Intro to RITHIM Webinar Q&A
A text compilation of questions asked during the August 19 2020 Webinar hosted by Freyja Arnason.
Q: I understand that the scope is currently for health research - how is review dealt with that starts outside of health or includes groups outside of scope?
A: We have routing questions that will be part of the system and the responses will direct you to CHIPER or back to your institution.
Please see: https://www.rithim.ca/do-i-apply-through-chiper
Q: I am assuming that the impact review can have some off-line clarifications? This might mean an update/correction outside of the RITHIM/CHIPER process.
A: It is likely in some cases. We will have the ability when the impact review is taking place to have a conversation between impact reviewers and the applicant if additional information is required.
Q: What if an institution decides they don't want to be part of RITHIM? How will this continue to be an efficient system if sites are allowed to opt out?
A: This is a provincial initiative that the Province has mandated to proceed. There won't be much choice once the PHIA legislation happens, the legislation will mandate that applications must go through the CHIPER Committee, which combines multiple committees (UofM's HREB & BREB and HIPC). We are happy to have individual meetings with any institution that has questions about this process.
Q: Will the oversight of all current studies move from the Ethics Research Committee, the Research Facilitator, and Research Clinical Nurse to RITHIM? What will happen with these positions?
A: No positions will be moving from RHAs, and CHIPER will not be responsible for this type of hands-on oversight. Our new process will streamline ethics and privacy review decisions, but those decisions will still be made at the institutional level.
Q: What is the anticipated volume of studies that CHIPER expects to receive on a monthly basis?
A: We anticipate an annual volume of 1,000 per year based on previous HREB and BREB review volume.
Q: Is the time frame for RITHIM confirmed for the end of 2020?
A: No, it has changed to Spring 2021.
Q: I assume that the budget and contract piece is not part of RITHIM?
A: The contracts are separate from RITHIM, but we hope to work closely with legal teams at institutions to provide necessary info to support these processes. But no, we are not involved in these processes.
Q: If all of the studies are to go to RITHIM, will there be a transfer of all of the documents from RHAs to RITHIM? Will all of the PI’s be notified of the new process?
A: No, all documents do not need to be transferred to RITHIM. When an existing or open study requires an amendment or update, that can be done through CHIPER. We will be providing educational resources and training regarding this for PIs for active protocols.
Q: Is there an idea of what the turnaround time will be for receiving approval?
A: We are aiming for a 30 day timeline from submission to decision for privacy and ethics reviews. Impact reviews vary more widely, but we hope to be able to support organizations meet their timelines.
Q: Will RHA's Regional Ethics Committees play any role at all within RITHIM/CHIPER?
A: That is up to each institution, the process for conducting impact reviews lies with each institution and we ask that you provide a delegate so we can send them the appropriate information from the applications.
Q: Will notifications for publications/presentations from ongoing projects (approved before CHIPER) have to go to CHIPER starting Spring 2021?
A: We will build a process to deal with these specific situations, which will likely involve a smaller version of the form that will allow an attachment of the original submission.
Q: Can you speak to the provincial nature of the institutions involved (e.g. St Boniface)?
A: We have a province-wide scope, so we are looking at all the RHA's and institutions across Manitoba. We have reached out to St. Boniface and there is some level of concern there about the process. If an institution does want to conduct their own ethics review, they can, but it will delay the process for the applicants, as it will require a CHIPER review in addition to the institution review.
Q: There is funding attached to some of the studies we are involved in that assists to pay the cost of having a Research Clinical Resource nurse. Where will that funding be funneled to?
A: As far as we know, funding will stay where it is.
Q: Are all the committee positions filled? Can we see a list to see who everyone is on both committees?
A: CHIPER has a maximum of 50 membership slots, and we are not yet at maximum. As such membership will be allowed on an ongoing basis, and must then be approved by the CHIPER Chairs and the PRC. You can email potential nominations to email@example.com. Once approved by the PRC, the roster will be made available online.
Q: For those using administrative data from MCHP which includes education, justice and other types of data, do we still need approvals from these agencies ontop of CHIPER?
A: Yes, there will still be approval needed from these organizations. We hope to have a system in place to help expedite this process in a post-approval system.
Q: Is the process entirely online?
Q: How dependent is the support for RITHIM on whoever is in provincial government? It's great that progress is being made and would hate for it to be negated depending on who's in power.
A: This initiative does have support across the board, it has support in the current government and in the previous government, so we don't anticipate any political issues.
Q: Many research studies that are tri council funded are multisite, will these be handled differently by RITHIM?
A: There will be a process for multisite trials, we hope to provide more information on this soon.
Q: You mentioned that we are a "fly-by" Province for research. How much growth (or retention) do you expect with the help of this streamlined service?
A: We anticipate that by improving our processes we can attract more talent to our province, as this is a completely unique process across Canada. We don't have a specific numbered goal yet.
Q: Is there a more detailed skills metrics for the future CHIPER members, besides the overview found under the website tab 'CHIPER Nominations'?
A: We do have a detailed skills matrix and we have now uploaded it to our website, you can view it here:
Q: What about amendments for existing projects? If they were originally submitted to HREB, HIPC etc. will they start going to CHIPER?
A: Yes, they will, those committees will no longer exist on their own in the future, HREB and BREB will become part of CHIPER, and HIPC later on as well. The amendment will be a part of our online form.
Q: So if there are 100+ submissions to review per month, will it not end up being a major time commitment for those people involved who have other responsibilities within their organization?
A: It is a big responsibility, but one that the members of BREB and HREB have been accustomed to, so this should not change anything.
Q: If nowhere else in Canada is doing this, is this model unique or based off of somewhere else in the world?
A: We have not heard about anything like this happening globally, though there is some form of research ethics harmonizations happening, just none that combine ethics, privacy, and impact into one process.
Q: Will researchers be able to see which institution/committee is delaying approvals?
A: Yes. One of our key values is transparency, so we want to make a system where researchers can see exactly where their application is at any point in time.
Q: Will there be a pilot lead in to the Spring 2021 start date?
A: Yes, we will have system testings with pre-approved applicants who have already been notified.
Q: How will we work with Indigenous communities?
A: We will not replace current Indigenous committees, and we have reached out and worked with various organizations to create routing processes that are appropriate that involve Indigenous populations. It is important for us to have meaningful enagement with these organizations.
Q: How will goals and performances be reported?
A: The PRC will provide an annual report to the province which includes an evaluation plan. More information can be found and will be updated here: https://www.rithim.ca/reporting-metrics
Q: Does the new process include animal ethics?
A: No, it does not.
Q: Are delegated reviews possible within the system?
A: Yes, for privacy and ethic reviews.
Q: Will there be a fee for applying?
A: No, unless it is for industry-sponsored research.