- Initial Review - 1. STUDY TITLE MUHC Study Code :

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- Initial Review - 1.

STUDY TITLE

MUHC Study Code :

(REO use only)



This symbol requires you to take note of the information.

 This symbol indicates that a supplementary document may be required to complete the review.

2. RESEARCH PERSONNEL

a) Principal Investigator: Dept:

MUHC appointment: McGill appointment:

tel: fax: email :

Study mailing address :

b) Co-Investigator(s) Use a separate page to include additional Co-Investigators Dept:

c) Study Coordinator: Dept:

tel: fax: email :

McGILL UNIVERSITY HEALTH CENTRE

Application to Conduct Human Subjects Research

Sponsor Protocol Number:

(as applicable)

PLEASE ANSWER ALL QUESTIONS AND CHECK ALL THAT APPLY

 A change of Investigator requires a Study Amendment. Use Annex A to report changes.

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3. SCIENTIFIC REVIEW

a) What source(s) of funding will be used to conduct the research?

Industry Public-Private Partnership Investigator-Initiated with Industry Funding Cooperative Group Public Agency Private Agency Internal Funds

b) Please indicate the study sponsor's complete name :

c) Are you aware of another MUHC study recruiting the same population?

d) Was the research developed to fulfill a student's academic requirement?

e) Has the scientific merit of the research been subject to peer review?

If Yes, name the reviewing agency, committee or person:

 If Yes please submit all documents indicating favorable scientific review

 The study protocol must include the details listed in the Description of a Research Protocol.

 A single page Executive Summary with study objectives (100 words or less) suitable for filing in patient's medical record must be attached.

 Suggestions for Scientific Reviewers must be provided on the Suggested Reviewers form and submitted with the Initial Review application (Investigator-initiated research only)

No Yes

Yes No

No Yes

4. STUDY DESIGN

a) The information to be collected for the study will be: New data Existing data b) Is the research an "extension" or "companion" study to an existing study? Yes No

If Yes, please indicate MUHC Study Code for the existing study:

c) The study involves a: Drug Surgical Technique Medical Device

Data or Tissue Bank Radiopharmaceutical Placebo Other:

d) If a drug or biological will be used, is a “wash-out period” required? Yes No N/A e) Is statistical justification given for study design and sample size? Yes No

Biological

f) Does the protocol include an appropriate safety monitoring plan? Yes No

 If you are unsure whether the study will use infectious or carcinogenic agents requiring Institutional Biosafety (IBC) review, contact the REO for appropriate referral.

g) Will the study use recombinant DNA or involve a biohazardous risk? Yes No

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Yes

5. SITES AND SUBJECT SELECTION

a) Which MUHC site(s) will be involved in some aspect of study conduct (specify):

MCH MCI MGH MNH

c) Does any MUHC investigator plan to recruit subjects for this study off-site from the MUHC?

Yes, in what setting(s)?

b) Is study conduct planned at another McGill affiliated institution (specify)? No JGH MNI Douglas Hospital Shriners Hospital

d) The study will include: In-patients Out-patients ER Patients

ICU Patients Matched Controls Healthy Subjects No

Yes

Private Patients

RVH Other:

Other:

Anonymized Data or Tissue e) Will subjects be recruited from a vulnerable population (specify)? Yes No

Institutionalized Incompetent Minor(<18 years) McGill Students Employees of the MUHC, RI MUHC or McGill Other:

f) Total subject enrollment from all centres required to complete the study (number):

or Open-ended enrollment g) Number of MUHC subjects projected for enrollment:

h) Describe the study advertising plan. N/A

i) Will the study be made public on an MUHC and/or another website? Yes No

 If any information about the study will be publicly available the MUHC Public Relations and Communication (PRC) must review the “format and context” of the information for

consistency with MUHC PRC policy.

 Please attach a copy of the approved PRC “Research Media Clearance Form” for REB review.

 If you are unsure about the “exemption levels” for ionizing radiation, contact the REO to determine if Radiological Protection Service review of dosimetric assessment is required.

No Yes

h) Will the study use radioisotopes or other forms of ionizing radiation?

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a) Will genetic material be extracted from the study specimens? Yes No If Yes, for what purpose?

b) Will the Investigator or Sponsor retain specimens after study is completed ? Yes No If Yes, for how long?

How will the specimens eventually be disposed of?

c) Will samples of specimens be made available to other investigators? Yes No

If Yes, to whom? For what purpose?

What information will be provided with these samples?

d) Is there any potential for commercialization of the specimens or data? Yes No If Yes, please comment?

e) Describe provisions in place to maintain confidentiality of data:

Yes No

f) Will study data be included in the subject's medical record?

Will individual study results be communicated to the subjects?

Will study data be provided to parties other than sponsor or regulators?

6. STUDY DATA AND SPECIMENS

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7. FREE AND INFORMED CONSENT

a) Identify the research personnel to whom you will delegate the responsibility to seek consent.

Use a separate page to identify additional persons, as required:

Name: Study Position:

b) How will subjects be identified and recruited?

c) Who will make the initial contact with the prospective subjects and how will this be done?

 Please review the website information on Free and Informed Consent.

d) Is written consent of the subject required to conduct the study?

e) Is the assent of a legally incompetent adult or child subject required?

 Consent and Assent Documents must be prepared according to the Elements of Free and Informed Consent and follow the guidelines for Drafting the Consent and Assent Document.

 REB will not review a sponsor-prepared version that does not conform with REO Guidelines.

 At the MUHC both English and French versions of the Consent and Assent Documents are required. REO oversees translation validation for the original REB approved document.

f) Is correspondence included to justify a request for a waiver of written consent?

Yes No

 REB will not review a sponsor-prepared version that does not conform with REO Guidelines.

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8. REGULATORY COMPLIANCE

 MUHC research is reviewed according to the “Tri-Council Policy Statement”, the “Plan d'action ministériel en éthique de la recherche et en intégrité scientifique”, in compliance with the “Food and Drugs Act” including the “Food and Drug Regulations”, and the Medical Device Regulations, and in conformity with standards set forth in the (US) “Code of Federal Regulations” governing human subjects research, and in a manner consistent with

internationally accepted principles of good clinical practice.

 MUHC standards governing the conduct of human subjects research are described in the

“Regulatory Framework in Health Research at the McGill University Health Centre”

 Policies and procedures are applied equally to all human subjects research conducted within the MUHC jurisdiction, regardless of the source of funding or sponsorship of the research.

Some variation may exist concerning a specific regulation due to the need for compliance with applicable law of a given jurisdiction. REBs apply the standard that provides the greatest level of protection for subjects where regulations in competing jurisdictions are concerned.

Yes No

 If Yes, please submit Annex C "Research Use of Ionizing Radiation" for review of the REB and RPS. The RPS written authorization is required prior to study initiation.

c) Is the study subject to Radiation Protection Service (RPS) review?

b) Is the study subject to Institutional Biosafety Committee (IBC) review ?

 If Yes, IBC authorization is required prior to study initiation. Please contact the REO for information concerning IBC review.

Yes No

a) Is the research study a clinical trial?

 If Yes, the Investigator must append Annex B “Clinical Trial Review” to this application.

Yes No

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If Yes, please explain:

Yes No

 The Principal Investigator must inform the REB of the existence of each financial arrangement or other reward involving local Study Investigators, Study Personnel and/or their immediate family members that creates a conflict of interest, or the appearance thereof.

 Please provide details concerning a real or apparent conflict of interest, prior to REB review, in confidential correspondence to the REB Chair, or the Director of the Research Ethics Office.

f) Is the Principal Investigator personally receiving financial compensation from any source to undertake the conduct or administration of the study?

a) Does the study involve per case funding for subject participation?

b) Is compensation offered for subject identification or recruitment?

c) Will participation result in any additional expense for a subject?

d) Does the sponsor offer financial compensation to subjects for potential injuries due to research-related procedures?

e) Will a subject receive an indemnity (financial compensation) for "loss and inconvenience"

suffered in the course of the research?

9. FINANCIAL AND RESOURCES

 Involving MUHC personnel and utilizing MUHC resources in the conduct of research is subject to approval of the Director of Professional Services (DPS). Contact the DPS to request information on the review procedures.

 Industry-sponsored clinical research is subject to review of the study budget and clinical research agreement. Contact theOffice of Clinical Contracts to request information on the review procedures.

Yes No

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10. AUTHORIZING SIGNATURES

Date:

MUHC Study Code:

(REO use only)

Date:

Print Name: Dept/Div:

b) As Department/Divisional Head, I assure the REB that the Principal Investigator is

professionally qualified to conduct the study and has met all departmental requirements to conduct the proposed research. (In cases where the Department/Divisional Head is involved in the research project, this statement must be made by an academic superior.)

Signature:

An application for Research Ethics Board approval to use human subjects in research for conduct in the MUHC jurisdiction requires the following declarations and signatures

 The Principal Investigator (Qualified Investigator) will obtain prior written approval from the REB for any substantive modification to the research, including changes to the study

procedures, financial arrangements and/or resource utilization, before initiating the change.

 Unexpected or otherwise significant adverse events, and/or alarming trends that occur during the study will be promptly reported to the REB as per the study protocol, and MUHC policy.

 Any new significant finding emerging during the course of the study that may affect a subject's decision to participate will be reported to the REB, and to all study subjects.

 If the research study is approved it will be subject to quality assurance assessment and to the continuing review and approval of the REB.

 The Principal Investigator will comply with all REB requests to report study information.

 The Principal Investigator will maintain study records according to regulatory requirements.

If these conditions are not met, REB approval for the research study may be withdrawn.

Signatures below certify that:(original ink signatures are required; no stamps or "per" signatures) a) As Principal Investigator (Qualified Investigator), I will comply with all relevant regulations

and guidelines governing the conduct of research involving human subjects and I understand that this research cannot be conducted without appropriate written approval of the REB.