Informed Consent in Clinical Trials

Lydia’s PhD project aims to further our understanding of informed consent and identify how emerging technologies including electronic consent may be used to streamline clinical trials. This project will include a comprehensive review of the current evidence with regard to both the effectiveness and challenges in informed consent, including quality of informed consent. The consent processes across ongoing clinical research studies will be evaluated, incorporating the perspectives of patients and staff. Strategies to improve the consent process, particularly the use of technology, will be identified. Finally, a study within a trial will be designed to evaluate impact of technology on improve the quality of informed consent.

Lydia has worked as a Clinical Trial Coordinator and a Clinical Research Associate and holds a BSc in Radiation Therapy and a post graduate diploma in Radiotherapy and Oncology.

Lydia studied under the supervison of Prof Peter Doran and Dr Rachel Crowley (both UCD School of Medicine) and Prof Éilish McAuliffe (UCD School of Nursing, Midwifery and Health Systems).

Update: Dr Lydia O’ Sullivan successfully defended her PhD thesis in March 2022.

Publications

PUBLICATION 1

2020

O’Sullivan L, Killeen RP, Doran P and Crowley RK.
Ethical Considerations for safeguarding human participants in pandemic research: a rapid review protocol
HRB Open Res 2020, 3:22
CLICK HERE TO ACCESS
PUBLICATION 4

2020

Leddy L, Sukumar P, O’Sullivan L, Keane F, Devane D, Doran P.
An investigation into the factors affecting investigator-initiated trial start-up in Ireland
Trials 2020, 23:21(1):962
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PUBLICATION 2

2020

O’Sullivan L, Sukumar P, Crowley R, McAuliffe E, Doran P.
Readability and understandability of clinical research patient information leaflets and consent forms in Ireland and the UK: a retrospective quantitative analysis.
BMJ Open 2020;10:e037994. 

CLICK HERE TO ACCESS

PUBLICATION 5

2020

Zaki M, Galligan M, O’Sullivan L, Devane D, McAuliffe E.
A protocol for a systematic review investigating the factors influencing the statistical planning, design, conduct, analysis and reporting of trials
HRB Open Res. 2020, 24;3:36
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PUBLICATION 3

2020

O’Sullivan L, Crowley RK., McAuliffe E. Doran P.
Contributory factors to the evolution of the concept and practice of informed consent in clinical research: A narrative review
Contem Clin Trials Comm 2020, Vol 19
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PUBLICATION 6

2021

Coleman E, O’Sullivan L, Crowley R, Hanbidge M, Driver S, Kroll T, Kelly A, Nichol A, McCarthy O, Sukumar P, Doran P
Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference
Res Involv Engagem. 2021 May 18;7(1):31.
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PUBLICATION 7

2021

O’Sullivan L, Killeen R.P, Doran P and Crowley R.K.
Adherence with reporting of ethical standards in COVID‑19 human studies: a rapid review
BMC Med Ethics (2021) 22:80
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PUBLICATION 8

2021

O’ Sullivan L, Feeney L, Crowley R.K, Sukumar P, McAuliffe E & Doran P
An evaluation of the process of informed consent: views from research participants and staff
Trials volume 22, Article number: 544 (2021)
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PUBLICATION 9

2022

Zaki M, O’Sullivan L, Devane D, Segurado R, McAuliffe E
Factors influencing the statistical planning, design, conduct, analysis and reporting of trials in health care: A systematic review
Contemp Clin Trials Commun. 2022 29;26:100897.
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PUBLICATION 10

2022

O’Sullivan L, Savinelli S, O’Hare S, Holden S, McHugh C, Mallon P, Doran P
An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)
Trials 2022 17;23(1):50
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  • Lydia O' Sullivan
  • HRB-TMRN - UCD
  • PhD Scholar (Health Research Board - Trials Methodology Research Network) University College Dublin, Belfield, Dublin 4, Ireland
  • lydia.osullivan@ucdconnect.ie

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