As more common areas of questions are identified, this section will be updated.
What is RITHIM?
Research Improvements Through Harmonization In Manitoba (RITHIM) is an operating division of Research Manitoba that will consolidate multiple and complex ethics, privacy and institutional impact review processes into one system. It began in 2015, when the provincial government asked Research Manitoba to lead an initiative to make recommendations on harmonizing processes and improving time-to-conduct for health research in the province. Streamlining and improving time-to-conduct will allow researchers to begin their work sooner. The new system will have one online application form (The Provincial Research Administration System, or PRAS) and harmonized review committees (The Committee for Harmonized Health Impact, Privacy and Ethics Review, or CHIPER). RITHIM will launch as an operating division of Research Manitoba in late 2020.
What is CHIPER?
The Committee for Harmonized Health Impact, Privacy and Ethics Review (CHIPER) is an independent, multidisciplinary committee consisting of health professionals, members of the scientific community, and experts in ethics, privacy and access to data, as well as public representatives.
CHIPER has two boards, one dealing with biomedical and clinical research, and the other, health research.
CHIPER’s mandate is to provide robust reviews of health research ethics and privacy, and to streamline the process for institutional impact reviews. CHIPER will conduct reviews of research protocols to ensure that researchers adhere to ethical principles with respect to the conduct of research and the access, collection, and storage of personal health information.
How Will RITHIM and CHIPER Work Together?
RITHIM staff will provide the administrative support necessary to support CHIPER in their work reviewing applications, and also guide the goals of the harmonization initiative to best serve the research community in Manitoba.
Who Is Involved In RITHIM?
There are multiple stakeholders involved in RITHIM, as we seek to incorporate feedback from everyone involved in the review of health research in Manitoba. The project team is led by Research Manitoba, with assistance from the Change Management & Project Services department at the University of Manitoba, technological implementation developers, representatives from the George & Fay Yee Centre for Healthcare Innovation and other consultants.
CHIPER will include current members from the University of Manitoba’s Research Ethics Boards in health and biomedical research, Ministerial representatives and public (community) representatives who will examine issues related to privacy and access to personal health information, as well as new members recruited from the Manitoba research community.
What is CHIPER’s Review Process?
A researcher will take required online training to learn how to use the electronic system to submit a high quality application to CHIPER.
A researcher will fill out an electronic application form.
The application will be screened by RITHIM staff to ensure that the application is relevant to CHIPER's mandated areas of review. RITHIM staff will also verify the completeness of the application, and then the application will be assigned to the appropriate CHIPER Board. Simultaneously, the application will be sent out for institutional impact review (as appropriate).
CHIPER will meet monthly to review applications.
Decisions are communicated to the applicant.
What Benefit Will A Researcher Gain By Submitting To CHIPER?
Submitting to CHIPER will enable the researcher to experience a streamlined process, a single electronic application form, transparency and tracking in the review process and timely communication of decisions for ethics, privacy and institutional impact reviews.
Who Is On CHIPER?
CHIPER will consist of no more than 50 members, with diverse expertise and experience in health research, privacy and ethics review, and from many different institutions. For more information on CHIPER’s requirements for members, please see the CHIPER SOPs on Composition.
For more information on joining CHIPER, please see the nomination information here.
What Committees Does CHIPER Replace?
CHIPER replaces the two University of Manitoba Bannatyne campus research ethics boards (HREB and BREB), the Health Information Privacy Committee (HIPC), and other REBs that review health research.
How does CHIPER handle the review of research involving the First Nations, Inuit and Metis people of Canada?
CHIPER does NOT replace the need for, or existing processes related to culturally appropriate reviews by Indigenous communities and/or ethics review boards including the Health Information Research Governance Committee (HIRGC). The RITHIM project team has reached out to the First Nations Health and Social Secretariat of Manitoba (FNHSSM), Ongomiizwin, the Manitoba Metis Federation (MMF) and the Manitoba Inuit Association (MIA) to engage in discussions around the development of routing processes within CHIPER for the appropriate review of research involving Indigenous populations. It is important to the RITHIM project team that there is meaningful engagement with these populations and organizations. This is why we have asked these partners to design questions within the CHIPER application form that will identify research that needs to be reviewed by Indigenous review committees and communities before it is reviewed by CHIPER. We will continue to engage these partners in the development of these processes with respect for their autonomy and the work they are doing to develop their own processes for the review of research.
Are There Other National Harmonization Initiatives For Health Research Applications?
Yes, there is a national movement towards harmonization of ethics reviews. RITHIM is supportive of efforts to streamline and harmonize review processes that support high quality reviews and improve time-to-conduct, and is proud to be one of the first institutions to bring together multiple aspects of the health research review process including ethics, privacy, and impact together. Please see the Partnerships page for more information.
How Often Will CHIPER Meet?
Each committee, health and biomedical, will meet monthly.
When Will CHIPER Begin Reviewing Applications?
The electronic application system is currently being built. We anticipate that CHIPER will begin reviews in Spring 2021. We will post all updates on timelines here.
Is CHIPER Independent?
Yes, CHIPER is an independent review board for privacy, ethics and the coordination of institutional impact reviews. Guidance and oversight of CHIPER occurs through the Provincial RITHIM Committee (PRC). Administrative support for CHIPER is provided through the RITHIM operating division of Research Manitoba.
How Will Goals and Performance Be Reported?
The Provincial RITHIM Committee (PRC) will provide an annual report to the province on CHIPER’s key performance indicators based on the evaluation plan. This annual report, along with quarterly reporting, will be available on the RITHIM website. Please see the Reporting Metrics page for more information.
Does The New Process Include Animal Ethics?
No. Please check with your institution regarding the appropriate review of research involving animals.
Is CHIPER Limited To Health Research? What Constitutes Health Research?
CHIPER is limited to health research, as defined by our routing questions, which can be accessed here.
What Is The Timeline For Submission To Approval Or Feedback?
We are currently aiming for a 30 day turnaround from the deadline for submission to decision communicated to an applicant. Full CHIPER review may be delayed if institutional impact reviews are not completed in the required timeframe.
Will There Be Capability For Delegated Reviews?
Yes. A guidance document regarding delegated reviews is currently being drafted and will be posted on the website when complete.
How Will An Institution Be Informed If A Project Is Applied Through CHIPER?
The electronic system, currently called PRAS, or the Provincial Research Administration System, provides a mechanism to inform institutions when a project has been submitted to CHIPER that involves that institution. Monthly reports will be available to each institution.
Is There An Appeal Process? What Will Be Involved In The Appeal Process?
An appeal process has been identified and outlined in a Standard Operating Procedure (SOP).
Will There Be A Fee For Applying?
There will be a fee for the review of industry sponsored research only. Details coming soon.
What Is PHIA And How Does It Relate To RITHIM & CHIPER?
The Personal Health Information Act, otherwise known as “PHIA”, is a privacy law that establishes rules for trustees and custodians of personal health information in Manitoba. A trustee is a person or organization that collects and maintains personal health information, and can include health professionals, hospitals, personal care homes, medical clinics, ambulance services, laboratories and regional health authorities, as well as public bodies such as government departments, crown corporations and school divisions.
Trustees must follow the rules set out under PHIA when collecting, using, disclosing, maintaining and destroying personal health information. PHIA also requires trustees to protect personal health information by adopting reasonable administrative, technical and physical safeguards that ensure the confidentiality, security, accuracy and integrity of the information. In addition, PHIA sets out the rights of individuals when they are trying to get access to their personal health information.
Currently, PHIA requires that any access to personal health information for research purposes must be reviewed by the HIPC (Health Information Privacy Committee). Changes to PHIA are being proposed, which would remove the HIPC from the legislation and identify that a committee will be established under the regulations. That committee will be CHIPER.
Will There Be A French Component To The System?
At the present time, we do not the PRAS available in French. Please contact the RITHIM office for assistance if the applying investigator has any questions regarding this.
What Will Be The Education And Training Program For CHIPER?
Planning for education and training related to CHIPER is underway. Stay tuned for more details in the coming months.
What is the Institutional Impact Review?
Institutional Impact Review refers to the review that takes place at each Regional Health Authority and/or hospital or health institution in Manitoba to determine the operational impact and feasibility of research at that particular institution. In the current system, there are over 25 different review committees, each with their own paper-based application form and process.
CHIPER's PRAS includes a section on institutional impact, and therefore researchers will no longer be required to complete a separate impact assessment application at the institution(s) where they plan to carry out research.
These impact reviews will be conducted within a 10 business day timeframe, and will feed back into the CHIPER review meetings. This means that CHIPER will provide researchers with decisions on ethics, privacy and institutional impact review all through one harmonized process.
What are the Privacy and Impact Communities of Practice?
One of the RITHIM recommendations was to create cultural change around the approach to privacy, impact and legal issues related to health research in Manitoba. To this end, we have created the Privacy Community of Practice and the Impact Community of Practice. You can find more information on the Committees section of our website.