committee of the Department of Psychology at St. Francis Xavier University

16. Faculty Supervisor Agreement Form For Application for Ethics Clearance to Conduct Research Involving Human Participants Department of Psychology St. Francis Xavier University Title of the Project: Faculty Supervisor: Names, phone numbers, and e-mail addresses of all student researchers involved in the project: Intended Start Date: Agreement to be signed by the Faculty Supervisor: I have read the application for Ethics Clearance to Conduct Research Involving Human Participants submitted by the student(s) listed above and verify that the information provided is accurate and complete.  I have ensured that all students involved in this research are familiar with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (website: http://www.pre.ethics.gc.ca/english/pdf/TCPS%20October%202005_E.pdf) and that the research described in this application complies with the policies and procedures outlined therein.  If, subsequent to REC clearance, any change is made in the design or procedure that has ethical implications, I will ensure that a supplementary application is submitted to the REC.  Finally, I agree to ensure that the procedures for handling participants’ Psychology 100 research participation credits are followed in a timely fashion. Signature of Supervisor:  ___________________________________  Date: _________ When you have completed the REC document you must have it approved and signed by your Faculty Supervisor.

17. Psych Department Ethics CommitteeExample of a completed Ethics Application Form(without Appendices)