Informed Consent - Waiver of Informed Consent Requirement

Waiver of Informed Consent Requirement

Waiver of the consent requirement may be applied in certain circumstances where no foreseeable harm is expected to result from the study or when permitted by law, federal regulations, or if an ethical review committee has approved the non-disclosure of certain information.

Besides studies with minimal risk, waivers of consent may be obtained in a military setting. According to 10 USC 980, the United States Code for the Armed Forces, Limitations on the Use of Humans as Experimental Subjects, a waiver of advanced informed consent may be granted by the Secretary of Defense if a research project would:

  1. Directly benefit subjects.
  2. Advance the development of a medical product necessary to the military.
  3. Be carried out under all laws and regulations (i.e., Emergency Research Consent Waiver) including those pertinent to the FDA.

Read more about this topic:  Informed Consent

Famous quotes containing the words informed, consent and/or requirement:

    Where people wish to attach, they should always be ignorant. To come with a well- informed mind, is to come with an inability of administering to the vanity of others, which a sensible person would always wish to avoid. A woman especially, if she have the misfortune of knowing any thing, should conceal it as well as she can.
    Jane Austen (1775–1817)

    What we seek is the reign of law, based upon the consent of the governed and sustained by the organized opinion of mankind.
    Woodrow Wilson (1856–1924)

    Reporters for tabloid newspapers beat a path to the park entrance each summer when the national convention of nudists is held, but the cult’s requirement that visitors disrobe is an obstacle to complete coverage of nudist news. Local residents interested in the nudist movement but as yet unwilling to affiliate make observations from rowboats in Great Egg Harbor River.
    —For the State of New Jersey, U.S. public relief program (1935-1943)