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Research Ethics Board

In order to minimize disruption of services during the COVID-19 outbreak, the REB will only be accepting submissions via email during this time:

  • Please submit signed and scanned Application Forms and accompanying documents to [email protected].
  • In the subject line, please include the REB number (for ongoing studies) and the type of submission.

PLEASE DO NOT SUBMIT PAPER COPIES TO THE REB OFFICE AT THIS TIME.

Please note that during the COVID-19 outbreak, in accordance with the recommendations of Dr. Jim Woodgett, Director of Research, all non-essential on-site research activities involving human participants are temporarily suspended. Research activities involving recruitment or direct contact with participants may only continue if ceasing such activity might pose risks to participant safety, or if it is related to the COVID-19 pandemic. Where possible, Investigators are encouraged to explore virtual options for participant visits.

The REB will continue to review and approve submissions during this time, but initiation or implementation of newly approved submissions will be contingent upon evolving institutional policies and recommendations. Principal Investigators are encouraged to consult with their Department Heads for further guidance.

Additional Resources:

NEW UPDATE (June 23, 2020): Restarting Clinical Research Activities

The plan to gradually restart clinical research activities must align with the approach taken by Sinai Health. The Hospital is following all applicable local, provincial and federal public health directives, and guidelines and direction from Ontario Health, which requires continued reassessment of activity based on local resources and regional COVID-19 activity. As research begins to resume for on-site studies that involve contact with participants, each Principal Investigator should review the ‘Restarting On-Site Clinical Research Activities: Principal Investigator Attestation and Agreement’ for requirements and considerations. Once the conditions can be confirmed as met, please complete and submit the document to [email protected]. If any modifications are required to the study, please also include a completed ‘Amendment/Administrative Change Form’ with the submission.

The Mount Sinai Hospital Research Ethics Board (REB) oversees all research involving human subjects conducted under the auspices of Mount Sinai Hospital to ensure that such research meets the highest scientific and ethical standards in order to protect patients, investigators and the institution.

In total, the Board is responsible for approving and monitoring an estimated 350 new studies each year involving human subjects as well as monitoring ongoing studies lasting in excess of one year.

 

Overarching Principles of Ethical Review

Ethics are principles of right conduct guiding “what ought to be done”. In the context of the Tri-Council Policy Statement 2, the REB subscribes to following ethical principles that are commonly held and valued by diverse research disciplines:

  • Respect for Persons which recognizes the intrinsic value of human beings and the respect and consideration that they are due; considers how people of all ages are treated as research participants; incorporates the moral obligations to respect autonomy; and protects those with developing, impaired or diminished autonomy.

  • Concern for Welfare which considers the impact on individuals of factors including physical, mental and spiritual health, as well as their physical, economic and social circumstances; encompasses factors including privacy and control of information about the person and the assessment of foreseeable risks and benefits; and the treatment of data and human biological materials according to the free, informed and ongoing consent of the person who was the source of the information and materials.

  • Justice which recognizes the obligation to treat people fairly and equitably.

All research involving human subjects within Mount Sinai Hospital (MSH) requires approval of the MSH Research Ethics Board prior to the initiation of a research project. The MSH REB has similar responsibility for investigators from other institutions who may wish to carry out research on Mount Sinai Hospital premises or with Mount Sinai Hospital patients.

IIn the event that an investigator cannot determine whether an intended investigation constitutes research (for instance, quality assurance studies do not constitute research), the investigator should approach the Research Ethics Board office for such a determination by calling 416-586-4875. Providing such consultation on ethics matters is part of the responsibility of the Board.

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