Communicable Disease Guidance

Version Date: July 17, 2017

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.

Defining communicable disease

For the purposes of this guidance, “communicable disease” refers to:

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:

IRB considerations for communicable disease research

To meet IRB requirements with regard to communicable disease testing or use of communicable disease test results:

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:

See Also: