What is informed consent?
Informed consent is a process to promote a patient’s full awareness of a certain situation before he or she makes a decision about healthcare choices. Care providers seeking informed consent must describe to the patient what he or she would like to do (i.e., treatment, procedure, research or trial, or sharing of electronic health record), what information will be collected, and what will be done with the information collected, what information the patient is willing to share, the risks and benefits of what is proposed, and the alternatives (including not performing the suggested intervention). By conducting informed consent, the patient is given the opportunity to fully participate in decisions about his or her healthcare. This process is an ethical obligation of all health care providers and is a law in all fifty states.
When is informed consent needed?
Informed consent applies to all research involving human subjects. It is also required for all diagnostic, therapeutic or surgical procedures that are considered complex, invasive and/or involve the risk of serious injury. Implied consent through the use of a letter of invitation may be used for studies involving anonymous surveys that do not contain items related to sensitive matters (i.e., drug use, sexual behavior).
The process of informed consent:
- Information needed to make an informed decision is disclosed
- Reasonable alternatives to the proposed intervention are described
- The relevant risks, benefits, and uncertainties related to each alternative is described
- The likelihood that the proposed treatment/decision will achieve its intended goals is discussed
- The patient’s understanding is assessed
- The patient decides to accept or decline the intervention
Paper Consent versus Electronic Consent
Traditionally, paper-based consent has been the medium through which researchers and physicians conducted the informed consent process. The paper-based process consists of giving a hard copy consent form to a patient for him or her to review. Then a care provider answers any questions from the patient and in some cases assists the patient in reviewing the paper consent forms. The issues surrounding this procedure are that the paper-based consent form tends to be long and monotonous, and the retrieval of paper forms are often time consuming.
The new electronic consent forms use tablets or computers as the medium for communicating information and seeking consent from the patient. Multimedia enhancements and web links to educational material are often incorporated into such electronic forms to provide a greater level of understanding for the patient.
The use of electronic consent and consent management systems has evolved with the emergence of the electronic health record. Currently, some institutions, such as the University of Nebraska Medical Center and the Medical University of South Carolina, are designing electronic consent applications and management systems, some of which are intended to become open source and available to the healthcare community. The Medical University of South Carolina has partnered with iDASH to begin a pilot study recruiting hundreds of patients to create a mechanism form managing informed consents and permissions and developing a Biomedical Research Permissions Ontology (RPO). The University of Nebraska Medical Center’s IRB is designing an informed consent system for their hospital’s use. The iDASH team is also currently working on two systems, iCONS and iCONCUR, which are intended for such open source use in the future.
iDASH electronic informed consent management system
iCONS is a system currently being tested in a clinical trials environment at Moores Cancer Center Biorepository. The system supports informed consent electronically by enhancing the consent process for patients and researchers by acting as a consent broker and by adding multimedia aspects to the process. This consent process is opt-in, meaning no patient information is shared with researchers until the patient specifies what specific information he or she would like to share with researchers. The iCONS system creates a permission ontology to model the consent choices of the patient to assist in the process of releasing data and specimens to researchers for their consented uses.
iCONCUR is a pilot study within the University of California - San Diego Health System. This system transforms the sharing of electronic records from the opt-out system that is currently in place, meaning a patient’s record is automatically entered into the system unless the patient specifically requests to have their records taken out, to an opt-in system. The tool presents the patient with a taxonomy of his or her medical record allowing the patient to dictate what parts of the medical record to share and with whom it may be shared with.