Research Studies Involving Human Participants – What should a participant be informed of before consenting?: Thursday, 15 June, 12:00 – 13:30

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Research Studies Involving Human Participants – What should a participant be informed of before consenting?

Day/Date/Time: Thursday, 15 June, 12.00 – 13.30

Location: Zoom

Capacity: 40 people

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Facilitator: Dr Seán Lacey, SLÁINTE Research Group, Munster Technological University
Bio: Dr Seán Lacey is the Research Integrity & Compliance Officer (RICO) in Munster Technological University (MTU). Previous to this appointment Dr Lacey was the Senior Lecturer in the Department of Mathematics, MTU. As MTU’s RICO, Dr Lacey has responsibility for fostering a research environment that promotes the responsible conduct of research which maintains the highest standards of integrity, along with leading the development, implementation and review of MTU’s research related policies and procedures.  Furthermore, Dr Lacey is required to ensure that MTU’s research training includes adequate coverage of the importance of research integrity, promotes responsible conduct of research, discourages research misconduct, and makes all stakeholders aware of the consequences of same. Dr Lacey is also Chairperson of MTU’s Research Council.

Dr Lacey has worked as lead statistician on numerous clinical trial studies and real word data studies.  These studies were wide reaching and varied and involved, for example: Creating randomisation schedules; Powering studies; Outlining a Statistical Analysis Plan (SAP); Compiling a detailed statistical report on a study’s findings and Clinical Study Report (CSR).  Dr Lacey has been lead statistician on over 35 industrial collaborative studies, designed and delivered over 70 Continuing Professional Development workshops, and is a co-author on over 30 peer-reviewed research publications.

In collaboration with Dr Fiona O’Halloran, Department of Biological Sciences (MTU) and Dr Mohammed Hasanuzzaman, Department of Computer Science (MTU), Dr Lacey is co-lead of SLÁINTE – Strategic Launch of research resources And Infrastructure for Novel clinical decision support Tools and data analytics Expertise – a research group sponsored by the Higher Education Authority Technological University Transformation Fund and MTU, with the aim of developing novel research tools and resources to support healthcare services, promoting health and well-being.

Outline: Informing participants of the appropriate information prior to consenting to participate in a research study is a core principle of ethical and good research practice.  As researchers, it is vital to fully understand the components to not only research ethics application forms but also the level of detail required in information leaflets and associated forms that participants base their consent on. Use of information gathered beyond what was consented to is potentially a case of research misconduct.

This seminar will provide an exploration of information leaflets and consent forms including matters ranging from, but not limited to, anonymisation, risk, debriefing, right to withdraw, dissemination and data management.

During the seminar, Seán will be joined by a medical scientist that has gone through the process of applying for ethical approval for a research study involving human participants, who will speak to their experiences of the process.

The seminar should be of interest to members carrying out research studies involving human participants including, but not limited to:

  • Data collection using research methods such as questionnaires, web surveys, interviews, observations, focus groups, etc.
  • Access to, or utilisation of, anonymised datasets or case files/records concerning identifiable individuals.

Conducting internet mediated research

Start Date - End Date

Jun 15, 2023 - Jun 15, 2023

Start Time - End Time

12:00 am - 1:30 pm


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