Strategies to reduce litigation
A common misperception among providers is that a signed consent form demonstrates
consent. It does not. By itself, a consent form does not verify that true consent was obtained; it
merely documents one phase of the informed consent process. For the patient to be truly
"informed," he/she must understand the information that the healthcare provider has disclosed.
Thus, as part of the consent process, the provider should consider:
. The patient's current knowledge and understanding of his/her condition and the proposed
treatment plan
The patient's overall capacity to understand
Cultural factors, personal values and beliefs, and other considerations that might affect
the patient's decision-making
Any language or communication barriers that could impede the consent process
Additionally, patients should have ample time during appointments to ask questions,
voice concerns, and clarify information with the treating provider.
Legal and Professional Considerations
States and their professional licensing boards may have statutes and regulations
governing informed consent. Healthcare organizations and providers need to ensure that their
informed consent processes and forms incorporate state requirements because they define the
standard of care specific to that state or profession. Although some states and professional
licensing boards may not address informed consent, national professional associations --- such as
the American Medical Association, the American Osteopathic Association, the American College
of Surgeons, the American Society of Anesthesiologists, the American Association of Nurse
Anesthetists, and the American Dental Association, etc. -- provide recommendations related to
the informed consent process. Healthcare providers should check with their professional
associations for specific guidance and best practices.
Improving the Process https://www.ahrq.gov/funding/policies/informedconsent/ictoolkit2.html
Adopting New Processes and Documents in Your Institution
This section of the toolkit offers some strategies for those who seek to serve as change agents in their organizations to improve the informed consent and authorization process.
Raise Awareness
Share examples of readable informed Health Insurance Portability and Accountability Act (HIPAA) consent and authorization documents that have been used succesfully by other institutional review boards (IRBs). Educate IRB members, institutional Iawyers, and researchers on regulatory requirements. Identify sections of documents that are not required and distract from the primary purpose of the documents. Host experts on health literacy, informed consent, and research ethics to educate the research and iRB communities. Share research findings regarding malpractice and communication.
Identify Leaders and Partners
Invite researchers and iRB officials from other communities or accrediting institutions such as the Association for the Accreditation of Human Research Protection Programs, Inc (AAHRPP, www.aahrpp.org) to model new approaches and demonstrate that changing the process for obtaining informed consent and authorization is feasible and worthwhile. Identify opinion leaders who can advocate change among their colleagues.
Enlist technical assistance from the Department of Health and Human Services (HHS) Office for Human Research Protections to resolve questions on whether informed consent document simplification complies with regulations. Review the Web site of the HHS Office for Civil Rights for general HIPAA Privacy Rule information, as well as specific information related to the HIPAA Privacy Rule and research. Review the We