Home  |  About us  |  Editorial board  |  Ahead of print  | Current issue  |  Archives  |  Submit article  |  Instructions |  Search  |   Subscribe  |  Advertise  |  Contacts  |  Login 
  Users Online: 165Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  
Year : 2010  |  Volume : 1  |  Issue : 3  |  Page : 98-100

Readability and comprehensibility of informed consent forms for clinical trials

Senior Manager, Clinical Research Quality, Eli Lilly & Company (India) Pvt Ltd

Correspondence Address:
Anvita Pandiya
Senior Manager, Clinical Research Quality, Eli Lilly & Company (India) Pvt Ltd

Login to access the Email id

Source of Support: None, Conflict of Interest: None

PMID: 21814628

Rights and PermissionsRights and Permissions

The signed informed consent form provides documentary evidence that the patient has given informed consent to participate in a clinical trial and that the patient has been given the requisite information. However, this document must not only provide the necessary information, it must also be provided in a way that can be understood by the patient. Non conclusive information suggests that research participants frequently may not understand the information presented during the informed consent procedure. Comprehension requires that the patient be able to understand the information presented and have the time and opportunity to read, evaluate and consider the information presented. A shortened Informed Consent Form, with information that a reasonable person would want to understand along with specific information that the person wants in particular would be a good option to improve understanding or comprehensibility. Additional informational meetings with a qualified person like a counselor could help in comprehension. Questionnaires designed to test comprehension of patient, peer review, patient writing the salient features could help evaluate the comprehensibility of the Informed Consent Form.

Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)

 Article Access Statistics
    PDF Downloaded743    
    Comments [Add]    

Recommend this journal