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Risk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee.

Saara Happo1, Tapani Keränen2, Arja Halkoaho3

  • 1University of Eastern Finland, Kuopio, Finland.

Journal of Empirical Research on Human Research Ethics : JERHRE
|February 11, 2020
PubMed
Summary

Researchers often fail to detail medical study risks in protocols and participant information sheets. Physical risks are prioritized over psychological ones, potentially omitting crucial information for participants.

Keywords:
medical research ethicsmedical study proceduresmedical study protocolparticipant information sheetrisk assessment

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Area of Science:

  • Medical research ethics
  • Clinical trial management
  • Patient safety

Background:

  • Research ethics committees (RECs) use frameworks for medical study risk assessment.
  • Limited understanding exists on how researchers document procedural risks in study protocols and participant information sheets.

Purpose of the Study:

  • To analyze the extent and nature of risk assessments for medical study procedures.
  • To evaluate how risks are described in study protocols and participant information sheets submitted to an REC.

Main Methods:

  • Reviewed 349 study protocols and participant information sheets.
  • Assessed risk descriptions for 1,510 study procedures.
  • Quantified the frequency of risk assessment reporting for different risk types.

Main Results:

  • Risk assessments were present for only 26% of procedures in protocols and 28% in information sheets.
  • Physical risks were documented six times more often than psychological risks.
  • Incomplete risk descriptions were noted, particularly for seemingly familiar procedures.

Conclusions:

  • Medical study protocols and participant information sheets frequently lack comprehensive risk details.
  • The underreporting of psychological risks and risks of familiar procedures may compromise informed consent.
  • Improved risk communication in research documentation is essential for participant protection.