Responsible Use of Molecular Epidemiology

Discussing Ethics of Molecular Epidemiology with Washington Communities 

In public health, we use many tools to track and prevent infectious diseases. One method, called molecular epidemiology, helps us see where individual pathogens are spreading in our communities.  

Some community members raised questions about how this practice works and how it affects people with health conditions that are often stigmatized, such as HIV and other sexually transmitted infections (STIs). The Washington State Department of Health Office of Infectious Disease (OID) is holding listening sessions to learn about these concerns and help educate the public about molecular epidemiology.

About Molecular Epidemiology 

When you get sick, your body is infected by germs – like bacteria, fungi, or viruses. Many germs have different types, or strains, that cause the same disease with different symptoms. Think about how the flu is a little different every year. It’s always the flu, but it feels a little different each year because it’s a different strain. 

Each of these strains has its own genome (like DNA). It’s like the germ’s blueprint, creating a unique identity for each strain. In public health, it’s part of our job to track how diseases spread. We look at the germ’s genomes in a group of sick people, compare them, and see if we can learn how different strains are spreading. The process of doing this is called molecular epidemiology. By doing this, we get a clearer picture of how a disease is spreading, and we can be more effective at stopping it. 

How Molecular Epidemiology Works 

When you take a blood test for certain conditions, it is sent to a laboratory. If the test is positive, the laboratory does something called “sequencing,” where we look at the whole germ genome or pieces of it. Those sequences from the germ are sent to DOH’s public health surveillance system. If there’s ever an active outbreak of that disease, we look at these sequences to find similar strains and identify patterns of how they are spreading. This process connects the disease together and helps us stop it from spreading and prevent future infections.

How Molecular Epidemiology Impacts You

These public health efforts help keep you safe from disease. When we know how diseases spread, we can do a better job of preventing them. That makes it less likely for you to catch one of these diseases. 

If you’ve been diagnosed with a disease, you probably gave a blood sample to a doctor to be tested. For a handful of diseases, a lab reviews those blood samples that test positive to find the germ’s blueprint (genome sequence). That sequence is added to national databases to be compared to others. Importantly, it’s the germ’s DNA that we look at – never a person's. The diseases that use molecular epidemiology include flu, hepatitis A, HIV, mpox, tuberculosis, E. coli, and Salmonella.   

Does molecular epidemiology test a disease or a person? 

Molecular epidemiology focuses on a germ (like bacteria, fungi, and viruses). It does not test a person. This is a common misconception. The person’s DNA or RNA is never analyzed, sequenced, or shared.  

How Information Collected Through Molecular Epidemiology is Used 

These data are sensitive, and there are many steps taken to protect people’s identities. Our public health surveillance systems are secure and confidential. Each disease record is labeled with a random ID number instead of a name. The person’s name and other personal information are stored separately. This keeps the data confidential, though not fully anonymous. This personal information is only ever linked back to the disease record in rare circumstances. This could include when public health workers are tracking a strain of public health importance, and we need to contact someone to help stop the disease from spreading. Otherwise, with very few exceptions, the information cannot be shared without a patient’s informed consent. STI disclosure can be requested by a court order if the request shows that it is important in the legal case and is authorized by the law. This information is not shared with law enforcement, except when someone is exposed to a person’s bodily fluids and needs to learn if they've been exposed to any infectious disease. See the list of laws and administrative codes related to this subject below. 

How We're Engaging with Communities and the Feedback We're Getting

OID is getting community feedback to understand concerns and address questions. We’ve held listening sessions with the Washington Syndemic Planning Group (WSPG) Molecular Epidemiology workgroup at DOH, community members involved with WSPG activities, local health jurisdiction staff involved in STI/HIV investigations, and tribal health partners. Outside of these sessions, we also regularly speak with WSPG about molecular epidemiology surveillance.  

Using this feedback, we will review how we use molecular epidemiology data in OID. We’ll aim to align our practices with community feedback about transparency, communication, informed consent, and data privacy. We’ll continue talking to community members about how we use molecular epidemiology and stay open to any feedback. 

In our DOH WSPG listening session, we asked about the following molecular epidemiology techniques: 

  • Seeing if a disease is spreading quickly in one group of people (called identifying clusters of rapid transmission). This is the best method of tracking HIV. It is also used for other diseases.  
  • Tracking strains that could cause more serious illness or are harder to treat. 
  • Describing similar ways a disease is spreading (called transmission patterns) of an epidemic. 
  • Filling in missing demographic information, like missing risk or exposure information. (This was done in the United Kingdom when studying HIV. This is not done in Washington or the rest of the United States.) 
  • Measuring the levels of germs in sewage to learn about the amount of disease in a community (called wastewater-based surveillance). 
  • Using data from secondary sequencing. That is, researchers take existing lab samples (from routine patient care) and perform a different test on them for research purposes. 
  • Sharing data with academic partners. Academics can do more in-depth analyses on these data and add context about different communities.  

 All workgroup members agreed that DOH should use molecular epidemiology to track strains of public health concern. The group agreed unanimously that molecular epidemiology shouldn’t be used to fill in missing demographic information, which does not occur in Washington state or the rest of the United States. Otherwise, the group conditionally approved of using these methods, as long as certain concerns like reducing stigma and criminalization were addressed. 

For transparency and communication, the WSPG group advised that in-person, open-ended conversations are best. They suggested using trusted ambassadors for focused community campaigns, using plain language, translating into multiple languages, and giving general information for all diseases that use molecular epidemiology. 

For informed consent, WSPG advised health providers should give information about how test results are used when they talk to the public. They advised explaining the flow of information from the lab to the other groups in public health. 

For data security and privacy, WSPG explained the need for clear, plain language explanations of Washington laws related to molecular epidemiology. Public health should be clear about the difference between confidential and anonymous, and more information should be provided about whether the information is shared with law enforcement. 

State Laws and Administrative Codes That Impact the Use of Molecular Epidemiology

Responsibilities and Duties of Healthcare Providers 

  • Every health care provider has to explain any instructions and disease prevention methods in an acceptable, culturally and verbally appropriate way. (WAC 246-100-021) 
  • With HIV testing, local health officers have to notify health care providers about any immediate infectious disease concerns. They need to make sure HIV testing is available to everyone, and that it’s voluntary and anonymous. They should only collect the minimum amount of information on people tested for HIV in order to conduct investigations if a person is positive. (WAC 246-100-036) 
    • This WAC also covers the specific ways a local health officer should collaborate with medical providers, health care facilities, emergency management, law enforcement, tribal governments, federal agencies, state agencies, and universities for notifiable infectious diseases.

Laboratory Testing and Reporting 

  • Diagnosis of an STI, including HIV, must be confirmed by a lab test. Labs testing for HIV must report all anonymous HIV results to the health department for health statistics purposes. (RCW 70.24.050) 
  • A person has to give written, informed consent before they give a specimen for a blood-borne pathogen test when the test result is requested for insurance underwriting or coverage purposes (like HIV). (WAC 246-100-207) 
  • Providers and medical facilities must report HIV and STIs to local health departments (where the person currently lives) within 3 days of the positive lab result. (WAC 246-101-101) 
  • Laboratories must report HIV and STIs to the Washington State Department of Health within 2 days of the positive lab result, unless the patient lives in King County. All HIV-positive results for King County residents should be reported directly to Public Health Seattle & King County. (WAC 246-101-201) 
  • If someone is exposed to another person’s bodily fluids during incidents for first responders, health care staff, or corrections, they can send a request to the state or local health officer to order a test for the person whose bodily fluid they were exposed to. (RCW 70.05.180)  
  • A person giving emergency care or transportation as a “Good Samaritan” (as defined by law) can request and receive appropriate infectious disease testing free of charge through the local health department in the county of their residence if they came in contact with bodily fluids while assisting and do not have insurance coverage for testing. (RCW 70.05.180) 

Disclosure 

  • Public health staff are not allowed to disclose someone’s health care information related to HIV unless they have written consent from the person. Public health staff may use identifiable information related to HIV for partner notification, referral to social or medical services, and linkage to other internal public health databases. (WAC 246-101-635). 
  • No one can disclose or be forced to disclose the identity, information, or records of any person who has investigated or requested a test or treatment for an STI. This RCW explains any exceptions. (RCW 70.02.220) 
    • STI disclosure is not shared with law enforcement, with the only exception being when they someone is exposed to bodily fluids to learn if they've been exposed to any infectious disease. 
    • STI disclosure can be requested by a court order if the request shows that it is important in the legal case and is authorized by the law. 
  • When a disclosure happens, it must be accompanied by a statement that includes (RCW 70.02.300):  
    • The information disclosed to you is from records that are confidentially protected by state law.
    • State law prohibits further disclosure of the information without specific written authorization from the person that it is about.
    • A general authorization for the release of medical or other information is NOT sufficient.