Communicable Disease Guidance
Collecting information about participants’ communicable disease status may be a necessity for some research studies. Such information may be needed, for example, in research investigating ways to reduce the transmission of infectious agents in group settings, or a study may exclude subjects with certain infections in order to minimize risks. The purpose of this document is to describe human subjects protection issues related to collecting information about participants’ communicable disease status and to describe the information study teams should provide to the IRB and to study participants when a study collects this information.
Version Date: July 17, 2017
Defining communicable disease
For the purposes of this guidance, “communicable disease” refers to:
- Health conditions that must be reported to health authorities under state and/or federal law, such as hepatitis, tuberculosis, or syphilis. For issues and regulations specific to HIV testing, reporting, or use of results in research, please see the HIV Testing in Research Guidance.
- Health conditions that may require health care providers to use contact precautions, such as gown and gloves or isolation, when interacting with an affected individual.
Testing Performed for Research vs. Clinical Results Used for Research
The implications for human subjects protection differ depending on whether communicable disease testing is a research activity or part of clinical care. The HS IRBs consider such testing to be a research activity if:
- Patients at the study site would not be tested for the same disease(s) if they were not study participants or potential study participants;
- The testing involves a different method of sample collection or analysis than would be used for clinical purposes at the study site; or
- Samples are analyzed by a lab that is not CLIA certified. Note that if the test is investigational or performed by a non-CLIA lab, a validated test must be performed in a certified laboratory prior to any reporting to subjects or their health care providers for use in clinical decision-making.
IRB considerations for communicable disease research
To meet IRB requirements with regard to communicable disease testing or use of communicable disease test results:
- There must be a sound scientific reason for the testing or use of results. For example, in a clinical trial, this information may be necessary in order to exclude patients with disease conditions that would put them at increased risk from investigational treatment. In a medical record review study, communicable disease test results may be necessary to analyzing the study population.
- The study must minimize risks to subjects by providing adequate protections for participants’ privacy and confidentiality, and for data security. To protect sensitive study data from unauthorized disclosures, study records should minimize the personal identifiers associated with the data. It may also be advisable for the study team to apply for a Certificate of Confidentiality. Risks related to communicable disease testing must be reasonable in relation to the anticipated benefits, if any, to participants, and to the importance of the knowledge that may reasonably be expected to result from the research.
- If the study requires testing for communicable disease, risks to participants may include the discomforts of sample collection, learning that they have a disease (usually with significant health consequences), and damage to the person’s reputation and personal relationships as a result of reporting requirements. If a positive test result means that others may also need to undergo communicable disease testing, similar risks apply to those individuals.
- When a research study uses results of communicable disease tests that were performed as part of a participant’s routine care (i.e. the testing is done regardless of whether the individual takes part in the research study), the research-related risks are generally limited to possible breach of confidentiality.
- The study must either inform participants that the research includes communicable disease testing or use of clinical test results, and the associated risks, or meet criteria for waiving informed consent.
- If participants will undergo communicable disease testing as a result of participating in the study, the consent form’s description of study procedures should specify the disease(s) for which participants will be tested, state why the testing is being done, and specify what will happen with the test results (including reporting requirements and whether results will be included in the participant’s clinical record). The description of risks should acknowledge the testing-related risks to the participant and others.
- To meet HIPAA requirements, the study must either obtain participants’ authorization to use and disclose their health information related to communicable disease, or meet criteria for waiving authorization.
- The authorization should be clear that results of communicable disease testing will be included in the protected health information used/disclosed as part of the research.
- The list of recipients outside the covered entity should include the health authorities to which positive test results must be reported.
- The authorization should specify if results of communicable disease testing will be reported in the participants’ clinical record.
Communicable diseases requiring contact precautions
When research involves testing for infections such as methicillin-resistant staphylococcus aureus (MRSA) or vancomycin-resistant enterococci (VRE), it raises human subjects protection issues in addition to those discussed above.
The primary concern raised by this kind of study is its potential impact on participants’ clinical care. Many hospitals have implemented isolation policies to prevent the spread of difficult-to-control diseases. The inclusion of positive results in medical records can also have long-term consequences, since a positive test for infections such as VRE or MRSA can trigger isolation procedures with future hospitalizations.
In addition to the information described earlier, when a research study involves testing for diseases/infections that may require contact precautions, the IRB application and/or protocol should:
- Describe how those diseases are addressed in the clinical setting, including the contact precautions used and how long they would be required. For example, would patients be re-tested at intervals to determine when they are no longer infected? Would extra precautions be lifted after a certain period of time?
- Describe why the potential benefits of reporting positive results in the clinical record outweighs the potential risks and burdens to the research participants. Risks must also be considered in conjunction with the potential benefits of minimizing the potential spread of infectious diseases to other patients.
- The consent form should describe how a positive test result will affect subjects’ interactions with care providers during their study participation (what precautions will be used) and how the test result may affect interactions with care providers after the study.