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

被引:24
作者
Corneli, Amy [1 ,2 ]
Namey, Emily [1 ]
Mueller, Monique P. [1 ]
Tharaldson, Jenae [1 ]
Sortijas, Steve [1 ]
Grey, Thomas [1 ]
Sugarman, Jeremy [3 ]
机构
[1] FHI 360, Durham, NC USA
[2] Duke Univ, Durham, NC USA
[3] Johns Hopkins Univ, Baltimore, MD USA
关键词
informed consent; consent forms; research ethics; US regulations; HIV; LENGTH; STANDARD; TRIALS; GUIDELINES; LONGER;
D O I
10.1177/1556264616682550
中图分类号
B82 [伦理学(道德学)];
学科分类号
摘要
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.
引用
收藏
页码:14 / 25
页数:12
相关论文
共 16 条
  • [1] Albala Ilene, 2010, IRB, V32, P7
  • [2] Beardsley E, 2007, J CLIN ONCOL, V25, pE13, DOI 10.1200/JCO.2006.10.3341
  • [3] The length of consent documents in oncological trials is doubled in twenty years
    Berger, O.
    Gronberg, B. H.
    Sand, K.
    Kaasa, S.
    Loge, J. H.
    [J]. ANNALS OF ONCOLOGY, 2009, 20 (02) : 379 - 385
  • [4] Informed consent for biobanking: consensus-based guidelines for adequate comprehension
    Beskow, Laura M.
    Dombeck, Carrie B.
    Thompson, Cole P.
    Watson-Ormond, J. Kemp
    Weinfurt, Kevin P.
    [J]. GENETICS IN MEDICINE, 2015, 17 (03) : 226 - 233
  • [5] Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process
    Dresden, GM
    Levitt, MA
    [J]. ACADEMIC EMERGENCY MEDICINE, 2001, 8 (03) : 246 - 252
  • [6] Randomization to standard and concise informed consent forms: Development of evidence-based consent practices
    Enama, Mary E.
    Hu, Zonghui
    Gordon, Ingelise
    Costner, Pamela
    Ledgerwood, Julie E.
    Grady, Christine
    [J]. CONTEMPORARY CLINICAL TRIALS, 2012, 33 (05) : 895 - 902
  • [7] OBTAINING INFORMED CONSENT - FORM OR SUBSTANCE
    EPSTEIN, LC
    LASAGNA, L
    [J]. ARCHIVES OF INTERNAL MEDICINE, 1969, 123 (06) : 682 - &
  • [8] Guest G., 2012, Applied thematicanalysis
  • [9] Research guidelines for the Delphi survey technique
    Hasson, F
    Keeney, S
    McKenna, H
    [J]. JOURNAL OF ADVANCED NURSING, 2000, 32 (04) : 1008 - 1015
  • [10] HIV Prevention Trials Network, 2013, HPTN 073 PREEXP PROP