RITHIM was designed to support the harmonization of administrative processes and reviews for health research related to ethics, privacy, and health institutional assessment reviews. The concept of harmonization is simple, but implementation is highly complex. RITHIM itself does not have the authority to make any of these decisions, nor does it support one single committee that makes these decisions. Instead, it provides one online application for researchers, distributing applications to the appropriate responsible entities for review, and providing streamlined responses and decisions to the researcher.

What are the Three Pillars of RITHIM?

RITHIM streamlines and harmonizes the process and reviews for health research in 3 key areas: ethics, privacy, and health institutional assessment reviews. Ethics and privacy each have a committee with the authority to review and approve the research. Health institutional assessment reviews are coordinated by institutional delegates and conducted at wide variety of sites within the health system.

Ethics

• The Committee for Harmonized Health Impact Privacy and Ethics Review (CHIPER) is a new provincial research ethics board. CHIPER’s mandate is to provide robust reviews of health research ethics as outlined in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2). CHIPER conducts reviews of research protocols to ensure that researchers adhere to ethical principles with respect to the conduct of research.

Privacy

• The Provincial Health Research Privacy Committee (PHRPC) is the only committee with the authority to approve the USE of personal health information (PHI) for research purposes. This includes PHI maintained by any Manitoba Trustee, including government and government agencies.

Health Institutional Assessment

• Health institutional assessment reviews are the reviews that are conducted within the health system to determine if it is feasible for proposed research to be conducted at a site. Health institutional assessment reviews consider factors like the institution’s ability to provide access to data, and the potential impact on health system human resources, physical space, medical tests, etc. associated with conducting the research.
• Institutional delegates, identified by the health system, will be responsible for receiving applications through Harmony, coordinating institutional reviews at sites within the health system, and providing the results of those reviews back through Harmony.

How Does RITHIM Harmonize Reviews?

The full launch of the RITHIM program and the electronic Harmony system supports increased coordination and harmonization between CHIPER ethics reviews, PHRPC privacy reviews and health system institutional assessment reviews. The true harmonization is achieved through harmonizing the application processes through the electronic Harmony system and administratively harmonizing the feedback from all three perspectives.

When a researcher submits an application through Harmony, it will be:

• assessed by RITHIM staff for completeness;
• assigned to reviewers from each of the 3 perspectives (as necessary);
• results of the reviews will be assessed by RITHIM staff to identify any conflicts between the 3 review perspectives and ensure alignment;
• any conflicts in review comments will be resolved via communication or at a RITHIM alignment meeting;
• a RITHIM Determination (a reflection of all three perspectives) will be provided to the Researcher through Harmony

Alignment During the Review Process

RITHIM has scheduled the CHIPER and PHRPC meetings sequentially. This means that relevant results of the CHIPER review can be considered by PHRPC before they issue their decision. Likewise, the health institutional responses will be provided after the PHRPC meeting, and therefore the health institutions can consider relevant results of the CHIPER and PHRPC reviews before issuing their final decision. This allows for the opportunity for the consideration of other perspectives and a level of harmonization to occur during the review process.

RITHIM Alignment Meetings

In the case where the results of the reviews (ethics, privacy, and health institutional assessment) contain conflicting feedback, RITHIM staff will identify the conflict and ensure it is resolved PRIOR to the researcher receiving their decision through Harmony.

In most cases, conflicts may be resolved through communication with the parties involved in a decision.

In the case where a conflict is not easily resolved, RITHIM staff will schedule a RITHIM alignment meeting which will include the relevant parties. Alignment meetings will be chaired by a CHIPER Chair and the goal will be to achieve consensus of all parties on the appropriate aligned feedback to be provided to the researcher.  

Attendees may include:

• RITHIM Staff
• CHIPER HREB Chair
• CHIPER BREB Chair
• PHRPC Chair
• Shared Health Delegate
• Relevant Institutional Delegate(s)

Alignment meetings will focus on:

• A description of the conflict
• A discussion of the issue from the relevant review perspectives
• A proposed solution for alignment of feedback
• Consensus

Applicable conditions from each relevant perspective will be revised in accordance with the consensus achieved.