Harmony Routing

public as clinical

Is this project considered research by the applicant, colleagues, institution and/or department, the public, or as per the definition in TCPS2? *

Yes
No/Not Sure

TCSPS2, Article 2.1 Application: “For the purposes of the Policy, ‘research’ is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.”

Is this project

Yes
No/Not Sure

• Quality assurance, quality improvement, or program evaluation
• A performance review, or testing within normal educational requirements
• Public health surveillance being conducted exclusively for assessment, management, or improvement purposes?

Are the project findings going to be used to change or evaluate processes and practices beyond the associated institution now or at any time in the future?

Yes
No/Not Sure

RITHIM Consultation May Be Recommended
It looks like the project may not be considered research and may not require a research ethics review. However, the obligation to make the appropriate determination remains the responsibility of the Principal Investigator (PI). A RITHIM Consultation Form may be submitted to obtain a determination regarding the requirement for REB review by CHIPER.

Does this research project require research ethics board review?

Yes
No/Not Sure

Does this project rely exclusively on information that is:

Yes
No

• Publicly available through a mechanism set out by legislation or regulation and that is protected by law?
OR
• In the public domain and the individuals to whom the information refers have no reasonable expectation of privacy?

Does this project require access to personal health information held in clinical and/or administrative databases by one or more trustees in Manitoba, including the Manitoba government and its agencies?

Yes
No

Does this project require access to data from the Manitoba Centre for Health Policy (MCHP)?

Yes
No

Does this project involve recruitment (active or passive) of patients/clients, health care staff, students, or resources (eg. MRI, space) at a health care facility, health services agency, or associated health care program in the Manitoba public health care system?

Yes
No

Examples include Riverview Health Centre, Thompson General Hospital, Youville Center, Pan Am Clinic, Maples Surgical Centre, Manitoba Home Care Services, Manitoba Personal Care Home facilities, Dynacare, etc.

Does this project involve biomedical or invasive interventions or measures (e.g. administration of drugs, vaccines, cannabis, natural health products, licensed and unlicensed medical devices, surgical procedures, diagnostic examinations such as biopsies, X-rays, MRIs, etc.)?

Yes
No

Does this project involve the collection, use, or retention of human biological materials (tissue, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva and other bodily fluids) from living or deceased individuals or materials related to human reproduction such as human embryos, fetuses, fetal tissue, and stem cells?

Yes
No

Does this project intend to create or add to an existing research registry or biobank of health-related information to be used for future research purposes?

Yes
No

Is any member of the research team for the project affiliated with a Manitoba post-secondary institution?

Yes
No

Is the project considered health research? Defined as research involving human participants, personal health information, or human biological material where the primary purpose of the research is to advance human health, health care, and health care systems but excluding research where the primary purpose is enhancing the education of health care professionals?

Yes
No

RITHIM Consultation May Be Recommended
It looks like this project may not fall under the jurisdiction of RITHIM. However, the obligation to make the appropriate determination remains the responsibility of the Principal Investigator (PI). A RITHIM Consultation Form may be submitted to obtain a determination regarding the requirement for review in RITHIM Harmony.

RITHIM Review Required
It looks like this project falls under the jurisdiction of RITHIM.

RITHIM Consultation May Be Recommended
Research that relies exclusively on publicly available data is exempt from research ethics board review. However, the obligation to make the appropriate determination remains the responsibility of the Principal Investigator (PI). Please review Article 2.2 of TCPS2 for further assistance on making a determination. When in doubt about the applicability of this article to their research, researchers should consult their REBs. A RITHIM Consultation Form may be submitted to obtain a determination regarding the requirement for REB review by CHIPER.

DO I NEED RITHIM APPROVAL?

Contact RITHIM

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