HIT Consultant
JANUARY 16, 2024
Director, Product & Strategy, Patient Consent, IQVIA Technologies The clinical trials landscape continues to evolve and with it, an exponential growth in the adoption of electronic informed consent (eConsent) solutions. Conventional, paper-based methods can overwhelm patients with lengthy, complex documents to read.
American Medical Compliance
SEPTEMBER 10, 2023
When a medical professional informs a patient of the advantages, disadvantages, and alternatives of a procedure or intervention, informed consent is obtained. According to the Joint Commission, all aspects of informed consent must be documented “in a form, progress notes, or elsewhere in the record.”
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Bill of Health
SEPTEMBER 23, 2022
While EA is intended for treatment and is not research, federal regulations require IRBs to review and approve EA protocols and requests, the consent process, consent documents, surrogate consent, and related documents. Additionally, the patient or a surrogate decision-maker must provide valid consent.
AIHC
NOVEMBER 12, 2024
Written by Gabriella Neff, RHIA, CHA, CHC, CHRC, CHPC This past year, in 2024, revisions were made to clarify hospital guidelines related to informed consent specifically addressing UIEs (unconsented intimate exams) to patients while under anesthesia. OCR recently issued an FAQ focusing on this right. [6]
Healthcare IT Today
SEPTEMBER 1, 2022
For this reason, the ability to provide the option for electronic informed consent (eConsent) to join a trial in place of traditional paper-based process plays a pivotal role in quickly enrolling the patient so that they may receive critical intervention as quickly as possible. The Challenge of Informed Consent in the ICU.
Hall Render
OCTOBER 5, 2023
Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. Informed consent includes the following basic elements: Description of clinical investigation.
Bill of Health
JULY 18, 2022
The study offered participants a prompt drawn from classical debates in bioethics on the ethical status of advance directives — documents composed while at full cognitive abilities that direct certain medical treatment in the event that the author later loses mental capacity.
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