Question

Waiver or Alteration of Informed Consent for No More than Minimal Risk Research

On 24 July 2017, the FDA issued guidance that they will not object if an IRB approves a waiver or alteration of consent for a no more than minimal risk clinical investigation if the IRB determines that:
a) The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3[k] or 56.102[i]) to subjects;
b) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
c) The research could not practicably be carried out without the waiver or alteration; and
d) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Answer 1

Informed consent is vital to protect participant rights in research involving human subjects, but in certain minimal risk studies, the IRB may permit a waiver or alteration if ethical criteria are met.

Step-by-step explanation:

When conducting research that involves human participants, especially in medical settings, it is essential to obtain informed consent to protect the rights and welfare of participants. The requirement for informed consent mandates that participants should be thoroughly informed about the research study, including the potential risks and benefits, so that they can make an educated decision about their participation. In certain cases, such as minimal risk research, an Institutional Review Board (IRB) may consider a waiver or alteration of consent if the study meets specific criteria, ensuring that the study's integrity and participants' rights are maintained. The FDA's guidance from 24 July 2017 provides circumstances under which an IRB may approve such a waiver or alteration. This includes situations where the research: involves no more than minimal risk, the waiver or alteration will not adversely affect the rights and welfare of the subjects, the research could not practicably be carried out without the waiver or alteration, and additional pertinent information is provided post-participation when appropriate.

Even when the explicit process of informed consent is waived or altered for specific studies, the principles of participant safety, autonomy, and respect for persons are always prioritized to uphold ethical standards. Those conducting the research must take special considerations with vulnerable populations, including children, prisoners, or marginalized communities to prevent potential exploitation or abuse as informed by the Nuremberg Code and other ethical codes and regulations.