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Cancer Chemotherapy and Pharmacology

, Volume 82, Issue 5, pp 907–910 | Cite as

A comparison of the quality of informed consent for phase I oncology trials over a 30-year period

  • Laeeq Malik
  • James Cooper
Short Communication

Abstract

Purpose

Efforts are underway in improving the informed consent process. The success of these efforts to improve quality of informed consent forms (ICFs) for phase I oncology trials has not been previously measured.

Methods

We reviewed and compared ICFs of all phase I trials for metastatic cancer conducted between 1986 and 1999 and 2000–2015 periods at our institution. Information pertaining to ICF length, study purpose description, research regimen/methods, potential risks and benefits was extracted. The reading level was assessed by Flesch–Kincaid readability tests.

Results

Of 364 ICFs screened, 310 ICFs were included in this analysis. The median length of ICFs from 1986 to 1999 and 2000–2015 was 12 and 23 pages, respectively. Only 42% (1986–1999) and 57% (2000–2015) of ICFs stated that individual participants might not benefit from treatment. Only 21% (1986–1999) and 12% (2000–2015) of all ICFs were written at ≤ 8th grade reading level. The median FRE, FKGL and GFI readability scores of ICFs from 1986 to 1999 were 53.6, 8.8, and 9.5, respectively. The median FRE, FKGL, and GFI scores of studies from 2000 to 2015 were 48.5, 10.7, and 12.4, respectively. These scores indicate that the ICF text was too hard for most people to read. The mechanism of action of the treatment, study schema/calendar, possibility of experiencing unexpected risks or death, and risks to pregnant/lactating women were not reported in a substantial number of forms.

Conclusions

Our results show that ICFs for phase I oncology trials over last 30 years have become longer, more difficult to read but are still lacking some important information.

Keywords

Phase 1 Consent Informed Risks Trial 

Notes

Funding

None.

Compliance with ethical standards

Conflict of interest

None to declare. All authors had full control of all primary data, which are available for review upon request.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Welfare of animals

This article does not contain any studies with animals performed by the authors.

Informed consent

Not required.

Supplementary material

280_2018_3673_MOESM1_ESM.docx (22 kb)
Supplementary material 1 (DOCX 22 KB)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Cancer Therapy and Research CenterUniversity of Texas Health Science CenterSan AntonioUSA

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