AIDS-Virus Antibody Testing:
Issues of Informed Consent and Patient Confidentiality
By: Madeleine M. Weldon-Linne,
C. Michael Weldon-Linne & Julie Murphy
During the past few years, news reports have extensively covered the growing AIDS1 epidemic and public reaction to it. Coming out of the resulting research efforts to find a cure for AIDS, a blood test was developed to detect the presence of antibodies to HTLV-III (Human T-lymphotropic Virus Type III) which causes AIDS.2
Increasing use of the HTLV-III test as both a diagnostic and medical screening procedure and the serious consequences of a positive test result given the fatality of AIDS,3 the extreme social stigma associated with it, and the inevitable inferences regarding lifestyle have raised anew the issue of informed consent and patients' rights for confidentiality.
Because of the seriousness of these issues, health care facilities and personnel which administer the HTLV-III test must examine their pre-test and test procedures to protect the patients and themselves. Lawyers and public policy makers must also familiarize themselves with the issues and concepts in order to carry out their responsibilities.
This article presents practical suggestions for the hospital and clinician to secure an informed consent and to protect the patient's confidentiality. A proposed consent form is included in this article. Also, a brief overview of the law in the areas of informed consent and confidentiality is provided.
Medical Background
An introduction to the medical aspects of HTLV-III infection is necessary. It is generally accepted that infection by HTLV-III is caused by exposure to human blood and/or body fluids, most commonly by way of intimate sexual contact or receipt (either therapeutically as in the case of blood transfusion, or illicitly as in the case of intravenous drug abusers using contaminated needles) of blood products.4
Infection by HTLV-III results in one of three different scenarios:
- Fifty percent or more of those infected will remain entirely asymptomatic with no clinical evidence of AIDS.
- Approximately 20 to 30 percent of those infected will develop AIDS related complex (ARC), a syndrome characterized by fever, weight loss, fatigue, and lymph node enlargement. This syndrome is sometimes referred to as "pre-AIDS" since some ARC patients go on to develop AIDS.
- Somewhere between 5 and 20 percent of infected individuals will go on to develop full blown AIDS as defined by the Center for Disease Control.5
It must be emphasized that, to date, the majority of individuals infected by HTLV-III do not develop AIDS.6
In March of 1985, the U.S. Food & Drug Administration granted several manufacturers the right to market a sophisticated enzyme immunoassay (ELISA) test for detection of circulating serum antibody to HTLV-III. The test is not capable of detecting the presence of the virus in the body but is, instead, devised to detect the body's immune/antibody response to HTLV-III infection.
In general, the presence of antibody to HTLV-III is considered presumptive evidence of infection by the virus. Since HTLV-III infection is a persistent/chronic phenomenon, the presence of antibody also identifies those individuals at potential risk for transmitting the infection.
The ELISA tests were developed primarily as a means for screening donated blood and blood products to minimize the risk of therapeutic blood product - associated HTLV-III and/or AIDS infections. These tests detect only circulating serum antibody to HTLV-III. A positive test result is not diagnostic of AIDS nor does it predict the future development of AIDS.7
The currently available enzyme immunoas say tests for HTLV-III antibody are extremely sophisticated but not without limitations. Although figures vary, the tests are widely reported to be approximately 99.8 percent specific.8 This means that two out of 1,000 individuals tested, who do not have circulating antibody, will have a positive test result. This phenomenon is referred to in laboratory medicine as a "false positive" test result. To a certain extent, it is a problem inherent in all medical laboratory testing.
The practical significance of such imperfect specificity is that when testing low risk populations (i.e., non-homosexual, non-drug addict, non-promiscuous, non-blood recipient individuals in the case of HTLV-III infection) most positive ELISA test results will, in fact, be false positives. For example, if 100,000 people from a population with a prevalence of HTLV-III infection of 0.1 percent (one infected individual per 1,000) are tested for antibody to HTLV-III, approximately 300 individuals will have a positive test result. Of these 300 people, 200 or 67 percent will be false positives (the two out of every 1,000 individuals predicted by the test's imperfect specificity as indicated above) while only 100 or 33 percent (representing the 0.1 percent prevalence) will actually have been infected by the virus). Although confirmatory tests are available, they are more difficult to obtain and have their own inherent specificity problems.
From this example, it is apparent that HTLV-III antibody testing can have significant shortcomings when used as a screening device for the population at large. In the realm of blood product testing, however, these shortcomings have proved to be of little practical significance since there is no risk entailed by screening out blood or blood products from an individual who is not truly infected with HTLV-III and has a false positive test result.
Additionally, blood collection screening test results are not routinely available to interested third parties, such as employers and insurance companies, thereby increasing the probability of maintaining the blood donor's confidentiality. The imperfections of HTLV-III antibody testing, however, may have great significance when used in the clinical diagnostic setting of patient care.
Given the imperfections of the HTLV-III antibody test and the extreme ramifications of a positive test, fully informing patients of the possible ramifications becomes an important issue.9
Informed Consent
Test results, including false positives and true positives of those who never develop AIDS symptoms, become a part of the patient's permanent medical record. Positive test results may then be used to discriminate against the patient in housing, personal relationships, employment, or insurability, to say nothing of the extreme emotional distress caused.10
The danger for health care facilities in this is that patients not advised of the ramifications of the testing procedure may hold the facility liable for those damages claimed resulting from reporting test results. To minimize this liability, physicians and hospitals will likely develop consent procedures for HTLV-III tests, expanding the standard of care to which all physicians and health care facilities are held to include acquiring informed consent before testing. In any event, given the serious ramifications of the test, informed consent should be a mandatory requirement whenever HTLV-III antibody testing is performed on patients in a clinical setting.
Recognizing the importance of such consent, California,11 Massachusetts,12 and Wisconsin13 have enacted legislation or regulatory safeguards requiring consent from patients before administering the HTLV-III test. Currently, Illinois requires consent to the test only at blood banks and alternative test sites.14
Despite the limited statutory requirements regarding HTLV-III test consent procedures, it is well settled for other medical procedures that in the absence of an emergency or unanticipated condition, a physician must obtain the consent of a competent patient or the consent of someone legally authorized to give consent on the patient's behalf before treating or operating on the patient.15 The corollary to this rule is that consent without adequate knowledge of the risks involved, is not an informed consent.16
The doctrine of informed consent is premised on patients' right to exercise control over their bodies by deciding whether or not to undergo a proposed therapy.17 The courts have based the physician's duty to disclose relevant information to the patient on the fiduciary nature of the physician-patient relationship.18 The physician is learned and experienced in a vitally important subject about which the patient knows little or nothing.19
In the context of ordinary medical therapy, the doctrine of informed consent is usually defined as a duty to warn a patient of:
- material risks;20
- possible complications expected;
- unexpected risks of the proposed treatment;
- reasonable alternatives to the treatment;
- risks and comparative benefits of the alternatives; and
- in most cases, the effects of non-treatment.21
Although the existence of a physician's duty to inform a patient of the risks of a proposed treatment has seldom been denied,22 there are two views as to the extent of the duty. The traditional view, adopted by the Illinois courts, is that the duty to disclose is measured by a medical community standard defined as (1) what is customarily disclosed by physicians, or (2) what a reasonable physician would disclose under like or similar circumstances.23
A more recent view adopted by a number of jurisdictions is that the physician's duty to inform is not measured by a medical standard but by the patient's need for material information.24 Using this standard, the role of the physician is one of advisor rather than decision maker.25
Regardless of the standard applied as to the extent of the physician's duty, tort doctrine requires that the patient must have been injured as a result of submitting to the treatment. Traditionally, "injury" as defined in the informed consent cases refers to physical harm.26
The injury suffered by those patients whose medical records contain a positive HTLV-III test result, however, would not be physical harm. Even though the HTLV-III test itself is non-invasive, positive test results could result in non-physical harm from discrimination and social stigma.27
To avoid liability for these injuries based on failure to inform, informed consent should be obtained from the patient undergoing an HTLV-III test procedure.28 Information should describe the test, its limitations, and the possible effects of the release of test results, and include a realistic evaluation of the limitations of confidentiality guarantees.
A sample consent form containing the suggested inclusions is provided in Appendix A. It contains the following elements:
- A description of the test and limitations of the test;
- A list of all possible results of the test;
- A list of all possible adverse personal and social effects of release of the test results;
- Explanation of the reporting and recording methods of the test results; and,
- Statement of the limitations of efforts to maintain patient confidentiality.
A copy of the consent form should be given to the patient, and placed in the patient's medical record. A signed consent form should accompany the patient's specimen to the laboratory with the lab test requisition. The laboratory file should retain the consent form as well as the test result.
In addition to the consent form, the patient should be given brief written information regarding HTLV-III antibody testing procedure to read over carefully. A sample information sheet is provided in Appendix B.
The information sheet should be attached to the consent form. If possible, the information sheet and consent form should be given to the patient 24 hours prior to the testing to ensure adequate time for the patient to review the information and reach a decision regarding submission to the test.
It is further suggested that the availability of pre-test counseling services would be helpful in obtaining the informed consent. This would supplement the treating physician's comments and the written consent form.
Patient Confidentiality
The patient's right to confidentiality is a right of privacy. The right of privacy is not explicit in the United States Constitution but the right has been recognized.29
In Illinois, the state constitution does specifically provide for protection against invasion of privacy.30 Illinois has further provided by statute that a physician-patient privilege exists which prohibits disclosure of patient information except in certain specific situations.31
The privacy statute was designed to encourage a patient to provide all information necessary for his or her treatment even if that information is embarrassing.32 The responsibilities of physicians and hospitals to protect their patients' medical record from exposure stems from the fiduciary nature of the physician-patient relationship.33
By implication, the Illinois legislature extended the privilege to encompass medical and hospital records.34 Illinois courts allow the hospital to assert the privilege on behalf of a patient.35 Moreover, the physician-patient privilege is a personal one and can only be waived by the patient.36
Despite these constitutional and statutory protections, the right to privacy and the non-disclosure privilege are qualified by a physician's duty to the public health.37 State statutes frequently require a physician to report to authorities certain facts about a patient considered in the best interest of society.38 Similarly, AIDS cases must be reported to the public health authorities.39
This required disclosure to public health authorities illustrates the conflict between the duty to protect the patient's privacy and the duty to the public health. As AIDS is studied by epidemiologists, scientists and government agencies, data must be collected and the patient may have increased concern regarding maintenance of confidentiality.
It would be difficult to argue with the imperative nature of research to study AIDS and its transmission. This research often involves study of the identifiable medical records of AIDS patients.
In that current medical ethics do not require informing patients that records are reported or subsequently submitted to research facilities, patients' expectation of privacy may be higher than it is in reality. Full disclosure of mandated reporting requirements in a consent form, such as that in Appendix A, for HTLV-III antibody testing is thus warranted.
Confidentiality is further complicated by access to medical records by third parties in other contexts.40 Insurance companies, for example, often require applicants for health, life and disability policies to sign authorization forms entitling companies to demand any medical records from hospitals, physicians and other health care providers.41
Also, most state and federal agencies, including those which finance and administer health related services require information concerning patient treatment as a prerequisite for reimbursement.42 Governmental agencies administering specially funded medical services have certain reporting 43 requirements.43
Furthermore, in most clinical settings, the internal handling of patient medical records by health care institutions' and physicians' offices can lead to unauthorized dissemination of confidential medical information.
The sensitive and explosive nature of the HTLV-III Antibody test result as part of the patient's record highlights the need for increased attention to the patient's right of confidentiality. The American Hospital Association (AHA) has joined in recommending that special care be taken to protect the confidentiality of the AIDS patient.44
Three states, including Illinois, have adopted specific legislation aimed at safeguarding the confidentiality of individuals tested for HTLV-III Antibody at blood banks and alternative test sites.45 Additionally, three states, Wisconsin,46 Florida,47 and California,48 prohibit the use of the HTLV-Ill test result to determine eligibility for disability, health or life insurance or to terminate employment.
To strengthen the confidentiality protections of the patient tested for antibody to HTLV-III, hospital and laboratory procedures for reporting HTLV-III Antibody test results should be examined. When the HTLV-III results are reported either "positive" or "negative," the report itself should contain language qualifying the "positive" or "negative" result. The language should appear on the report of the results to the physician and on the chart copy, as in the language suggested in Appendix C.
Measures to protect the confidentiality of the medical chart can also be taken. The patient's chart which contains an HTLV-III test result should be identified as highly confidential and sequestered in the medical records department. This type of special attention to confidentiality is already in wide practice for alcohol and drug abuse patients' charts and psychiatric patients' charts.49
Furthermore, the release of the chart through legitimate channels should be done with great caution. A special and separate consent form should be obtained from the patient before the chart is released for any reason.50
Laboratories that perform the HTLV-III test should set up similar procedures for confidentiality. Laboratory records of test results should be segregated in a confidential file and should not be released without the special signed consent of the patient.
Furthermore, verbal or telephone reports of HTLV-III testing and test results should be prohibited. A better policy would be to refuse to acknowledge by telephone that a test has been administered51 and to require a signed written consent for the release of the written test result, and attachment to the test-result forms the suggested explanations in Appendix C of the positive or negative results.
Current Illinois law does not require that positive test results be reported. Only cases of AIDS must be reported. Failure to report an AIDS case could subject the physician and health care facility to civil and criminal penalties.
Currently, however, there is much debate over the reporting of HTLV-III rest results. If it becomes mandatory to report results, it could be retroactive so that all tests would be reportable to public health authorities.
Confidentiality becomes especially difficult when subsequent treatment is required and complete medical records are necessary. To maximize confidentiality, some facilities accept anonymous out-patient specimens which are identified by number only. The referring source usually devises a coding system.
It would be impractical to devise an anonymous in-patient system for HTLV-III antibody testing, however, because of the charting difficulties surrounding the ordering of lab work on an in-patient and the difficulty in charting the results if the in-patient is known only by number. Logistically, in general, a coded system is difficult to administer and is contrary to the intent of public health directives and accreditation requirements.
Conclusion
A patient should not be tested for HTLV-III antibody without first giving an informed consent regarding the limitations of the test and the consequences of reported test results. The physician and hospital can be held liable for failure to inform a patient fully before administering the HTLV-III test.
The patient also has the right to expect that his or her medical records remain confidential. That confidentiality is not guaranteed and information in the patient's medical record can be released through legitimate channels to interested third parties. The health care facility and laboratory can strengthen the expectation of confidentiality by taking proposed precautions with the records of the patient tested for HTLV-III antibody.
Copyright l986, Illinois Bar Journal. Reprinted with Permission.