Presented by: Franca Cantini Dr. Susan Kahn The New MSSS Multi-centre Mechanism for Research Ethics Review

Presented by:

Franca Cantini

Dr. Susan Kahn

The New MSSS Multi-centre Mechanism for Research Ethics Review

New MSSS Multicenter Mechanism

January 2013 Ministère de la Santé et des Services Sociaux

(MSSS) began in collaboration with:

FRQ-S (Research Fund of Quebec) RUIS (Integrated University Health Networks)

McGill University Université de Montréal Université de Sherbrooke Université de Laval


Objective


The Goal of the New Mechanism is to:

• Protect the participants involved in the research

• Foster research excellence

• Create a dynamic in which the expertise of RECs is shared not only within its own institution but throughout the Réseau de la Santé et des Services Sociaux (RSSS).

• Streamline research ethics review of the multi-center research


STREAMLINE THE PROCESS!!! NETWORK APPROACH

The New MSSS Review Mechanism “Cadre de Référence des établissements publics du RSSS pour l’autorisation d’une recherche menée dans plus d’un établissement”

Sets out rules allowing 1 single ethics approval for research taking place in MORE THAN ONE (multicenter) public institution within the Health and Social Services Network (RSSS).

THIS IS GREAT NEWS!!!!

One review for Multiple Research Sites

YES IT IS TRUE!!!

Any research conducted in more than one public institution of

RSSS (more than 1 site in Quebec) will undergo only one Review

by a recognized Research Ethics Committee (REC) of the Health

and Social Services Network (RSSS).

BUT HOW???

Recognized Competent REC

• Meet the normative requirements outlined by the MSSS

• Designated Committee by MSSS

• Been constituted by the Board of Directors of one or more public institutions of RSSS

• Have the expertise required to review the research project: e.g., oncology, psychosocial etc.,

• be willing and able to act as the evaluating REC

An agency of the Health and Social Services or be the Central Research Ethics

Committee (CREC) established by the Minister of Health and

Social Services (MSSS).

1. Researcher/Research Teams

2. Evaluating REC (EREC) – “CER Evaluateur”

3. Institutional Authorization (by Board mandated person) to carry-out the research

at each site – “Autorisation par la personne mandaté par le Conseil de l’établissment”

• Feasibiltiy Review – “Examen de la convenance”

Key Players

Key Players Researcher/Research Team

Scientific Review of a Research Project

It is recommended that the scientific review of a research project be conducted before the researcher asks a REC to act as the Evaluating REC

Submitting to the REC without Scientific Review

•If the researcher has not already obtained a favorable review from a scientific review committee when submitting to the Evaluating REC, then a scientific review will be included in the Evaluating REC’s research ethics review.

Must choose the Evaluating REC based on following criteria in order of priority:

• The affiliation of the principal investigator

• Main location for recruitment of participants

If there are no RECs in these institutions, the researcher must submit to the CCER

Question # 1: Who is the Principal Investigator and where does he/she have an affiliation with within the RSSS?

Question # 2: Where are the research participants being recruited?

Example:Dr. XXXX is conducting a multicenter investigator initiated study involving 5 sites in the Province of Quebec. She is the Principal Investigator and is affiliated to McGill University and a staff member with research privileges to conduct research at the JGH and the MGH.

Question # 1: Where can she submit for ethics review?• McGill University Institutional Ethics Committee• Jewish General Hospital Research Ethics Committee• MUHC Research Ethics Board

Question # 2: Where are research participants being recruited from mostly? JGH

Step1:

Determine where the Researcher is to submit the Research Project for Ethics Review:

In this case the Researcher would submit to the Jewish General Hospital Research Ethics Committee because it has a greater population of potential research participants.

STEP # 1

Choosing an

Evaluating REC

Step # 2

PI asks REC to be

Evaluating REC (EREC)

1. PI sends a request to the REC asking it to act as the Evaluating REC for a given multicenter research study

2. REC shall, with diligence, and no later than five (5) working days after the filing of the application, determine whether or not it has the required competencies to act as the Evaluating REC for the project.

3. The REC must declare in writing to the researcher whether it will act as the Evaluating REC for the project in question or not and why

Letter of Declaration

STEP #3

Provide LOCAL Information

Submit to EREC on time

Considering that the research study will beConducted in more than one Institution of the RSSS, the Researcher must provide information about:

other sites and the researchers who agreed to undertake the responsible for the research conducted in their respective institutions

other sites Researchers competence and knowledge with regard to the population targeted by the research project

the local requirements and needs with regards to the safety of the population in question and the local considerations (Local Commissioner of Complaints & Quality of Services)

Factors that need to be evaluated by the REC

Article 7.2 Cadre de Référence (MSSS)

si la recherche implique des personnes mineures ou majeures inaptes en application de l'article 21 du Code civil du Québec, auquel cas le CER doit être un CER désigné ou institué par le ministre;

si le CER compte parmi ses membres des personnes ayant une expertise pertinente en ce qui concerne la population visée par la recherche, la méthode, la discipline ou le domaine de recherche liés au projet de recherche proposé; et

si le CER est en mesure de tenir une réunion pour effectuer l’examen éthique du projet de recherche dans les 30 jours de calendrier suivant la date à laquelle il déclare qu’il accepte d’agir comme CER évaluateur.

Letter of Declaration - Acceptance

In its declaration to act as the evaluating REC:• When the project will be reviewed by the Committee

• What Documents are required for the REC review

• How many copies and when they need to be submitted (deadline for submission)

If the researcher does not provide the documentation within the given timeframe,

the Evaluating REC (EREC) is not required to conduct its research ethics review

within the 30 calendar days of the date first stated it's declaration to the

researcher.

Letter of Declaration Issued by the EREC

Once an Evaluating REC has agreed to review the research ethics of a research project, no other REC from the RSSS can conduct a research ethics review

Once the researcher has committed to an Evaluating REC of the RSSS for the review of the research project - no other researcher can submit the same project to another Evaluating REC for research ethics review.

• Exception: If the evaluating REC is not able to respond in a timely manner

(30 calendar days), the researcher can send a request to another REC to act as the Evaluating REC.

STEP #4

Request Authorization to conduct the

Research Project at each site

Once the Letter of Declaration is issued, the Researcher can proceed with getting authorization from each of the Institutions where the study is to take place.

1. Institutional Authorization from Person Mandated for Authorizing Research at each site – “Autorisation par la personne mandaté par le Conseil de l’établissement”

a) Feasibiltiy Assessment Review – “Examen de la convenance”

The Mandated person sees to it that the Feasibility Assessment is initiated.

STEP #5

Review by the EREC

The EREC must provide feedback to the researcher no later than five (5) working days following the date of the meeting at which the project was reviewed

Researcher/Research Team work in collaboration with the EREC to address concerns and provide response to issues raised during review.

The Evaluating REC may review the response of the researcher under a full board or delegated review.

The Evaluating REC deliver its final decision via a favourable or negative opinion.

Letter must be submitted within 5 days of final documentation being submitted

Research Ethics Review must be conducted within 30 calendar days

of the date of declaration

Declaration by the REC must be forwarded to the Researcher

within 5 working days

Determine to which REC the ethics request

should be addressed

Determine to which REC the ethics request

should be addressed

REC evaluates request

Ensures criteria to act as EREC

REC evaluates request

Ensures criteria to act as EREC

A written declaration will be provided to the

researcher


A written declaration will be provided to the

researcher


Researcher will submit all study documents to EREC –Submission

Form

Researcher will submit all study documents to EREC –Submission

Form

Researcher can ask for authorization to conduct research at each site

Researcher can ask for authorization to conduct research at each site

Results of Review by EREC

Results of Review by ERECPositive Result:

Final Ethics Approval granted

Final Science Approval granted

Positive Result:

Final Ethics Approval granted

Final Science Approval granted

Negative Result

Re-submit to same ERECAppeal Process

Negative Result

Re-submit to same ERECAppeal Process

•Supply copy to other PI identified by the Sponsor so they can request Authorization at own site

•Supply copy to other PI identified by the Sponsor so they can request Authorization at own site

Review Process of the

Evaluating REC

Key Players Personne Mandaté(Person Mandated to Authorize Research)

Person Mandated to Authorize Research

Person mandated to Authorize Research within an RSSS Institution

• The Board of Directors of the institution formally mandates a person who has an employment relationship with the institution and whose name is forwarded to the MSSS as the appointed individual.

• The Formally Mandated Person is responsible to authorize the conduct of research within its institution for multicenter research that fall under this new Mechanism that will be conducted in one or more public institution of RSSS.

• This person should not be in a situation of actual/potential/apparent conflicts of interest.

Responsibility of EACH of the Institutions

The Person Mandated for Authorizing Research, on behalf of the institution,forwards the decision as to whether or not the research may be conductedin the institution to the:

• Researcher/Research Team

• Evaluating Research Ethics Committee

• The Person Mandated to Authorize Research of the collaborating institutions (other sites)

STEP # 6

EREC provides Final Approval for the Project

The Evaluating REC issues Final Approval Letter confirming that the project has been subject to scientific review and research ethics review in which the outcome was favorable

Final Approval EREC

Step # 7

Final Authorization

to conduct research

at Siteby

Mandated Person

The Researcher provides to the Person Mandate by the institution theCorrespondence provided to the researcher by Evaluating REC, which States:

• The project has been the subject of scientific review, and has been deemed acceptable.• The project has been the subject of research ethics review the has been deemed

acceptable.

The researcher must also provide the letter from the Evaluating RECto all Sites:

• Documents that allow to see the content of research ethics review as well as the exchanges between the researcher and the Evaluating REC

• The final documents relating to the research as approved by Evaluating REC

• The guidelines regarding the purely administrative changes that may be made by a collaborating institution, to the approved versions of the research related documents.

The Person Mandated to Authorize Project must reply within 5days of receipt of the above.

Letter of Authorizationmust be sent within 5 working days

Researcher with Letter of Declaration from EREC requests permission to

carry-out research at each institution (sites)

Researcher with Letter of Declaration from EREC requests permission to

carry-out research at each institution (sites)

Initiate Feasibility Assessment ReviewInitiate Feasibility Assessment Review

Once the Person Mandated to Authorize research has received the confirmation of Final Approval from the EREC:

• Get Feasibility Approval • Authorize the conduct of research in the institution •(Article 11.4)

Once the Person Mandated to Authorize research has received the confirmation of Final Approval from the EREC:

• Get Feasibility Approval • Authorize the conduct of research in the institution •(Article 11.4)

Letter of authorization to conduct research in Institution is issue.

Letter of authorization to conduct research in Institution is issue.

Review Process of the

Person Mandated to

Authorize Research The Person Mandated to Authorize research must

reply with 5 working days

Person Mandated to Authorize Research must communicate with:

• Researcher • Evaluating Research Ethics Committee• The Person Mandated to Authorize Research of the collaborating institutions

For the duration of the study

Person Mandated to Authorize Research must communicate with:

• Researcher • Evaluating Research Ethics Committee• The Person Mandated to Authorize Research of the collaborating institutions

For the duration of the study

Feasibility Review

The Person Mandated to Authorize Research in the institution shall ensure that a Feasibilityreview of the project is carried out expeditiously and that the result of this examination iscommunicated to the appropriate Individuals.

The Feasibility Review of the research project at the institution must cover the following aspects:

• The impact of the project in light of other research activities currently active in the institution, in particular

with regards to the concern of the institution to avoid over-solicitation of the population targeted

• The availability of facilities, equipment and human resources establishing that the project requires;

• The correlation between local research environment and the proposed project;

• Contractual and financial aspects of the project;

• The terms of medication management, if applicable;

Revoking the right to conduct Research

The person mandated to authorize research in the institution may suspend or revoke the authorization given to researcher may upon receipt of information that calls into question the conduct of the research project.

The Person Mandated to Authorize Research must promptly notify the EREC the measures taken, while providing the justification if research has been suspended or authorization has been revoked.

EREC Review Positive Outcome

EREC meeting occurs with 30 days of

declaration

The letter from the Person Mandated to

authorize research should be sent to EREC within 5 working days

Letter sent within 5 working days

of receipt of final documents

receipt of the final documents

EREC Review Negative Outcome

Declaration by EREC sent within

5 working daysOR

immediately if Researcher

is member of same institution

New research project in more than one public institution of the RSSS

New research project in more than one public institution of the RSSS

Determine to which REC the request should be addressed

to

Determine to which REC the request should be addressed

to

Have on hand the positive results of the

scientific review

Have on hand the positive results of the

scientific review

Send Request REC asking them to be EREC

Send Request REC asking them to be EREC

Declaration from the REC to act as the Evaluating REC

Declaration from the REC to act as the Evaluating REC

Forward the letter declaration to the Person Mandated to Authorize Research in the each institution

Person Mandated to Authorize Research initiates the Feasibility of the project for the Institution

Forward the letter declaration to the Person Mandated to Authorize Research in the each institution

Person Mandated to Authorize Research initiates the Feasibility of the project for the Institution

The Researcher, as required, provides additional documents to complete the file prior to EREC meeting Respond to comments raised during the ethical review, make the required changes and submit the final documents to the Evaluating REC.

The Researcher, as required, provides additional documents to complete the file prior to EREC meeting Respond to comments raised during the ethical review, make the required changes and submit the final documents to the Evaluating REC. Re-submit to

project to the Evaluating

REC

Appeal Process

Re-submit to project to the

Evaluating REC

Appeal Process

Send the EREC letter & the final documents to the person mandated to authorize research in each collaborating Institutions. Receive letter from person mandated to authorized research stating whether or not it allows the research in its institution

Send the EREC letter & the final documents to the person mandated to authorize research in each collaborating Institutions. Receive letter from person mandated to authorized research stating whether or not it allows the research in its institution

Researcher Process

EREC Letter addresses:-Result ethical review

- Confirmation of a favorable review of the scientific committee

EREC Letter addresses:-Result ethical review

- Confirmation of a favorable review of the scientific committee

Effective Date

Effective February 1, 2015

Transition period will run from February 1, 2015 – March 31, 2016

Will replace “Méchanisme encadrant l’examen éthique et le suivi continu des projets multicentriques” (April 1, 2008)

Project in the MSSS Multicenter Mechanism 2008

Effective February 1, 2015

Prior to February 1, 2015

Research reviewed under Multicenter Mechanism prior to February 1, 2015

Research currently active under the 2008 Multicenter Mechanism

WANT TO ADD A SITE:

Starting from February 1, 2015, any addition of one or more sites of currently active multicenter trial research site, the researcher is expected to contact the Main REC and request they act as the EREC of the study and proceed with the new framework for the addition of the study site(s).

THANK-YOU!

Questions…