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St. Michael’s Hospital Research Ethics BoardInformed Consent Form Checklist

REB Number:

The following checklist can be used to check for the inclusion of all required elements in the informed consent form for the research study. Some elements are optional and may be indicated as “not applicable (N/A)”, depending on the type of research study.

ELEMENT Version Date(dd / mmm / yyyy)

Reference GENERAL REQUIREMENTS Please organize the headers in the order

according to this checklist.SMH REB St. Michael’s Hospital Letterhead/logo on the first page

SMH REB Title of the consent form e.g. “Letter of Information and Consent to Participate in a Research Study”

SMH REB Full Study Title (as it appears on the study protocol and REB application)

SMH REB Short Study Title, version date (dd-mmm-yyyy), pagination “Page x of y” in the footer of each page of the consent form

SMH REB Written consistently in second person (“You/Your”) except signature page (first person)

SMH REB Written in simple non-technical language; suitable reading level (Grade 6 to 7). All acronyms and abbreviations must be clearly defined at first use.

SMH REB Thorough check of formatting: font size 11 points or larger, adequate margins, consistent order of headings, spacing (no page breaks across sections)

SMH REB Thorough check of spelling, punctuation, grammar, clarity

Reference INTRODUCTIONTCPS23.2 (a)

Information that the individual is being asked to consider taking part in a research study

Reference INVESTIGATOR(S)TCPS23.2 (b)

The name and contact number of the St. Michael’s Hospital Principal Investigator/ Qualified Investigator e.g. “Study Doctor”; Clinical Division; PI’s Availability

SMH REB The name(s), Division/Department and contact number(s) of the St. Michael’s HospitalCo-/Sub-Investigator(s)

SMH REB The name(s), Division/Department and contact number(s) of the research coordinator(s)

21CFR 50.25(a)

(7)

24 Hour Contact Number (required for studies that include greater than minimal risk study procedures)

Reference CONFLICT OF INTERESTTCPS23.2 (e)

The identification of any real, potential or perceived conflicts of interest for the investigator(s) and/or research staff

Reference STUDY SPONSOR /FUNDERTCPS23.2 (b)

The name of the Study Sponsor

TCPS23.2 (b)

The source(s) of funding for the study

Reference PURPOSE OF THE RESEARCHICH GCP

4.8.10 (b)The purpose of the study

Version Date: 05 November 2013 of 5


ICH GCP4.8.10 (a)

A statement that the study involves research

SMH REB Provide information on relevant background; justification for this studyReference DESCRIPTION OF THE RESEARCH

TCPS23.2 (b)

A description of the research procedures

ICH GCP4.8.10 (c)

For clinical trials: An explanation of the study treatment(s) / intervention(s)

ICH GCP4.8.10 (c)

The probability for random assignment to each study treatment, if applicable

TCPS211.2(c)

For clinical trials involving a placebo control, explain what a placebo means. Describe any therapy that will be withdrawn or withheld for the study and any anticipated consequences of withdrawing or withholding the therapy

SMH REB If masking (blinding) is used, explain what this means and how the code may be broken.

ICH GCP4.8.10 (d)

The study procedures to be followed, including all invasive procedures; indicate the frequency and duration of testing

SMH REB If multiple study procedures/visits, should include a flow chart and/or tableICH GCP4.8.10 (f)TCPS211.6

Indicate the aspects of the study that are experimental; distinguish between standard clinical care and research

ICH GCP4.8.10 (e)

The participant's responsibilities

TCPS212.1

(a) – (g)

If the study involves the collection of human biological samples, include:(a)Type and amount of sample to be taken; (b) manner in which sample will be taken; (c) intended use of sample, including commercial use; (d) measures to protect privacy; (e) length of time sample to be kept, how it will be preserved, location of storage and process of disposal; (f) any linkage of sample with information about participant; and (g) plan for handling results and findings

SMH REB If samples are collected for future unknown research and/or banking, a separate consent form should be used

SMH REB If study involves taking photographs, videotaping or sound recordings, explain

ICH GCP4.8.10 (s)

The expected duration of the participant’s participation in the study

ICH GCP4.8.10 (t)SMH REB

The approximate number of participants involved in the study; total number from St. Michael’s Hospital; total for entire study, if multi-site

SMH REB If a genetic study is optional, a separate consent form should be used. If the genetic study is mandatory, information about the genetic study may be included in the main consent form.

TCPS213.2

For genetic studies, provide participants with the plan for managing information that may be revealed through the research

TCPS213.7

For genetic studies, provide participants with the plan for managing associated ethical issues, including confidentiality, privacy, storage, use of data and results, possibility of commercialization of research findings and withdrawal by participants as well as future contact of participants, families, communities and groups

Reference POTENTIAL HARMS (Injury, Discomforts or Inconvenience)

ICH GCP4.8.10 (g)

TCPS23.2 (c)

SMH REB

The reasonably foreseeable risks or inconveniences to the participant; Probability of occurrence, severity and expected duration of side-effects, if applicable. Major or significant risks must be included even if the possibility of occurrence is low.

21CFR 50.25(b)(1)

For clinical trials, a statement that the study may involve risks which are currently unforeseeable.

Reference REPRODUCTIVE RISKSICH GCP

4.8.10 (g)Potential risks to females of child-bearing potential



ICH GCP4.8.10 (g)

Potential risks to an embryo, fetus, or nursing infant, if applicable

Potential male reproductive risks.

Reference POTENTIAL BENEFITSICH GCP

4.8.10 (h)TCPS23.2(c)

SMH REB

The reasonably expected benefits to the participant. Include a statement that the participant may not receive any benefit from participating in the research.

ICH GCP4.8.10 (h)

When there is no intended clinical benefit to the participant, the participant should be made aware of this

TCPS23.2 (c)

Potential benefits to society that may arise from the research may be included

Reference ALTERNATIVES TO PARTICIPATIONICH GCP4.8.10 (i)

The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks

Reference PROTECTING YOUR HEALTH INFORMATIONTCPS23.2 (i)

Indicate what information will be collected and the purposes for which the participant’s information is being collected, used or disclosed

TCPS23.2 (i)

Indicate who will have access to the participant’s research data/samples and how and where data/samples will be stored

TCPS23.4

The participant will be made aware of any incidental findings discovered during the course of the study

TCPS23.2 (e)

Include information regarding the possibility of commercialization of research findings (and the presence of any real, potential or perceived conflicts of interest on the part of the researchers, their institutions or the research sponsors)

ICH GCP4.8.10 (o)

TCPS23.2 (i)

Records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available

ICH GCP4.8.10 (o)

TCPS23.2 (f)

If the results of the study are published, the participant’s identity will remain confidential, to the extent permitted by the applicable laws and/or regulations

ICH GCP4.8.10 (n)

The monitor(s), the auditor(s), the REB, and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of study procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the participant or the participant’s legally acceptable representative is authorizing such access

Reference STUDY REGISTRATION and STUDY RESULTS

TCPS23.2(f)

State whether and how the participant may be informed of the study results when the research study is completed

21CFR 50.25 (c)

For clinical trials, include statement of online registry: e.g. “A description of this clinical trial will be available on http://www.ClinicalTrials.gov. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

Reference COMMUNICATION WITH YOUR FAMILY DOCTORICH GCP

4.3.3The investigator should inform the research participant’s primary physician about the research participant’s involvement in the research if the research participant agrees to the primary physician being informed

SMH REB If notifying the primary physician is mandatory for the safety of the participant, consider making this an exclusion criterion. The participant should still be made aware of this and consent to it



Reference POTENTIAL COSTS OF PARTICIPATION AND REIMBURSEMENT TO THE PARTICIPANT

ICH GCP4.8.10 (k)

The anticipated prorated payment, if any, to the participant for participating in the study; reimbursement for study-related expenses e.g. transportation

ICH GCP4.8.10 (l)

The anticipated expenses, if any, to the participant for participating in the study

Reference COMPENSATION FOR INJURYICH GCP4.8.10 (j)

The compensation and/or treatment available to the participant in the event of study-related injury

ICH GCP4.8.4

A statement to the effect that, by consenting, participants have not waived any rights to legal recourse in the event of research-related harm

Reference PARTICIPATION AND WITHDRAWALICH GCP

4.8.10 (m)Participation in the study is voluntary and the participant may refuse to participate or withdraw from the study, at any time, without penalty or loss of benefits to which the participant is otherwise entitled

TCPS23.2(d)

Information on the participant’s right to request the withdrawal of data or human biological materials, including any limitations on the feasibility of that withdrawal

ICH GCP4.8.10 (r)

The foreseeable circumstances and/or reasons under which the participant's participation in the study may be terminated

21CFR 50.25 (b)

(2)

For clinical trials, the circumstances under which the study may be terminated by the Principal Investigator or Sponsor

21CFR 50.25 (b)

(4)

For clinical trials, if the participant chooses to withdraw, describe the procedures for the participant’s orderly termination of participation in the study

Reference NEW FINDINGS OR INFORMATIONICH GCP

4.8.10 (p)Include a statement that the participant or the participant's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the participant's willingness to continue participation in the study.

Reference RESEARCH ETHICS BOARD CONTACTICH GCP

4.8.10 (q)The person(s) to contact for information or questions regarding the rights of study participants: i.e. “Research Ethics Board Chair at 416-864-6060 ext. 2557”

Reference STUDY CONTACTSICH GCP

4.8.10 (q)The person(s) to contact for further information or questions regarding the study

ICH GCP4.8.10 (q)

The person(s) to contact in the event of study-related injury; include Emergency contact information, as applicable

Reference SIGNATURE PAGE: DOCUMENTATION OF INFORMED CONSENTSMH REB All signatures should be contained on the same page

ICH GCP4.8.8

Personally signed and dated by the participant or the participant’s substitute decision maker

ICH GCP4.8.8

Personally signed and dated by the person who conducted the informed consent discussion

ICH GCP4.8.9

Personally signed and dated by an impartial witness assisting with the consent process if applicable (only if participant or the participant’s substitute decision maker is unable to read)



SMH REB If the participant or the participant’s substitute decision maker is unable to speak or understand English, an interpreter is required to assist with the consent process. The interpreter must also personally sign and date the consent form

ICH GCP4.8.11

Prior to participation in the study, the participant or the participant’s substitute decision maker should receive a copy of the signed and dated written consent form and any other written materials provided to participants


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