Research Ethics An Overview of Research Ethics and the Tri-Council Policy Statement 2 Grace Kelly Ethics Officer Health Sciences Delegated Boards - Level 1 & 2 Non-Medical Full Board and Delegated Board

The Office of Research Ethics plays an administrative role to two main boards here at Western : The Health Sciences Research Ethics Board (HSREB) The Non-Medical Research Ethics Board (NMREB)

Each of these two main boards are divided further, based on the level of risk indicated in the protocol. HSREB Full Board, Delegated Level 1, Delegated Level 2 NMREB Full Board, Delegated Faculty level sub-REBs

Delegated Review Any research that is deemed minimal risk or lower and does not use vulnerable participants, children or in some cases elderly. Minimal Risk: Research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research.

Vulnerability Often caused by limited capacity, or limited access to social goods, such as rights, opportunities and power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women, prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethnocultural minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly and inequitably in research, or have been excluded from research opportunities. People or groups whose circumstances cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in research.

Delegated Review Level 1 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) The TCPS2 is a policy that has been created as a benchmark for the ethical conduct of research involving humans.

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.

The following require ethics review and approval by an REB before the research commences: (a) research involving living human participants; (b) research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.

The following MAY NOT require ethics review and approval by an REB before the research commences: Research that relies exclusively on publicly available information does not require REB review when: (a) the information is legally accessible to the public and appropriately protected by law; or (b) the information is publicly accessible and there is no reasonable expectation of privacy.

REB review is not required for research involving the observation of people in public places where: (a) it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups; (b) individuals or groups targeted for observation have no reasonable expectation of privacy; and (c) any dissemination of research results does not allow identification of specific individuals.

REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information.

Quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of REB review.

Creative practice activities, in and of themselves, do not require REB review. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review.

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 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 where the REB is satisfied, and documents, that all of the following apply: (a)the research involves no more than minimal risk to the participants; (b) the lack of the participant’s consent is unlikely to adversely affect the welfare of the participant;

(c) it is impossible or impracticable to carry out the research and to answer the research question properly, given the research design, if prior consent of the participant is required; (d) whenever possible and appropriate, after participation, or at a later time during the study, participants will be debriefed and provided with additional pertinent information at which point they will have the opportunity to refuse consent; and (e) the research does not involve a therapeutic intervention, or other clinical or diagnostic interventions.

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 NMREB Full Board – Deadlines –Delegated – No deadlines HSREB Full Board – Deadlines –Delegated Level 1 – No deadlines –Delegated Level 2 – Deadlines the same as HSREB Full Board

Timelines –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 data indicated online –Recommendations sent out within 5 days of review

Forms –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. –We are currently in the process of going electronic with our submissions - ROMEO

ROMEO New electronic database currently used in-house. Within the next six months the ORE will be going live with the new online submission form. Training and education sessions institution wide. Hoping that this will cut down on turn around time.

Thank you! We are always here to help. If you have any questions please contact Grace Kelly at ext or or Julie Pfeiffer at ext or

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