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Guidelines for Defining Public Health Research and Public Health Non-Research

Revised October 4, 1999

PURPOSE

The Centers for Disease Control and Prevention (CDC) is committed to preventing disease and injury and improving health for all Americans. CDC is also committed to protecting individuals who participate in all public health activities. In the conduct of public health research, CDC follows the Code of Federal Regulations, Title 45, Part 46, The Public Health Service Act as amended by the Health Research Extension Act of 1985, Public Law 99-158, which sets forth regulations for the protection of human subjects.

This document, Defining Public Health Research and Public Health Non-Research, sets forth CDC guidelines on the definition of public health research conducted by CDC staff irrespective of the funding source (i.e., provided by CDC or by another entity). Under Federal regulations (45 CFR 46), the final determination of what is research and whether the Federal regulations are applicable lies with CDC and, ultimately, with the Office for Protection from Research Risks (OPRR). Thus, this document is intended to provide guidance to state and local health departments and other institutions that conduct collaborative research with CDC staff or that are recipients of CDC funds. The guidelines are intended to ensure both the protection of human subjects and the effective practice of public health.

BACKGROUND

In 1974, the Department of Health and Human Services (formerly the Department of Health, Education and Welfare) developed regulations to assure the protection of human subjects from research risks. These regulations were developed to address ethical issues raised in connection with biomedical or behavioral research involving human subjects. Because most biomedical research is funded by the National Institutes of Health (NIH), the regulations were developed to deal specifically with the types of research funded by NIH. The regulations have been revised several times; currently the Department is operating under Title 45 Code of Federal Regulations Part 46, 1991 revision. The regulations will be referred to as 45 CFR 46.

The practice of public health poses several challenges in implementing 45 CFR 46. Although some public health activities can unambiguously be classified as either research or non-research, for other activities the classification is more difficult. The difficulty in classifying some public health activities as research or non-research stems either from traditionally held views about what constitutes public health practice or from the fact that 45 CFR 46 does not directly address many public health activities. In addition, the statutory authority of state and local health departments to conduct public health activities using methods similar to those used by researchers is not recognized in the regulations. Human subject protections applicable for activities occurring at the boundary between public health non-research and public health research are not readily interpretable from the regulations.

The regulations state that "research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Obtaining and analyzing data are essential to the usual practice of public health. For many public health activities, data are systematically collected and analyzed, blurring the distinction between research and non-research. Scientific methodology is used both in non-research and research activities that comprise the practice of public health. Because scientific principles and methodology are applied to both non-research and research activities, knowledge is generated in both cases. Furthermore, at times the extent to which that knowledge is generalizable may not differ greatly in research and non-research. Thus, non-research and research activities cannot be easily defined by the methods they employ. Three public health activities - surveillance, emergency responses, and evaluation - are particularly susceptible to the quandary over whether the activity is research or non-research.

The key word in the regulations' definition of research for the purpose of classifying public health activities as either research or non-research is "designed." The major difference between research and non-research lies in the primary intent of the activity. The primary intent of research is to generate or contribute to generalizable knowledge. The primary intent of non-research in public health is to prevent or control disease or injury and improve health, or to improve a public health program or service. Knowledge may be gained in any public health endeavor designed to prevent disease or injury or improve a program or service. In some cases, that knowledge may be generalizable, but the primary intention of the endeavor is to benefit clients participating in a public health program or a population by controlling a health problem in the population from which the information is gathered.

Classifying an activity as research does not automatically lead to review by an institutional review board (IRB) for the protection of human subjects. Once an activity is classified as research, two additional determinations must be made: (1) does the research involve human subjects and, if so, (2) does the research meet the criteria for exemption from IRB review. This policy deals only with the first determination of whether a public health activity is research or non-research.

DEFINITIONS

Research - As defined in 45 CFR 46, research means "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Human Subjects - As defined in 45 CFR 46, a human subject means "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects."

Surveillance - The ongoing, systematic collection, analysis, and interpretation of outcome-specific data, closely integrated with the timely dissemination of these data to those responsible for preventing and controlling disease or injury (Thacker and Berkelman, 1988).

Emergency Response - A public health activity undertaken in an urgent or emergency situation, usually because of an identified or suspected imminent health threat to the population, but sometimes because the public and/or government authorities perceive an imminent threat that demands immediate action. The primary purpose of the activity is to document the existence and magnitude of a public health problem in the community and to implement appropriate measures to address the problem (Langmuir, 1980).

Program Evaluation - An essential organizational practice in public health using a systematic approach to improve and account for public health actions (Centers for Disease Control and Prevention, 1999)

Evaluation - The systematic application of scientific and statistical procedures for measuring program conceptualization, design, implementation, and utility; making comparisons based on these measurements; and the use of the resulting information to optimize program outcomes (Rossi and Freeman, 1993; Fink, 1993).

POLICY

CDC is required to and has an ethical obligation to ensure that individuals are protected in all public health research activities it conducts. All CDC activities must be reviewed to determine whether they are research involving human subjects. When an activity is classified as research involving human subjects, CDC and its collaborators will comply with 45 CFR 46 in protecting human research subjects.

Some surveillance projects, emergency responses, and evaluations are research involving human subjects; others are not. Each project must be reviewed on a case-by-case basis. Although general guidance can be given to assist in classifying these activities as either research or non-research, no one criterion can be applied universally. The ultimate decision regarding classification lies in the intent of the project. If the primary intent is to generate generalizable knowledge, the project is research. If the primary intent is to prevent or control disease or injury or to improve a public health program, and no research is intended at the present time, the project is non-research. If the primary intent changes to generating generalizable knowledge, then the project becomes research.

GUIDANCE FOR COMPLIANCE

I. General

II. Specific

1. Surveillance - Surveillance is a term describing a method for public health data collection. Surveillance systems may be either research or non-research. Surveillance systems are likely to be non-research when they involve the regular, ongoing collection and analysis of health-related data conducted to monitor the frequency of occurrence and distribution of disease or a health condition in the population. Data generated by these systems are used to manage public health programs. They have in place the ability to invoke public health mechanisms to prevent or control disease or injury in response to an event. Thus, the primary intent of these surveillance systems is to prevent or control disease or injury in a defined population by producing information about the population from whom the data were collected. These attributes of surveillance that is non-research are generally found in state statute or regulation where the intent of the activity, its purposes, and uses of the data are specified. Surveillance systems that most easily fit into this category are ones in which the data are limited to describing the occurrence of a health-related problem (disease reporting) and systems in which no analytic (etiologic) analyses can be conducted. Subjects are rarely selected according to a design; rather, all cases are entered into the surveillance system because they are passive reporting systems. Hypothesis testing is not part of the system.

   Surveillance systems are likely to be research when they involve the collection and analysis of health-related data conducted either to generate knowledge that is applicable to other populations and settings than the ones from which the data were collected or to contribute to new knowledge about the health condition. The information gained from the data collection system may or may not be used to invoke public health mechanisms to prevent or control disease or injury, but this is not a primary intent of the project. Thus, the primary intent of these surveillance systems is to generate generalizable knowledge. Characteristics of surveillance systems that most easily fit into this category are: longitudinal data collection systems (e.g., follow-up surveys and registries) that allow for hypothesis testing; the scope of the data is broad and includes more information than occurrence of a health-related problem; analytic analyses can be conducted; and cases may be identified to be included in subsequent studies.

   In general, lawful state disease reporting, monitoring requirements and other data collection activities conducted under state statute or under recognized public health authority are non-research. Disease reporting activities are not research. Disease reporting, for these purposes, is defined narrowly to include the reporting of the specific health condition or disease, demographic information; and accepted, known risk factors as specified in state statutes or regulations. When reporting systems collect data beyond standard reporting information, the reporting activity is not automatically considered to be non-research. Collection of data that would allow etiologic analysis is likely to be research.

   If other activities are added to a surveillance project with the specific intent of generating new or generalizable knowledge, these additional activities are considered to be research. It becomes important to distinguish between disease reporting activities that are non-research and uses of the reported data that may be either non-research or research.

   Sometimes, CDC funds state and local health departments to establish surveillance systems with dual intentions on the part of CDC: to build state capacity in disease reporting and for CDC to generate new knowledge. Disease reporting activities conducted at the state level are generally non-research. However, if CDC uses the data collected through such reporting to generate new knowledge, CDC would be engaged in research. CDC may consider state health departments to be engaged in the research depending upon their role. If state health departments are participating beyond merely providing the data, they may be considered as engaged in the research. Institutions providing information to state health departments would not be considered engaged in the research (see OPRR memorandum dated 1/26/99).

   Some surveillance projects do not fit easily into the categories described above. For these projects, the primary intent and elements of the project must be examined carefully.

2. Emergency Responses - Most emergency responses tend to be non-research because these projects are undertaken to identify, characterize, and solve an immediate health problem and the knowledge gained will directly benefit those participants involved in the investigation or their communities. However, an emergency response may have a research component if: 1) samples are stored for future use intended to generate generalizable knowledge or 2) additional analyses are conducted beyond those needed to solve the immediate health problem. When investigational new drugs are used or drugs are used off-label, the emergency response is almost always research. The same applies to medical devices. For emergency responses, whenever a systematic investigation of a non-standard intervention or a systematic comparison of standard interventions occurs, the activity is research.
3. Evaluation - The terms "evaluation" and "program evaluation" are used interchangeably. Yet, there are subtle differences between the two terms (see definitions and reference provided above). Evaluation is a term, broad in meaning, that refers to the systematic use of scientific methods to measure efficacy, implementation, utility, and so on of a program in its entirety or its components. Evaluations may or may not be research. Program evaluations are a subset of evaluations. As defined here program evaluations are almost never research.

   When the purpose of an evaluation is to test a new, modified, or previously untested intervention, service, or program to determine whether it is effective, the evaluation is research. The systematic comparison of standard or non-standard interventions in an experimental-type design is research. In these cases, the knowledge gained is applicable beyond the individual, specific program. Thus, the primary intent is to generate new knowledge or contribute to the knowledge in the scientific literature. Further, it is intended to apply the knowledge to other sites or populations.

   When the purpose is to assess the success of an established program in achieving its objectives in a specific population and the information gained from the evaluation will be used to provide feedback to that program, the evaluation, referred to as program evaluation, is non-research. In the non-research scenario, the evaluation is used as a management tool to monitor and improve the program. The evaluation activity is often a component of the regular, ongoing program. Information learned from the evaluation has immediate benefit for the program and/or the clients receiving the services or interventions. The information is often not generalizable beyond the individual program. Interventions and services that are evaluated are never experimental or new; they are known (either from empirical data or through consensus) to be effective.

   Sometimes, the term "formative evaluation" is used to describe data collection activities that occur prior to the implementation of an intervention, service, or program. Whether the "formative evaluation" is research or non-research depends upon its intent. If the evaluation is conducted prior to implementing a new, modified, or previously untested intervention, the evaluation is part of the overall research project. If the evaluation is conducted to provide information on how to tailor a proven-effective intervention, service, or program in a specific setting or context, the evaluation is not research.

   Evaluations of CDC's national programs, i.e., programs that CDC funds to all state health departments and in which evaluation is one component, are not research. These evaluation activities are on-going and involve generally the collection of minimal, standard data elements across all sites. The data are generally used at the local level as a management tool as well as at the national level for the same purpose. Sometimes, data from these evaluation activities will be aggregated at CDC and used for other purposes. When this occurs, subsequent use of the data may be research.

   In some cases, program activities and evaluation activities are separable. For example, interventions or services are being provided; they have a history of being provided and there is an intention to continue to provide them. An evaluation is conducted to determine the efficacy of these program activities. In another example, a public health department, under its public health authority, may provide an untested intervention in an outbreak situation. An evaluation component is added. In both of these examples, because the intervention and evaluation activities are undertaken with different intentions and are separable, the intervention activities are not research but the evaluation activities are research.

APPENDIX

Examples of CDC surveillance, emergency responses, and evaluation activities that are non-research and research.

SURVEILLANCE:

Non-research -

National Notifiable Diseases Surveillance System (NNDSS) - States and territories have asked CDC to act as a common data collection point for data on nationally notifiable diseases. A notifiable disease is considered by the Council of State and Territorial Epidemiologists to be a condition for which regular, frequent, and timely information about individual cases is necessary at the national level for the prevention and control of disease. NNDSS data are collected and published weekly in the Morbidity and Mortality Weekly Report and annually in the Summary of Notifiable Diseases, United States. The NNDSS is essential to the day to day practice of public health. The primary intent of the surveillance system is to provide CDC and state and local health officials with information to detect and control outbreaks of disease. The NNDSS is also used to measure the impact of programs such as immunization. The intended benefits resulting from the NNDSS are for the residents of the states and local areas who contribute data to the system.

Diabetes Surveillance Report - Using public use data from several national surveys, a national diabetes surveillance system is produced. Data from the surveillance system are used to describe the burden of diabetes and its complications on a national and state level. The primary intent of the surveillance system is to provide information for the development of national and state public health priorities and policies regarding the prevention and control of diabetes. The intended benefits are for those who have diabetes or those who are at risk of developing diabetes.

Research -

A Sentinel Surveillance System for Lassa Fever in the Republic of Guinea - Four study sites were selected to identify and describe cases of Lassa fever. Cases were identified from hospital and outpatient admissions. The purpose of the project was to generate baseline information on the Lassa virus and human clinical Lassa fever in the Republic of Guinea. No public health interventions were planned as part of this project; there was no direct benefits for study participants. Thus, the primary intent was to contribute to the knowledge of Lassa fever.

Developmental Disabilities in Very Low Birthweight Children: Linkage of the Georgia Very Low Birthweight Study and the Metropolitan Atlanta Developmental Disabilities Surveillance Program - The Metropolitan Atlanta Developmental Disabilities Surveillance Program, an ongoing CDC surveillance program to monitor trends in the occurrence of selected developmental disabilities in children living in the metropolitan Atlanta area, and the Georgia Very Low Birthweight Study, conducted in the 1980s to investigate the environmental and other risk factors for very low birthweight were linked for specific investigations of adverse developmental outcomes. Linkage of these primary files provides a unique opportunity to assist efforts to assess the occurrence of selected developmental disabilities in metropolitan Atlanta children and to identify causes of these conditions without the additional time and resource expenditure of additional field data collection. For these investigations involving secondary analyses of the linked primary data sets, no individuals were contacted; only information available from the linkage were used. The purpose of the project was to estimate the prevalence of cerebral palsy, mental retardation, and hearing and visual impairments and to identify pre- and perinatal medical and sociodemographic risk factors for these disabilities in a population-based cohort of very low birthweight children in Atlanta. The primary intent was to generate generalizable knowledge about developmental disabilities.

EMERGENCY RESPONSES:

Non-research -

Outbreak of Gastroenteritis - Three days after a cruise ship left Los Angeles, California for several ports in Mexico, CDC was notified that 24 of 1,899 passengers and 6 of 670 crew had presented to the ship=s infirmary with gastrointestinal illness. The purpose of the investigation was to determine the cause and extent of the outbreak and to prevent and control gastrointestinal illness among the ships passengers and crew. Although this type of investigation is often undertaken after the outbreak has occurred and therefore information gained is likely to benefit the ship=s next set of cruise passengers and crew, the primary intent of the investigation is to assist in controlling the current disease outbreak.

Recall of Six Lots of Influenza Vaccine - One of the pharmaceutical companies who manufactures influenza vaccine instituted a voluntary recall of six lots of influenza vaccine. The lots were recalled due to decreased potency of the A/Nanchang/933/95 (H3N2) component of the vaccine. CDC was notified by a state health department that a nursing home had vaccinated its residents with the recalled vaccine. The purpose of the investigation was to determine whether residents of this nursing home who received the vaccine had a suboptimal immune response and required revaccination. The primary intent of this investigation was to prevent the occurrence of influenza among the participants if they demonstrated a suboptimal immune response; there was a potential for participants to receive a direct benefit in the form of revaccination if they participated.

Research -

Childhood Exposure to Nicotine-Containing Products in Rhode Island - Between January 1, 1995 and June 30, 1996, 90 cases of nicotine-containing products were reported to the Rhode Island Poison Control Center. No known population-based investigation has been conducted to determine risk factors associated with nicotine-containing products poisoning. The purpose of the Epi-Aid was to determine risk factors associated with childhood exposure to nicotine-containing products, and to develop appropriate control measures. Although there may be some benefit to the 90 children exposed in Rhode Island, the benefits from this study extend beyond the study participants to the population of children who are at risk of exposure to nicotine-containing products. In addition, there was no immediate health problem to be controlled. Thus, the primary intent of the investigation was to generate generalizable knowledge about the risk factors associated with childhood exposure to nicotine-containing products.

Azithromycin Used as Prophylaxis Against the Spread of Illness Due to Mycoplasma Pneumoniae in the Setting of an Outbreak - During the first week of freshman entering a post high school academic institution, a cluster of respiratory illness was recognized by the infirmary staff. Early serologic testing suggest Mycoplasma pneumoniae as the etiologic agent. About four weeks later 42% of the freshman and 17% of the upperclassmen reported a respiratory illness; 50% of those tested had serologic evidence of Mycoplasma pneumoniae infection. The lower attack rate among upperclassmen was likely a consequence of them returning to campus 15 days after the freshmen arrived. A trial of chemoprophylaxis with azithromycin was proposed. Highly effective control measures in the setting of an outbreak have not been described. There is limited information about the role of antimicrobials in controlling an epidemic of Mycoplasma pneumoniae. Thus, the primary intent of the investigation was to generate generalizable knowledge about the efficacy of azithromycin to prevent the spread of Mycoplasma pneumoniae in an outbreak situation.

PROGRAM EVALUATION:

Non-research -

Evaluation of School-based HIV Prevention Program - As part of the evaluation of the school-based HIV prevention program in Denver public schools, principals, teachers, student contact staff, students, and parents were interviewed. HIV program efforts in policy awareness, staff development, curriculum implementation, and status of students receiving HIV prevention education were assessed.

The purpose (primary intent) of the program evaluation was to provide information to Denver public schools that will be used to improve their school-based HIV prevention programs. The results from the evaluation were used to assess the success of the interventions in a specific population (Denver public school children) and to refine the interventions in that population.

IMPACT Progress Reports - The Office on Smoking and Health awarded 32 states and the District of Columbia health departments cooperative agreements to build capacity to conduct tobacco use prevention and control programs. These cooperative agreements are part of CDC=s Initiatives to Mobilize for the Prevention and Control of Tobacco Use (IMPACT), which is a nationwide effort to establish comprehensive, coordinated tobacco use prevention programs. Evaluation of IMPACT is comprised of awardees submitting semi-annual progress reports. Information in the evaluation includes staffing, coalition composition and efforts, status of a state tobacco control plan, development of a resource center, training efforts, community outreach and mobilization, and participation in CDC national campaigns.

The primary intent of these state tobacco control program evaluations is to assess the success of the intervention activities within each state. The information gained from the evaluation is used to refine the interventions in that state. In addition, the information is used nationally to evaluate the success of the IMPACT program.

Research -

Evaluation of Community Based Organization Intervention to Reduce Sexually Transmitted Disease (STD) Rates Among STD Patients in Miami - Male STD Patients were randomized to either the standard HIV prevention counseling or intensive counseling comprised of four sessions of HIV counseling from a community based organization. STD clinic records were reviewed to determine whether there was a difference in return rates with new STDs between the groups. The objective of intervention and evaluation is to determine whether intensive counseling reduces the acquisition of new STDs among high risk people attending a STD clinic. The purpose of the project was to evaluate a new intervention for reducing the transmission of STDs. Knowledge gained from this evaluation would be used to generalize to other sites.

A Comprehensive Evaluation for Project DIRECT (Diabetes Intervention: Reaching and Educating Communities Together) - Project DIRECT is a community diabetes demonstration project targeting African American adults residing in Raleigh, North Carolina. The project is three-tiered and addresses diabetes care, community screening for persons at high risk for developing diabetes, and population based approaches to increase physical activity and reduce dietary fat intake (two risk factors for diabetes). The goals of the community project are to reduce preventable complications of diabetes via a health systems approach, increase the proportion of persons at risk for diabetes who are screened, and increase the proportion who participate in regular vigorous physical activity and eat a reduced fat diet. Baseline and follow-up population-based surveys are planned to evaluate the community intervention. The purpose of this project is to evaluate new and innovative interventions to prevent diabetes and its complications. Knowledge gained from this project will be used to develop similar intervention projects in other communities.

References

Fink, A. Evaluation fundamentals. Newberg Park: California:Sage Publication, Inc., 1993

Centers for Disease Control and Prevention. Framework for program evaluation in public health. MMWR 1999;48(No. RR-11):1-40.

Langmuir, AD. The Epidemic Intelligence Service of the Center for Disease Control. Public Health Reports 1980;95:470-7.

OPRR Memorandum. Engagement of Institutions in Research, January 26, 1999.

Rossi, PH and Freeman, HE. Evaluation: A systematic approach. Newberg Park, California:Sage Publications, Inc., 1993.

Thacker, SB and Berkelman, RL. Public health surveillance in the United States. Epidemiologic Review, 1988;10:164-190.

Associate Director for Science
Centers for Disease Control and Prevention
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