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Excluding particular information from consent forms.

Neal Dickert1, Nancy Kass, Michael Paasche-Orlow

  • 1Department of Health Policy and Management, Phoebe R. Berman Bioethics Institute, John Hopkins University Bloomberg School of Public Health, Hampton House 348, 624 N. Broadway, Baltimore, MD 21205, USA. ndicker@jhmi.edu

Accountability in Research
|July 19, 2005
PubMed
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Excluding sensitive information from informed consent forms is sometimes necessary to protect research participants. This paper argues for ethical and regulatory changes to permit such exclusions when risks outweigh disclosure benefits.

Area of Science:

  • Bioethics
  • Clinical Research Ethics
  • Human Subject Protection

Background:

  • Informed consent is vital for protecting human research subjects.
  • Specific information on consent forms can inadvertently pose risks to participants.
  • The ethical and regulatory landscape for excluding information from consent forms is underdeveloped.

Purpose of the Study:

  • To examine the ethical implications of excluding sponsor names from consent forms.
  • To address the lack of literature and regulatory guidance on information exclusion from consent forms.
  • To argue for the ethical obligation to exclude risky information from consent forms.

Main Methods:

  • Case study analysis of a scenario where sponsor names could reveal HIV status.
  • Ethical argumentation regarding risk-benefit analysis in informed consent.
Keywords:
Analytical ApproachBiomedical and Behavioral Research

Related Experiment Videos

  • Review of existing regulations and literature on informed consent.

    • Main Results:

    • Including sponsor names on consent forms can act as a surrogate for participants' HIV status.
    • Current regulations offer limited guidance on excluding information from consent forms.
    • There is a lack of scholarly work addressing the ethics of such exclusions.

    Conclusions:

    • Excluding specific information from consent forms is ethically obligatory when its inclusion poses risks to subjects.
    • Current regulations should be amended to acknowledge and permit the exclusion of high-risk information.
    • Protecting participant confidentiality may necessitate deviations from full written disclosure in consent forms.