Psychology 291 – Lab 4Ethics

October 9, 2012

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

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)

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

CCAC modules1. Guidelines, Legislation & Regulations2. Ethics in Animal Experimentation3. The Three R’s of Humane Animal

Experimentation4. Occupational Health & Safety5. Research Issues6. Basic Animal Care7. Environmental Enrichment *making home area as pleasant as

possible

8. Basic Diseases and the Animal Facility9. Pain, Distress & Endpoints10.Analgesia11.Anesthesia12.Euthanasia of Experimental Animals

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.

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

Proposing Human Research

• The REC committee consist of:– Dr. John Edwards (Coordinator)– Dr. Ted Wright– Dr. Karen Brebner

• 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

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

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

• 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)

Completing a REC applicationSection 2

• Describe any risk to participants– Apparatus– Risk of non – confidentiality

• Describe any benefits to the participants– Will they be compensated ($, Psych 100

credit …)

Completing a REC applicationSection 3

• 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.

Completing a REC applicationSection 4

• 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

Completing a REC applicationSection 5

Faculty Supervisor Agreement FormFor Application for Ethics Clearance

to Conduct Research Involving Human ParticipantsDepartment of Psychology

St. Francis Xavier UniversityTitle 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.

Psych Department Ethics Committee

Example of a completed Ethics Application Form

(without Appendices)