FAQ Categories International

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  1. What other requirements should I be aware of when conducting international research outside of the U.S. and Canada?

    Comments Off on What other requirements should I be aware of when conducting international research outside of the U.S. and Canada?

    In addition to the initial review process, Quorum will require continuing review and review of modifications to the research as required by the U.S. Common Rule. The Board can request additional information as needed to properly evaluate such reviews in the context of international research. Investigators will also be expected to comply with Quorum Review’s safety reporting requirements, unless otherwise specified in a joint oversight agreement with the local ethics committee.

  2. What type of additional information does Quorum Review’s Board need in order to review an international clinical trial conducted outside of the U.S. and Canada?

    Comments Off on What type of additional information does Quorum Review’s Board need in order to review an international clinical trial conducted outside of the U.S. and Canada?

    The Board may take a range of information into account when reviewing international research. You should be prepared to inform the Board regarding the country’s laws regarding human subjects research, other additional pertinent information regarding conducting human subjects research in the country; for drug and device studies, the regulatory status of the product in that country and/or status of research applications held with applicable regulatory authorities, and additional relevant cultural or other local issues about doing research in that setting. The Board also might have specific questions about the country’s geography, economic structure, political system, social/cultural information, and health/medical information as related to the research.

  3. The country I seek to conduct research in does not appear to have any applicable regulations. What standard will Quorum Review apply when reviewing my international research?

    Comments Off on The country I seek to conduct research in does not appear to have any applicable regulations. What standard will Quorum Review apply when reviewing my international research?

    Quorum Review will apply HHS’s “Common Rule” under 45 CFR 46 in absence of other applicable research regulations. If other regulations apply but have a less protective standard than the Common Rule, Quorum Review may apply the Common Rule. Quorum Review will also apply CIOMS standards, FDA regulations, ICH GCP, WHO GCP guidelines, or the Canadian TCPS 2 as appropriate.

  4. Where can I find information about the laws, regulations, and guidelines that may apply to my international research project?

    Comments Off on Where can I find information about the laws, regulations, and guidelines that may apply to my international research project?

    A good place to start researching the requirements of the country you are interested in conducting research in is the International Compilation of Human Research Standards, published annually by the Office for Human Research Protections.

  5. Does Quorum Review have a special Board to review international research?

    Comments Off on Does Quorum Review have a special Board to review international research?

    Generally, international research may be reviewed by any of Quorum Review’s Boards with the exception of Canadian studies. Quorum Review maintains an ethics review board (referred to as the “North American” Review Board) that serves as a convened research ethics board (REB) and a central institutional review board (IRB) for Canadian studies. For more information about Quorum’s Canadian research ethics board, please click here.

  6. What are the turn-around times for the review of studies involving international research conducted outside of the U.S. and Canada?

    Comments Off on What are the turn-around times for the review of studies involving international research conducted outside of the U.S. and Canada?

    Once Quorum Review has obtained all relevant information necessary for review and has coordinated with local consultants, other IRBs/Ethics Committees, or other involved parties, standard turn-around times will apply. Careful planning and providing the specific information outlined above will assist Quorum Review in helping you meet your timelines. It is recommended you contact Quorum as early as possible in development of your project to assess the requirements that may apply to your specific study and the services that Quorum can offer to help ensure your timelines are met.

  7. What type of information will the Board consider when reviewing international research conducted outside of the U.S. and Canada?

    Comments Off on What type of information will the Board consider when reviewing international research conducted outside of the U.S. and Canada?

    In addition to reviewing the protocol, the Board will consider coordination of review with the local IRB/ethics committee (if applicable), country specific background information, local laws, qualifications of the investigator(s) for conducting research in the country, and any particular issues relating to the consent process in the country where the research will be conducted.

  8. Does Quorum Review IRB work with local IRBs or Ethics Committees when reviewing international clinical trials conducted outside of the U.S. and Canada?

    Comments Off on Does Quorum Review IRB work with local IRBs or Ethics Committees when reviewing international clinical trials conducted outside of the U.S. and Canada?

    Yes. Quorum will work with local IRBs or Ethics Committees whether by regulatory requirement or client preference or needs. You may seek dual oversight (meaning each IRB oversees the study) or the IRBs may divide oversight responsibilities (for example, the local IRB may review for local context and compliance with local laws and regulations, while Quorum Review provides ethics review under U.S. regulatory standards). In some circumstances, Quorum Review may serve as the sole IRB if permissible under the country of interest’s laws and regulations.

  9. Does Quorum Review IRB require a special submission form for international clinical trials located outside of the U.S. and Canada?

    Comments Off on Does Quorum Review IRB require a special submission form for international clinical trials located outside of the U.S. and Canada?

    No. Quorum Review IRB does not require international clinical trials located outside the United States and Canada to use a special submission form.  You should fill out the standard submission documents.  The Quorum Review Regulatory Attorney assigned to your submission will contact you to obtain the additional information required for your international ethics review.

     

  10. Does Quorum review research that will be conducted at Canadian sites

    Comments Off on Does Quorum review research that will be conducted at Canadian sites

    Yes. Quorum’s North American Board is an institutional review board/research ethics board that meets on Wednesdays and is authorized to review research involving Canadian sites. Some Canadian sites may qualify for a daily review of sites; other site and protocol reviews will be scheduled for the North American meeting. Read more about our North American review.

  11. Does Quorum review research in Canada?

    Comments Off on Does Quorum review research in Canada?

    Yes. Quorum Review IRB maintains an ethics review board (referred to as the “North American” Board) and serves as a duly convened research ethics board (REB) and central institutional review board (IRB). The North American Board complies with applicable regulatory requirements and meets every Wednesday and Friday to review U.S. and Canadian studies. Quorum is AAHRPP-accredited and accepts both privately and publicly funded research in Canada. Read more about our North American review here, or contact us for more information.

  12. What submission documents are required by Quorum?

    Comments Off on What submission documents are required by Quorum?

    Quorum requires the following documents:

    • “Site Information Questionnaire: Primary Research Facility” form
    • Principal investigator’s Curriculum Vitae including clinical research experience with human subjects and education (if applicable,the principal investigator needs to submit a CV to Quorum only once)
    • Medical License
      • Quorum Review IRB verifies the PI’s medical license for all locations where he/she will be conducting research under Quorum Review’s jurisdiction.
      • If the PI is conducting research in a location which does not provide online license verification (e.g. Puerto Rico, certain Canadian provinces, etc.), submission of the PI’s medical license(s) is required.
      • If you do not know if online license verification is available for the location(s) applicable to the PI’s medical license(s), it is recommended to include a copy of the PI’s medical license(s) with the PI’s site submission.
      • If Quorum Review is unable to verify the PI’s medical license(s), processing of the PI’s site submission will be delayed.
  13. Will all my Board correspondence post to the OnQ Portal?

    Comments Off on Will all my Board correspondence post to the OnQ Portal?

    All Board correspondence will be posted to the OnQ Portal for U.S. and Canadian studies. Sponsors that are approved to conduct research in both the U.S. and Canada will see two separate links to their approval documents when logging into the OnQ Portal. One link will route you to the U.S. arm and another link will route you to the Canadian arm. To easily identify the Canadian arm vs. the U.S. arm, Quorum has assigned an identical Quorum Review tracking number (QR#) with an addition suffix for the Canadian arm. The U.S. arm will contain our standard 5 digit number (e.g. QR# 23333) and the Canadian arm will be assigned the same number with an additional suffix (e.g. QR# 23333CDN).

  14. In what ways do you support French Canadian speakers?

    Comments Off on In what ways do you support French Canadian speakers?

    For sites with personnel and/or study subjects who speak French, Quorum can provide French translations of the study Consent Form(s) and any other participant materials (such as diaries, recruitment materials, etc.). Quorum also has a phone support system in place with a dedicated mailbox for study personnel and participants who speak French.

  15. Can Quorum provide French Canadian translations?

    Comments Off on Can Quorum provide French Canadian translations?

    Yes. Quorum can provide French Canadian translations and offers translation services in over 100 languages and dialects for all study related documents. By coordinating translation through Quorum staff, you can help ensure that additional translations are not needed for your study documents for submission to the Board. Please contact your Study Manager if you would like more information regarding these services.

  16. Does Quorum have a physical office in Canada?

    Comments Off on Does Quorum have a physical office in Canada?

    Yes. Quorum Review IRB has an office in Canada; however, our staff is available at the main office in Seattle to support Canadian sites and research. Please send all submissions to the main Seattle office.

  17. Do Quorum’s consent forms comply with PIPEDA?

    Comments Off on Do Quorum’s consent forms comply with PIPEDA?

    Yes. Quorum’s template consent form is PIPEDA compliant, but it is the ultimate responsibility of the of the principal investigator to comply with the federal, provincial, and local law requirements.

  18. What is PIPEDA?

    Comments Off on What is PIPEDA?

    PIPEDA refers to the federal Personal Information Protection and Electronic Documents Act (S.C. 2000, Ch. 5) (Federal Act). The Act applies to all organizations that collect, use or disclose personal information in the course of commercial activities. The term “commercial activity” means any particular transaction, act or conduct or any regular course of conduct that is of a commercial character. Clinical research under contract to a private organization is a “commercial activity”. As of January 1, 2004, the Act applies to all personal information collected, used or disclosed in the course of all commercial activity. Note: If a province passes a law that is substantially similar to the Federal Act, the organizations or activities covered by the provincial law will be exempted from the federal law for collection, use, or disclosure within the province.

  19. Do Quorum’s consent forms comply with Canadian provincial requirements?

    Comments Off on Do Quorum’s consent forms comply with Canadian provincial requirements?

    Although compliance with provincial and local law requirements are ultimately the responsibility of the principal investigator, Quorum has developed consent forms that are in compliance with provincial and local law requirements where Quorum provides review.

  20. Why do I have to submit a Clinical Trial Budget?

    Comments Off on Why do I have to submit a Clinical Trial Budget?

    In accordance with Article 11.11 of the Tri-Council Policy Statement (TCPS 2), Quorum’s REB is required to review the clinical trial budget for Canadian studies in order to “ensure that conflicts of interest are identified and minimized, or otherwise managed.”

  21. Why do I have to be TCPS 2 compliant when my study is not publicly funded?

    Comments Off on Why do I have to be TCPS 2 compliant when my study is not publicly funded?

    Since many organizations in Canada have voluntarily elected to adopt TCPS 2, even if they are not required to do so, there is a likelihood that we will encounter a site that will require Quorum to comply with the TCPS 2. As a matter of policy we therefore apply the TCPS 2 to all studies unless the organization provides and explanation regarding why it should not apply.

  22. Is Quorum TCPS 2 compliant?

    Comments Off on Is Quorum TCPS 2 compliant?

    Yes. Quorum will review Canadian research in accordance with applicable regulations and guidelines, including the Tri-Council Policy Statement (TCPS 2).

  23. What is TCPS 2?

    Comments Off on What is TCPS 2?

    The Tri-Council Policy Statement (TCPS 2) is a Canadian Government policy statement that sets ethics standards for conducting research on human subjects. The agencies that make up Tri-Council are as follows: (1) Canadian Institutes of Health Research (CIHR), (2) Natural Sciences and Engineering Research Council of Canada (NSERC), and (3) Social Sciences and Humanities Research Council of Canada (SSHRC). These agencies will consider funding organizations that certify that they will comply with the TCPS 2 for the research study involving human subjects. Many organizations apply the TCPS 2 standards to all studies even if only specific studies are being funded by one of the three agencies. In addition, many organizations voluntarily apply the TCPS 2 to all studies as a matter of policy even if no public funding is being received for any study.

  24. Does Quorum review research in Canada?

    Comments Off on Does Quorum review research in Canada?

    Yes. Quorum Review IRB maintains an ethics review board (referred to as the “North American” Board) and serves as a both a duly convened research ethics board (REB) as well as a central institutional review board (IRB). The North American Board complies with Canadian and U.S. requirements and meets every Wednesday and Friday to review U.S. and Canadian studies. Quorum accepts both privately and publicly funded research. Quorum is subject to the same provincial restrictions that apply to other central REBs in Canada. Therefore, Quorum does not provide review in Alberta, Newfoundland and Labrador, and Saskatchewan. In Quebec, Quorum reviews only studies involving adult participants.

  25. What is a research ethics board (REB)?

    Comments Off on What is a research ethics board (REB)?

    A “research ethics board” (REB) performs the same function in Canada as an IRB does in the U.S. (see above). An REB is a group of individuals responsible for reviewing a study to make sure that the research participant’s rights and welfare are protected. Most clinical research studies cannot begin in Canada without REB approval. REB members generally include health care personnel such as doctors, nurses, and pharmacists. The REB also includes other members of the scientific community, non-scientists such as clergy or social workers, and community members. The REB carries out its responsibility to protect the rights and welfare of research subjects by reviewing the protocol to make sure that risks to participants are minimized, that risks are acceptable in light of the possible benefits, that the informed consent document is accurate and complete in describing the study and its risks and benefits, and that the clinical research study is conducted in an ethical manner. If the REB believes that these conditions have been met, it may approve the study and allow it to begin. Once the clinical research study begins, the REB is responsible for periodically reviewing the approved study to assure that the rights and welfare of research participants continue to be appropriately protected. Usually, the informed consent document will provide the research participant with a phone number to contact the clinical investigator or the REB if the participant has a question or concern about how the study is being conducted.

  26. Under what regulatory authorities does Quorum operate?

    Comments Off on Under what regulatory authorities does Quorum operate?

    Quorum provides review services in accordance with the ICH Guidelines for Good Clinical Practice. For research to be conducted in the U.S., Quorum applies the requirements for institutional review boards found in the U.S. Food and Drug Administration regulations (21 CFR Part 56) and the U.S. Department of Health and Human Services regulations (21 CFR Parts 50 & 56). For research to be conducted within Canada, Quorum Review applies the requirements for research ethics boards found in the Canadian Food and Drug regulations (Part C, Division 5). Quorum conducts its review in accordance with the ethical principles outlined in the Belmont Report.