Laurentian University Research Ethics Board (LU’s REB)

Who are we: Contact People

Jean Dragon Ph.D. (Ethics Officer)

RDC Office L-313

jdragon@laurentienne.ca

Phone: 675-1151-3213

Pauline Zanetti (Administrative Assistant)

RDC Office L-350f

pzanetti@laurentienne.ca

Phone: 675-1151-2436

Daniel Côté Ph.D. RSW (Chair of the LUREB)

dcote@laurentian.ca (do not send him directly your proposal…)

Phone: 675-1151-5081

Committee Members representing university departments and the community

What We Do

• Ethics review of research proposals with human subjects based upon the TCPS (mainstream) and CIHR (Canadian Aboriginal) guidelines and also Health Canada etc.

• Advice to fill forms and assist with the understanding of processes and policies

• Collaborate with departmental REBs in terms of UG projects

• //We’re an IRB…

What will I present today?

• -General presentation of the framework for ethics in research;• -The review process at LU;• -Looking at the form we use at LU + answering questions

• This presentation is based in part upon :• -the objective 3 of your course outline which states : «develop understanding

of ethical considerations for conducting human research and the process of obtaining ethics approval from Research Ethics Boards».

•  • - Learning outcomes C which states : «Learners will understand the

requirements for conducting ethical research involving humans, and be able to apply for ethics approval to a Research Ethics Board».

• **Please excuse me for my lack of good English…

Contemporary sources for ethics principles

International

• Nuremberg’s code (1947): suite aux atrocités de la seconde guerre Mondiale

• Helsinki declaration (1964-2004): éthique médicale

• Etc.*Of course if you did the tutorial you already know that

Contemporary sources for ethics principles

Canada

• Tri-Councils (TCPS -1998-today : *next version is under review

• Health Canada

Ethics: definition (s)

Comme from the Greek word «ethos»: values, discourse on values…

*different definitions and domains: General ethics, regional ethics (applied, deontology, professionals etc.), Ethics of research.

Here we are giving the sense of:

Set of principles, values, rules, standards, guidelines and practices to govern the behavior and attitudes in a given field.

Who is concerned by ethics?

Students• Researchers-professors• Administrators (YES!)• University presidents and vice-presidents

(institutional research)• *The Participants (that have to be respected)• Etc.

A «sine qua non» condition

• Agencies will consider funding only to individuals and institutions that certify that they comply with the TCPS policy regarding the use of human subjects.

• Students: that goes also with diplomation and the right to publish.

Why ethical standards in research?

• Because the research, whether medical or else, shall be subject to ethical standards designed to ensure respect for all human beings and protect their health and their rights

• Source: Déclaration d’Helsinki, article 8.

//To enrich the knowledge of World Heritage in compliance and safety of human subjects.

- Reduce pain, validate scientific theories, dissolve ignorance, policy analysis, understanding human behavior etc..

*These standards reflect our commitment to humanity.

An Ethical framework

• The ethical standards reflect the complexity of social norms (that are always changing).

• These standards must remain an open and free discussion.

• The ethical framework is a decision-making framework based on proven consensusal principles.

• *Ethics is not censorship.

The «art» of reviewing

• It may happen that the principles (8) come into conflict with one another.

• Reviewers must acquire the experience to know what principles apply in specific contexts.

• They must reach an «ethical» conclusion («praxis»).

• *Ethics is not law and there is no notion of "precedent ». Each proposal and each review is UNIQUE.

// Ethics is not a science but a praxis.

The «art» of reviewing

• No formal way to review;• Must understand context and apply with flexibility;• Principles must be understood as a whole.

• // Art of reviewing is a dynamic balance between the understanding of TCPS principles and local Terms’s of reference.

The «art» of reviewing

• The key concept for review is the proportional approach;

• This means that the more invasive or harmful the proposal is, the more the care for its review should be.

• This will determine the type of review (exemption, expedited or full).

• **This is also why you have to well define the risks (and how you will

handle them) and ratio benefits of your research (ultimate justification).

Principles

• Respect of Human Dignity (cardinal principle): *could be the only one

• Respect of Free and Informed Consent: translates into the dialogue, process, rights, and duties required for there to be informed consent

• Respect for Vulnerable Persons: those with diminished competence or decision making capacity are vulnerable, requiring special protection

• Respect for Privacy and Confidentiality: standards of privacy pertaining to the access, control, and dissemination of personal information from data collection, onward

Principles

• Respect for Justice and Inclusiveness: guideline pertaining to the REB (fair standardized treatment of all researchers) and for all sectors of the population (no sector should be unfairly exploited)

• Balancing Harms and Benefits: foreseeable harms should not outweigh anticipated benefits

• Minimizing Harm: participants should not be subjected to unnecessary risks or harm (number of participants also considered)

• Maximizing Benefit

Under the NEW TCPS

• The 8 principles are now under the following 3 : 

• 1- Respect for Persons ; 2- Concern for Welfare and 3- Justice

•  Here is how they explain how they are related to the old TCPS 8 principles : 

• The three core principles incorporate within them the eight principles set out in the 1998 TCPS. Respect for human dignity is expressed through the three core principles. Respect for free and informed consent and respect for vulnerable persons are both reflected in the principle of Respect for Persons, while respect for vulnerable persons is also reflected in the principle of Justice. Respect for privacy and confidentiality is an element of Concern for Welfare. Respect for Justice and Inclusiveness is covered in the core principle of Justice. Balancing Harms and Benefits, Minimizing Harm and Maximizing Benefit are in fact not principles, but are the means by which the principle of Concern for Welfare is put into effect. Each of these elements is addressed in greater detail in a chapter or section of this Policy. By using these broader and more encompassing core principles, this Policy seeks to provide a more focused framework for the ethical guidance that follows. It is also a framework that harmonizes with other national and international ethics policies.

Principles are there to defend vulnerable populations

• Children• Minors• Incarcerated• Cognitively impaired• Economically

disadvantaged• Educationally

disadvantaged, STUDENTS

• Socially disadvantaged

• Physically disadvantaged

• Military• Students• Elderly• Veterans

We are a Subject Centered Perspective

• The interests of researchers and participants are not always one and the same.

• Researchers and REBs must strive to understand the diverse views of participants, especially in the process of free and informed consent.

The notion of Minimal Risk

• Minimal risk means that the probability and the magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

• *[I know this is pretty flexible… and some have a more dangerous life

than others…]

LU’s REB is not a clinical REB

• There is no clinical REB but a general REB!

When we have certain types of clinical proposal, especially clinical trials, we must whether send them for PEER or ask to health Canada to review them (which never happened yet).

•  • /// This is also why we are putting on place, in

association with NOSM (and multi hospitals institutions) a PAN REGIONAL CLINICAL REB.

Typical reviews in Radiotherapy

• Secondary data: (need 1- confidentiality agreement 2- evidence of consent for secondary purpose from participants on initial resarch 3- permission from the owner of the database). /// Generally goes on Expedite review.

– **Difference between hospitals and Academic REB: Upon TCPS we cannot accept implicit consent.

– A consent for health care services or medical acts is not necessaritly a consent for research and or secondary research upon explicitely indicated as such on a consent form.

– THIS WILL MAYBE CHANGE UPON NEW TCPS.

• Human tissues: (considered as clinical and invasive) /// FULL review

• Experimenting on devices and or with phantoms: generally not considered as not subject to REB evaluation: ///Exemption

General Policies for the Submission of an Ethics Proposal at Laurentian University

• According to the TCPS, all research activities, funded or non-funded, using primary or secondary data, human tissues or embryo materials, external or international, national or international, etc. (see Appendix 1 of the Policy on

Human Subjects Research) have to be approved by the Laurentian University Research Ethics Board (LUREB).

• Only undergraduate students projects that involve non intrusive and minimal risk research activities can be approved by a sanctioned departmental ethics committees

Application Process: 3 Types of Review 

• Full review by CENTRAL REB is the default requirement for all research involving human subjects.

• The reviews (below) are all accountable to the IRB

A) Full REB review (often takes approximately 6 weeks from complete submission acceptance, with *additional time for incomplete

submissions)

B) Expedited REB review by two people from the REB (often requires up to 4 weeks upon receipt of the complete submission, with *additional time for incomplete submissions)

C) Departmental-level review of UG projects carried out within formal course requirements **all graduate student work and student projects that are faculty work require IRB approval

Monitoring – non compliance

• According to article 1.13 c of TCPS, «(…) continuing review should consist of at least the submission of a succinct annual status report to the REB. The REB shall be promptly notified when the project concludes».

• You will receive notification for this annual report.• If you do not report, you won’t have anymore ethics

clearance.• Without ethics clearance, you cannot have: dissemination

activities related to your project; no access to funds and no diplomation (if this proposal is part of a scholarship or a thesis).

Guidelines for Submission at LU

1.The length of the general application must be no more than 12 pages (appendices can be added as additional supplements) using common language whenever possible.2.According to the TCPS, only UG student projects that involve non-intrusive and minimal risk research activities can be approved by a departmental ethics committee.3.Expedited reviews will require a minimum of 15 working days. Full reviews require a minimum of five (5) weeks for evaluation, and those submitted closest to the committee’s meeting will be deferred until the following meeting, if meeting time limits are exceeded.4.All necessary documentation is provided, including assessment tools / protocols, letters of partnership / endorsement, scripts, and consent forms as part of the original submission. Incomplete submissions will not be evaluated and immediately returned to the applicant, until complete.5.If secondary data are being used for research, there must be explicit approval in writing from each participant pertaining to the immediate study’s objectives. If this is not possible, complete justification must be included (and shall respect laws such as PHIPA and FIPPA, see links below).6.If the project reflects multi-institution / multinational initiatives, then approval is to be sought at all sites, and accompanying documentation is to be provided to the Research Office c/o Dr. Jean Dragon prior to the study’s commencement.

1. Each new submission will receive a specif ic identif ication number. Please always refer to this number when you communicate with the REB off ice.

2. Once the original project is off icially submitted to the REB, no other version or attachments will be accepted until completion of the f irst review.

3. Unfunded research projects designated for full review can be sent for peer review (two peer reviewers are consulted and one of them, at least, will be from outside of the university) before they are reviewed by the LU REB upon specif ication by the committee’s Chair, or when the REB deems as such. The coordinator will be in charge to send and receive the reviews and communicate them to the REB.

General Guidelines for Re-Submission 4. If the project is re-submitted, there is to be an explicit overview of all modifications in a separate document, and

all modif ications within the revised application are to be completed in track changes. 5. Research is deemed as pending until there is a response received from the REB Chair (i.e., outright acceptance,

which differs from condit ional / provisional acceptance). 6. Al l project modif ications and addendums (such as changes in the consent forms, methodological steps, addition,

deletion of people on the project, etc.) are to be provided to the REB and considered prior to the project’s alteration.

7. Proposed timelines can be revised providing the researcher is still wi thin them, however a letter of explanation must be provided with reasonable justif ication. All approvals reflect a specif ied timeline, and wil l not extend without written and signed authorization from the REB Chair approving the modif ication. Requested extensions after the timeline has been exceeded are considered as “new submissions” .

Electronic submission process only

Any Questions?**CONSULT THE ‹FAQ» on our website.

Jean Dragon Ph.D. (Ethics Officer)

RDC Office L-313

jdragon@laurentienne.ca

Phone: 675-1151-3213

Pauline Zanetti (Administrative Assistant)

RDC Office L-350f

pzanetti@laurentienne.ca

Phone: 675-1151-2436