Individual research projects have been and will continue to be impacted by the COVID-19 pandemic, in particular, in order to maintain the public health requirements. As public health guidance changes, often at a pace, it is important that researchers review and re-consider their research studies to ensure compliance is met.
Many researchers are now considering the (re)commencement of research with human participants. In order to do so it is important that this is considered in accordance with the principles outlined the document “Research Involving Human Participants during COVID-19 Pandemic” and the necessary risk assessments are completed and submitted within your own School/Faculty for review. As a quick point of reference, the Research Governance, Ethics and Integrity Team have detailed relevant questions below:
Q: I was to undertake focus groups/interviews with participants, given the social distancing requirements how do I complete my research?
A: The nation has been advised that individuals must practice social distancing, therefore you must consider your research and identify if there are alternative methods that can be used to complete your research. For example, telephone interviews, conducting focus groups using an on-line meeting tool, undertaking a postal or on-line survey. Remember, any amendment to the study protocol will require ethical consideration either from your Faculty/School REC. For those studies involving an NHS/HSC REC contact your Sponsor in the first instance regarding any proposed changes.
Q: How do I collect consent from my participants if I am using an on-line forum?
A: This depends on whether you are undertaking an on-line survey or whether you plan to hold a telephone interview/on-line focus group.
i: For surveys, the consent process can be captured as part of the response. Build a consent statement into the preamble at the start of your survey and make sure that it is explained that the participant can withdraw and exit at any time, however, data already collected may well be retained and used.
ii: For a telephone interview/on-line focus group consider asking participants to put an electronic signature onto the consent forms or to return the consent from via email with a confirmation that they consent in the email.
Q: I have been recruiting patients/clients from the local health and social care Trust – should I continue?
A: This is very much dependent on the capacity of individual Trusts. Given the pressures being faced by health and social care organisations, it is important that you carefully consider whether your current research may be adding an additional strain. Studies can be temporarily suspended or halted and this can be discussed with the study Sponsor.
Q: My target population are health and social care professionals, is it possible to still involve them in my research?
A: Again, this is dependent on capacity and the pressures being faced by health and social care professionals, as stated in question 3 above.
Q: What do I do if I want to amend a study that was approved by an NHS/HSC REC?
A: You need to discuss the amendment with your study sponsor, on the most part, for QUB Staff and Students this shall be the Research Governance, Ethics and Integrity Team (firstname.lastname@example.org). The Sponsor will consider and classify your amendment. Depending on whether it is a major or minor amendment you will be guided to complete the appropriate documentation and notify the relevant parties involved. Further information is available from the Health Research Authority: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/covid-19-guidance-sponsors-sites-and-researchers/
Q: I want to set up a new research study that is relevant to COVID-19 – how do I make this happen quickly?
A: Given the public health emergency that has been developing regarding COVID-19, an expedited review process is available to the Research Ethics Service and a proportionate approach can be adopted to the ethical review. Early conversations with your Research Sponsor and the Director of Approvals Services/REC Operational Manager will be able to advise and support, as required.