Guidelines for Research Involving Participants

Introduction

  • Participant Studies – Research involving human participants
  • Applies to all researchers and research activities, across all disciplines/Colleges, involving research participants.   
  • 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. 
  • In general, compiling/drafting Covid-19 Response Plan (CRP) Documentation for participant studies research will be the responsibility of the PIs and the Unit Research Manager(s)/authorised person within the Research Unit. 

General Guidelines

  • All Participant Research studiesrequire approval of your Covid-19 Response Plan (CRP) Documentationthis includes any updates to your previously approved Participant Study CRP, 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 Participant Research. 
  • Where Participant Research (CRP Documentation) has been previously approved, as these are living documents your CRPs and Risk Assessments will/may require updating as necessary: changes to the CRP and Risk Assessment; changes to the investigational site (or adding a new one); change in research personnel; recruiting new participants etc. 

    National Covid-19 Level 5 Restrictions: 

  • In addition to approved CRP Documentationresearchers (PIs) must complete a Justification for Continuation of Essential Research during Level 5 Restrictions 2021 form (see Research Continuity Further Guidelines & Templatesto obtain prior approval. 
  • Additional approval may be required by the Head of College for studies involving participants – this additional/further approval is at the discretion of the Head of College (see RBCT Research Continuity Approval & Reporting Processes).

    National Covid-19 Levels 1-5 (all) Restrictions

  • National Covid-19 Levels 1-5 (all) Restrictions (see RBCT Research Continuity Approval & Reporting Processes)  
  • Where the approving person (Head of School/RICU, or where delegated Head of Department/equivalent) is directly involved in the Participant Study, approval is required from the Head of College. 

   Travel

CRP Documentation Guidelines for Participant Studies

  • The Ethics webpages provide further Guidance on the Ethics of research conducted in UCC in light of the Covid-19 pandemic* 
  • Refer to Guidelines for Access to Research Facilities. 
  • In addition, to the details required for CRP Documentation (including CRPs and Risk Assessments), that are outlined in the Guidelines for Access to Research FacilitiesCRPs involving participants should follow the templates for research involving participants (Research at Interface with Society, Volunteers on Campus) CRPs, which can be accessed at Research Continuity Further Guidelines & Templates, and they should detail the following: 
  • A Statement of Assurance and/or, if necessary, a Letter of Assurance from the Head of School/RICU to the Head of College 
  • The relevant Ethics Committee Letter of Approval (*see above). 
  • A Policy Statement 
  • The investigational site 
  • Detail persons of responsibility for the Participant Study 
  • Detail of researchers undertaking the Research and what they will be doing/their role. 
  • Overview of the Study 
  • Detail where and how the participant interaction will occur 
  • Detail the number of and how participants are recruited 
  • If applicable, scheduling/managing participant access 
  • If applicable, detail how and where face-to-face interviews are being conducted, and how and where biological samples, physiological measurements are being obtained and in the case of biological samples how they are being transported/collected. 
  • Face-to-face interviews: these should be avoided if at all possible and conducted remotely. If face-to-face interviews are necessary, such interviews are best conducted in the open, with social distancing in place, interview time is kept to a minimum and facemasks should be worn. 
  • Relevant SOPs (Standard Operating Procedures). 
  • Reference to mandatory training (including  Covid-19 Induction Training for researchers) and the mandatory Return to Work Form prior to undertaking the research. 
  • Any other relevant training for researchers (e.g. HSELand, infection control, applicable specialised techniques e.g. obtaining biological samples etc).

And/Or

  • An Occupancy Log, where researchers are accessing Campus/hospital-based research facilities
  • system to log the engagement/activity of named researchers undertaking community-based research, for instance the date/detail of the named researcher travelling to named investigation site to undertake named study. 
  • Covid-19 Infection Control Measures – relating to all aspects of the research undertaken. 
  • Protocols in place for what to do if a researcher develops Covid-19 symptoms while out engaging in Participant Research in the community and/or at an investigational site on/off Campus (e.g. hospital-based research). See CBCT Preparing for and dealing with a suspected case of Covid 19. 
  • Risk Assessment for your study (Covid-19 Risk Assessment Guide & Risk Assessment Template). 
  • Travel considerations if applicable 
    • Domestic Travel:
      • In drafting CRPs, researchers need to be aware of national guidelines for essential travel to work. Also see template for research involving participants accessed at , for domestic travel considerations to apply as appropriate when drafting the CRP.
      • Ensure a Travel to Work/Study Letter is available to the researcher undertaking domestic travel for work if/as required. 
    • International Travel: 
      • Prior approval by Head of School/RICU AND the Head of College is required.
      • In drafting the CRP, researchers must be cognisant of current governmental guidelines for essential international travel at https://www.dfa.ie/travel/travel-advice/coronavirus/
      • Also see Travel Guidelines for Researchers, accessed at 
      • A Letter of Assurance from Head of School/RICU to the Head of College is required along with the Covid-19 Response Plan and Risk Assessment. 
      • In drafting the Covid-19 Response Plan, researchers must be aware of the following: 
        • Local restrictions/guidelines in place at the destination they are travelling to at the time, and over the period of their stay.
        • Quarantine, Covid-19 testing and documentation requirements (including the researcher's return to Ireland).
        • Measures in place to address situations where a researcher may contract Covid-19 whilst abraod.
        • Insurance requirements.

 

Research at the Interface with Society

  • Use the Template for CRP – Research at the Interface with Society (accessed at Research Continuity Links Guidelines & Templates) to draft/update your response plan. 
  • In addition to the details given in the CRP Documentation Guidelines for Participant Studies (outlined above) the Research at the Interface with Society CRP should include the additional points as necessary: 
  • Letter of Assurance from Clinical Lead (if study is being undertaken in a medical/hospital facility and/or is of a clinical nature). 
  • Letter of Assurance from the Head of School/RICU to the Head of College if required (template accessed at Research Continuity Further Guidelines & Templates). 
  • 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, as per indicated in the Template for CRP – Research at the Interface with Society (accessed at Research Continuity Further Guidelines & Templates). 

Research with Volunteers on Campus

Additional Links

For additional information, see the following: 

Research and Innovation

Taighde agus Nuálaíocht

Office of Vice President for Research & Innovation 4th Floor Block E, Food Science Building UCC

Top