There has been an increased focus over the past couple of years on patient rights, resulting in a renewed emphasis on informed consent by healthcare regulators, such as The Joint Commission. This ...
Obtaining a patient’s consent is not the same as having a patient sign a consent form. While a written, countersigned document provides important evidence if consent is disputed in court, in order for ...
Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.
Increasingly, medical procedures in the United States are being performed in ASCs. According to statistics released earlier this year, the Centers for Disease Control and Prevention’s National Center ...
Centers for Medicare & Medicaid Service (CMS) revised hospital interpretive guidance in the State Operations Manual, Appendix A-Hospitals on April 1, 2024 in response to media stories of nation’s ...
The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed consent process. Investigators can avoid delay in the review process ...
It's time to revise the informed consent process and create a reasonable-patient standard through shared decision-making between physicians and patients, according to a viewpoint piece in the Journal ...
Fostering global data sharing that allows collaborative work on scarce and disparate resources is essential for research into rare diseases (RDs). 1 The challenges posed by new sequencing technologies ...
Pursuing Interventions for an Incurable Cancer: Adding to Hope or Delusion? In the United States, physician aid in dying (PAD) is now legal in several states. However, neither a requirement for a ...
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.
Research participants have commonly been found to lack basic understanding of fundamental aspects of the studies in which they are participating. The informed consent process is one of many aspects of ...