Disclosure of Test Results to Subjects

http://www.jhsph.edu/CHR/PolicyGuidelines/pandp/OTT-9.pdf

Neal HalseyHolly Taylor

Basic Context

• As part of their enrollment in a research project, a subject has provided samples of blood/tissue that will be processed by the investigator(s) to reveal information relevant to their research question.

• As simple as blood type or as complex as HIV status.

Ethical Principles in Play

• Respect for autonomy

• Every research subject ought to have access to information collected/processed on samples they have provided.

Ethical Principles in Play

• Beneficence

• There are some cases when having access to information may not be in best interest of research subject.

Policy Guidance

• Goal of policy is to provide a framework to facilitate decision making about whether an investigator has an obligation to disclose information.

• Distinguishing the black and white cases so we can attend to the gray.

CHR Policy

• Investigators need to include a plan for disclosure, or a justification for no disclosure.

• The CHR must review the plan for each protocol.

Guiding Principles

1. When subjects agree to be tested as part of a research study, there is an implicit assumption that they will be informed of results that have implications for their present or future health status.

2. Test results should be provided to subjects in a timely manner when:

Test results should be provided to subjects in a timely manner when:

1. diagnostic tests are accurately performed, [and]

2. the results are clinically-relevant, i.e. they indicate the need for, and guide the selection of, effective treatment or measures for prevention, and

3. effective treatment or other intervention is available.

Circumstances in Which Reporting of Test Results May Not Be Required -1

1. the disorder is mild and self-limited;

• e.g. mild respiratory infection, mild rash

2. there is lack of agreement in the medical/scientific community as to the meaning of the test result or what action it indicates,

• unproven test, unknown value (e.g. serum zirconium in myocardial infection, or cancer)

Circumstances in Which Reporting of Test Results May Not Be Required -2

3. the results will not be available in time to provide effective treatment or preventive action;

• e.g. viral cause of transient respiratory infections

• Test is only available at research lab far removed from study site and performed in batch at end of study. e.g. Prevalence of hepatitis C antibody in pregnant women in Togo [This is not a justification for deliberately delaying testing]

Circumstances in Which Reporting of Test Results May Not Be Required - 3

4. the study participant is fully informed about the disease or condition and chooses not to receive the information,

5. the test is performed on unlinked or anonymous specimens, and [or?]

• e.g. prevalence of serum markers for disease in population

Circumstances in Which Reporting of Test Results May Not Be Required - 4

6. the test identifies a condition that is not be treatable, and which, when revealed, may cause the subject psychological stress. This may, however, be balanced by the potential to relieve psychological stress by providing a presumptive diagnosis for an illness, even when it is not treatable.

• e.g. a new test with a predictive value positive of 60% for alzheimers disease

Decision Process

When deciding whether to report test results to subjects, investigators should consider:

1. the seriousness of the subject’s condition, including the risk that a serious illness or condition may develop;

2. the accuracy with which the findings of the test identify or predict the illness or condition, or serve to guide effective treatment or preventive measures; and

3. whether agreed effective measures are available to avoid or ameliorate the illness or condition.