Research involving human participants

 

August 2020: Updated guidance for NRC research involving human participants during the COVID-19 pandemic

The health and safety of NRC employees and our communities are of utmost importance. As the NRC begins to consider a limited return to work in light of the COVID-19 pandemic, the following guidance is provided to assist those carrying out research involving in-person contact with human participants.

As per the NRC Policy for Research Involving Human Participants , this applies to: studies conducted by NRC employees, studies whereby the NRC allows the use of its equipment, laboratories, products, or facilities in the research; or instances where the NRC provides financial support to the research, such as through the NRC Industrial Research Assistance Program (IRAP).

The NRC Research Ethics Board (REB) has implemented additional requirements for research ethics review, in order to help protect the safety and health of research participants. These requirements are:

  1. Adherence to public health guidelines and protocols: As is the case for all NRC activities, NRC research activities involving human participants must follow the relevant provincial/territorial public health guidelines and the NRC's Special COVID-19 Operating Protocols. Should human research participants be required to be onsite at an NRC facility, this should be reported through the relevant NRC Building Authority to be included in the total number of building occupants as per established NRC protocols.
  2. Alternatives to in-person research participation: Researchers should review proposed research activities involving human participants (whether part of an existing NRC REB-approved protocol or a new proposed protocol to be submitted for REB approval) with an aim to use virtual tools to limit or eliminate direct in-person contact with research participants wherever possible and practicable.
  3. COVID-19 risks and participant consent: All protocols (whether new or revised) must specify whether participants will be exposed to risks related to COVID-19 as a result of their participation in the research study. These risks must be outlined in the ethics application (Part 2 Form) for any new or revised protocol, as well as clearly outlined in the participant consent form (using sample language as per the NRC REB COVID-19 Addendum form available through the NRC Research Ethics Board). Re-consenting of participants will be required for projects that present additional risks related to COVID-19.
  4. Current NRC REB-approved protocols: Research with human participants that was temporarily suspended due to the COVID-19 pandemic cannot be re-initiated until the research ethics protocol is revised to comply with the relevant public health guidelines. The revisions must outline the new extent of risk to participants and what specific modifications are being proposed, including procedures to re-consent participants. All COVID-19-related revisions, as well as any proposed changes to the recruitment, data collection, informed consent processes, and other study procedures, must be reviewed and approved by the NRC REB before they can be implemented. Revisions to existing protocols must be indicated by completing and submitting NRC REB COVID-19 Addendum form available through the NRC Research Ethics Board and include the revised Part 2 and consent forms.
  5. New protocols requiring NRC REB approval: Researchers submitting new protocols for review by the NRC REB must include in the ethics application (Part 2 Form) and consent form the special considerations and procedures that are required to protect the safety and health of research participants. New ethics applications must be accompanied by the completed NRC REB COVID-19 Addendum form available through the NRC Research Ethics Board.
  6. IRAP attestations: IRAP-funded studies that are attested by an IRAP Human Ethics Industrial Technology Advisor (HE ITA) will proceed according to the usual NRC REB process. The NRC REB will not require additional COVID-19 measures beyond the primary REB requirements. In the event that the primary REB requires special COVID-19 measures, this documentation must be submitted as part of the attestation process.
  7. Research related to COVID-19: It is important that researchers planning to undertake research with human participants related to the COVID-19 pandemic contact the NRC REB at the study planning stage in order to discuss special considerations and options for expedited review.

Learn more about the NRC's commitment to high ethical standards in research involving humans and get details about the policies and standards of the NRC Research Ethics Board, which reviews all NRC research involving human participants for approval.

 

Policies and processes

Advisory Statement on Human Ethics in Artificial Intelligence and Big Data Research

Ethical principles the NRC follows when reviewing research driven by big data and artificial intelligence applications

Criteria for review

Criteria guiding review of applications for ethics approval of projects that involve human participants

Guidance on completing applications and forms

Information about applying for ethics approval to an NRC research ethics board

NRC policy for research involving human participants

About the NRC's commitment to excellence in ethics and respect for human dignity in research

Research Ethics Board

About the board

Overview of the NRC Research Ethics Board, meeting schedule, membership

Standard Operating Procedures

Procedures that support the work of the NRC Research Ethics Board