Document control – Version 6
Author: Mary-Anne Woodnorth, Research Office
Approval: Te Whatu Ora | Te Toka Tumai Auckland on _06/07/2022__
Conducting research away from our facilities helps to minimise interpersonal contact as we continue to respond to COVID-19, and reduces the cost of travel for our patients. Our research teams have told us that mitigations put in place to obviate hospital research visits during lockdown were appreciated by participants as efforts to keep them safe.
When it's appropriate and clinically safe, we encourage research teams to carry out more patient appointments by phone or video conference, to courier investigational products to participants’ dwellings or dispense from community pharmacies, and use community laboratories for sample collection.
Researchers in the hospital and community are asked to reconsider or reduce the frequency of laboratory tests that are non-essential, discretionary, routine or could be delayed.
This guidance does not take precedence over other organisational COVID-19 rules. Staff must comply with all relevant COVID-19 guidelines when carrying out their research work.
As a responsibility to carry out study procedures may have to be assigned to another research team member if one is stood down due to COVID-19 it is recommended that all research teams review their delegation logs to ensure study continuity.
Outpatient research clinic appointments can proceed. Patients coming to our campuses for an outpatient research appointment are able to bring two support people with them. On arrival, the support people must be provided with a mask and given information to help keep everyone safe.
Research participants and their support persons presenting to a Te Whatu Ora | Te Toka Tumai Auckland facility should be screened for COVID-19 using the current screening tool.
When a research visit will be conducted outside a routine clinical appointment, the screening MUST be conducted by a member of the research team who is employed by Te Whatu Ora | Te Toka Tumai Auckland.
In very limited circumstances if it would be clinically unsafe for a participant to not complete their research visit as planned and if it is feasible for them to be managed with transmission-based precautions, high-risk participants may proceed with their research visit. Any study which proposes to accommodate outpatient research visits with probable, suspected or possible COVID-19 participants must submit their consent plans to the Research Office, which will organise liaison with infection control regarding the appropriate balance of risks.
Visits by non-Te Whatu Ora | Te Toka Tumai Auckland research personnel must evolve to accommodate public health regulations around social distancing. Having in-person research visits increases the risk of COVID-19 transmission. If remote meetings can be delivered these should be supported.
When in-person visits are the only viable option the Te Whatu Ora | Te Toka Tumai Auckland investigator or clinical supervisor should complete the Training, meetings and other events COVID-19 risk management plan available from Hippo.
Visitors should be informed prior to their accessing our facilities that they should stay home if they have any symptoms or if they have been asked to isolate by Public Health.
Visitors must have as a minimum double vaccination status. Accurate records of attendance must be kept including contact details. Physical distancing requirements in line with MoH guidelines must be adhered to. Masks must be worn at all times.
Non-Te Whatu Ora | Te Toka Tumai Auckland research personnel should go directly to the area they will be working. Staff supervising the visit should organise a QR code for the area and ensure the visitor scans in when they arrive.
COVID-19 patients in our hospitals may be enrolled in studies if appropriate precautions are taken.
COVID-19 does not release researchers from their obligation to obtain written informed consent when this is stipulated in the study protocol but the risk of transmission through close proximity of researchers must be appropriately managed.
Alternatives to traditional written consent that give effect to the Code of Right’s requirement (Section 7.6[1]) for “written informed consent for research” (e.g. photo of signed forms which remain in the room, e-signatures, recorded verbal statements etc.) may be used if researchers can defend their use as “reasonable in the circumstances” (as per Section 3 of the Code: “A provider is not in breach of this Code if the provider has taken reasonable actions in the circumstances to give effect to the rights, and comply with the duties, in this Code”).
Study participants who test positive for COVID-19 during the period of their enrolment may remain on study at the discretion of the local principal investigator but will not be permitted to access hospital facilities unless as in-patients. Therefore in addition to clinical decision-making about the participant’s best interest, the PI must also give full consideration as to whether it will be feasible to maintain the participant on study remotely. This may be achieved with telehealth visits, courier or community-dispensed investigational products, and other mitigations.
All research conducted during COVID-19 alert levels must be consistent with the national ethical standards(), as at any other time. For all research approved by a Health and Disability Ethics Committee (HDEC) or due to be reviewed by an HDEC, researchers should ensure they are aware of HDEC’s most up-to-date COVID-19 guidance and operating procedures.
Usually, to resume an HDEC-approved study after a temporary halt requires that an amendment is first submitted for review by the HDEC. For studies seeking to resume after lockdown, this is not necessary as long as those studies will be resuming according to the previously approved protocol.
[1] The HDC Code of Health and Disability Services Consumers' Rights
Regulation 1996.
