Guidelines for Research Ethics Review Involving Human Participants
All research projects involving Baycrest physicians, staff, students or patients must obtain ethical approval from the Research Ethics Board (REB) before research can begin. The Baycrest REB ensures that all research carried out under the auspices of Baycrest is reviewed for scientific merit, ethical considerations and resource implications. It also ensures that safeguards are developed, and continually monitored, to provide the greatest protection to patients, residents and members of the community who serve as research participants.
Research proposals are either reviewed by the full board at a scheduled meeting or in an expedited manner, depending on the level of risk associated with the study and prior review. Regardless of the type of review, a full application form must be completed. A complete research proposal/and or protocol must also be submitted. Please submit all applications electronically to the Manager of Research Ethics at email@example.com. You are required to submit hard copies of any documents included as part of the submission (i.e., application form, protocol, consent form, etc.) to the REB office (Rm 820, Kimel Family Building) at Baycrest.
Types of Review
I. Full Board Review:
This is the default that will apply unless there is sufficient justification for other levels of review. Submissions are reviewed in the order of their arrival at the Research Ethics office. Please contact the REB or visit the REB website for meeting dates and deadlines for submission.
II. Expedited review:
Studies that may qualify for expedited review:
- Are considered either minimal risk or non-invasive (e.g. retrospective chart reviews, nonintrusive questionnaires or surveys, non-invasive assessments, use of existing samples).
- Involve only current standards of care.
- Have had prior approval from another Research Ethics Board. Studies that have been approved by a Toronto Academic Health Science Network (TAHSN) or other REB are not considered for expedited review unless the relevant documentation (REB review letter, reply to any REB concerns and approval letter) is provided. A Baycrest initial application may not be required, but researchers will be asked to submit an addendum form to obtain appropriate Baycrest signatures and approval for any institutional impacts. Consult with the REB office to determine the appropriate steps.
The investigator must include the justification for requesting expedited review. The decision of whether a study qualifies for expedited review rests with the REB Chair.
If your study involves multiple sites in Ontario it may qualify for review through Clinical Trials Ontario (CTO). CTO assigns one site to be the board of record for the study meaning applications and amendments do not have to be submitted to each site individually. This streamlines the ethics application and review process.
Contact the REB office to discuss whether a CTO submission is appropriate for your study and for any guidance with the submission process.
Program Evaluation / Quality Improvement
Your research may qualify as a program evaluation / quality improvement project and not require ethical review. The REB can provide you with a letter explicitly stating this.
Whether or not your project qualifies is decided by the REB on a case by case basis. Please fill out the Program Evaluation Application
found in the “forms” section of the website and submit electronically to the REB office.
Initial REB Application
The Baycrest REB Initial Application Form must be completed for full board and expedited reviews. If a section does not apply, indicate N/A. All applicable signatures must be obtained. All sections of the form must be completed before signatures are obtained.
Please include the following attachments as part of your submission.
- Appendix 1 – Study Protocol [refer to “How to write a protocol” document on website]
- Appendix 2 – Consent Form(s) [Refer to informed consent guidelines below]
- Appendix 3 – Recruitment Materials, including advertisements and scripts (if applicable)
- Appendix 4 – Questionnaires & Surveys (if applicable)
- Appendix 5 – Screening/Data Collection Forms (if applicable) [examples can include intake screening, demographic collection form, contact information form etc.]
- Appendix 6 – Participant debrief materials [please use lay language]
- Appendix 7 – Itemized Budget
- Appendix 8 – Personnel log [refer to template on website]
The following are further explanatory notes regarding some items on the application form. The numbering corresponds to the items on the application form.
Section I: General Information
1. Principal Investigator
The Principal Investigator (PI) is the responsible leader of the research team. There should be one PI per site per protocol. Students/trainees cannot be listed as the PI. Where the investigator is a student, the supervisor should usually be designated as the PI.
For “clinical studies” as defined by Health Canada (i.e. involving an investigational drug or medical device), the Principal Investigator must be a Qualified Investigator (a physician or, where applicable a member in good standing of a professional medical or dental association).
2. Full Study Title
Include the full title as it appears on the protocol.
Include the PI contact information and a signature following the PI agreement. Include a full list of co-investigators, and faculty supervisor (if applicable)
4. Study Coordinator / Contact Person
For studies originating from outside of the institution, a staff member must be involved as the institutional liaison who will accept responsibility for the research activities at the institution, as well as serve as the administrative contact with the REB. The role of institutional liaison applies only when the PI is not a Baycrest staff member.
5. Department/Division/Program Approval
a) Department/Division/Program Head
The application forms for all projects submitted for review will require the signature of the Department/Division/Program Head where the research is to be conducted. Approval must come from Head of the same Department / Division / Program as the Baycrest PI OR Baycrest staff member if PI is external. The signature indicates agreement that the Department/Division/Program Head supports the project and that the PI is qualified by education, training, and experience to perform his/her role in the study. This attestation cannot be signed by the Principal Investigator or a Co-Investigator. When the the Department/Division/Program Head is an investigator on the study, the signature of an individual one level above the investigator is required – inquire with Research Ethics Office about the appropriate signing authority.
b) President and Chief Scientist of Research
All research at Baycrest must be signed-off by the President and Chief Scientist of Research or a designate authority. This attestation cannot be signed by the Principal Investigator or a Co-Investigator. Inquire with Research Ethics Office about the appropriate signing authority. If the President and Chief Scientist of Research (or designate) has signed as department head in n 5A (skip to 6)
Attach an itemized study budget (as Appendix 6 in your submission). This applies to ALL full board and delegated review studies. The budget should reflect all costs to complete the study (e.g. database extraction, student payments, participant reimbursement etc.)
7. Managing Conflicts of Interest
The term "conflict of interest" refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising, a researcher’s professional judgments. The bias such conflicts could conceivably impart may inappropriately affect the goals of research. For more information, you may refer to the Baycrest policy on Conflict of Interest (on the intranet.
8. Other Ethic/Scientific/Scholarly Review
If a Research Ethics Board at an affiliated Toronto Teaching Hospital or other institution has approved the study, it may qualify for expedited approval. The relevant documentation (REB review letter, reply to any concerns, approval letter) must be provided.
9 & 10. Clinical Trials
These sections need only be completed if the research study is a clinical trial.
Health Canada, under Division 5 defines a clinical trial (requiring Health Canada approval) as “an investigation in respect of a drug for use in humans that involves human participants and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug”. Investigational drugs or devices include all drugs (including biologics and natural health products) or medical devices requiring Health Canada approval, as well as all approved drugs being tested for a new indication (e.g., age group, disease entity), dosage or method of administration.
Studies involving investigational drugs or medical devices must apply for authorization for research use from Health Canada. For investigational drug trials a “Clinical Trial Application” form must be submitted to Health Canada. Provide a copy of the authorization or “No objection” letter from Health Canada as soon as it becomes available. Final REB approval of the study will not be granted until the no objection letter has been received.
If results are to be submitted for US Food and Drug Administration (FDA) approval, provide the IND number (drug studies) or PMA number (device studies).
Include the full study protocol (as Appendix 1 in your submission).
Section II: Study Summary
11. Clinical Trials
Ensure that the abstract is described using lay language. Community members without a scientific background are part of the REB.
These sections must specify if a clinical population is involved, and if so whether there will there be changes to their clinical care. If participants are required to meet certain eligibility criteria that necessitate changes to or termination of treatments, describe them too. Include all patient contact and be as specific as you can.
The inclusion/exclusion criteria and sample size must be described and justified in the protocol.
Indicate the time commitments, requirements, and restrictions for study participants. Identify the source of participants. If you will be recruiting from the Research Participant Database, the signature of the Participant Coordinator is required.
Participants should not be expected to incur expenses as a direct result of participation in a research study; reimbursement for out-of-pocket expenses (e.g. travel) is encouraged. Payment should not be used in such a way that it could be construed as an undue inducement to participate (e.g. unreasonable amount, payment tied to completion of study). Reimbursement should be for expenses, time or inconvenience, but should not be used to encourage subjects to accept increased risk. If reimbursement for time is proposed, explain. It is expected that expenses will be fully covered and any payments for time (including honoraria) will be pro-rated for partial participation.
Section III: Ethical Issues
14. Recruitment and Consent
Attach the consent form(s) (Appendix 2), recruitment materials (e.g., recruitment posters/letters, phone/email script) (Appendix 3), screening/data collection forms (Appendix 4), and questionnaires/surveys (Appendix 5).
The REB must review all study-related materials that will be given to participants, including advertisements or letters regarding recruitment. Note that no specific dollar amount of payments to participants should be listed in the advertisement. You may say “compensation for your time and travel will be provided” (if applicable).
In this section, identify the recruitment and consenting procedures. This includes how participants will be identified, who will be involved in identifying participants, and how initial contact will be made. Will the research involve vulnerable populations? How will a participant’s capacity to consent be assessed, and will assent be determined in individuals who lack the capacity to consent? Issues to consider include whether the contact person is known to the subject/authorized third party, has access to patient information as part of their normal professional duties, or is able to assess capacity to consent.
Note: Informed consent should ordinarily be obtained in writing, unless the PI can demonstrate that there are good reasons for obtaining consent orally. If consent is obtained orally, the consent process should be documented in writing, and a written statement of the information conveyed in the consent process should be provided to the participant.
Finder’s Fees include money or other reward given to a physician (or group of physicians, or other health care providers) in payment for identifying or recruiting a patient into a study or a trial. Finder’s fees are prohibited. For more information the University of Toronto Policy on finder’s fees can be found here
There may be occasions where a number of different research projects focus on a particular patient population, and individual patients may be eligible for more than one study. Enrollment in multiple studies raises concerns whether the studies are ongoing simultaneously or in succession. In this situation, investigators must explain what procedures are in place to avoid enrollment of patients in multiple studies. If enrollment in multiple studies is anticipated, justify and explain what extra precautions are in place to ensure patient safety and welfare.
Section IV: Risks, Benefits, and Safety
15. Risk/Benefit Estimates
It is the expectation that the proposed research will be designed to benefit participants where possible. Studies that involve significant risk without a balance of significant benefit may be inappropriate.
Potential benefits and harms (injury, discomfort and inconvenience) to participants (including psychological factors) that may result from study participation must be disclosed in the study protocol and consent form.
The list of benefits may include direct benefits to the subjects or benefits to knowledge or to society.
Monitoring refers to oversight activities performed by groups other than the REB, such as the study sponsor (e.g. site visits to check for Good Clinical Practice (GCP) compliance, interim analysis of results by a data and safety monitoring board or steering committee).
17. Feedback/Dissemination of Results
Since the contribution to knowledge is one of the primary purposes of medical research, researchers are encouraged to publish their results. Furthermore, where possible, researchers are strongly encouraged to share the study results of the research with the participants who made the research possible, and/or with the relevant patient communities.
Section V: Privacy and Confidentiality
18. Collection, Use, and Disclosure of Personal Health Information
During collection and storage data and samples must be kept secure from theft, interception, unauthorized reading and copying. Investigators must state their means of protecting study data or samples from such violation, for instance by coding systems and/or security systems.
The Personal Health Information Protection Act (Bill 31) which came into force in Ontario on Nov. 1, 2004, requires that for research studies involving the collection, use and disclosure of personal health information the REB must receive a description of what information will be collected, and how it will be collected, used and stored. The act defines personal health information as follows (s. 4):
Personal Health Information means identifying information about an individual in oral or recorded form, if the information,
- Relates to the physical or mental health of the individual including information that consists of the health history of the individual’s family,
- Relates to the providing of health care to the individual, including the identification of a person as a provider of health care to the individual,
- Is a plan of service within the meaning of the Long-Term Care Act, 1994 for the individual,
- Relates to payments or eligibility for health care in respect of the individual,
- Relates to the donation by the individual of any body part or bodily substance of the individual or is derived from the testing or examination of any such body part or bodily substance,
- Is the individual’s health number, or
- Identifies an individual’s substitute decision-maker.
Identifying Information means information that identifies an individual or for which it is reasonably foreseeable in the circumstances that it could be utilized, either alone or with other information, to identify an individual.
Please submit a PERSONNEL LOG (Appendix 8)
and identify all persons including non-institutional service providers that will have access to the personal health information now or in the future, their roles in the study (e.g., chart review), their reason for access (e.g., eligible study recruits). This log should be updated and submitted to REB for review throughout the course of the study.
List the identifying and identifiable information that will be collected, used, or disclosed from the records for the purposes of recruitment only
. Attach a copy of the screening/data collection form (Appendix 4)
. Describe the security measures taken and describe what will happen to the data at the completion of recruitment.
List all personal health information and personal identifiers (e.g., name, DOB) required to be collected and included as part of study data
. Please attach data collection forms. (Appendix 4).
Indicate the potential sources of this information. If data is being collected from health records, approval must be granted from the Privacy Officer / Director of Health Records (Section VII). Indicate how the data will be stored and what security measures will be taken. Will personal health information be transferred to or from Baycrest? Describe any harms that could arise if personal health information were to be inappropriately released.
19. Storing and/or Sharing of Data for Future Use
As set out in TCPS Articles 3.2 and 12, explicit consent from participants is needed to re-use study data to answer research questions not described in the consent forms. Will researchers want to store and/or share the study data for future research use(s)? Is future use unspecified?
If data will be stored or shared for future unspecified use, please include in the consent form a description and separate consent option for the storage and future unspecified use of data and/or human biological materials as set out in TCPS Articles 3.2 and 12 (Please refer to Baycrest Academy Open Science Policy Companion Document on REB office website for more information). Explain plans for storage/sharing of data for future use.
Section VI: Contracts and Agreements
20. Contracts and Agreements
Agreements regarding publishing of medical research should not prevent the publication of results or the communication of information important to participant safety.
Material Transfer Agreement: This refers to agreement for transfer of biological materials (e.g., tissues, cell lines) from the institution to another institution or other entity. The agreement usually originates from the institution sending out the materials. If biological material (e.g., tissues, cell lines) is to be transferred from this institution to another institution or entity, indicate what arrangements are in place to ensure that appropriate consent has been obtained for this use and that donor confidentiality will be protected.
Information Sharing Agreement :An information sharing agreement is recommended when a health information custodian shares a patient’s personal health information with a researcher from another hospital or institution. The agreement should specify who are the information custodians, and the outside researcher with whom the information is being shared. The agreement should also describe the use, storage and disposal of the information. Contact your REB or contracts office for more information regarding the use of information sharing agreements at your institution.
Please indicate who will cover the costs of treatment not covered by the provincial health plan in case of injury directly resulting from participation in a research study (i.e. sponsor, institution, other). This may not be applicable for behavioral studies.
Section VII: Institutional Impact
22. Impact on Baycrest Departments
Investigators must obtain prior agreement from the Director or Department Head in every area impacted by the study. Approval to start the project will not be given until this is done.
Application to Access Retrospective Data for Research Purposes
Please note that there may be a cost associated with chart pull and data extraction requests. Baycrest may not have the internal resources available to write the routines for data extraction requests. Charges will be on a cost recovery basis.
These guidelines have been developed to assist in the submission of chart review applications. Chart reviews are expedited. All revisions, additions or deletions to approved chart reviews are considered amendments and must be submitted to the Baycrest Research Ethics Board (REB) for review to ensure that the review remains scientifically and ethically sound. The Principal Investigator (PI) is responsible for ensuring that amendments are submitted to the REB for review and written approval is received prior to implementation.
Provide a description of the procedure for examining the patient files in order to identify which ones will be used in the chart review. Specific information should be provided about how the number of files accessed will be minimized to ensure that files for patients unlikely to meet the study criteria are not accessed unnecessarily.
Once the charts for the review have been identified, the patient or his/her representative can be contacted by someone within the “circle of care”. The purpose of the contact is to obtain informed consent for their clinical information to be used in the chart review.
Provide a description of the procedure to contact the patient or representative. The description must include what will be done to minimize actual or perceived coercion and the name and position of the person who will be making this contact. Provide a description of how informed consent will be obtained.
Note: Researchers may seek permission to access retrospective data with an alteration or waiver of consent. The REB may waive the requirement to obtain informed consent if the PI can demonstrate to the REB that the research could not practicably be carried out without the waiver.
Amendments and Administrative Changes
These guidelines are in accordance with the requirements for continuing ethical review as set out in the Tri-Council Policy Statement and in the regulations and guidelines governing clinical trials (Health Canada Clinical Trial Regulations for new investigational drugs, radiopharmaceuticals, biological drugs, natural health products, and medical devices), ICH GCP, and where relevant, US Codes of Federal Regulations. All revisions, additions or deletions to approved studies are considered amendments
and must be submitted to the Baycrest Research Ethics Board (REB) for review to ensure that the research remains scientifically and ethically sound. The Principal Investigator (PI) is responsible for ensuring that amendments are submitted to the REB for review and written approval is received prior to implementation.
A written description of a change(s) to, or formal clarification of an ongoing currently approved protocol. Amendments include any change to the study documents that affects the scientific intent, study design, patient safety, or human subject protection.
Some examples of amendments include:
- change of Principal Investigator or change of Co-Investigator(s)
- change in recruitment methods
- change in sample size or study duration
- change to inclusion/exclusion criteria
- change in study procedures
- change to protocol that affects the selection, monitoring or dismissal of a
- study subject(s)
- change to protocol that affects the evaluation of the clinical efficacy and
- safety of the drug
- change to protocol that alters the risk to the study subject(s)
- rephrasing a line or section, or typographical or numeric corrections that may affect safety of subjects (i.e. change in eligibility criteria, change of dose, change in risk regardless if risk is increased or decreased).
A minor change(s) to any study document(s) that does not affect the scientific intent of the study, study design, study subject risk, or human subject protection.
Some examples of administrative changes include:
- Rephrasing a sentence or section to add clarity or correct inconsistencies
- Reformatting the document
- Change of study coordinator or monitor
- Change of address, telephone, or e-mail address of study staff.
The REB generally does not consider sub-studies, ancillary studies, rollover studies, continuation studies, and extension studies to be amendments. These are usually considered new studies and the decision of whether they qualify for review as amendments rests with the REB Chair.
Although most amendments must be reviewed and approved prior to implementation, amendments can be implemented prior to REB review and approval under the following circumstances:
- Amendments should be implemented prior to REB review and approval when the amendment is essential to eliminate any immediate hazards to research subjects. These amendments must be submitted to the REB within 7 days of implementation.
- Amendments may be implemented prior to REB review and approval when the amendment involves only logistical or administrative aspects of the study. These administrative changes must be submitted to the REB within 30 days of implementation.
Submitting an Amendment or Administrative Change
The REB Amendment and Administrative Change Form must accompany all amendments and administrative change submissions. The form directs the PI to identify change(s) to be made to study documents and to provide justification/rationale for the change(s). All study documents affected by the change must be included with the submission (e.g.):
- amendment document
- revised protocol
- informed consent form(s)
- supporting documentation (e.g. new information supporting the amendment)
All revised study documents must have version dates that reflect the most recent amendment/ administrative change submission. Further details regarding version dates can be found below.
The REB will not accept amendment/administrative change submissions without the original signature of the PI. This signature attests that the PI accepts the amendment/administrative change. For amendments, the PI’s signature further attests that the PI has assessed the safety implications of the amendment, its impact on study procedures and is prepared to take all necessary steps to implement the change. Incomplete amendment/administrative change submissions will be returned to the Principal Investigator with a return notification form that indicates the documentation that is outstanding. The REB will process and review the amendment/administrative change submission once all required documentation is received.
Version dates identify the latest edition of study documents. Version dates, including the day, written month, and year (e.g. 04-Jan-05) must be presented in this format in the footer of all study documents. If a study document requires further modification based on comments received during the REB review process, the version date must be modified to reflect the most recent edition of the study document. Informed Consent Forms will not be approved without revised version dates in the format outlined above.
Full board review of amendments is the default requirement for all research involving human participants. The decision of whether an amendment qualifies for expedited review is based primarily on the risks that are expected to arise from the change to the research protocol. The decision of whether an amendment qualifies for expedited review rests with the REB Chair.
Full Board Review
The following types of amendments will be considered for full board review and approval:
- changes that increase the risks to the study subject(s) and/or changes that significantly affect the study procedures, study design, or conduct of the study
- changes that have been implemented to eliminate any immediate hazards to study subjects without prior REB approval. (The REB office will review these amendments and provide a preliminary decision; however, the final decision rests with the full board.)
Amendments that qualify for full board review are reviewed at the next meeting of the board. REB questions or concerns regarding amendment submissions are communicated to the PI in a written format that is sent to the PI following the review.
Health Canada No Objection letters (NOLs) must be included with amendment submissions for clinical trials when applicable. REB approval will not be granted until the NOL is received.
For full board review please submit the following documents:
- Relevant study documents with changes tracked, (or in bold or highlighted) that accurately reflects the changes to study outlined in the request form.
- Clean copies of relevant study documents (without tracked changes, handwritten notes or highlights)
Many amendments and all administrative changes qualify for review under the expedited review process. REB questions, concerns and/or recommendations regarding amendment/administrative change submissions are generally communicated to the PI via email.
For expedited review submit the following documents:
- one copy of relevant study documents with changes tracked (or in bold or highlighted) that accurately reflects the changes (additions and deletions to study outlined in the amendment form.
- one clean copy of relevant study documents (without tracked changes, handwritten notes or highlights)
In the event that the REB finds one or more of the parts of an amendment/administrative change submission unacceptable, the PI will be informed via written letter or email communication of what was not acceptable and why. The PI will have the opportunity to submit a revised amendment that corrects the issues outlined by the REB or provides additional justification to support the original request.
Amendments Submitted During the Initial Review Process
Whether an amendment submitted for a study that has not yet been approved by the REB is reviewed by the full board or qualifies for expedited review depends upon the risk(s) associated with it.
Amendments that have greater than minimal risk(s) associated with them will be reviewed at the next meeting of the same full board that conducted the initial review of the study. Once all of the concerns are addressed, the initial approval and the amendment to study will be approved in separate approval letters that reflect the dates of the full board meetings where the review of each was conducted.
Amendments that have minimal risk(s) associated with them will be expedited and once all of the concerns are addressed, the initial approval and the amendment to study will be approved in separate approval letters that reflect the dates and types of review.
Amendments Not Approved by the REB
In the event that the concerns of the REB cannot be resolved and an acceptable alternative cannot be found, the amendment will not be approved and the reasons will be communicated to the Principal Investigator. In accordance with Division 5 C.05.008 (C) (ii), it is the responsibility of the Sponsor (for clinical trials only) to inform Health Canada that the amendment was not approved by the REB and the reasons for this.
REB approval lasts for one year. The study expiry date will be listed on the initial or annual approval letters. No study activities may continue once Reb approval lapses.
To renew your ethics approval, you will need to submit an “Annual Renewal or Termination Form”. Fill out all the sections and obtain the PI signature. If a section does not apply, indicate N/A. This form will not be accepted without copies of the informed consent form(s) (if applicable)
The purpose of the annual renewal is to inform the REB of the following
- Status of the study
- The number of participants that consented and participated
- Summary of progress
- Participant withdrawals and reasoning
- Participant complaints/feedback
- Safety concerns
- Conflicts of interest
- Changes to Pi and study coordinator contact information
If the study is completed or being terminated prematurely, please submit the same form indicating the termination date and reason termination (i.e., study completed). If available please also include a final report.
Informed Consent Guidelines
When writing a consent form please make sure to
- Use plain (lay) language that is easy for a non-medical person to understand, and is consistent with the study population
- Us a size and font of text that is consistent and easy to read (size 11 or larger is recommended)
- Define all acronyms and abbreviations when they first appear
- Ensure that the final form is properly formatted and free of spelling and grammatical errors
The informed consent form is only a component of the informed consent process. Researchers still need to have an informed discussion with, and respond to any questions raised by participants. Consent is an ongoing process throughout the conduct of the study to ensure consent for participation is maintained.
Body of text should include:
- Title of Study in language a lay person can understand (not necessarily the formal title for grant application)
- Name of investigators
- Short description of the study (include methodology)
- The nature of their involvement (number of visits, number of hours, the location of the testing)
- MRI protocols (if applicable) – please refer to MRI informed consent form wording document
- Time period for active involvement in the study (this is not the length of the study)
- Risks & benefits
- Procedures to ensure privacy and confidentiality
- Information about storing/sharing of data for future unspecified use with a separate consent option (if applicable) – please refer to Open Science Consent Wording document (REO website) and TCPS2 Article 3.13 requirements for Broad Consent for the Storage of Data and Human Biological Materials for Future Unspecified Research (https://ethics.gc.ca/eng/tcps2-eptc2_2022_chapter3-chapitre3.html#e)
- Remuneration, if any
- Rights and withdrawal – Include the following statement – “In no way does signing this consent form waive your legal rights nor does it relieve the investigators, sponsors or involved institutions from their legal and professional responsibilities.”
- Access to medical records, if required
- Whether any audio/video taping would be done
- What will be done if abnormal findings/results are obtained
- Contact people (include PI)
- Whether there are alternative interventions (i.e. treated in some way, alternatives to being part of the study)
- If new information related to the risks/benefits of the study is obtained, you will be informed.
- Statement – “If you wish to contact someone not connected with the project about your rights as a research participant, feel free to call Dr. Daphne Maurer, Chair of the Research Ethics Board at (416) 785-2500 ext. 2440”
Signature Section should include:
- Statements about what has been explained:
- Risks and benefits
- That confidentiality will be maintained
- Special items such as accessing medical records, audio/video taping
- Right to withdraw from study
- Informed about abnormal findings/results
- Participants will be given copy of Informed consent form
- Name and signature of subjects/substitute decision maker
- Name and signature of person obtaining consent (Note: a witness is not required)
- Add the following in a Footer
- The Version number of the informed consent form
- The date that the form is created and/or updated
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. August 1998.
Good Clinical Practice: Consolidated Guideline. ICH Harmonised Tripartite Guideline. 1997.
Health Canada Consolidated Statutes and Regulations, Food and Drug Act, Division 5 Drugs For Clinical Trials Involving Human Subjects. August 2004.