Guidelines for Human-Focused Research

General Guidance

  • Applies to all researchers and research activities involved in human-focused research across all disciplines/colleges.
  • Human-Focused Research relates to the following activities:
    • Research at Interface with Society - an investigational site off-campus, including community-based activities (e.g. face-to-face interviews, collecting samples/measurements from a participant’s home/off campus site, and hospital-based research).
    • Research with Volunteers on Campus – volunteers accessing campus research facilities for a specific research study.
  • To draft Covid-19 Response Plans, there are two separate templates for both kinds of human-focused research: see Template for Research at the Interface with Society or Template for Volunteers-on-Campus, both available at Templates and Resources for Research Continuity.
  • In general, compiling/drafting Covid-19 Response Plan documentation for human-focused research will be the responsibility of the PIs and the Unit Research Manager(s)/authorised person within the Research Unit. Post-doctoral researchers may also be involved in drafting/contributing to the necessary documentation.
  • All human-focused research studies, require approval of the Covid-19 Response Plan documentation (this includes any updates to previously approved human-focused studies), prior to researchers undertaking this work.
    • Prior approval by Head of School/RICU, or where delegated the Head of Department/equivalent is required for all researchers to undertake human-focused research, see Research Continuity Approval & Reporting Processes.
    • In some instances, additional approval by the Head of College may be required:
      • Research involving >1 School
      • Researchers travel to/from abroad involving countries outside the EU + Iceland, Liechtenstein, Norway, Switzerland –see DFA General Covid-19 Travel Advisory in Operation
      • Where the approver (Unit Head) is the PI or is directly involved in the research.
      • Any other cases deemed necessary by the Head of College (see recommendations for Face-to-face interview below.
  • The Covid-19 Response Plan documentation required for human-focused research must include the following:
  • Where a study (Covid-19 documentation for human-focused research) has been approved previously, as these are living documents, these will/may require updating as necessary. Instances where documentation should be updated and resubmitted for approval include the following:
    • Changes to the Covid-19 Response Plan and/or Risk Assessment;
    • Changes to the investigational site (or adding a new one);
    • Change in research personnel;
    • Recruiting new participants etc.
  • Covid-19 Response Plans for human-focused studies must pay due consideration to the safety of both members of the public (study participants) and researchers
    • Pre-study symptom checks for research participants
    • For volunteers on campus, a Volunteer Declaration Form must be completed by the participant on arrival at the research facility on campus. A template form is available at Templates and Resources for Research Continuity.
    • Scheduling of research participants must be managed to avoid congregation and ensure compliance with social distancing requirements, along with due consideration of access/egress and circulation routes.
    • Preparing for and dealing with a suspected case of Covid-19 both on and off campus must be planned for. Consideration for both researchers and participants must be detailed in the Covid-19 Response Plan documentation.
    • Face-masks must be worn by participants and researchers, along with any other relevant PPE, as necessary (also see advice on Face-to-face interview).
    • Extra vigiliance must be implemented regarding Covid-19 Infection Control Measures
  • Face-to-face interview- see below for further details.

Guidance on Response Plan Content for human-focused research: Coversheet/introduction

  • Name & reference ID of study
  • Include the name/s and location/s of the investigational site/s.
  • The revision number of the Covid-19 Response Plan (ie Revision 1/2/3 etc.)
  • The name of the responsible UCC Dept/Research Unit
  • Name of the PI for the study.
  • The name, signature of the authorised approving person - Head of School/RICU, or where delegated the Head of Department/equivalent, and in some cases the Head of College, as outlined in Research Continuity Approval & Reporting Processes.
  • Name of the Clinical Lead, if appropriate (*Research at the Interface with Society only).
  • The author/s of the Covid-19 Response Plan
  • Details of Covid-19 Response Team and Persons of Responsibility
  • Contents (list contents of the Covid-19 Response Plan, and associated documentation).
  • A Signed Statement of Assurance from the approving person -  Head of School/RICU/Department
  • A Policy Statement (see Templates and Resources for Research Continuity).

Key Associated Documents

  • COVID-19 Risk Assessment
  • Ethics Approval: CREC or SREC Signed Letter of Approval
  • (*Research at the Interface with Society only) An Occupancy Log where researchers are accessing UCC hospital-based research facilities OR system to log the engagement/activity of named researchers undertaking community-based research, for instance the date/detail of the named researcher travelling to a named investigation site to undertake named study.
  • (*Research at the Interface with Society only) Letter of Assurance from Clinical Lead (if study is being undertaken in a medical/hospital facility and/or is of a clinical nature).
  • Details regarding insurance to undertake the research as appropriate.

Guidance on Response Plan Content for human-focused research: Main Body

All content of the main body of a Covid-19 Response Plan for a human-focused study should be detailed/updated in accordance with  the Template for Covid-19 Response Plan for Research at Interface with Society or the Template for Covid-19 Response Plan for Volunteers-on-Campus, both available at Templates and Resources for Research Continuity

 

The main body of the Covid-19 Response Plan for human-focused studies should include the following details, which should be updated to reflect changes in National/Institutional Policies & Guidance.

  • Study Research Personnel
    • A table providing details of key persons involved in the study, their role, contact details and any other relevant information in relation to their role e.g. training they may have undertaken that is relevant to implementing Covid-19 infection control measures.
  • Overview of Study and Covid-19 Measures
    • Summarise what is the study about, aims of the study, study objectives
    • Funding and timeframe for the Study
    • Outline the study requirements in terms of the time-frame involved. 
    • How will volunteers will be recruited and how many volunteers you intend to recruit?
    • Relevant demographics of volunteers (age, underlying health condition)
    • List research activities involving the participants, e.g. measurements, what biological samples you are taking, what these methods involve – particularly outlining areas where there is a risk of cross-infection between researchers/volunteers including conducting Face-to-face interviews.
    • In detailing an overview of the study, provide an overall summary of the following measures:
      • Cross-infection protocols: Refer to SOPs, Risk Assessment and sections of the document where Covid-19 cross-infections measures will be/are addressed. Bullet point a brief summary outlining cross-infection protocols such as circulation of volunteers accessing building, equipment, PPE, social distancing, hand sanitizing, measurements, taking biological samples. List the relevant SOPs.
      • The number of staff members interacting with participants will be kept to a minimum: Refer to refer to relevant SOPs, Risk Assessment and sections of this document outlining , only the researchers and the participant will be present in e.g. the study room/site, that participants will be asked to attend the appointment on their own, and  the researcher will escort the participant into and out of the building before and after their research visit in order to minimise movement around the building and potential interaction with other members of staff. 
      • Management of scheduling participant study visits and recording their access to the study site. Detail what processes are in place to minimise the number of participants at the investigational site, how you will log their attendance and manage scheduling study visit appointments.
      • Face-to-face interviews: If applicable, detail measures in place regarding social distancing, infection control measures and ventilation that will be in place at the investigational site.
      • (*Research at the Interface with Society only) Hospital-based studies (if applicable): 
        • Details on how participants are recruited, e.g. they may be patients accessing a clinic for a follow-up appointment.
        • If undertaking hospital/clinic-based research or research at a community- based facility, reference must be made to local policies.
      • (*Research at the Interface with Society only) Community-based studies (if applicable): Reference must be made to local policies at a comunity based facility as necessary.
  • Covid-19 Measures-Researchers
  • Dealing with a Suspected COVID-19 Case – Researchers
  • Covid-19 Measures-Research Participants
  • Dealing with a Suspected Case of Covid-19  - Research Participants
  • Study Procedures (Standard Operating Procedures (SOPs))

Appendices

  • Map of building/area detailing (with arrows) access/egress, circulation/footfall of volunteers around building, isolation room, hand hygiene facilities. For UCC hospital-based research facilities (e.g. CUH), include a map of building/area detailing (with arrows) access/egress, circulation/footfall of UCC researchers around building, location of isolation room.
  • Template for Covid-19 Health Questionnaire for study participants
  • Template for Volunteer Declaration (*Volunteer-on Campus Study only), see Templates and Resources for Research Continuity.
  • Standard Operating Procedures (SOPS) – these are the SOPs which you need to refer to in the main text and RR. You will need to highlight the content of these documents which are directly relevant to cross-infection measures outlined in the main body of the Response Plan and the Risk Register. Relevant SOPs need to be updated to include Covid-19 Cross-Infection Measures

 

 

 

Research at the Interface with Society

Research at the Interface with Society can include

  • Hospital-based research involving patients 
  • Community-based research e.g. where the investigational site may be in a community-based facility
  • Face-to-Face interviews out in the community

The Covid-19 Response Plan for Research at the Interface with Society should be tailored and adapted to suit the specifics of the research study, see template available at Templates and Resources for Research Continuity.

To complete the Covid-19 Response Plan for Research at the Interface with Society, see the sections above on this page Guidance for Covid-19 Response Plan Documentation for Human-Focused Research and the General Guidance for human-focused research.

Additional key points to note for the Covid-19 Response Plan for Research at the Interface with Society:

  • For hospital/clinical-focused studies include the name of the Clinical Lead, if appropriate and Letter of Assurance from Clinical Lead (if study is being undertaken in a medical/hospital facility and/or is of a clinical nature).
  • An Occupancy Log where researchers are accessing UCC hospital-based research facilities OR system to log the engagement/activity of named researchers undertaking community-based research, for instance the date/detail of the named researcher travelling to a named investigation site to undertake named study.
  • Hospital-based studies (if applicable):
    • The researcher will escort the participant into and out of the building before and after their research visit in order to minimise movement around the building and potential interaction with other members of staff. 
    • Details on how participants are recruited, e.g. they may be patients accessing a clinic for a follow-up appointment.
  • If undertaking hospital/clinic-based research or research at a community- based facility, reference must be made to local policies.
  • Travel: If travel is required to undertake the study, details should be provided in the Covid-19 Response Plan and should detail the applicable information provided in the Research Continuity Guidelines for Travel for Research.
    • For work-related travel and/or work in community settings, researchers should also consult with the national Work Safely Protocol

 

Volunteers-on-Campus

Volunteers-on-Campus studies involve research participants attending UCC research facilities on campus for study visits.

The Covid-19 Response Plan for Volunteers-on-Campus tailored and adapted to suit the specifics of the research study, see template available at Templates and Resources for Research Continuity, as well as the sections above General GuidanceResponse Plan for Human-Focused Study: Guidance on Content -Coversheet/intro and Guidance on Response Plan Content for human-focused research: Main Body.

 Key points to note for the Covid-19 Response Plan for Volunteers-on-Campus:

  • Link this Covid-19 Response plan to the Covid-19 Response Plan for Access to Research Facilities/Buildings.
  • Detail what processes are in place to minimise the number of volunteers on site, how you will log their attendance and manage scheduling study visit appointments.
  • Participants should complete a Volunteer Declaration Form for each study visit, and a template for this form should be included in the Appendices, see template at Templates and Resources for Research Continuity.

Face-to-face interviews

  • Applies to both Research at Interface with Society (human-focused studies off campus) and Volunteers-on-Campus studies.
  • Researchers should consult with guidance on work in community settings given in the national Work Safely Protocol
  • Face-to-face interviews are permitted, with prior approval and appropriate Covid-19 infection control measures.
  • Prior approval is required by the Head of School/RICU Director; Additional Approval from the Head of College may be required in the following instances (see Research Continuity Approval & Reporting Processes):
    • In the case where masks cannot be worn by interviewer/interviewee (see below*)
    • If research involving face-to-face interviews is being conducted in a different country.
      • Reserchers must detail in their Covid-19 Response Plan and adhere to Covid-19 policies in the jurisdiction to which they are travelling to and where interviews will be taking place.
      • Also see Guidelines for Travel for Research
    • The advice/recommendation is that for the above cases the Head of School/RICU consults with the Head of College to establish if further approval is required at college level.
  • The interviewer and interviewee must be compliant with 2m social distancing.
  • Interviews should take place either outdoors (weather/suitability permitting), or if indoors in a sufficiently sized room. The room should be well-ventilated and should be able to facilitate 2m social distancing.
  • Covid-19 infection control measures must be adhered to, including a handsanitiser must be available in the interview room. Common touch points must be sanitised with 70% ethanol before/after each interview.
  • For contact tracing purposes the attendance of interviewees must be logged e.g. sign in/out log – a recording system must be detailed in the Covid-19 Response Plan. Date/ Time/ Name/Contact Number of interviewees should be logged for contact tracing purposes If a paper log in log out system is used Covid-19 infection control measures must be taken/ adhered to and detailed in the response plan and risk assessment
  • Candidates should be escorted to/from the interview by the researcher/staff, with clear routes of access/egress mapped in the building plan, see Template Covid-19 Response Plan-Research at Interface with Society or Template Covid-19 Response Plan-Volunteers on Campus, available at Templates and Resources for Research Continuity
  • Before the interview/study visit, candidates should complete a pre-study visit Covid 19 questionnaire (this should be drafted by the researcher and a template should be given in the appendices – see Template Covid-19 Response Plan-Research at Interface with Society or Template Covid-19 Response Plan-Volunteers on Campus, available at Templates & Resources for Researchers).
  • For Volunteers on Campus studies, volunteers are required to complete a Self-Declaration form, see template when they arrive on campus, see .
  • *Face-masks
    • In general, candidates should use their own face mask/covering unless it is a requirement in certain settings such as a clinical setting, ie in certain settings the researcher may have to provide the candidate with an appropriate face-mask. Where a face-mask is being provided by the researcher, this should be given to the candidate on arrival, and disposed of appropriately before leaving the premesis (see point below on disposal).   
    • Candidates (and researchers) must wear facemasks at all times when circulating the building, such as corridors, foyers, stairs etc.
    • During the interview, the interviewer and interviewee should wear facemasks if at all possible. However, for interviews this may not always be practical/possible. *If wearing of facemasks is not feasible during the interview (for instance it may hamper the interview if the interviewer cannot hear the interviewee responses),  the following measures are advised:
      • The rationale and justification why face masks cannot be worn during the interview - detail as necessary in the Covid-19 Response Plan.
      • Adhere and implement Covid-19 infection control measures, ventilation and 2m social distancing - outline in detail in  the response  (in the response plan and risk assessment; consideration may be given to additional measures such as a screen for instance, if reasonably practicable).
      • As with all research activities, including face-to-face interviews, prior approval is required from the Head of School/RICU Director - where face masks are not going to be worn, the recommendation is to consult with the Head of College to ascertain if additional approval is required at college level.
  • Interviews should be such that they are conducted in a short a time frame as possible; this may require more than one interview with a given interviewee.
  • Scheduling of interviewees should be implemented as follows:
    • Extra time should be factored in to scheduling interviews.
    • Waiting time for a candidate to enter the interview room must be avoided/kept to an absolute minimum.
    • Candidates do not meet one another while waiting.
    • Candidates should be asked to attend only at the appointed time, so that they can be brought directly to the interview room.
    • Allow sufficient time for cleaning of surfaces with 70% alcohol between interviews; common touch areas should be cleaned between (before/after each interview), this includes cleaning of toilets if the candidate has required their use during the study visit.
  • Preparing for and dealing with a suspected case of Covid-19, for researcher/interviewer and interviwee, must be planned for and detailed in the response plan see Template Covid-19 Response Plan-Research at Interface with Society or Template Covid-19 Response Plan-Volunteers on Campus, available at .
  • All disposable items must be disposed of in a manner which is fully compliant with Covid-19 Infection Control measures, and a protocol for disposing of items must be detailed in the Covid-19 Response Plan .

 

Research and Innovation

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