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

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.

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 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

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 Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration

2020 ◽  
Vol 20 (1) ◽  
pp. 76-80
Author(s):  
Grace Gartel ◽  
Heather Scuderi ◽  
Christine Servay
Keyword(s):  
Informed Consent ◽  
Institutional Review Board ◽  
Consent Form ◽  
Research Staff ◽  
Common Rule ◽  
Institutional Review ◽  
Informed Consent Form ◽  
Rule Changes

scholarly journals Pelaksanaan Informed Consent pada Pemeriksaan Intra Vena Pyelografi di Instalasi Radiologi Rumah Sakit Umum Sukoharjo

2017 ◽  
Vol 3 (1) ◽  
pp. 199-203
Author(s):  
Rini Indrati ◽  
Meita Shinta Fatikhatul Laila ◽  
Andrey Nino Kurniawan
Keyword(s):  
Qualitative Research ◽  
Informed Consent ◽  
Consent Form ◽  
Radiology Department ◽  
Medical Council ◽  
Patient Understanding ◽  
Informed Consent Form ◽  
Descriptive Qualitative

Background: The implementation of informed consent at Radiology department of Sukoharjo Hospital was conducted by administrative officer and radiographer. The officer explained the preparation of pyelographic intra-venous examination to the patient then the patient was asked to fill out and sign the informed consent form. According to the Indonesian Medical Council and Regulation of the Minister of Health of Indonesia, the delivery of informed consent is carried out by doctors. The doctor explains all the information contained in the contents of informed consent before taking any medical action. The purpose of this research is to know the implementation of informed consent done in the radiology department and patient understanding of the contents of the informed consent form.Methods: The type of this research is descriptive qualitative research with the observational approach. Data were collected in March-June 2017 by observational of informed consent and interviews of 30 patients who will conduct intra vena pyelographic examination. Data analyzed by descriptively.Results: The results showed that the provision of informed consent to intravenous pyelographic examination patient at Sukoharjo Hospital was performed by administration officer and radiographer before conducting the examination. The patient's understanding of the contents of informed consent has not been in accordance with the content of the informed consent form because the information submitted by the radiologist only concerning the preparation of intravenous examination of pyelography does not include examination procedures, objectives, risks, complications, diagnoses, prognoses, alternative other measures and risks, and costs.Conclusions: In radiology department of Sukoharjo hospital at Intravenapyelography patient informed consent delivered by administrative officers and radiographer. Patients understanding the content of informed consent

Usability Testing

2001 ◽  
Vol 9 (2) ◽  
pp. 15-20
Author(s):  
Susan Waters ◽  
Melody Carswell ◽  
Eric Stephens ◽  
Ada Sue Selwit
Keyword(s):  
Informed Consent ◽  
Usability Testing ◽  
Consent Form ◽  
Research Project ◽  
Informed Consent Form ◽  
The Difference

How information is presented in an informed consent form can mean the difference between success and failure in a research project.

Sign in / Sign up

Export Citation Format

Share Document