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Health Professionals - Research

Research

Living with COVID 19: Guide to research operations at Alert Level 3

Auckland DHB is committed to its programme of research and the viability of active studies. COVID-19 research guidelines will continue to be updated as information becomes available. Play it safe, continue to do everything you can to reduce the risk of COVID-19 when conducting research.

This document is evolving and will not cover all possible scenarios.

Document control – Version 4

Author: Mary-Anne Woodnorth, Auckland DHB Research Office

Approval: Auckland DHB on _01/11/2021__

Using Telehealth and mitigations for outpatient research

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 product to participant’s 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.

Using hospital facilities for research at low alert levels

Auckland DHB staff

This guidance does not take precedence over other organisational COVID-19 rules. Staff of Auckland DHB must comply with all relevant Auckland DHB COVID-19 guidelines when carrying out their research work.

As 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.

FACE to FACE outpatient research appointments

Outpatient research clinic appointments can proceed with appropriate use of PPE. Patients coming to an Auckland DHB facility for an outpatient research appointment are able to bring a support person with them. Support persons will be classed as visitors and must access hospital buildings via the visitors’ pathway (see above).

Research participants and their support persons presenting to an Auckland DHB 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 Auckland DHB.

  • Research participants and support persons who are NOT possible, suspect, probable or confirmed cases or close contacts can proceed with their research visit as planned.
  • Research participants who are possible, suspect, probable or confirmed cases should have their research visit deferred. It will be at the discretion of the principal investigator as to whether the participant may remain on study with mitigations (see Enrolled participants who contract COVID-19).
  • 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.

Non-Auckland DHB research personnel (monitors, sponsors’ representatives, research students)

Non-Auckland DHB research personnel who have had two doses of COVID-19 vaccine may access DHB facilities for research-related appointments but via the visitors’ pathway with screening at the hospital entrance. Masks must be worn at all times while on our campuses.

Non-Auckland DHB research personnel must not access hospital facilities if unwell. Anyone who has cold, flu or Covid symptoms must get a Covid test. Those who test positive for COVID-19 may only resume accessing hospital facilities when they have Public Health clearance from self-isolation. In addition the Auckland DHB research team must obtain clearance for the person from Occupational Health. Non-Auckland DHB research personnel who test negative can access the hospital 24 hours after their symptoms have resolved.

Access for non-Auckland DHB research personnel is limited to non-clinical areas (NOT wards, operating rooms, emergency departments, clinics or laboratories). Access to clinical areas will only be permitted on a case by case basis by application to the Research Office (researchoffice@adhb.govt.nz). Applications must be made by an Auckland DHB staff member supervising the research activity. Apply well in advance of requiring the access.

Non-Auckland DHB research personnel should go directly to the area they will be working in. Auckland DHB staff supervising the visit should organise a QR code for the area and ensure the visitor scans in when they arrive. There must be only one visitor at a time in the area and the Auckland DHB team supervising the research should keep a log of visitors including arrival and departure times. Visitors must maintain physical distancing from Auckland DHB personnel who are not involved with the research and not enter common spaces such as break rooms and kitchens.

COVID-19 patients in studies

COVID-19 patients in our hospitals may be enrolled in studies if appropriate precautions are taken.

Written informed consent

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 managed. Any study which proposes to enrol in-patients with COVID-19 in a study which requires written consent should submit their consent plans to the Research Office, which will organise liaison with infection control regarding the appropriate balance of risks.

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”).

Enrolled participants who contract COVID-19

Study participants who test positive with 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 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 product, and other mitigations.

COVID-19 and research ethics

All research conducted during COVID-19 alert levels must be consistent with the national ethical standards, as at any other time (https://neac.health.govt.nz/publications-and-resources/neac-publications/national-ethical-standards-health-and-disability). 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