Ethical issues in Public Health Surveillance: the Pan American STEPS Survey for the Surveillance of Noncommunicable Diseases and Risk Factors

› Public health surveillance is an essential function of public health. It applies a methodical, periodic, and standardized data collection process that can map disease, discern patterns over time, place, and population, identify causes, disseminate results, target interventions, and facilitate sharing of scientific knowledge. Surveillance provides “ongoing systematic collection, analysis, and interpretation of health-related data [that is] essential to the planning, implementation, and evaluation of public health practice” (1).

› Public health surveillance is critical because, “what doesn’t get counted doesn’t count”(2). Surveillance seeks to go beyond knowledge and instead focus on action that can address an issue. Surveillance is particularly important for population health, which countries have an ethical duty to protect, and can be used to address inequalities within populations. As such, countries have an obligation to devote the necessary resources to establish “appropriate, feasible, sustainable” surveillance systems with clear purpose and plans for data collection (2). Furthermore, surveillance is “central to the success of the Sustainable Development Goals” (4).

› Surveillance is certainly essential to outbreak and epidemic response and historically, it has focused on infectious diseases. However, as our understanding about the causes of morbidity and mortality evolve and the burden of disease shifts toward noncommunicable diseases (NCDs), countries, too, need to review their surveillance system objectives and structures to address NCDs and their risk factors (RFs) (3).

› Public health surveillance of NCDs and their RFs requires data collection beyond the health sector.

› There are several key sources of information needed to monitor NCDs and their RFs. These include: civil registration and vital statistics that capture mortality data, population-based surveys, NCDs registries, and health care information systems, especially primary health care information.

› Population-based surveys capture a probabilistic sample and measure information within the general population, as opposed to only capturing information from people who were able to access or attend care within the public health system. Population-based surveys are the main sources used to monitor RFs, such as tobacco use, harmful use of alcohol, insufficient physical activity, unhealthy diet, raised blood pressure, raised blood glucose, overweight and obesity. It can also assess compliance of public policies and implementation of programs and interventions.

› STEPS is a NCD/RF surveillance tool based on the concept that surveillance requires ongoing/periodic, systematic, standardized data collection. The survey methodology uses a probabilistic sample to select potential participants that respond to a multi-topic questionnaire through a face-to-face interview conducted in households. The target population are persons 18-69 years old. The STEPS methodology allows comparison within a country and among countries.

The STEPS approach has three levels and within each level, the instrument is divided into core, expanded, and optional modules.

• Step 1- Questionnaire: provides information about the population distribution of NCDs and their RFs.
• Step 2- Physical measurements: includes simple physical measurements, such as height, weight, waist and hip circumference, heart rate, and blood pressure.
• Step 3- Biochemical measurements: Step 3 includes Steps 1 and 2 and adds biochemical measurements. Conducting biochemical measures is a multifaceted process that can be done in the context of a comprehensive survey and in settings where appropriate resources are available. The addition of Step 3 can increase the cost and complexity of data collection. However, if resources allow, it is recommended that countries apply all 3 of the Steps in order to accurately measure 11 of the 25 NCD key indicators presented in the Global Monitoring Framework (GMF).

› STEPS is an essential surveillance tool that can be used to conduct public health surveillance within populations. It is also designed to help countries build and strengthen their surveillance capacity. It allows countries to monitor policies and programs related to NCDs and their RFs. STEPS also helps countries report on global, regional, and national commitments, including the GMF; STEPS relates to 7 of the 9 global targets in the GMF.

› The Step 1 questionnaire covers the following topics: tobacco use; alcohol consumption; diet, including fruit and vegetable intake; dietary salt intake; physical activity; history of raised blood pressure/hypertension, raised blood glucose/diabetes, raised total cholesterol and cardiovascular diseases; lifestyle advice; cervical cancer screening; and, other health screenings. In Step 2, the following physical measurements are taken: blood pressure, height and weight, waist, hip circumference, and heart rate. Step 3 collects biochemical measurements from urine and blood samples (wet or dry), including: urinary sodium and creatinine, blood glucose, blood cholesterol, HDL cholesterol, and triglycerides.

› Some RFs use physical and biochemical measurements as the gold standard of data collection as opposed to self-reported information in an effort to limit social desirability bias, which is when individuals respond to questions in a way that would be viewed favorably by others (5). For instance, women tend to self-report lower body weight and men higher statures than their true physical measurements (5). Applying the STEPS protocol of collecting physical and biochemical measurements ensures the standardization of data collected. It is important to note that the data collector does not provide a diagnosis for individuals based on their physical and/or biochemical measurements, as STEPS is a surveillance tool that aims to measure and asses the health of populations, not individuals.

› STEPS was developed with sufficient flexibility to be implemented in various settings, including in countries where resources are scarce. As such, countries have the ability to implement Step 1, 2 and/or 3 based on the resources and capacity available. The use of technologies such as tablets, digital blood pressure devices, and other devices to measure blood glucose and cholesterol at the household are designed to help decrease costs of survey implementation and increase response rates. STEPS is considered a cost-effective survey compared to other household surveys that collect physical and biochemical measurements because of its flexible design and the limited number of resources required to produce data for a variety of topics. Therefore, it is important to ensure that funds are available for the implementation of a NCD/RF household survey (STEPS or STEPS-like) every 4-5 years, just as funds are routinely allocated for surveillance of transmissible diseases.

› Trends of NCDs and their RFs should be measured every 4-5 years to monitor the impact and implementation of policies, programs, and interventions, such as the “NCDs Best Buys,” applied at the population level and within the healthcare system. The “NCDs Best Buys” were introduced in the World Health Organization’s (WHO) Global Action Plan for the Prevention and Control of Noncommunicable Diseases, 2013-2020 and are essentially a menu of policy options and cost-effective interventions that address key NCDs and their RFs (6,7). The process of implementing these “Best Buys” is not instantaneous, as many require gradual behavioral change modifications within the population and the adoption of public policy actions. Therefore, to capture these changes in a cost-effective manner, it is recommended that STEPS and similar household surveys be conducted every 4-5 years. In addition, while STEPS is a survey carried out in a sample population within a defined time period, if STEPS is repeated routinely every 4-5 years, it can form the foundation of a surveillance system.

› No. Research with human subjects is an activity that aims to produce generalizable knowledge. This is done by testing a hypothesis or determining if an intervention effectively addresses a health issue, among other activities. Ultimately, we all benefit from the conduct of research because it yields valuable knowledge. In contrast, public health practice aims to protect the health of the population in which the collection and analysis of data occurred. Surveillance is a key component of public health practice.

Surveillance resembles research in that both activities apply systematic and rigorous collection of data. However, surveillance serves as a catalyst for public health action, which includes advocacy, planning, implementation, and evaluation of public health policies, programs, and interventions. As a surveillance tool, the STEPS survey collects population data with the main objective of monitoring NCDs and their RFs and assesses countries’ progress toward achieving global, regional, and national commitments. Unlike research, the STEPS survey does not test a hypothesis, nor does it seek to develop new knowledge. The results of STEPS, however, may reveal the need to conduct future scientific research to produce more in-depth information that is not adequately captured in the STEPS surveillance tool.

›  Ethics review committees are tasked with reviewing all research proposals with human subjects to ensure the research is ethical. Unlike research with human participants, which requires prior approval by an ethics review committee, surveillance activities do not need ethics approval. PAHO/WHO advises that determinations of whether an activity constitutes research with human subjects be made by a relevant third party, such as an Ethics Review Committee, instead of those in charge of the activity. This is particularly relevant for activities like STEPS that share important similarities with research.

PAHO/WHO therefore advises countries to submit the STEPS survey implementation plan to an Ethics Review Committee within the implementing country to confirm the proposal is not considered research with human participants according to local laws and regulations in the relevant jurisdiction and is thus exempt from the requirement of an ethics review. In jurisdictions where mechanisms for ethical oversight of surveillance are in place, such oversight must be sought prior to conducting the survey. This same procedure should be followed within PAHO/WHO, as well. STEPS survey implementation plans are to be submitted to PAHO/WHO Ethics Review Committees for clearance. Furthermore, PAHO’s Regional Program on Bioethics provides guidance to anticipate and address ethical challenges that may arise when planning and conducting the STEPS survey and when communicating and sharing its results (2, 8).

› The WHO Guidelines on Ethical Issues in Public Health Surveillance provide the ethical framework that should be followed when implementing STEPS surveys. Applying STEPS ethically includes taking the values and concerns of the population into account and ensuring that no unnecessary additional burdens are imposed on individuals or groups that are particularly susceptible to disease, harm, or injustice. Moreover, risks must be identified, assessed, minimized and disclosed, as well as monitored during survey conduct. In the event a harm occurs, appropriate actions should be taken to mitigate the harm. Those that are responsible for the STEPS survey must treat participants respectfully, ensure that all identifiable data is secured, and use the results of the survey to advance the health of the population, which includes communicating the results to the public in an understandable and meaningful way (2).

› Yes, informed consent must be obtained from every potential participant before conducting the interviews for Step 1, 2, and/or 3. While informed consent is not the default in surveillance activities, it is appropriate for STEPS and a valid, comprehensive consent process must be ensured (2). The consent process begins with an explanation of the survey’s aims, procedures, and collection methods and includes a review of the potential participant’s rights, as well as assurance that their privacy and confidentiality will be protected. During this process, the potential participant has the ability to ask questions about the survey and their participation. Then, the potential participant can decide if he or she will provide consent, which must be expressed verbally and in writing. Step 1 and 2 use Consent Form 1 and Step 1, 2, and 3 use Consent Form 1 and 2. Two copies of the consent form are used: one for the participant’s records and the other to be securely stored in the STEPS coordination office (8).

› Protecting the confidentiality of participants is an ethical duty of those responsible for the conduct of the STEPS survey. They must safeguard the privacy of participants and guarantee confidentiality throughout the entire process. Collected data must also be secured. Those responsible for STEPS must implement the necessary operational and technological safeguards to prevent any unauthorized access or disclosure of data obtained through the surveys. Finally, all individually identifiable information must be removed from the STEPS database prior to public use.

› The STEPS survey team must protect the confidentiality of the collected data and ensure that all individually identifiable data are appropriately secured. Before initiating the survey, it is important to identify, assess, minimize, and disclose perceived risks associated with participation in the STEPS survey, including the risk of stigmatization. The public should be informed about the conduct of the STEPS survey and efforts must be made to engage with the public and consider the values and potential concerns of the participating communities. Most importantly, it is the responsibility of those conducting STEPS to ensure that populations particularly susceptible to disease, harms, or injustice, for example those who are extremely poor or live in remote areas, do not endure any additional unnecessary burdens during or as a result of the conduct of the survey. Routine monitoring of harm is critical; if harm does occur, appropriate actions to immediately mitigate must be taken.

› Yes. Consistent with framework of the WHO Guidelines on Ethical Issues in Public Health Surveillance, the STEPS protocol promotes the access and use of final datasets to advance public health. As mentioned, these datasets do not contain any individually identifiable information; instead the datasets contain information valuable for the advancement of health within the population and can contribute to additional surveillance efforts and future research (2).

› Data collected in the STEPS survey must abide by WHO’s data policy, which states that data is to be made available “to any interested part on request on terms that allow non-commercial, not-for-profit use of the data for public health purposes (provided always that publication of the data shall remain under the control of WHO)” (9). Such policy is consistent with WHO Guidelines on Ethical Issues in Public Health Surveillance, which calls for an obligation to share data with public health agencies for legitimate public health purposes, provided the relevant safeguards are in place (2). The Guidelines further specify that “personally identifiable surveillance data should not be shared with agencies that are likely to use them to take action against individuals or for uses unrelated to public health” (2).

› Information about the conduct of the STEPS survey and its value as part of public health surveillance efforts should be publicly available. Likewise, unidentifiable results of the STEPS survey must be produced in a timely manner after the completion of the survey and communicated in a “clear, concise and usable” way to ensure comprehension by those whose data was collected as well as other relevant target audiences. Communication of surveillance findings to the public should seek to raise awareness about the prevention of NCDs and their RFs, guide public health policies and interventions to address NCDs, and inform future health research. Transparency and dissemination of the findings may also contribute to the strengthening of trust within the population, which is critical for future surveillance efforts. Finally, communication must be strategic and culturally appropriate to prevent stigmatization or discrimination among participants (2, 8).

› After the dissemination of the STEPS survey results and final report, it is the responsibility of the health authorities to make timely use of the findings to inform public health policies and develop programs or interventions to address identified health gaps within the population. In addition, it is critical that countries plan and allocate funds for future implementation every 4-5 years to ensure routine and standardized surveillance of NCDs and their RFs.