scholarly journals Improved participants’ understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials

2016 ◽  
Vol 73 (2) ◽  
pp. 141-149 ◽  
Author(s):  
Nut Koonrungsesomboon ◽  
Thipaporn Tharavanij ◽  
Kittichet Phiphatpatthamaamphan ◽  
Ratha-korn Vilaichone ◽  
Sudsayam Manuwong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Consent Form ◽  
Research Information ◽  
Randomized Controlled ◽  
Informed Consent Form

How well informed is the informed consent for cancer clinical trials?

2014 ◽  
Vol 11 (6) ◽  
pp. 686-688 ◽  
Author(s):  
Laeeq Malik ◽  
James Kuo ◽  
Desmond Yip ◽  
Alex Mejia
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Tertiary Care ◽  
Reading Level ◽  
Consent Form ◽  
Consent Forms ◽  
Investigational Agent ◽  
Informed Consent Form ◽  
Grade Reading Level

Aims: The purpose of this study was to analyze the content of informed consent forms for clinical trials in medical oncology to assess readability, determine their completeness, and identify any shortcomings. Methods: Informed consent forms for Phase I–III studies that were conducted at two tertiary care cancer centers over a 3-year period were reviewed. Information pertaining to length of the informed consent form, research regimen/methods, treatment agent, potential risks, and benefits was extracted. The reading level was assessed by Flesch–Kincaid and Gunning-Fog index readability tests. Results: All of the 112 informed consent forms clearly stated the voluntary nature of participation. Nearly one half of the forms (51.8%) were of Phase I studies. The median length of informed consent form was 20 pages (range: 8–28). A detailed estimation of the frequency or intensity of risks (range: 3–8 pages) was provided. The average reading level of the informed consent forms was high (Flesch–Kincaid Grade Level of 9.8), which corresponds roughly to 10th-grade reading level. Less than 15% of all consent forms were written at the recommended eighth-grade reading level. A substantial number of forms did not report a potential risk to pregnant/lactating women (16.9%), mechanism of action of the investigational agent (34.8%), study schema (77.6%), a possibility of receiving sub-therapeutic dose (37%), or death (12.5%). Nearly one half of the forms (49.1%) stated clearly that individual participants may not benefit. Conclusion: Overall, these informed consent forms provided a detailed description of the trials in accordance to international guidelines. However, there remains room for improvement, particularly in areas of readability and document length.

scholarly journals Improved participants’ understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study

2015 ◽  
Vol 72 (4) ◽  
pp. 413-421 ◽  
Author(s):  
Nut Koonrungsesomboon ◽  
Supanimit Teekachunhatean ◽  
Nutthiya Hanprasertpong ◽  
Junjira Laothavorn ◽  
Kesara Na-Bangchang ◽  
...  
Keyword(s):  
Informed Consent ◽  
Healthy Volunteer ◽  
Consent Form ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Informed Consent Form ◽  
Volunteer Study ◽  
Healthy Volunteer Study

Assesment of a written informed consent form in clinical trials

2012 ◽  
Vol 19 (2) ◽  
pp. 223.3-224
Author(s):  
P. Marrero Álvarez ◽  
J. Ruiz Ramos ◽  
J.E. Megías Vericat ◽  
S. Rodríguez Capellán ◽  
M. Tordera Baviera ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Consent Form ◽  
Informed Consent Form ◽  
Written Informed Consent

scholarly journals Utilization of a Spanish-language low-literacy informed consent form to improve understanding of sterilization: a randomized controlled trial

Contraception ◽  
2016 ◽  
Vol 94 (4) ◽  
pp. 426
Author(s):  
C Sterling ◽  
N Brown ◽  
K Ciesielski ◽  
H Eggers ◽  
NB Zite ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Informed Consent ◽  
Controlled Trial ◽  
Spanish Language ◽  
Consent Form ◽  
Low Literacy ◽  
Randomized Controlled ◽  
Informed Consent Form

Do patients participating in oncology clinical trials understand the informed consent form? A Brown University Oncology Research Group study—BrUOG 274.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. e17702-e17702
Author(s):  
Andrew Schumacher ◽  
Howard Safran ◽  
Carolyn Bartley ◽  
Brittany Cammisa ◽  
Alise Lombardo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Research Group ◽  
Consent Form ◽  
Oncology Research ◽  
Informed Consent Form ◽  
Brown University ◽  
Oncology Clinical Trials

scholarly journals Perception of the informed consent form by participants in clinical trials

2014 ◽  
Vol 32 (1) ◽  
pp. 97-102 ◽  
Author(s):  
Silmara Meneguin ◽  
◽  
Jairo Aparecido Ayres ◽  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Consent Form ◽  
Informed Consent Form

scholarly journals Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e029530
Author(s):  
Nut Koonrungsesomboon ◽  
Chanchai Traivaree ◽  
Charnunnut Tiyapsane ◽  
Juntra Karbwang
Keyword(s):  
Informed Consent ◽  
Primary Endpoint ◽  
Drug Trial ◽  
Consent Form ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Ethical Review ◽  
Paediatric Drug ◽  
Randomized Controlled ◽  
Informed Consent Form

ObjectiveThis study was designed to evaluate the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in paediatric research requiring parental consent. The objective of this study was to compare the parental understanding of information between the parents who read the SIDCER ICF and those who read the conventional ICF.DesignA prospective, randomized, controlled design.SettingPaediatric Outpatients Department, Phramongkutklao Hospital, Thailand.Participants210 parents of children with thalassemia (age=35.6 ± 13.1 years).InterventionsThe parents were randomly assigned to read either the SIDCER ICF (n=105) or the conventional ICF (n=105) of a paediatric drug trial.Primary and secondary outcome measuresParental understanding of trial information was determined using 24 scenario-based questions. The primary endpoint was the proportion of parents who obtained the understanding score of more than 80%, and the secondary endpoint was the total score.ResultsForty-five parents (42.9%) in the SIDCER ICF group and 29 parents (27.6%) in the conventional ICF group achieved the primary endpoint (relative risk=1.552, 95% CI 1.061 to 2.270, p=0.021). The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001).ConclusionsThe SIDCER ICF was found to be superior to the conventional ICF in improving parental understanding of trial information.

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