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http://www.uwo.ca/research/services/ethics/

Research EthicsResearch Methods

Grace KellyEthics Officer

Health Sciences Research Ethics Board


The main Health Sciences Research Ethics Board has been broken up into three boards:

Full Board

Delegated Level 1 (chart review / databases, etc.)

Delegated Level 2


Full Board Review

Research which may include but is not limited to clinical trials, medical intervention or therapy.

Research that is deemed minimal-risk to patients and participants or is a chart review is eligible for delegated review. All other research should be submitted to the full board for review


Delegated Review Level 1 (Chart Review)

Research which includes for example chart reviews, database or registry creation, analysis of tissue samples.

Generally speaking research which does not involve participant contact.

Delegated Review Level 2

Research which includes contact with patients, participants in the form of focus groups, questionnaires, surveys, etc.

Generally low risk patient / participant contact.


Tri-Council Policy Statement 2 (TCPS2)

• 2010 replaces 1998 version• The TCPS2 is a policy that has been

created as a benchmark for the ethical conduct of research involving humans.


Tri-Council Policy Statement 2 (TCPS2)

New Sections

Multi-Jurisdictional Research (Chapter 8)

Research Involving First Nations, Inuit and Métis Peoples of Canada (Chapter 9)

Qualitative Research (Chapter 10)


The Tri-Council Policy Statement 2 (TCPS2)

•When do you need ethics approval?

•What is informed consent and when is it needed?


• ALL research involving human participants is subject to ethics review by an REB, even if approval may not be needed.

• If you are doing research with humans please contact our office first if you are unsure.


The following MAY NOT require approval by an REB before the research commences:

Research that relies exclusively on publicly available information.

Research involving the observation of people in public places.

Research that relies exclusively on secondary use of data (fully anonymous).

Quality assurance work / program evaluation.


The Informed Consent Process

(a) Consent shall be given voluntarily and informed.(b) Consent can be withdrawn at any time.(c) If a participant withdraws consent, the participant can

also request the withdrawal of their data or human biological materials.


Alternate forms of Informed Consent

Certain types of research require alternate processes for seeking consent. Where elements of the consent process may need to be adapted to the requirements of a particular research project, the research ethics board (REB) can play an educational and consultative role in determining the appropriate process for seeking and maintaining consent.


It should be noted that you ALWAYS still need to inform a participant of the research, the risks, benefits, etc. and they must consent to this.

• Verbal Scripts• Explicit Consent by completion of a survey


Assent Form

• All children participating in research also need the consent of their parent unless it is more risky to have the parents sign also or the child is emancipated.

• Children 7-12 should read and sign the Assent Form• Children 13-18 can use the same Letter of Information

as their parents but sign a separate consent.


Waivers of Informed Consent

The REB may approve low risk (Level 1) research without requiring that the researcher obtain the participant’s consent.


The University of Western Ontario Research Ethics Board (REB) and Office

of Research Ethics (ORE)

• Deadlines

• Timelines

• Forms

• Romeo


Deadlines– The ORE sets deadlines for each of its major boards

• Please see our website for these deadline dates if applicable to the board you are submitting to.

HSREB Full Board – Deadlines

Delegated Level 1 – No deadlines

Delegated Level 2 – Deadlines the same as HSREB Full Board


Timelines

Full Board–Protocols are submitted on the deadline date–Reviewed at the meeting date indicated online–Recommendations sent out within 5 days of review


HSREB Delegated Level 1–Protocols can be submitted at anytime –Reviewed within 2 weeks of being submitted–Recommendations sent out within 5 days of review

HSREB Delegated Level 2–Protocols are submitted on the deadline date–Reviewed by the meeting date indicated online–Recommendations sent out within 5 days of review


Forms

All new forms due to the fact that we have switched over to an electronic database / submission system - Romeo

The REB provides initial review and approval to a research

project and the REB and the ORE provide ongoing post

approval review to research revision, etc.

Full Board moving toward fully electronic, Delegated already there.


Romeo

New electronic database has been used in-house for some time and for submissions starting this past May, 2012.

Training and education sessions have now begun institution wide and will continue as we continue to roll out new modules of the program.


Thank you!

We are always here to help. If you have any questions please contact:

Grace Kelly at 519-661-2111 ext. 84692 or [email protected]


Acknowledgements:

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2010.

http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

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