Information for Researchers

Please review the WWREB application instructions before you begin.

WWREB uses two separate application forms. Choose the one that matches how you are collecting your data:

• Collecting new data (prospective): Use this form if you are planning to collect new data moving forward in time.
• Using existing data (retrospective): Use this form if you are looking at data or records that already exist from the past.

Email your submission to the WWREB administrative coordinator at [email protected].

To keep your study active. Use this form if your study is still ongoing and needs to be renewed for another year.

To make a change. Use this form if you want to change anything about your study that has already been approved.

To update your team. Use this form to add or remove people (personnel) working on your study.

To finish your study. Use this form when your work is done and you are ready to close your study with the WWREB.

To report a problem. Use this form to report Serious Adverse Events or any problems you did not expect that might be related to your study.

To report a change in plan. Use this form to report a protocol deviation. This is any time you had to move away from your approved plan, consent process, or documents.

Submit your completed forms to the WWREB administrative coordinator at [email protected].

The WWREB charges fees for the review of studies conducted by a for-profit company (e.g., industry-sponsored pharmaceutical, medical device or tech companies). These fees help support the administrative and committee resources required to maintain the ongoing operations of the WWREB.

A request for consideration of an exemption should be submitted to the chair of the WWREB at [email protected].

Industry-sponsor review fees:

• Initial review of new ethics applications: $3,000
• Annual renewals of ongoing research: $500
• Amendments or protocol changes*: $500

Attach a cheque payable to “Cashier, Waterloo Regional Health Network” and address it to “ATTN: WWREB”.

Good Clinical Practice (GCP) is an international set of quality rules for clinical trials to make sure they are done safely and that the results can be trusted. GCP has two main goals:

1. Protect people
2. Ensure good data

The TCPS 2 is the national ethics standard for conducting research in Canada. It ensures that all studies follow three core principles:

1. Respect for persons
2. Concern for welfare
3. Justice

The WWREB ensures participant rights and safety always come first by following the TCPS 2.

All researchers are recommended to complete the TCPS 2: CORE-2022 (Course on Research Ethics) offered for free online by the Tri-Agency Council. The CORE 2022 is an online tutorial that introduces researchers to the Tri-Council Policy Statement 2, which provides ethics guidance on research involving human participants.

Health Canada Division 5 outlines the federal requirements that clinical trials involving drugs must follow in Canada to help ensure participant safety and ethical oversight.

Being a member gives you a chance to shape research in Waterloo Region and protect the people who take part in it. Contact us if you’re interested in learning more about serving as a member.

Studies must get administrative approval from the hospital(s) before being submitted for ethics review by the WWREB.

The WWREB meets the first Wednesday of every month. To review your study, we must receive your completed study package in advance. The deadline to submit the package is the second Wednesday of the month prior to the meeting.

The WWREB will review study amendments, annual renewals, protocol deviations, study closures, reports of unanticipated problems/serious adverse events, study endings, and changes in study personnel in the order we receive them.

Research conducted at WRHN and CMH in partnership with the University of Waterloo may be qualified for either coordinated review or multi-jurisdictional single REB review.

All research, regardless of review type, must first receive administrative approval at the hospital where the research will be conducted. Contact the hospital’s Office of Research before proceeding.

Research conducted in partnership between WRHN/CMH and the University of Waterloo will receive coordinated review between the Office of Research Ethics (ORE) and the WWREB researchers. More information can be found on the University of Waterloo website.

Research conducted in partnership with a principal investigator (PI) from the University of Waterloo may be eligible for a single multi-jurisdictional review by the ORE. Contact the Office of Research at the hospital where you are proposing to conduct your research.

The primary mandate of the Waterloo Wellington Research Ethics Board (WWREB) (formally known as THREB) is to ensure that research involving the participation of humans meets current scientific and ethical research standards for the protection of human research participants. The WWREB has the authority to independently approve, reject, propose modifications to, suspend, or terminate any proposed or ongoing research involving human participants, their data and/or biological materials. This mandate extends to all research conducted at Cambridge Memorial Hospital and Waterloo Regional Health Network, with the exception of research reviewed by an alternate Research Ethics Board of Record for the hospital(s) (for example, The Ontario Cancer Research Ethics Board (OCREB), where necessary agreements are in place.

The WWREB complies with the Tri-Council Policy Statement (TCPS 2) requirements for activities that require review by an REB. These activities include:

• Research involving living human participants.
• Research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals and includes secondary use of biological materials.
• Research that relies exclusively on the secondary use of data or human biological materials.

The WWREB also complies with the International Conference on Harmonization Good Clinical Practice Consolidated Guideline (GCP), Part C Division 5 of the Food and Drug Regulations of Health Canada, the provisions of the Ontario Personal Health Information Protection act (PHIPA) and where applicable, the United States Food and Drug Administration regulations and other applicable laws and guidelines.

1. To provide research ethics review and oversight to ensure the ethical acceptability of research prior to initiation and throughout the lifecycle of a research study.
2. To approve, require changes to, or reject research studies or proposed changes to approved research studies, and to monitor, suspend or terminate any ongoing research.
3. To place restrictions on a research study.
4. To take any actions considered reasonably necessary to ensure the protection of the rights, safety and wellbeing of participants in research.
5. To recommend policies and procedures governing ethical conduct of research at the three hospitals.
6. To act as a resource on matters of research ethics for the three hospitals.
7. To provide education regarding research guidelines to the membership of the THREB in order to promote adherence by researchers to the TCPS2 and other accepted standards, as applicable.

The WWREB receives its authority from and reports to the board of directors of Cambridge Memorial Hospital and the board of directors of Waterloo Regional Health Network.

In order for the WWREB to retain the independence required of it by the TCPS 2, a decision made by the WWREB may not be overruled by member hospitals except for reasons other than research ethics.

The decisions of the WWREB related to initial study reviews are open to appeal through an appeal mechanism established by the member hospital.

The WWREB will be comprised of at least five members represented by the following categories:

• At least two members who have broad expertise in the relevant research disciplines, fields and methodologies reviewed by the board
• At least one physician representative(s)
• At least one member knowledgeable in ethics
• At least one external community member who has no current employment affiliation with the institutions
• At least one member affiliated with each hospital who is not a senior institutional administrator member(s)
• At least one member knowledgeable in Canadian law relevant to the research
• At least one member(s) knowledgeable in privacy issues
• Ad-hoc reviewers as necessary (non-voting)

Membership will be a renewable three-year term based on mutual agreement between the member and the WWREB chair. Members will complete relevant training and education as required by the chairperson. Members are expected to attend a minimum of 70 per cent of scheduled meetings.

Members who cannot attend a meeting are expected to provide written comments to WWREB for each of the studies under review at the respective meeting. WWREB may have observers attend meetings at the discretion of the chair.

The chairperson is appointed by the boards of the three hospitals for a renewable three-year term(s).

All WWREB members are required to sign a conflict of interest declaration form, and to declare any conflicts prior to the review of a submission. If there is any doubt concerning conflict of interest, the member is expected to discuss the matter with the WWREB chair. If a member has a conflict with a submission under review, they will be absent for the review and vote, and this will be noted in the meeting minutes.

Decisions made by WWREB are based on scientific and ethical merits of a research study, and are made independently of other interests of CMH or WRHN. WWREB is guided by the following core ethical principles as defined in Article 1.1 of the Tri-Council Policy Statement, “Ethical Conduct for Research Involving Humans”:

• Respect for persons
• Concern for welfare
• Justice

For studies that do not qualify for a delegated review process carried out by the chair and/or a qualified member of WWREB, a full board review will occur. Although attempts will be made to reach consensus on decisions, a vote of the majority present will be taken as the Waterloo Wellington Research Ethics Board’s decision provided there is a quorum. Written positions are encouraged to facilitate discussion when a member cannot attend.

WWREB is entitled to invite researchers to a meeting to discuss a study under review or for which WWREB provides oversight. WWREB is also entitled to seek input from ad hoc reviewers at its discretion.

At minimum, the WWREB will follow the quorum requirements of TCPS 2 and will apply additional quorum requirements as necessary based on applicable regulations and guidelines that may apply to the study under review.

Meetings will be held monthly. At the discretion of the chairperson, scheduled meetings may be cancelled or additional meetings called.

The WWREB meeting agenda and related discussion, minutes, and information contained in study submissions are all confidential. Official copies of reviewed documents will be retained by the WWREB Office for as long as legally required. All WWREB members and observers of WWREB meetings must sign a confidentiality agreement form.

Retrospective review pertains to records that exist at this time. Please use this form only if you plan to conduct research that involves a retrospective review of medical records and if you will not collect ongoing or any other information from or about the patient. This form is meant to capture the necessary elements of the research plan for this project. If you are proposing to contact patients for consent or for any other purpose, please use the prospective study form.

Federal and provincial privacy regulations require that all individuals provide informed consent and authorization for the use of their personal health information. For Ontario, this is the Personal Health Information Protection Act (PHIPA – Nov. 1, 2004).

The provisions of the regulations cannot be waived unless the following criteria are met:

• a. the research purposes cannot be achieved without the information;
• b. it is impracticable to obtain consent;
• c. the information is used in a manner that will ensure its confidentiality; and
• d. the public interest in conducting the research exceeds the public interest in protecting the privacy of the individuals.

A research ethics board (REB) is allowed to waive the requirement for subject consent and authorization if these criteria are met. The WWREB will review this application and determine whether consent is required. However, it is the responsibility of the applicant to provide the justification for waiver of consent and it is at the discretion of the WWREB to determine whether the justification is to its satisfaction.

The use of personal health information for research is regulated in Ontario Personal Health Information Protection Act, 2004 (PHIPA). Investigators must comply with the duties set out for researchers in PHIPA.

Personal health information (PHI) includes identifying information about the health and health-related treatment of an individual. Identifying information can be both direct and indirect, meaning that it includes information that either 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. For example, a coded data collection form is PHI as long as a key linking the coded data to an identified individual exists.
Investigators should plan to collect personal data at the lowest level of identifiability necessary to achieve the study objectives. Even a dataset without direct identifiers may present a risk of indirectly identifying data subjects if the dataset contains sufficient information about the individuals concerned. For advice, consult the CIHR Best Practice Guidelines for Protecting Privacy and Confidentiality.

The act defines personal health information and for research on personal health information it requires review by a research ethics board and provides some criteria on which the REB should base its decisions.

For further information, consult the “Guidelines for Protecting Privacy and Confidentiality in the Design, Conduct and Evaluation of Health Research: Best Practices” from the Canadian Institutes of Health Research.

Yes. Any secondary use of data/biological materials must be approved by the research ethics board (REB) prior to implementation.

Any transfer of funds, data, and/or biological specimens outside of the hospital’s stewardship (e.g., to an external collaborator) must be formally governed by an agreement, as determined by the hospital. This agreement will define the scope of data/biological specimen use, outline security and privacy protocols, retention and destruction timelines, and mandate compliance with relevant regulations and policies as it relates to the use of data for research purposes.