spacer
home > > spring 2009 > under the sheets
PUBLICATIONS


Under the Sheets

When we ask people to take part in a clinical trial, what information do they need in order to make up their minds? And after they have consented, what information would we like them to know as participants to ensure the trial runs smoothly and efficiently? Suppose the trial involves the testing of a new unlicensed medicine – would that change what we tell potential participants? Can we be sure that they will understand the days and times of their planned blood test visits? We provide the participant with written information – the ‘participant information sheet’ – so that they know about all these things. The information sheet plays an essential role in the process of obtaining consent from a participant.

The Declaration of Helsinki – first adopted in 1964 and revised several times since – lays out the requirements for recruiting participants to clinical research (1). Participants should be given written information to allow them to make an informed decision about whether or not to participate. They should also have access to a clinician when giving consent – someone who will answer their questions and provide clarification, if required.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

Dr Peter Knapp is an experienced health services researcher who has worked on aspects of medicines information for patients since 1998. He is a Senior Lecturer in the School of Healthcare at the University of Leeds, UK. His clinical background in nursing and academic degrees in Psychology underpin his research, and he has published and presented his work widely. He is a Director of a university spin-out company, Luto Research Ltd, which provides consumer information testing services to the pharmaceutical industry.

After 20 years in hospital pharmacy practice, Professor DK Theo Raynor completed his PhD on medicines information for patients in 1991. He became inaugural Professor of Pharmacy Practice at the University of Leeds, UK, in 2001. His research focuses on the effective delivery of medicines information for patients. He is Chair of the World Pharmacy Federation working group on Medication Literacy and is Chairman of Luto Research Ltd.

spacer
Peter Knapp
spacer
spacer
spacer
DK Theo Raynor
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Merck to Provide BioReliance® End-to-End Solutions to Phanes Therapeutics

• Collaboration to accelerate development and manufacturing of Bispecific Antibody • Merck plans to offer Phanes a full suite of products and services under its BioReliance® offering
More info >>

White Papers

Outsourcing and Insourcing: How Eurofins solves the bio/pharma industry’s challenges associated with meeting drug development timelines and budgets with restricted headcounts

Eurofins BioPharma Product Testing

Pharmaceutical and biopharmaceutical companies face a significant challenge to get their drug products developed and launched quickly, all while keeping development costs down. One of the most common ways for companies to lower development costs is to manage fixed headcounts. But when the same scope of work still needs to be completed by a designated time with fewer staff members, this presents a significant challenge. So, how do bio/pharma companies solve this ever so common challenge of increasing output while decreasing headcount? There are essentially three options: temporary staffing, outsourcing, or insourcing.
More info >>

 
Industry Events

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement