Literature DB >> 21556181

Subjects agree to participate in environmental health studies without fully comprehending the associated risk.

Robin Lee1, Samantha Lampert, Lynn Wilder, Anne L Sowell.   

Abstract

Recent advances in environmental health research have greatly improved our ability to measure and quantify how individuals are exposed. These advances, however, bring bioethical uncertainties and potential risks that individuals should be aware of before consenting to participate. This study assessed how well participants from two environmental health studies comprehended consent form material. After signing the consent form, participants were asked to complete a comprehension assessment tool. The tool measured whether participants could recognize or recall six elements of the consent form they had just reviewed. Additional data were collected to look for differences in comprehension by gender, age, race, and the time spent reading the original consent form. Seventy-three participants completed a comprehension assessment tool. Scores ranged from 1.91 to 6.00 (mean = 4.66); only three people had perfect comprehension scores. Among the least comprehended material were questions on study-related risks. Overall, 53% of participants were not aware of two or more study-related risks. As environmental public health studies pose uncertainties and potential risks, researchers need to do more to assess participants' understanding before assuming that individuals have given their 'informed' consent.

Entities:  

Keywords:  bioethics; comprehension; consent forms; environmental health; ethics; informed consent; research subjects

Mesh:

Year:  2011        PMID: 21556181      PMCID: PMC3083672          DOI: 10.3390/ijerph8030830

Source DB:  PubMed          Journal:  Int J Environ Res Public Health        ISSN: 1660-4601            Impact factor:   3.390


  34 in total

1.  Decision-making and informed consent: a study of the impact of disclosed information.

Authors:  Ruth R Faden; Tom L Beauchamp
Journal:  Soc Indic Res       Date:  1980-01

2.  Improving informed consent: a comparison of four consent tools.

Authors:  Patricia Agre; Bruce Rapkin
Journal:  IRB       Date:  2003 Nov-Dec

Review 3.  Interventions to improve research participants' understanding in informed consent for research: a systematic review.

Authors:  James Flory; Ezekiel Emanuel
Journal:  JAMA       Date:  2004-10-06       Impact factor: 56.272

4.  Improving informed consent: the medium is not the message.

Authors:  Patricia Agre; Frances A Campbell; Barbara D Goldman; Maria L Boccia; Nancy Kass; Laurence B McCullough; Jon F Merz; Suzanne M Miller; Jim Mintz; Bruce Rapkin; Jeremy Sugarman; James Sorenson; Donna Wirshing
Journal:  IRB       Date:  2003 Sep-Oct

Review 5.  Consent in impaired populations.

Authors:  Paul S Appelbaum
Journal:  Curr Neurol Neurosci Rep       Date:  2010-09       Impact factor: 5.081

6.  Informed consent, memory and age.

Authors:  H A Taub
Journal:  Gerontologist       Date:  1980-12

7.  Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders.

Authors:  Laura B Dunn; Laurie A Lindamer; Barton W Palmer; Shahrokh Golshan; Lawrence J Schneiderman; Dilip V Jeste
Journal:  Am J Geriatr Psychiatry       Date:  2002 Mar-Apr       Impact factor: 4.105

8.  Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group.

Authors:  Cathy A Coyne; Ronghui Xu; Peter Raich; Kathy Plomer; Mark Dignan; Lari B Wenzel; Diane Fairclough; Thomas Habermann; Linda Schnell; Susan Quella; David Cella
Journal:  J Clin Oncol       Date:  2003-03-01       Impact factor: 44.544

Review 9.  Improving informed consent: insights from behavioral decision research.

Authors:  Margaret Holmes-Rovner; Celia E Wills
Journal:  Med Care       Date:  2002-09       Impact factor: 2.983

10.  The therapeutic misconception: problems and solutions.

Authors:  Charles W Lidz; Paul S Appelbaum
Journal:  Med Care       Date:  2002-09       Impact factor: 2.983

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  5 in total

1.  Did I Tell You That? Ethical Issues Related to Using Computational Methods to Discover Non-Disclosed Patient Characteristics.

Authors:  Kenrick D Cato; Walter Bockting; Elaine Larson
Journal:  J Empir Res Hum Res Ethics       Date:  2016-07       Impact factor: 1.742

2.  Involving Medical Students in Informed Consent: A Pilot Study.

Authors:  Costanza Chiapponi; Frank Meyer; Olof Jannasch; Stephan Arndt; Patrick Stübs; Christiane J Bruns
Journal:  World J Surg       Date:  2015-09       Impact factor: 3.352

Review 3.  Informed Consent in the Genomics Era.

Authors:  Shannon Rego; Megan E Grove; Mildred K Cho; Kelly E Ormond
Journal:  Cold Spring Harb Perspect Med       Date:  2020-08-03       Impact factor: 5.159

4.  Improving readability of informed consents for research at an academic medical institution.

Authors:  Kristie B Hadden; Latrina Y Prince; Tina D Moore; Laura P James; Jennifer R Holland; Christopher R Trudeau
Journal:  J Clin Transl Sci       Date:  2017-12

5.  Interactive informed consent: randomized comparison with paper consents.

Authors:  Michael C Rowbotham; John Astin; Kaitlin Greene; Steven R Cummings
Journal:  PLoS One       Date:  2013-03-06       Impact factor: 3.240

  5 in total

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