Barriers and pathways to informed consent for ionising radiation imaging examinations: A qualitative study

IntroductionInformed consent for ionising radiation medical imaging examinations represents a recent change to medical imaging practice. This practice has not had a definitive and authoritative integration into clinical practice, and lack of direction has caused many health care professionals to be unsure of an appropriate consent methodology. Consent practices have been undertaken inconsistently and sometimes poorly. This research sought to investigate what barriers exist to meaningful informed consent, and what pathways are suggested to overcome these barriers. These views are then discussed in the context of practical health care consent practices.MethodsA semi-structured interview explored the views of radiographers and radiologists on the practice of disclosing the ionising radiation risk of a clinical medical imaging examination. Qualitative data was analysed using a nominal method of quantitative transformation. Responses were reviewed, and a set of definitive themes constructed. Participants considered the influences, logistics and barriers to the informed consent process. Participants were then asked what pathways might be developed that would improve the process.ResultsTwenty-one (21) radiographer participants and nine (9) radiologists were interviewed. The barriers to consent identified issues of time constraints, lack of a unified message, and patient presentations. Pathways suggested included limiting the scope of the consent practice, sharing the consent responsibility, and formulation of definitive consent guidelines.ConclusionA unified, definitive series of guidelines for informed consent for ionising radiation examinations would alleviate many of the identified barriers. Having the consent process consistently begin with the referring doctor would facilitate more meaningful consent.     

Response of patients to informed consent for excretory urography

The desirability of obtaining written informed consent for low-risk radiologic procedures has been the subject of controversy. A group of 80 patients was studied to evaluate the effect of informed consent for excretory urograms on: (1) incidence of contrast reactions; (2) discomfort during the procedure; (3) level of patients' anxiety before and after the procedure; (4) patients' perception of the procedure; and (5) desirability of informed consent from the patients' viewpoint. Results revealed no statistically significant difference between the 2 groups in the incidence of reactions, discomfort, perception of the examination, or anxiety level prior to the procedure. The informed consent group had a statistically greater factual knowledge of the procedure evaluated objectively (P less than 0.01). Of the patients who received the written consent form, 83% regarded it as helpful and none viewed it as harmful or refused the examination. In the control group, 32% desired more information.     

ISAT and ISUIA: the impact on informed consent

The International Subarachnoid Aneurysm Trial (ISAT) was a multicenter randomized trial that compared the safety and efficacy of endovascular coil treatment versus surgical clipping for the treatment of ruptured brain aneurysms. To be eligible for enrollment in the ISAT trial, each patient had to be deemed equally suitable for either coiling or clipping. The investigators used the term "clinical equipoise" to describe this balance. This study more than any other has set the playing field for the future of interventional radiology/endovascular neurosurgery politics.     

The radiologist and informed consent: A review, comments and proposals

In summary, the physician's duty to inform has been described and discussed. The minority and majority rule have also been defined and analyzed along with the major causes of physician failure and resistance to disclose risks. In a proper physician-patient relationship, informed consent controversy should be rare. A calm, clear, direct and properly documented disclosure of risks of a procedure is the best defense in any jurisdiction.     

Controversy, alternatives, and decisions in complying with the legal doctrine of informed consent.

The complexities involved in conforming with the legal doctrine of informed consent at present are seemingly limitless. This communication is designed to acquaint the physician attempting to comply with this legal doctrine with an experience gained during the last four years. The major points are aimed at the most frequently asked questions and decisions involved in its implementation. An alternative approach to the question of how and whom to inform is provided, which may make the task easier for those seeking to inform their patients.     

Use of informed consent for ionic and nonionic contrast media.

The use of informed consent before intravenous administration of contrast material remains a controversial issue. It involves explaining the risks of intravenous contrast material and obtaining the patient's permission for its use. All physician groups who had billed Pennsylvania Blue Shield for at least three intravenous contrast material-enhanced procedures performed in 1989 were surveyed. Informed consent was obtained from at least some patients by about two-thirds of physician groups before using intravenous contrast material, regardless of whether it was ionic or nonionic. Nonradiologists were more likely to obtain informed consent before the use of ionic contrast material than radiologists. Regardless of specialty, practices associated with larger hospitals (greater than 250 beds), larger physician groups (greater than 10), or a university used informed consent less often than smaller physician groups or those associated with a smaller hospital or a private practice. Though results may be affected by regional variation or increased usage since previous surveys, the use of informed consent before the intravenous injection of contrast material is a common practice; it is obtained in the majority of patients.     

Revisiting informed consent in forensic genomics in light of current technologies and the times

Informed consent is based on basic ethical principles that should be considered when conducting biomedical and behavioral research involving human subjects. These principles—respect, beneficence, and justice—form the foundations of informed consent which in itself is grounded on three fundamental elements: information, comprehension, and voluntary participation. While informed consent has focused on human subjects and research, the practice has been adopted willingly in the forensic science arena primarily to acquire reference samples from family members to assist in identifying missing persons. With advances in molecular biology technologies, data mining, and access to metadata, it is important to assess whether the past informed consent process and in particular associated risks are concomitant with these increased capabilities. Given the state-of-the-art, areas in which informed consent may need to be modified and augmented are as follows: reference samples from family members in missing persons or unidentified human remains cases; targeted analysis of an individual(s) during forensic genetic genealogy cases to reduce an investigative burden; donors who provide their samples for validation studies (to include population studies and entry into databases that would be applied to forensic statistical calculations) to support implementation of procedures and operations of the forensic laboratory; family members that may contribute samples or obtain genetic information from a molecular autopsy; and use of medical and other acquired samples that could be informative for identification purposes. The informed consent process should cover (1) purpose for collection of samples; (2) process to analyze the samples (to include type of data); (3) benefits (to donor, target, family, community, etc. as applicable); (4) risks (to donor, target, family, community, etc. as applicable); (5) access to data/reports by the donor; (6) sample disposition; (7) removal of data process (i.e., expungement); (8) process to ask questions/assessment of comprehension; (9) follow-up processes; and (10) voluntary, signed, and dated consent. Issues surrounding these topics are discussed with an emphasis on addressing risk factors. Addressing informed consent will allow human subjects to make decisions voluntarily and with autonomy as well as secure the use of samples for intended use.

     

Sterilization of mentally retarded individuals: informed consent in Guidelines in the Netherlands

The purpose of this paper is to describe and discuss the Guidelines of the Dutch Health Care Inspectorate' with respect to sterilization of mentally retarded individuals. In 1998, the Minister of Health had the 1989 Guidelines replaced by new ones. Two new laws were integrated into these new Guidelines: the Medical Treatment Agreement Act (hereinafter referred to as WGBO, being the Dutch abbreviation) and the Mentorship Act. The minister was also inspired to draw up new Guidelines by the revelation in the media of involuntary sterilizations still taking place in several European countries. She is adamant that the Guidelines should be a 'guarantee against involuntary sterilizations'. This issue requires special guidelines because of judicial questions connected with the sterilization of individuals who are more or less incapable of giving informed consent. Involuntary sterilization is a violation of basic human rights, such as the right of physical integrity and protection of privacy. The Guidelines describe how the decision-making process between doctor, patient, representatives, proxies or guardians should proceed and what to do when parties do not reach consensus. A distinction has been made between competent and incompetent patients. The Guidelines and the WGBO give answers to questions like the following: will the informed consent of representatives and proxies be sufficient to perform sterilization? Do doctors have to follow representatives and proxies? Can sterilization take place in spite of a patient's resistance? The Guidelines focus on the process of decision-making, in order to guarantee an appropriate procedure, with the best possible outcome for the mentally retarded individual. The Guidelines do not answer the question of what legitimate reasons doctors may have for performing sterilization on such a person. Given the substantial questions involved the Minister of Health has asked the Health Council to add possible grounds to the Guidelines that should be taken into account when deciding on sterilization.