Can the written information to research subjects be improved?--an empirical study.

Bjørn, Else; Rossel, Peter; Holm, Soøren

doi:10.1136/jme.25.3.263

Cited by 86 publications

(58 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Scholars have suggested simpler alternatives to complex and commonly used phrases in consent forms. 33 More worrisome than readability were findings about forms' length. Median length of the 124 consent documents was 22 pages, and the 85 adult forms had a median length of 27 pages.…”

Section: Discussionmentioning

confidence: 99%

Length and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials

et al. 2011

View full text Add to dashboard Cite

BACKGROUND: Informed consent is required in most clinical research with humans. While federal regulations state consent information should be understandable to participants, concerns have been raised that consent forms are overly long and complex. DESIGN: Consent forms from 2006 HIV network trials sponsored by the National Institutes of Health (NIH), Division of AIDS (DAIDS), were analyzed for complexity and length. Comparisons were made between US and international sites, template and site forms, adult and pediatric trials, and trial type. How randomization and placebos were explained was examined as these are frequently misunderstood. RESULTS: One hundred twenty-four consent forms (21 template and 103 site forms) were reviewed. Median readability was 9.2 grade level, although confidentiality sections were 12.35 median grade level. International sites' forms had lower readability than US forms (p= 0.025), template forms had lower readability than site forms (p=0.046), and adult forms were less complex than pediatric (parent) forms (p<0.0001). Median length of all forms was 22.4 pages; the 85 forms from adult studies had a median length of 27.4 pages. Sections describing randomization were a median length of 53 words. CONCLUSIONS: Consent forms are extremely long, exceeding recommendations for how much information readily can be processed. Networks should consider providing shorter consent templates, consistent with federal recommendations, given that sites' forms are based on these models. Further research should examine whether forms emphasizing key information (rather than providing details about all aspects of the research) improve understanding of research.

show abstract

Section: Discussionmentioning

confidence: 99%

Length and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials

et al. 2011

View full text Add to dashboard Cite

show abstract

“…In this context empirical studies may provide valuable data. 20,34 This study also suggests the importance of discussing how strategies of information and informed consent can be analysed and designed in longitudinal studies. As we most likely will see more of longitudinal research correlating genetic status with long-term environmental factors, there will be a growing need for special ethical considerations, not only for the protection of participants' autonomy and integrity, but also because the public confidence in the commitment of researchers to the welfare of child subjects and respect for the rights of parents need to be upheld and promoted.…”

Section: Discussionmentioning

confidence: 99%

Information and informed consent in a longitudinal screening involving children: a questionnaire survey

et al. 2004

View full text Add to dashboard Cite

This empirical study explores participants' perceptions of information and understanding of their children's and their own involvement in a longitudinal screening, the ABIS Study. ABIS (All Babies In Southeast Sweden) is a multicentre, longitudinal research screening for Type 1 diabetes and multifactorial diseases involving 17 005 children and their families. For this study, a random selection of mothers was made, using perinatal questionnaire serial numbers from the ABIS study. In total, 293 of these mothers completed an anonymous questionnaire (response rate 73.3%). Our findings from the questionnaire indicate a marked difference between the reported satisfaction with and understanding of the information provided on the one hand and the significant lack of knowledge of some of the aims and methods of the ABIS screening on the other, namely concerning high-risk identification of involved children, potential prevention and future questionnaires. Two questions evoked by our results are: (1) what information is required for participants in longitudinal studies involving children? and (2) how do we ensure and sustain understanding, and thus in a prolonging, informed consent in these studies? This study underlines the importance of an increased understanding of the ethical issues that longitudinal research on children raise and the need to discuss how information and informed consent strategies should be analysed and designed in longitudinal studies.

show abstract

“…It means that beside the medical doctors responsible for the content of messages, other specialists should be involved in tailoring the messages for different patient groups: sociologists, psychologists, and certainly linguists as well. Increased attention to linguistic features has already shown to improve both the readability and understanding of information for patients [24], so it might be a good advice to have a linguist among the hospital ethics committee members when assessing the suitability of informed consent documents.…”

Section: Discussionmentioning

confidence: 99%

Improving comprehension of informed consent

Kušec

Orešković

Škegro

et al. 2006

Patient Education and Counseling

View full text Add to dashboard Cite

Can the written information to research subjects be improved?--an empirical study.

Cited by 86 publications

References 14 publications

Length and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials

Length and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials

Information and informed consent in a longitudinal screening involving children: a questionnaire survey

Improving comprehension of informed consent

Contact Info

Product

Resources

About