REQUIREMENTS WHEN TESTING FOR REPORTABLE DISEASES SUCH AS HIV AND HEPATITIS
Subjects must be told when this testing is done for purposes of the study. (Note: They should also be informed if testing for illegal drug use.) Clarify whether HIV and/or hepatitis testing will be done for purposes of the study or as part of standard care. Would HIV and/or hepatitis testing have been required for standard clinical management (done regardless of study participation)? If not, then the screening will be done for research purposes and the specific issues must be addressed.
in the protocol:
(i)whether a positive result will be confirmed and, if so, how and when
(ii)timing between test results and informing subject
(iii) structure for counseling those who are seropositive
(iv)provision for transmitting the information to those who may be at risk because of exposure (see Health Department link below)
(v)state who will provide counseling
(vi)the extent to which confidentiality will be maintained [for example, will results be recorded in the subjects medical record, or only the subject's study/research record; will the information be available to third parties who request medical record information for billing or insurance, etc.]
in the consent form:
(i)why the screening is necessary
(ii)Explain the meaning of a positive and negative result (explain that a positive does not mean they have HIV or AIDS only that confirmatory tests are required, a negative does not mean they are negative…)
(iii)how subjects will be informed of results and whether subjects will be allowed to continue in the study
(iv)that counseling and/or treatment will be available
(v)the extent to which the confidentiality of the results will be maintained and safeguarded
(vi)a discussion of the risks of being tested for hepatitis and risk of disclosure of positive results.
All subjects who sign the local consent must be told what reporting is required by this State.
The following website can provide more information regarding what diseases must be reported and what PHI is included in the report. http://www.tdh.state.tx.us/ideas/report/default.asp You may also contact the IRB office if you need further guidance.
NOTE: If testing for illegal drug use, the subject must be informed:
· Whether the testing is done as part of standard care (would be done at this time regardless of study participation) or solely for research purposes (such as to determine study eligibility)
· Whether a positive test result will exclude the subject from study participation
· Whether the results will be placed in the medical record (where 3rd parties, such as an insurance company or an employer might gain access) or only in the research record [You should check with the site where the study is being conducted regarding that facility’s policy.]