As July comes to an end, the Food and Drug Administration (FDA or agency) has issued a new guidance document for “immediate implementation” entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More than Minimal Risk to Human Subjects.” The guidance document outlines FDA’s new enforcement policy with regard to IRB waivers or alterations of informed consent requirements for certain minimal risk clinical investigations.

According to FDA, the agency has received numerous inquiries over the years “from sponsors and investigators about conducting important minimal risk clinical investigations for which obtaining informed consent was not practicable[i].” However, FDA did not have the statutory authority to allow for a waiver of informed consent for these types of investigations until the recent passing of the 21st Century Cures Act (Cures Act).

The Cures Act, which was signed into law on December 13, 2016, amended the Federal Food, Drug and Cosmetic Act and provided FDA with the authority to “permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.[ii]” Currently, FDA regulations only allow an exception from the informed consent requirements in life-threatening situations (21 CFR 50.23) or for emergency research (21 CFR 50.24). Thus, FDA intends to publish regulations to reflect this statutory change, including any appropriate human subject protection safeguards.

Until the new regulations are published, FDA does not “intend to object to an IRB approving a consent procedure that does not include, or that alters some or all the element of informed consent set forth in 21 CFR 50.25,” as long as the IRB finds and documents that:

  • The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subject;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The clinical investigation could not practicably be carried out without the waiver or alteration; and
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

According to FDA, it intends to “withdraw th[e] guidance after [it] promulgate[s] regulations to permit a waiver or alteration of informed consent under appropriate human subject protection safeguards consistent with Section 3024 of the Cures Act.[iii]” However, the agency does not provide a timeframe for when it plans to issue these regulations. In the meantime, while the guidance is for immediate implementation, the agency “will consider all comments received and will revise this guidance when appropriate.[iv]