Chapter 6 sections 1-5

What is unlikely to be considered “key information”?

The name of the principal investigator

Which of the following is not a provision under which documentation of consent can be waived under the Common Rule?

The subject does not speak English.

What statement about waiving documentation of consent is true under the Common Rule?

“Implied” consent is permissible with an IRB-approved waiver of documentation.

Which shortcoming of the pre-2018 Common Rule consent requirement is addressed by the key information provision?

Ensuring that consent documents were “understandable” was limited to the language used in the consent document, rather than addressing the broader concept of how information is presented.

Are signed consent forms essential for human subjects research to be ethically sound?

No. IRBs may use their discretion to waive documentation of consent, or to waive the requirement for informed consent altogether, if certain criteria are met.

The provision for waivers or alterations of consent for public benefit or service programs may be applied to research that is:

regulated by the Common Rule

An “alteration of consent” refers to which of these?

The omission or alteration of one or more elements of consent

Which of the following statements about the basic elements of informed consent is correct?

Basic elements must be presented in a way that facilitates understanding.

True or false: Researchers are not required to document that consent was obtained when a signed consent form is not obtained, but it is considered best practice.

True

correct statement regarding the additional elements of informed consent

Additional elements are required if the IRB determines they are applicable to the research study

A “waiver of consent” refers to

Not obtaining informed consent from subjects for their inclusion in research

What are the challenges to implementing the new key information provision?

Specific information considered to be “key” is not articulated in the Common Rule, and there is no general tool or algorithm to identify which information is “key” for a specific research study.

What are the four central functions of consent to participation in research?

Protecting subjects’ welfare, respecting their autonomy, providing transparency, fostering trust

Which statement most accurately describes the general requirements of informed consent?

The general requirements speak to how information should be presented, rather than what must be included.