Informed consent is one of the primary requirements of research involving human participants. It is important to remember that informed consent is an ongoing process, not a document or single event.

Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers. This requirement is founded on the principle of respect for persons. Potential participants must be ...

Informed Consent Exceptions. Per HHS regulations 45 CFR part 46, the investigator must obtain informed consent from the participant or their legally-authorized representative (LAR). Unless the ...

Exempt Research. Participant Information Sheet Template (Bowdoin Approved) Exempt research does not require the informed consent to be documented (it is at the discretion of the researcher), but the ...

Research that is exempt under 45CFR46.104 is also exempt from Department of Health and Human Services (DHHS) requirements for informed consent as described under §46.116 and for documentation of ...

The federal EFIC rules were developed in 1996 to allow for the waiver of obtaining and documenting informed consent for a strictly limited class of research. Research carried out under EFIC rules ...

Informed consent (IC) is a fundamental aspect of ethical clinical research, safeguarding the rights and well-being of participants. It empowers participants with comprehensive information about the ...

Furthermore, unless the consent process has been specifically waived by the IRB, no subjects may be included in research unless the investigator has obtained the legally effective informed consent of ...

Informed consent involves a subject being given information that a reasonable person would want to have to make an informed decision about whether to participate in research, and the chance to discuss ...

Trial sponsors have struggled to improve trial diversity. Homing in on informed consent may be the key to changing that—with the welcome side effect of empowering patients to participate in ...