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An Introduction to Clinical Research$
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Piers Page, James Carr, William Eardley, David Chadwick, and Keith Porter

Print publication date: 2011

Print ISBN-13: 9780199570072

Published to Oxford Scholarship Online: November 2020

DOI: 10.1093/oso/9780199570072.001.0001

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PRINTED FROM OXFORD SCHOLARSHIP ONLINE (oxford.universitypressscholarship.com). (c) Copyright Oxford University Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in OSO for personal use. date: 17 June 2021

Data collection and research conduct issues

Data collection and research conduct issues

Chapter:
(p.133) Chapter 7 Data collection and research conduct issues
Source:
An Introduction to Clinical Research
Author(s):

Piers Page

Publisher:
Oxford University Press
DOI:10.1093/oso/9780199570072.003.0012

A large proportion of this chapter is common sense. We’ll start with the most basic of all—looking after your participants. You have a clear legal, ethical, and procedural duty to do this and events such as Alder Hey demonstrate what happens when the academic good is held to be of higher priority than this. By definition, any participant enrolling in your study is vulnerable, simply by means of a doctor–patient relationship (and a scientist – patient or nurse – patient dynamic can be every bit as uneven). If participants are perfectly physically and mentally well, they are still letting you intrude into their world for the sake of research; in pathological research, of course, patients may be far from well. Take the time to talk to participants, even if they are only giving a few cc’s of blood for a lab project. Was it easy to find you? Do they have any further questions? Was there anything about their encounter they felt could have been better? At the next level, observational studies have potential to create a degree of symptom awareness, so the participant looks harder and harder for a symptom you’ve asked if they have. This can be very hard for them to deal with and they may need reassurance. Your patient information leaflet should have a contact number for your study; larger, well-funded studies sometimes even have on-call clinically trained cover for advice and reassurance. At the highest level, although you won’t be responsible for this in your first foray into research, clinical trials have rigorous requirements for patient and clinician support. Patients will generally carry some kind of identification card with a 24-hour contact number on it, to ensure that advice is available to them or someone treating them whenever it is required. Any kind of adverse clinical event must be reported to the appropriate bodies. Drug reactions must be notifi ed to the Medicines and Healthcare Regulator Agency, in addition to your local R&D department. Any other form of harm, including allegations of it, should be discussed with R&D.

Keywords:   changes to study, data protection, memory sticks, misconduct

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