Research review - How to submit
Instructions for using the eReviews online application system
Please find attached a short video presentation containing the instructions for using the eReviews application system (15 minutes). To watch this video, you need Flash Player version 10 or newer. To download, please click here.
You can also download this step-by-step quick reference guide (PDF).
If you have any questions regarding the new central online study review submission process or if you encounter difficulties while using the system, please contact us at study [dot] review [at] muhc [dot] mcgill [dot] ca. You may also call 514-934-1934 ext. 42953 and we will be happy to answer any question.
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How to submit a new human subjects study
All research proposals designed to involve human subjects, or to use human material or information held by MUHC records to be conducted at the MUHC must be submitted for review through the electronic submission system. The single submission will trigger reviews for scientific merit, ethical acceptability and site specific assessment to review the study agreement, and all planned uses of MUHC resources for research purposes such as pharmacy and medical imaging.
To proceed with the submission of a new research study, please access the central online study eReviews application at http://muhc-ri.eReviews.evision.ca/ethicsMcGill/loginForm.do?locale=en
To avoid any delay in the various reviews required for the study, you must respond to every question in eReviews and attach all required document. The review process will be delayed if required information is missing or incomplete.
Once you receive the MUHC Study code from the RI MUHC administrator, please confirm with the Ethics Review Coordinator the exact number of collated packages of study documents required for REB review. You must include in the package this signature page with original signatures to indicate appropriate study endorsement.
If you are a first-time user, we strongly recommend viewing a short training video on eReviews.
Also, you may find the answer to your questions at the additional information link or the FAQ link.
Important: The electronic system will send all communications to the Principal Investigator and the name of the last Study Coordinator entered in the study review submission. If the Principal Investigator wishes to delegate the task of completing the forms, he/she must ensure that the name of the delegate is correctly listed at the end of the Study Coordinator section.
At any time, you may log onto the eReviews system to track the review status for your study. You may access the status of review on “Review Progress Statuses” under “study management” on the left side of the screen.
When the study has been approved, the Investigator receives correspondence providing MUHC Authorization to conduct the study. A study cannot be initiated at the MUHC until the Investigator receives written MUHC Authorization.
For the period of time that you are conducting the study you must inform the REB concerning the following ongoing events:
- Change in Study Status Report including confirmation of the study initiation
- Revision to an Approved Study
- Serious Adverse Event
- Protocol Deviation
- Continuing Review
- Study Completion or Termination
To submit a report for any of the events listed above, please consult how to submit an ongoing research study review at the MUHC.
If you need assistance, please refer to helpline and contact information.
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How to submit an ongoing study
Once the research is underway and in an ongoing manner for the duration of study conduct, you must inform the REB of the following study events using the eReview system:
- Change in Study Status
- Revision to an Approved Study
- Serious Adverse Event
- Protocol Deviation
- Continuing Review
- Study Amendment
- Study Completion or Termination
To proceed with the submission of an ongoing study, please access the central online study eReviews application at http://muhc-ri.eReviews.evision.ca/ethicsMcGill/loginForm.do?locale=en
To avoid any delay in the various reviews required for the study, you must respond to every question in eReviews. The review process will be delayed if required information is missing or incomplete.
Important: Please note that for any studies submitted prior to April 2011, the only information contained in the eReviews database is the study name, MUHC study code and the Principal Investigator’s (PI) full name. This means that only the PI will receive communications from eReviews concerning a study submitted prior to April 2011. The PI may want a delegate (e.g. a study coordinator) to be copied on communications. If the Principal Investigator wishes to delegate the task of completing the forms, he/she must ensure the delegate’s name is correctly entered in the “Delegate Update” section.
If you are a first-time user, we strongly recommend viewing a short training video on eReviews.
Also, you may find the answer to your questions at the additional information link or the FAQ link.
At any time, you may log onto the eReviews system to track the review status for your study. You may access the status of review on “Review Progress Statuses” under “study management” on the left side of the screen.
Once the study has been approved, the Investigator receives correspondence providing MUHC Authorization to conduct the study. A study cannot be initiated at the MUHC until the Investigator receives written MUHC Authorization.
If you need assistance, please refer to helpline and contact information.
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How to submit a Quebec multicentre study
The review procedures for Quebec multicentre research vary according to the role assigned to the Investigator by the Study Sponsor. Refer to the information at the link below that describes the Investigator’s role at the MUHC:
- MUHC Investigator as Coordinating Principal Investigator
- MUHC Investigator as Local Principal Investigator
Important: Only MUHC staff with the “Privilege to Conduct Research” can submit through the eReviews system.
To avoid any delay in the various reviews required for the study, you must respond to every question in eReviews. The review process will be delayed if required information is missing or incomplete.
MUHC Investigator as Coordinating Principal Investigator
As of November 1, 2008, Coordinating Principal Investigators involved with studies intended for conduct at four or fewer Quebec research institutions may choose to apply for ethics review locally at their own institution OR to apply for ethics review using the MSSS Multicentre Review System.
Human subject studies to be conducted at 5 or more institutions of the MSSS Health Network must be submitted through the Multicentre Review System.
- An explanation of the multicentre review mechanism is available in English.
- You may download the MSSS application forms (M-Éval) directly from the MSSS website.
- The MSSS is offering online training at:
http://ethique.msss.gouv.qc.ca/site/fr_formation_ethique.phtml
Multicentre research study involving human subjects, and/or use of human material proposed for conduct at the McGill University Health Centre must be submitted through the research review electronic system. The single submission will trigger reviews for scientific merit, ethical acceptability and site specific assessment including appropriate use of MUHC resources for research purposes, study agreement and pharmacy reviews.
In order to make a complete submission using eReviews, you will be asked to attach:
- "Formulaire de demande d’évaluation d’un projet multicentrique" (M-Éval form)
- Research Protocol
- Consent Document and Assent Document (if applicable)
- Investigator’s Brochure or Report of Prior Investigations (if applicable)
- Suggested Reviewers for Scientific Merit Review (if applicable)
To proceed with the submission of a new research study, please access the central online study eReviews application at http://muhc-ri.eReviews.evision.ca/ethicsMcGill/loginForm.do?locale=en
To avoid any delay in the various reviews required for the study, you must respond to every question in eReviews. The review process will be delayed if required information is missing or incomplete.
If you are a first-time user, we strongly recommend viewing a short training video on eReviews.
Also, you may find the answer to your questions at the additional information link or the FAQ link.
Important: The electronic system will send all communications to the Principal Investigator and the name of the last Study Coordinator entered in the study review submission. If the Principal Investigator wishes to delegate the task of completing the forms, he/she must ensure that the name of the delegate is correctly listed at the end of the Study Coordinator section.
Once the study has been approved, the Investigator receives correspondence providing MUHC Authorization to conduct the study. A study cannot be initiated at the MUHC until the Investigator receives written MUHC Authorization.
At any time, you may log onto the eReviews system to track the review status for your study. You may access the status of review on “Review Progress Statuses” under “study management” on the left side of the screen.
If you need assistance, please refer to helpline and contact information.
MUHC Investigator as Local Principal Investigator
As of November 1, 2008, Coordinating Principal Investigators involved with studies intended for conduct at four or fewer Quebec research institutions may choose to apply for ethics review locally at their own institution. In your role as Local Principal Investigator, we urge you to maintain contact with the Coordinating Principal Investigator in order to remain aware of the ethics review outcome. The roles of the Investigators within the Quebec Multicentre mechanism is explained here: http://ethique.msss.gouv.qc.ca/site/60.367.0.0.1.0.phtml.
Human subject studies to be conducted at 5 or more institutions of the MSSS Health Network must be submitted through the Multicentre Review System.
- An explanation of the multicentre review mechanism is available in English.
- The MSSS is offering online training at:
http://ethique.msss.gouv.qc.ca/site/fr_formation_ethique.phtml
Multicentre study involving human subjects, and/or use of human material proposed for conduct at the McGill University Health Centre must be evaluated within the research review electronic system for scientific merit, ethical acceptability, site specific assessment, contract and pharmacy review (if applicable).
In order to complete the central submission online application, you will be asked to attach:
- "Formulaire de demande d’évaluation d’un projet multicentrique" (M-Éval) as completed by the Coordinating Principal Investigator
- Research Protocol
- Consent Document and Assent Document (if applicable)
- Investigator’s Brochure or Report of Prior Investigations (if applicable)
- Suggested Reviewers for Scientific Merit Review (if applicable)
*You may request the copy of the documents listed above from the Coordinating Principal Investigator of the multicentre study.
To proceed with the submission of a new research study, please access the central online study eReviews application at http://muhc-ri.eReviews.evision.ca/ethicsMcGill/loginForm.do?locale=en
In order to submit, the Local Investigator will have to electronically sign the eReviews forms. In this case only, the local Investigator represents the “Principal Investigator”.
To avoid any delay in the various reviews required for the study, you must respond to every question in eReviews. The review process will be delayed if required information is missing or incomplete.
If you are a first-time user, we strongly recommend viewing a short training video on eReviews.
Also, you may find the answer to your questions at the additional information link or the FAQ link.
Important: The electronic system will send all communications to the Local Principal Investigator and the name of the last Study Coordinator entered in the study review submission. If the Local Principal Investigator wishes to delegate the task of completing the forms, he/she must ensure that the name of the delegate is correctly listed at the end of the Study Coordinator section
Once the study has been approved, the Investigator receives correspondence providing MUHC Authorization to conduct the study. A study cannot be initiated at the MUHC until the Investigator receives written MUHC Authorization.
At any time, you may log onto the eReviews system to track the review status for your study. You may access the status of review on “Review Progress Statuses” under “study management” on the left side of the screen.
If you need assistance, please refer to helpline and contact information.
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How to submit a study involving ONLY access to health information (Health Records Research)
Important changes to the review and authorization of research involving access to health information had to be introduced recently in order to ensure compliance with the requirements of the Unité d’éthique du Ministère de la Santé et des services sociaux (http://ethique.msss.gouv.qc.ca/site/145.249.0.0.1.0.phtml).
Please take note that all studies that require access to health information held at the MUHC must be reviewed by a Research Ethics Board with jurisdiction at the MUHC. In addition, if you propose to conduct the study without obtaining individual informed consent from each subject (i.e. request of a waiver of informed consent), the access to health information must be authorized by the Director of Professional Services (DPS). The DPS or Associate DPS perform this review to comply with the requirements of the Loi sur les services de santé et les services sociaux (LSSSS).
Unfortunately, this new requirement could not be incorporated in the first version of eReviews. Therefore, the Research Ethics Office developed a short version of the Initial Review application form to submit for REB review.
1) Download and complete the Ethics review form for HRR studies;
2) Submit the “application form” to newstudy [at] muhc [dot] mcgill [dot] ca.
3) The Central Administrator will provide to you the MUHC Study Code for your study;
4) After receiving the MUHC Study Code, you may access eReviews to complete the standard submission*.
*In this case, you will have to answer YES for the first “initial question” (does your study require existing medical record only for which no subject will be contacted).
Understanding eReviews system information:
If you are a first-time user, we strongly recommend viewing a short training video on eReviews.
Also, you may find the answer to your questions at the additional information link or the FAQ link.
Important: The electronic system will send all communications to the Local Principal Investigator and the name of the last Study Coordinator entered in the study review submission. If the Local Principal Investigator wishes to delegate the task of completing the forms, he/she must ensure that the name of the delegate is correctly listed at the end of the Study Coordinator section.
Once the study has been approved, the Investigator receives correspondence providing MUHC Authorization to conduct the study. A study cannot be initiated at the MUHC until the Investigator receives written MUHC Authorization.
At any time, you may log onto the eReviews system to track the review status for your study. You may access the status of review on “Review Progress Statuses” under “study management” on the left side of the screen.
If you need assistance, please refer to helpline and contact information.
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Categories of research requiring MUHC review
All the categories of research described below require specific reviews and approvals to be conducted at the MUHC. All approved studies must receive MUHC Authorization prior to initiation.
- Studies involving living human subjects, cadavers, human remains, tissues, body fluids, embryos or foetuses;
- Studies conducted on gametes;
- Studies using personal information contained in medical records or clinical or new or existing administrative databases (e.g. paper, film, electronic);
- Studies to be conducted entirely or in part at the MUHC (including studies conducted beyond the MUHC by its staff);
- Studies that recruit subjects on the MUHC premises or from records held at the MUHC;
- Studies involving a Sponsor-Investigator or Investigator affiliated with the MUHC;
- Studies that utilize human, financial or material resources from the MUHC;
- Studies that utilize material from tissue banks or laboratories for human subjects research.
To facilitate transition to the online eReviews application system, the previous submission forms will be accepted until May 15, 2011.
You can access the old forms here.
Investigators are requested to suggest names of at least two (2) persons within the institution who are qualified to assess the scientific merit proposal.
Please be advised that the Scientific Review Director may decide not to use your suggested reviewers and appoint a different investigator for the study scientific review.
For Multicentre studies
MUHC Investigator as Coordinating Principal Investigator
A favorable review for scientific merit is the first step in multicentre review. A local MUHC scientific review is not required if the research proposal received favourable scientific peer review by a recognized agency or committee
MUHC Investigator as Local Principal Investigator
The review for scientific merit is conducted only once for all Quebec sites and submitting for review is the responsibility of the Coordinating Principal
Investigator (CPI). The scientific review or the verification of existing
scientific peer review is conducted according to procedures in place at the
CPI’s institution.
For Pediatric studies
Additional information by clicking here.
The Research Ethics Board (REB) is required to review the following study documents:
- Research protocol and all amendments to the study;
- Informed Consent and Assent documents in English and French and all proposed modifications
- Subject identification method (if not included in research protocol)
- Subject recruitment method (if not included in research protocol)
- All printed, electronic and recorded documentation to be given to research subjects
- Investigator’s Brochure, Report of Prior Investigators or Product Monograph (phase IV CT only) (if applicable)
- Other available information on the safety of the investigational product used in the study (if applicable)
- No-objection letter (NOL) for studies requiring a CTA (Clinical Trial Application)
- Information on’ compensation to the subject (Information in the protocol and consent document must correspond)
- Current curriculum vitae of the Principal Investigator (CVs are submitted and kept on file at RI MUHC)
At the MUHC, every document to be presented to a research subject must be available in French and English versions. This includes all research instruments such as questionnaires for screening or data collection purposes, informed consent and assent documents, subject diaries, and all supplementary information about the research study. All documents to be given to a research subject must be approved by the MUHC REB of Record prior to use in the study.
Please confirm with the Ethics Review Coordinator the exact number of collated packages of study documents required for REB review. You must ensure to include in the package this signature page with original signatures to indicate appropriate department/division endorsement.
You may contact the staff of the Research Ethics Office (REO) here, and access further information on the REO website.
If you need a contract template, please contact the Contract office at contracts [at] muhc [dot] mcgill [dot] ca.
MUHC Study Review Fees
|
Type of study |
Applicable review fee |
|
Industry-sponsored and funded; over $75,000 |
$10,000 |
|
Industry-sponsored and funded; under $75,000 |
$5,000 |
|
Investigator-initiated, industry-funded |
$3,500 |
|
Unrestricted Educational Grant funding |
$3,500 |
|
Service agreement (no ethics or science review) |
$3,500 |
|
Multi-site study managed via the RI MUHC |
$500 per site up to a maximum of $10,000 (if eligible) |
|
Publicly or foundation-funded |
Waived |
MUHC Overhead Rates Effective January 1, 2010 - As required by the MSSS
|
Source of funding |
Applicable overhead |
|
Industry* |
30% |
|
Public |
15% OR maximum allowable by agency |
|
Foundation |
10% OR maximum allowable by agency |
* Investigator- or company-initiated; applicable on all clinical trial agreements, service contracts and grants
All publicly available information about a research study including a poster, flyer, press release, electronic publicity or recording must comply with MUHC Public Relations and Communication (PRC) policy.
The REB will review the publicity text to be posted at the MUHC within the eReviews submission.
The MUHC PRC produced Guidelines for the Use of the MUHC Logo with a section entitled “Clinical Trial Advertising” describing the MUHC standard and providing a model in English and in French.
Template: Newspaper Advertisement
Access to Health Information
This section is under construction
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How do I get my login and password information to access eReviews?
Can the Principal Investigator delegate the task of completing the forms?
Who will receive emails for clarification requests or confirmations?
Where can I track the study review status?
What do I do if sponsors are sending me paper documents instead of electronic ones?
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How do I get my login and password information to access eReviews?
As a first-time user, the Principal Investigator needs to access the central online eReviews application through: http://muhc-ri.eReviews.evision.ca/ethicsMcGill/loginForm.do?locale=en.
-Click on “Create an Account”
-Complete the required information and click “Save”
-A request will automatically be sent to the RI MUHC account administrator.
-Once your account is validated, you will receive an email confirmation that your eReviews account is active.
-Revisit the eReviews link to login and start your submission.
Only the Principal Investigator can add staff members; therefore, a Study Coordinator cannot create a login/password without being authorized by the PI.
Can the Principal Investigator delegate the task of completing the forms?
Yes, the Principal Investigator may delegate the task of completing the forms. However, only the Principal Investigator can submit new studies and sign forms electronically after logging in with her/his own credentials.
The delegate can complete the forms and submit them only after they are signed by the Principal Investigator.
If, as a Principal Investigator, you wish to delegate:
- Follow the “delegate update” link in the “Study management” section of the left-hand side menu
- Use the “Search” button to search the person to whom you wish to delegate.
If the person is not in the database, please add them through the “Add staff”
link on the top menu.
- The request will be sent to the delegate via Email.
Who will receive emails for clarification requests or confirmations?
The electronic system will send all communication to the Principal Investigator and the last study coordinator entered in the system. If the Principal Investigator wishes to delegate the task of completing the submission application, please ensure that the name of the delegate is the last entry on the list of names in the Study Coordinator table.
Important: Please note that for any studies submitted prior to April 2011, the only information contained in the eReviews database is the research study title, MUHC Study Code and the Principal Investigator’s (PI) first and last name. This means that only the PI will receive communications from eReviews.
The PI may want a delegate (e.g. a study coordinator) to be copied on communications. To do this the Principal Investigator must ensure that the name of the delegate correctly appears as the last entry on the list of names in the Study Coordinator table.
Where can I track the study review status?
At any time, you may log onto the eReviews system to track the review status for your study. You may access the status of review on “Review Progress Statuses” under “study management” on the left side of the screen.
What do I do if sponsors are sending me paper documents instead of electronic ones?
Just as with the current Central Intake process, you are required to submit electronic copies of study documents in order to initiate the review processes required for an application to conduct research at the MUHC.
Does the new submission system mean that I no longer have to prepare multiple collated copies of paper submissions for the REB?
No, you must still submit the required number of collated documents in paper copies for the REB.
The eReviews system is designed to facilitate the initiation of applications to conduct research and works much the same way as the Central Intake process. It is not intended to replace paper records and therefore the investigator must retain paper copies of essential study documents for the regulatory file.
You also must append this signature page with your REB package.
The signature of the Department Head is required to endorse the study. Why does eReviews not ask for the signature?
You are correct, however, the eReviews system was not planned to include the Department Head electronic signature. As endorsements signatures are required by the MUHC policy, we have prepared a paper signature page to be attached to the REB submission package.
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Helpline and Contact information
Study review department
study [dot] review [at] muhc [dot] mcgill [dot] ca
Helpline: 514-934-1934 ext. 42953
Contract Office
contracts [at] muhc [dot] mcgill [dot] ca
Research Ethics Office
reo [at] muhc [dot] mcgill [dot] ca
http://muhc.ca/reo/dashboard
