Literature DB >> 28078953

Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research.

Amy Corneli1,2, Emily Namey1, Monique P Mueller1, Jenae Tharaldson1, Steve Sortijas1, Thomas Grey1, Jeremy Sugarman3.   

Abstract

Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants' understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.

Entities:  

Keywords:  HIV; U.S. regulations; consent forms; informed consent; research ethics

Mesh：

Year:  2017        PMID： 28078953      PMCID： PMC5821132          DOI： 10.1177/1556264616682550

Source DB:  PubMed          Journal:  J Empir Res Hum Res Ethics        ISSN： 1556-2646            Impact factor:   1.742


  12 in total

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Authors:  Ilene Albala; Margaret Doyle; Paul S Appelbaum
Journal:  IRB       Date:  2010 May-Jun

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Authors:  Emma Beardsley; Michael Jefford; Linda Mileshkin
Journal:  J Clin Oncol       Date:  2007-03-20       Impact factor: 44.544

4.  The length of consent documents in oncological trials is doubled in twenty years.

Authors:  O Berger; B H Grønberg; K Sand; S Kaasa; J H Loge
Journal:  Ann Oncol       Date:  2008-10-15       Impact factor: 32.976

5.  Length and complexity of US and international HIV consent forms from federal HIV network trials.

Authors:  Nancy E Kass; Lelia Chaisson; Holly A Taylor; Jennifer Lohse
Journal:  J Gen Intern Med       Date:  2011-07-06       Impact factor: 5.128

6.  Research consent forms: continued unreadability and increasing length.

Authors:  M E LoVerde; A V Prochazka; R L Byyny
Journal:  J Gen Intern Med       Date:  1989 Sep-Oct       Impact factor: 5.128

7.  Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process.

Authors:  G M Dresden; M A Levitt
Journal:  Acad Emerg Med       Date:  2001-03       Impact factor: 3.451

8.  Randomization to standard and concise informed consent forms: development of evidence-based consent practices.

Authors:  Mary E Enama; Zonghui Hu; Ingelise Gordon; Pamela Costner; Julie E Ledgerwood; Christine Grady
Journal:  Contemp Clin Trials       Date:  2012-04-20       Impact factor: 2.226

9.  Informed consent for biobanking: consensus-based guidelines for adequate comprehension.

Authors:  Laura M Beskow; Carrie B Dombeck; Cole P Thompson; J Kemp Watson-Ormond; Kevin P Weinfurt
Journal:  Genet Med       Date:  2014-08-21       Impact factor: 8.822

10.  A randomized controlled trial of short and standard-length consent forms for a genetic cohort study: is longer better?

Authors:  Kenji Matsui; Reidar K Lie; Tanvir C Turin; Yoshikuni Kita
Journal:  J Epidemiol       Date:  2012-03-24       Impact factor: 3.211
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  13 in total

1.  Informational needs for participation in bioequivalence studies: the perspectives of experienced volunteers.

Authors:  Nut Koonrungsesomboon; Saranyapin Potikanond; Mingkwan Na Takuathung; Wutigri Nimlamool; Juntra Karbwang
Journal:  Eur J Clin Pharmacol       Date:  2019-08-19       Impact factor: 2.953

2.  Can we make informed consent forms more informative?

Authors:  Elizabeth E Foglia
Journal:  Arch Dis Child Fetal Neonatal Ed       Date:  2017-12-08       Impact factor: 5.747

3.  An Assessment of a Shortened Consent Form for the Storage and Research Use of Residual Newborn Screening Blood Spots.

Authors:  Erin Rothwell; Aaron Goldenberg; Erin Johnson; Naomi Riches; Beth Tarini; Jeffrey R Botkin
Journal:  J Empir Res Hum Res Ethics       Date:  2017-10-26       Impact factor: 1.742

4.  Too Dense and Too Detailed: Evaluation of the Health Literacy Attributes of an Informed Consent Document.

Authors:  Vanessa W Simonds; Dedra Buchwald
Journal:  J Racial Ethn Health Disparities       Date:  2019-12-10

5.  Shortened consent forms for genome-wide sequencing: Parent and provider perspectives.

Authors:  Emma C Hitchcock; Causes Study; Alison M Elliott
Journal:  Mol Genet Genomic Med       Date:  2020-05-08       Impact factor: 2.183

6.  What information and the extent of information research participants need in informed consent forms: a multi-country survey.

Authors:  Juntra Karbwang; Nut Koonrungsesomboon; Cristina E Torres; Edlyn B Jimenez; Gurpreet Kaur; Roli Mathur; Eti N Sholikhah; Chandanie Wanigatunge; Chih-Shung Wong; Kwanchanok Yimtae; Murnilina Abdul Malek; Liyana Ahamad Fouzi; Aisyah Ali; Beng Z Chan; Madawa Chandratilake; Shoen C Chiew; Melvyn Y C Chin; Manori Gamage; Irene Gitek; Mohammad Hakimi; Narwani Hussin; Mohd F A Jamil; Pavithra Janarsan; Madarina Julia; Suman Kanungo; Panduka Karunanayake; Sattian Kollanthavelu; Kian K Kong; Bing-Ling Kueh; Ragini Kulkarni; Paul P Kumaran; Ranjith Kumarasiri; Wei H Lim; Xin J Lim; Fatihah Mahmud; Jacinto B V Mantaring; Siti M Md Ali; Nurain Mohd Noor; Kopalasuntharam Muhunthan; Elanngovan Nagandran; Maisarah Noor; Kim H Ooi; Jebananthy A Pradeepan; Ahmad H Sadewa; Nilakshi Samaranayake; Shalini Sri Ranganathan; Wasanthi Subasingha; Sivasangari Subramaniam; Nadirah Sulaiman; Ju F Tay; Leh H Teng; Mei M Tew; Thipaporn Tharavanij; Peter S K Tok; Jayanie Weeratna; Tri Wibawa; Renu Wickremasinghe; Phanthipha Wongwai; Subhash Yadav
Journal:  BMC Med Ethics       Date:  2018-09-15       Impact factor: 2.652

7.  Ethical Considerations in Clinical Trials for Disorders of Consciousness.

Authors:  Michael J Young; Yelena G Bodien; Brian L Edlow
Journal:  Brain Sci       Date:  2022-02-02

8.  Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study.

Authors:  Mariana Rodriguez-Patarroyo; Angelica Torres-Quintero; Andres I Vecino-Ortiz; Kristina Hallez; Aixa Natalia Franco-Rodriguez; Eduardo A Rueda Barrera; Stephanie Puerto; Dustin G Gibson; Alain Labrique; George W Pariyo; Joseph Ali
Journal:  J Empir Res Hum Res Ethics       Date:  2020-09-25       Impact factor: 1.742

9.  Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence.

Authors:  Suzanne Day; Meredith Blumberg; Thi Vu; Yang Zhao; Stuart Rennie; Joseph D Tucker
Journal:  J Int AIDS Soc       Date:  2018-10       Impact factor: 5.396

10.  Reimagining Global Oncology Clinical Trials for the Postpandemic Era: A Call to Arms.

Authors:  Kamal S Saini; Begoña de Las Heras; Ruth Plummer; Victor Moreno; Marco Romano; Javier de Castro; Philippe Aftimos; Judy Fredriksson; Gouri Shankar Bhattacharyya; Martin Sebastian Olivo; Gaia Schiavon; Kevin Punie; Jesus Garcia-Foncillas; Ernesto Rogata; Richie Pfeiffer; Cecilia Orbegoso; Kenneth Morrison; Giuseppe Curigliano; Lynda Chin; Monika Lamba Saini; Øystein Rekdal; Steven Anderson; Javier Cortes; Manuela Leone; Janet Dancey; Chris Twelves; Ahmad Awada
Journal:  JCO Glob Oncol       Date:  2020-09
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