Report No. 185 – Evaluating and Communicating Radiation Risks for Studies Involving Human Subjects: Guidance for Researchers and Institutional Review Boards (2020)

Product Details

Sort Title : Report No. 185

ISBN : 9781944888220

Scientific Committee :

  • Julie K. Timins, Chair
  • Jerrold T. Bushberg
  • Patricia A. Fleming
  • Linda A. Kroger
  • Edwin M. Leidholdt, Jr.
  • Donald L. Miller
  • Robert E. Reiman
  • J. Anthony Seibert
  • Steven G. Sutlief
  • Michael P. Grissom, Staff Consultant

Executive Summary

The extent of knowledge about ionizing radiation in general, radiation involved in medical procedures, and the potential adverse effects of radiation varies substantially among members of the public and within the medical community. Also, although many U.S. academic institutions provide guidelines for the conduct of human research, including research involving radiation, these guidelines lack uniformity. There is a need to provide comprehensive, consistent and accurate guidance on radiation risks of research protocols that involve the use of ionizing radiation to those who develop protocols and conduct research involving human subjects and to institutional review boards (IRBs) that review these protocols.

This Report seeks to fill these gaps by:

  • providing basic information about ionizing radiation and radiation biology, including medical imaging and treatments that involve radiation;
  • identifying the governmental agencies that oversee research and radiation;
  • citing the relevant regulatory requirements;
  • providing guidance regarding the estimation of radiation dose and risk in research protocols;
  • discussing the ethical considerations involved in humanstudies research; and
  • presenting in detail the requirements for ensuring and obtaining truly informed consent.
  • Excerpts and Related Information


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    Weight 15 oz
    Dimensions 23.495 × 15.875 × 1.588 cm

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