NORTHYORKGENERALHOSPITAL

Research Ethics Board Information Package

NorthYorkGeneralHospital

Research Ethics Board Office

4001 Leslie St Ste 6 North Room 630

Toronto ON M2K 1E1

Telephone: 416-756-6828 Fax: 416-756-6916

Updated –July 23, 2010

Table of Contents

Terms of Reference...... 3

Guidelines...... 4

A.Scientific Review...... 4

B.Ethical Review...... 5

C.Monitoring...... 5

Authorizing Signatures...... 6

Informed Consent...... 6

Study Information Sheet (sample)...... 8

Consent Form (sample)...... 9

The Review Process...... 10

Research Ethics Board Application Checklist...... 11

Research Ethics Board Processes...... 12

Research Ethics Board Membership List ...... 13

NORTHYORKGENERALHOSPITALOriginal Date: Jan.’99

Terms of Reference – Research Ethics BoardRevised Date: Oct.’00; Jun.’01, Jan. 05

MISSION STATEMENT: / On behalf of North York General Hospital (NYGH), the Research Ethics Board (REB) ensures that all research conducted within NYGH involving human participants meets the highest standards of safety, quality and respect for privacy and dignity in accordance with:
  • TriCouncil Policy Statement: Ethical Conduct for Research Involving Humans: August 1998
  • The International Conference on Harmonization (ICH)
  • Good Clinical Practice (GCP) Guidelines
  • Personal Health Information Protection Act & applicable legislation
  • Current scientific and ethical standards

PURPOSE/
RESPONSIBILITIES: / The REB is an independent, multidisciplinary body whose mandate is to
approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human subjects conducted within, or by members of NYGH.
Scope: / All proposed research projects involving NYGH patients, staff or trainees as research subjects must obtain ethical and scientific approval from the REB. NYGH means General Division, Senior’s Health Centre and Branson Division.
Responsibilities: /
  1. NYGH requires that each submission has a local investigator.
  1. Except in certain circumstances, the Principal Investigator (PI) must be on staff at NorthYorkGeneralHospital and will become responsible for co-ordinating and overseeing the study.
  1. The P I is responsible for ensuring adherence to the application process as per the REB guidelines.
  1. The REB will review, meet and approve, reject or propose modifications to these applications.
  1. The Principal Investigator will be responsible to monitor the quality and process of the study in ongoing fashion and to report annually to the REB.

FREQUENCY OF MEETING: / 9 time per year (September, October, November, January, February, March, April, May and June) Fourth Tuesday of each month.
QUORUM: / Quorum for a meeting will consist of 50% of the minimum allowed number of REB members plus 1 REB member.
REPORTING STRUCTURE: / The REB will report to the Board of Governors through the Medical Advisory Committee.
MEMBERSHIP: /
  • no more than 15 members approved by the Board,
  • at least one community representative,
  • the Chair will be elected from the members,
  • all members will have a vote.

All research projects involving NorthYorkGeneralHospital staff, patients or trainees as research subjects must obtain ethical approval from the Research Ethics Board (REB). The REB is responsible, on behalf of NorthYorkGeneralHospital, for ensuring that all research involving human participants under the auspices of NorthYorkGeneralHospital (which includes General Division and Seniors’ Health Centre; and Branson Division) meets current scientific or ethical standards.

GENERAL GUIDELINES

  1. SCIENTIFIC REVIEW

Research Requiring Ethics Review

Article 1.1 of the Tri-Council Policy Statement states the following:

a)All research that involves living human subjects required review and approval by an REB in accordance with this Policy Statement, before the research is started, except as stipulated below.

b)Research involving human remains, cadavers, tissues, biological fluids, embryos or foetuses shall also be reviewed by the REB.

c)Research about a living individual involved in the public arena, or about an artist, based exclusively on publicly available information, documents, records, works, performances, archival materials or third-party interviews, is not required to undergo ethics review. Such research only requires ethics review if the subject is approached directly for interviews or for access to private papers, and then only to ensure that such approaches are conducted according to professional protocols and to Article 2.3 of the Tri-Council Policy Statement.

d)Quality assurance studies, performance reviews or testing within normal educational requirements should also not be subject to REB review.

Canada adheres to a model of ethics review that has emerged in the international community in recent decades. The model generally involves the application of national norms by multidisciplinary, independent local REBs for reviewing the ethical standards of research projects developed within their institutions.

The REB is established to help ensure that ethical principles are applied to research involving human subjects. The REB, therefore, has both educational and review roles. The REB serves the research community as a consultative body thus contributes to education in research ethics; it also has responsibility for independent, multidisciplinary review of the ethics of research to determine whether the research should be permitted to start or to continue.

In order for a study to be considered ethically acceptable, it must also be scientifically sound. The following factors are considered by the REB:

  1. objectives of the research;
  2. importance of the problem being addressed;
  3. type of project;
  4. background analysis;
  5. methodology and design of the study; and
  6. expertise of the applicant(s).
  1. ETHICAL REVIEW

The following factors are considered by the REB to ensure that a protocol is ethically sound:

  1. The research must conform to generally accepted ethical principles. For further information see the following resources:
  • “Guidelines on the Use of Human Subjects,” Office of Research Services, University of Toronto[ and
  • “Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans” [ which describes the policies of the Medical Research Council (MRC), the Natural Sciences and Engineering Research Council (NSERC) [, and the Social Sciences and Humanities Research Council (SSHRC) [.
  • World Medical Association Declaration of Helsinki “Recommendations guiding physicians in biomedical research involving human subjects” [.
  1. The research must be conducted by qualified persons having available facilities for the proper conduct of work and for dealing with emergencies.
  1. All patients and their parents or guardians (if appropriate) must be appropriately informed about their participation in a research project. (See The Tri-Council Policy Statement, Section 2, Article 2.1c)
  1. A “Criteria Checklist for Approval of Research Proposals” is used by a chosen REB member reviewer to decide whether the study meets REB criteria (included in this package for your information).
  1. (See The Tri-Council Policy Statement, Section 1, Article 1.1d)Quality assurance studies, performance reviews or testing within normal educational requirements should also not be subject to REB review. Article 1.1(d) indicates that studies related directly to assessing the performance of an organization or its employees or students, within the mandate of the organization or according to the terms and conditions of employment or training, should also not be subject to REB review. However, performance reviews or studies that contain an element of research in addition to assessment may need ethics review. The opinion of the REB should be sought whenever there is any doubt about the applicability of this Policy to a particular research project.
  1. No applications that involve Finder’s Fees will be processed or approved.

The REB reserves the right to determine the definition of Finder’s Fees.

C.MONITORING

The Research Ethics Board reserves the right to monitor research in progress to ascertain that it is being conducted according to the principles and protocols agreed to by the researcher.

To monitor ongoing study activities the REB requires the following:

  • Receipt of any amendments to the protocol or consent form. The changes should be highlighted or clearly noted in the cover letter.
  • Receipt of copies of all Adverse Events. All Adverse Events are reviewed and monitored by the REB Pharmacy representative and REB Chair.
  • A summary report every six months of all Adverse Events and actions taken if any.
  • Notification of study cessation.
  • If the REB has concerns, frequent updates will be requested.
  • Copies of publications should be forwarded to the REB

AUTHORIZING SIGNATURES

The proposal must have support of all the departments directly involved including the department in which the research is occurring, and other affected departments including Medical Records, Diagnostic Imaging, Laboratories, Information Services, Pharmacy, Emergency, Operating Room, etc. This support must be indicated by the signature of the appropriate Chief/Head and Program Director on the “Departmental Approval for Application to the Research Ethics Board” form, appendix 1.

All studies involving drugs require notification of the Director of Pharmacy upon commencement and cessation of the study.

INFORMED CONSENT

All research involving human subjects must have written/verbal consent (subject to the Tri-Council Policy Statement, Section 2.1c). The consent process mustprovide potential

participants with sufficient information about the research to enable them to make an informed choice about whether they will participate.

While there are no formal rules governing the length or style of written consent, typically it should consist of a Study Information Sheet and a Consent Form (SAMPLES ENCLOSED). The Study Information Sheet outlines what the research is about, and what is expected of the study subject. It is usually written in the second person, is one to five pages in length, and has clear headings under which the information is provided. The consent form is the written record that the study subject signs, confirming that she or he understands the research and the Study Information Sheet, and is providing written consent to participate. The Consent Form is usually one page, and in the first person.

For more information about consent, please refer to The Tri-Council Policy Statement - Ethical Conduct for Research Involving Humans; Section 2; “Free and Informed Consent.”

As a fundamental ethical principle, free and informed consent is required prior to patient participation in any research study in which:

  1. There is therapeutic intervention by way of either provision or denial of medical treatment in any form; and/or
  2. There is real risk that the privacy rights of the patient may not be fully protected.
  3. Patients should be made aware that they are able to withdraw from the study.

Research may be conducted in the absence of free and informed consent, without violating this fundamental principle, where there is no more than minimal risk to the patient and his rights and welfare will not be adversely affected. Research studies may properly be conducted where:

  1. Use is made of patient information records obtained for the purpose of treating that patient and/or maintaining general hospital patient records; and
  2. Appropriate steps are taken to protect the privacy rights of that patient through use of recognized references to patient identification.

The Consent Form and Study Information Sheet must be on NorthYorkGeneralHospital letterhead.

The Principal Investigator must retain copies of both the signed Consent Form and Study Information Sheet on file. A copy must be retained on the Patient’s Medical record in cases where the study impacts the medical care of a patient, and a copy must be given to the patient and/or parent/guardian.

Registration of Clinical Trials

For publication purposes, all clinical trials must be registered with

Sample

STUDY INFORMATION SHEET

TITLE OF RESEARCH PROJECT:

INVESTIGATORS:(Including telephone number(s) for contact person)

POINTS REQUIRED TO BE INCLUDED ON CLINICAL INFORMATION SHEET:

  1. PURPOSE OF RESEARCH:
  • give a brief description IN LAY TERMS of the why/how of the study
  1. PROCEDURES:
  • give a brief description of the experimental protocol, e.g. “You will be asked to fill out a questionnaire, undergo a drug treatment, have a sample of blood taken, etc.”
  • indicate total volumes to be taken (blood in drops, teaspoons, etc.)
  • indicate any radiation exposure
  • indicate frequency and duration of testing
  • indicate if any additional visits to hospital or prolongation of hospital stay will be necessary
  • indicate any uses of confidential information, and additional resorting to the medical record for research purposes only
  1. BENEFITS:
  • describe benefits to the subjects themselves, to patients having a similar condition, or to patients in general
  1. DISCOMFORTS/POTENTIAL HARMS:
  • indicate potential harm or discomforts, even if none are anticipated
  1. ALTERNATIVE TREATMENT/THERAPY:
  • alternative treatment(s)/therapy to study treatment(s)/therapy must be clearly explained in the consent form
  1. COMPENSATION:
  • In the event of an injury that occurs to you as a result of taking the study medication or undergoing study procedures, you will receive the necessary medical treatment. This will be covered by the (name of sponsor) product liability insurance for subjects treated according to the protocol.
  1. SPONSOR / FUNDING:
  • any organization, company, or funding agency that is financially supporting this research must be identified

8.RIGHTS OF SUBJECTS:

It must also be stated that:

  1. this research project has been reviewed by the Research Ethics Board at NYGH, and
  2. patients or study volunteers having questions/concerns about their rights in this research project should contact the Research Ethics Board Office at 416-756-6828.

(NOTE: Subjects or their parents/guardians can be offered money for reasonable expenses, i.e. reasonable transportation costs, babysitters, etc., but one should not pay for pain, risk or discomfort).

CONSENT FORM

CONSENT FORM

TITLE OF RESEARCH PROJECT:

INVESTIGATOR (S):

I acknowledge that the research procedures described on the attached study information sheet, and of which I have a copy, have been explained to me. Any questions that I have asked have been answered to my satisfaction. I have been informed of the alternatives to participation in this study. The possible risk and discomforts have been explained to me. I know that I may ask now, or in the future, any questions I have about the study or the research procedures. I have been assured that records relating to my care will be kept confidential and that no information will be released or printed that would disclose my personal identity without my permission.

I understand that I am free to withdraw from the study at any time. I further understand that if the study is not completed, or if there is withdrawal from it at any time, the quality of medical care for me at NorthYorkGeneralHospital will not be affected.

If you have any questions about your rights as a research participant, please call Dr. David Kaplan, Chair of NorthYorkGeneralHospital Research Ethics Board at (416) 756-6828. This person is not involved with the research project in any way and calling him will not affect your participation in the study.

I hereby consent to participate.

______

(Signature)(Name)

______

(Witness)(Date)

The person who may be contacted about this research is:

Who can be reached at this telephone number:

IF THIS CONSENT HAS BEEN VERBALLY TRANSLATED:

I confirm that I have verbally translated this consent form for the patient noted above, and in my opinion the patient has understood what I have explained to them.

Name of TranslatorSignatureDate

Languate of TranslationRelationship to Subject (if applicable)

THE REVIEW PROCESS

Upon receipt of the study proposal (three weeks prior to a scheduled REB meeting), a copy is sent to an appropriate member of the Research Ethics Board (REB) who possesses the necessary scientific knowledge for review. All REB members will review the proposal. The study will be considered at one of the monthly REB meetings. You will be notified in writing on approvals, suggestions for changes or disapprovals two to five weeks after the meeting.

All Research studies/projects are initially submitted to the REB office. The REB co-ordinator will forward all Research projects involving drug(s), food/dietary supplements to the Pharmacy, Dietary and Therapeutics Committee (PD&T). Drug related studies will be evaluated on the drug profile and the protocol’s place in current standard of practice before they are reviewed by the REB. Upon approval by both committees, the PD&T Committee is responsible to submit to the Medical Advisory Committee (MAC) for final approval and the Research Ethics Board is responsible to report all research studyactivities directly to the Medical Advisory Committee.

RE-APPROVAL REQUEST:

It is Hospital policy that all Research Studies obtain annual re-approvals from the REB. An “Annual Re-approval Request Form” is included in this package. At least two months prior to the re-approval deadline this form must be completed and returned to the REB office. Any changes to the original protocol or consent form must be clearly delineated.

CESSATION OF STUDY:

The REB requires written notification when the study is completed. If terminated, please provide an explanation. Ensure that all involved departments are also notified.

FOLLOW-UP SUMMARY:

When the research study/project is officially completed, please provide the REB with a summary of research findings, indicating whether the objectives were achieved. In addition, please inform us of any problems/concerns encountered with the REB process or within the NYGH organization and if any suggestions for improvement.

RESEARCH ETHICS BOARD APPLICATION CHECKLIST

Except in certain limited circumstances, the Principal Investigator must be on staff at NYGH and will become responsible for co-ordinating and overseeing the study. If there is doubt about whether a research proposal requires REB approval, it is the responsibility of the Principal Investigator to ascertain this in consultation with the REB.

The following must be submitted:

1 electronic version

(contains a complete description of proposal and methods to be used, TAHSN Form completed, product monograph as well as a copy of any questionnaires or interview forms which will be used; on 8.5 x 11 inch paper)

Information sheet must be on NYGH letterhead

Consent form must be on NYGH letterhead

Promotional brochure if required

Detailed Budget

Investigator’s Brochure

Industry Sponsored (check if applicable)