Psychology Departmental Research Ethics Board

(Psych-REB)

October, 2007

Dr. Pascual-Leone, Chair

Overview

• Introduction: Why an ethics review?

• Procedures: Submission and review

• Tips & key issues for your method

• Common reasons for non-approval

• Closing remarks

Overview

• Introduction: Why an ethics review?Introduction: Why an ethics review?

• Procedures: Submission and review

• Tips & key issues for your method

• Common reasons for non-approval

• Closing remarks

What is it? Who is this for? • All research that is done at the University of

Windsor must first get ethics clearance.

• The Psychology Departmental Research Ethics Board (Psych-REB) is a satellite of the University of Windsor Research Ethics Board and it approves undergraduate projects that are completed in a 12 month period.

• This is of special interest to undergraduates who are beginning 4th year honours theses

Purpose of the Psych-REB

1. Ensure that research participants are being treated in ways that respect their dignity and integrity.

2. Teach students about ethical practices and standards in conducting psychological research.

3. Create a paper trail that demonstrates ethical conduct if and when concerns arise at any level (departmental, university, tri-council, civil law).

Educational Objectives

• To help thesis students better understand the ethical issues at hand.– Informed consent– Minimal risk…

• Create a tutorial on ethics through the application (rather than it being a “black box” process).

• Streamline the process to allow for less down time and more student involvement.

Overview

• Introduction: Why an ethics review?

• Procedures: Submission and reviewProcedures: Submission and review

• Tips & key issues for your method

• Common reasons for non-approval

• Closing remarks

How to Submit an application1. Print out and complete the “Ethics Application” by

hand.2. Download and modify the “Informed Consent Form” to

suit your project. 3. (If applicable, you may also need to print out and

complete the “Deception Checklist”). 4. Use the first page of the application form to ensure that

you package is complete.5. Make a copy. Ethics applications are submitted in

duplicate (even revised applications must be submitted in duplicate).

6. Submit the 2 packages to the Psych-REB chairperson.7. Feedback from Psych-REB in about 1 week.

Forms are on the psychology, undergraduate website

• http://www.uwindsor.ca/units/psychology/psycNew.nsf/SubCategoryFlyOut/478CC63BA0E8EC70852573680045EA97

Feedback• Approved in its present form

• Pending minor changes specified below. – (These changes can be made by the student

researcher alone, and there is no need to resubmit these changes to the Psych-REB).

• Pending minor changes & resubmission. – (Changes are specified and resubmission to the

Psych-REB for final approval and clearance). • Pending major changes.

– (Project requires major changes, which are specified, and must be resubmitted before receiving ethical clearance).

Overview

• Introduction: Why an ethics review?

• Procedures: Submission and review

• Tips & key issues for your methodTips & key issues for your method

• Common reasons for non-approval

• Closing remarks

6 Tips for Ethical Research designs

• Following are some practical tips for designing and conducting research that is ethical.

• Children, the elderly, animals…

People with mental health problems…

• Research with vulnerable populations will likely be extensively reviewed and may have to go through the UW-REB.

Tips #1 for Ethical Research:Vulnerable Populations

• Participants must know and understand what they are getting themselves into.

• A clear and consistent presentation in ad’s, consent forms, etc. is key.

Tips #2 for Ethical Research:Informed Consent

• There are some research paradigms which are well documented in peer-reviewed literature. If your study makes use of an established procedure you should:

– Cite research relevant that used similar designs, especially if there is research indicating whether there were or were not harmful effects to participants.

– Provide and consider the year of the study

Tips #3 for Ethical Research:Refer to the literature

Tips #4 for Ethical Research:Participants leave feeling the same

state as when they came• Some procedures are emotionally evocative or

shift participant’s expectations in some way. If you do this it is good practice to:

1. Provide a follow-up intervention to help participants return to a positive or at least neutral state before they leave the study. A “mood neutralizer” could be in the form of a relaxation exercise or imagining/remembering some positive experience.

2. After a “mood neutralizer”, it is good practice to ask participants to rate their current level of distress or anxiety on a scale of 1 to 10;

– this is a manipulation check to ensure that participants feel “normal” again before they leave.

Tips #5 for Ethical Research:Debriefing

• A debriefing in which the true nature of the study is disclosed to participants and an opportunity to ask questions is an important part of data collection from human participants. A good debriefing tries to:

1. Engage the participant as a collaborator to discuss the process he/she was involved in.

2. Disclose to the participant, in plain everyday language and in sufficient detail, exactly what has happened in the data collection process and the true nature of the study.

3. Explain the rationale for using the method in this particular study.

4. Provide an opportunity for participants to ask questions of clarification.

5. Provide, in writing, resources and/or contacts for participant who may have concerns that have come to bear through the nature of the study.

Tips #6 for Ethical Research:Protect trust

• Participants initially volunteer to partake in whatever the study entails. In doing so they entrust themselves to the researcher and the institution that is hosting the research.

• It is important to ensure that participants do not feel embarrassed or betrayed as a result of research procedures.

• When the study and debriefing is complete, is there a reasonable possibility that participants may perceive themselves as having been a betrayal of trust or somehow treated unfairly?

Overview

• Introduction: Why an ethics review?

• Procedures: Submission and review

• Tips & key issues for your method

• Common reasons for non-approvalCommon reasons for non-approval

• Closing remarks

Top 8 most common set backsInadequate consent forms (#1 - 4)1. Did not use the informed consent template as a guide

and therefore did not include essential information.2. Did not provide contact information for

1. student (you), 2. Dr. XXX, supervisor of the project (who is ultimately

responsible for addressing participant concerns), and

3. Chairperson of the Psych-REB.3. Used the UW REB contact information instead of the

Psychology-REB contact info.4. Did not include a section in consent form giving

permission to use the data in subsequent studies (when you or your supervisor plans to do so) OR did not state that data will not be used in subsequent studies.

Top 8 most common set backs Con’t…

5. Participant pool ad missing: Did not include a recruitment ad to be approved for use in the Participant Pool.

6. Participant pool points: Presented participation time in a way that was not in line with Participant Pool standards • (Currently, 1 bonus point = 30 minutes of participation).

7. Incomplete packages: Did not submit ALL materials in duplicate (or did not re-submit in duplicate).

8. Inconsistencies between the application form, method section, and consent forms.• i.e. The title on the ethics submission form is different than that

stated on the consent and/or recruitment ad.

Overview

• Introduction: Why an ethics review?

• Procedures: Submission and review

• Tips & key issues for your method

• Common reasons for non-approval

• Closing remarksClosing remarks

Future directions:The writing is on the wall

• In the not too distant future there will likely be a government agency that will monitor and set the standards for practice for research conducted with human participants.

• U Windsor REB is discussing the possibility of standardizing an undergraduate ethics application across departments.

• Psych-REB has the opportunity to have a say in this process by creating a template that may be adapted for use across other departmental Ethics committees.

Website & Contact• Psych-REB website.

• linked to the honors thesis course website.

Dr. Antonio Pascual-LeoneChair, Psychology Departmental Research Ethics Board.University of WindsorWindsor, ON N9B 3X2519-253-3000 ext. 4702email: apl@uwindsor.ca

Questions?