Grace Kelly Ethics Officer

Office of Research EthicsThe University of Western Ontario

grace.kelly@uwo.ca x84692

An Introduction to Research Ethics at Western

Ethics Considerations for Teachers’ Research with

Students in their own Classroom

Guiding Principles ofResearch Ethics

Policy Framework

Nuremberg Code, 1949 (end of 2nd world war)

Declaration of Helsinki, 1964 – cornerstone document of human research ethics.

Belmont Report, 1979

PHIPA section 44 -disclosure for research/REB

TCPS

**Tri-Council Policy Statement (TCPS):

Ethical Conduct for Research Involving Humans, 1998

-Federal Granting Agencies – SSHRC; CIHR; NSERC

-Funding is only given to individuals at institutions that comply with this policy

TCPSCore PrinciplesWelfare (assess risks and benefits)

Autonomy and Decision Making (informed consent and voluntary participation)

Equal Moral Status of All (inclusive, everyone treated the same)

How does the TCPS fit into the ORE?

• Based on the Core Principles of the TCPS the ORE’s main goals are as follows:– Protection of human subjects– Assess risks and benefits– Assess research design to ensure minimal

risk and meet objectives– Review subject recruitment to ensure

informed consent– Protect vulnerable groups of individuals

What Research Goes Where?

Research Ethics at Western

HSREBFull Board(high risk)

HSREBDelegated Board

(lower risk)Level 1 & Level 2

NMREBNon-MedicalHigher andLower Risk

UWOOffice of Research

Ethics

UWO is the Board of Record for all London Hospitals

UWO Faculty, Staff and Students & institutions

Assessment of Risk

• Greater scrutiny and expertise required for research that is potentially more invasive or harmful

• REB is responsible for assessing magnitude and probability of potential harms and benefits

When Do You Need to Apply?

ALL research involving human subjects and their data must be reviewed by a UWO REB.

This includes all research conducted on campus by UWO Faculty, Staff and Students Research conducted on campus.

Determining if REB Review is Necessary can be Tricky!

• You wish to conduct a study of the ways in which space and resources are used in the Library– Goal #1: to improve service, see what areas

are used, how could physical space be improved?

– Goal #2: to interview students and staff to understand their perceptions of the library, how important access to materials is to their work, what their demographics are, etc.

If you’re not sure, please ask.

Everyone’s research is different and unique.

• If my research requires REB approval• Factor time in as part of research

process– Back and forth process with the ORE

and REB.• Are you the PI of a study? Using UWO

staff, faculty, students or facilities.

How does the Board Review my Research Proposal?

(From the Guiding Principles)

What the REB Reviews

• UWO Research Submission (HSREB or NMREB)– Objectives, rationale, hypotheses– Methods, including surveys/instruments– Participants– Confidentiality

• Letter of Information & Consent

• Scripts & Advertisements

The REB also Reviews…

• Any ‘item’ used to solicit participation in a study including:– Telephone scripts– Recruitment scripts (for on-the-spot surveys)– Cover letters– Email messages– Follow-up/reminder notices (a la Dillman

Method)

Additionally…The REB Reviews

• All Revisions to already approved research

• FYIs• Adverse Events• Updated Approvals• Protocol Violations• Protocol Deviations

Sound Methodology• Have you provided support, in the form of

references for your current research question?

• Sample size? Does it work?• Are human participants really necessary to

answer the question?• Clear explanation of steps – also to letter of

information• Do the benefits of the research outweigh the

risks?

Coercion or Inducements to Participate

• overwhelmed by institutional approval

• fear of loss of health benefits, employment or educational status

• obligation to participate

• financial gain

Privacy & Confidentiality Issues

• Privacy and confidentiality are recognized as fundamental human rights.

• What counts as loss of privacy may vary from individual to individual and society to society.

What Constitutes “Identifiers”?

• Name, initials

• Date of birth or death (partial)

• Initials and DOB together

• PINs, OHIP numbers, SIN, others

• Postal code

• Mapping of data

Assessing Identifiability & Risk

• Identifying information: identifies a specific research participant directly (e.g., name, address, SIN or PIN)

• Identifiable information: could be used to re-identify a participant through a combination of indirect

• De-identified/coded information: Identifiers are removed/replaced with a code. Those with access to the code and the data (or those working directly with those with the code) have identifiable information.

• Anonymized information: Information is irrevocably stripped of identifiers, and a code is not kept

• Anonymous information: Information never had identifiers

If I need REB Review, do I also always need to obtain

consent?

Waiver of Consent• Principle of Beneficence• Sheer size• Proportion of individuals relocated or died• Creation of privacy risk by linking ID to de-

identified data• Risk of psychological, social or other harm• Difficulty in contacting individuals• Identifiability

Waiver of Consent

• Not to be confused with other forms of consent. – Explicit Consent (eg. Completion of Survey)– Explicit Verbal Consent (eg. Telephone

Survey)– Passive Consent (Opt-Out)– Previous Consent

You still need a Letter of Information or script for these forms of consent.

Informed Consent

• Subjects must be told exactly what is going to happen to them

• Subjects must agree to participate

• Letter of Information

• Consent Form

• Assent Form

Informed Consent Guidance

HSREB & NMREB GUIDELINEShttp://www.uwo.ca/research/ethics/

•Required Wording•Letter explains clearly the study methods•What will be done with the data •Participant confidentiality/anonymity•Participant contact information•Grammar & Spelling

Teachers’ Research with Students in their own Classroom

The main issue that exists when a teacher wants to conduct research in their own classroom is the power relationship that exists between a teacher and her/his own students and even further – the issue of coercion.

However…..

Teachers’ Research with Students in their own Classroom

• …with proper planning and consideration a teacher may be able to use the students within his/her own class as study participants provided (s)he is able to avoid both the reality and appearance of coercion and coercion itself.

Step 1

• When thinking about your research, distinguish between activities that constitute ‘research’ and those that fall under ‘professional development’. – Look back at our examples of whether or not

ethics is needed. • If not publishing and only examining the teacher’s

pedagogical practices then no ethics is needed.• If publishing best to get ethics approval

Step 2

• Decide how you will avoid both the reality and perception of coercion– A potential ‘risk’ in these studies is being

coerced into participating in a study in which one does not want to participate.

• (eg. Parents or students feel obligated to participate to avoid offending teacher or so that the child’s marks are not affected).

Step 3• Create a plausible plan for avoiding

coercion in your submissions. – Alternatives forms of data collection should be

made to avoid coercion. • Anonymous online questionnaire

• Study students in a different classroom

• Use another researcher to do the research for you (3rd party) – they collect consent and keep results until final grades submitted, therefore teacher doesn’t know who participated and can’t base grades on that

Summary• Careful consideration must be taken to

avoid any undue influence on the participant which will undermine the voluntary character of the consent.

• Where possible, the approach to the participant inviting to participation in a research project should be made by someone not in a position of authority over the subject.

Summary

• Students must be assured that withdrawal will not result in any academic penalty.

• Similarly students should not be promised academic reward.