Conducting research in the public health setting is extremely important in ensuring the health and welfare of the public. The institutional review board (IRB) of a public health agency or academic institution is well positioned to serve as a partner for the public health researcher in ensuring that the research they conduct meets ethical and regulatory standards. However, at the Journal of Public Health Management and Practice (JPHMP), we publish numerous reports of investigations that are born of practice, not of research. While this distinction may seem nuanced at first, it has substantial ramifications during the review and publication process if we at the JPHMP are to adhere to the high ethical standards entrusted to us as editors, publishers, and keepers of the public trust.
A Historical Perspective on Human Subjects Research
An IRB is an independent board appointed by an institution charged with the ethical and regulatory review of proposed research projects involving human subjects. The federal regulations for the protection of human subjects require a minimum of 5 members with diverse backgrounds and expertise sufficient “...to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.”1 An IRB should review all research proposals involving human subjects. The federal regulations for the protection of human research subjects were written and adopted because of a number of ethical lapses in the conduct of research involving human subjects (eg, The Tuskegee Syphilis Experiment2). In 1974, Congress passed the National Research Act (Pub L 93-348),3 establishing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Research Act charged the National Commission with identifying “... the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.”4 The National Commission issued its final report, the Belmont Report,4 in 1979. The current regulations protecting human research subjects are based on the basic principles set forth in the Belmont Report: Respect for Persons, Beneficence, and Justice. The 3 principles are equally important, rather than any one having precedence over another. An easy way to remember each principle is as follows:
- Respect for persons: voluntariness and informed consent
- Beneficence: benefit must justify risk
- Justice: equitable subject section; do not burden a population with participation without potential benefit to that population
Preserving the Public Trust
Public health activities depend on the availability of accurate data. Many public health programs are based on information gleaned from registry data (such as birth and death registries, infectious disease registries, cancer registries, AIDS registries, etc) to provide critical information necessary to assess trends and the status of public health. These registries rely on data collected and reported by health care agencies and providers. When assessing the impact of an immediate event, such as an infectious disease outbreak, environmental spill, etc, the public health agency must rely on collection of data from, or about, the people directly affected by the event. If people trust the public health agency to do the right thing, they willingly provide accurate information to the public health agency. If, however, the public health agency, or government in general, has violated this trust, those affected will be less likely to contribute accurate information that is needed to assess the effects of the event. The result could be the design and implementation of public health policies or activities, or dissemination of data, based on inferior or inaccurate data.
Human Subjects Protections and the Public Health Practitioner
An institution that is engaged in research involving human subjects, which is conducted, supported, or otherwise subject to regulation by any federal agency, must comply with the applicable federal regulations regarding the protection of human research subjects.1 This entails review of the protocol and protections prior to conduct of the investigation. Ideally, investigators should not make the determination if their research project must be submitted to the IRB for review and approval, as it is best to consult with the IRB for that information. However, it is often the case that practitioners decide that information generated through the normal conduct of their jobs warrants publication in a scientific journal, often after the work has been completed. In this situation, it would be advisable to seek consultation of an IRB. However, there are numerous situations where public health practitioners may not have ready access to an IRB to whom they can defer the decision. In that case, they should be ready to apply the ethical principles set forth in the governmental regulations in an informed manner and be prepared to defend their decision to the editorial staff of the JPHMP.
What Constitutes Human Subjects Research?
The regulations offer definitions of “research” and “human subjects.” To determine if a project actually is considered human subjects research under the regulations, a few questions must be answered. First, is the project research? Under the regulations, “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”1 If the project meets the definition of research, one must next ask if human subjects are involved. Under the regulations, “Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains, (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.”1 “Intervention or interaction” includes both physical procedures by which data are gathered (eg, venipuncture) 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 (eg, a medical record). Private information must be individually identifiable (ie, the identity of the subject is or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects.1 Note that the definition of human subjects limits its scope to living individuals. Research involving death certificate data, for example, does not fall under the human subjects regulations. However, if the proposed research involves deceased individuals and their immediate families, for example, those family members would likely be considered human subjects, and the research would need IRB review and approval to begin.
When Is IRB Review Required?
As mentioned earlier, the regulations define human subject research. Some research qualifies as “exempt” from the regulations.1 The investigator should not assume that a research project does not need review if it falls within one of the exempt categories. Often it is difficult to differentiate between public heath surveillance and human subject research. It has been suggested that the investigator reflect upon whether the project would have been conducted if they would not receive any formal credit or recognition for conducting the project. Again, the IRB is a useful partner in making this determination as the IRB office has the expertise to help researchers to navigate the review and approval process.
Human Subjects Protections and the JPHMP
It is the policy of the JPHMP that all investigations meeting the criteria for human subjects research are reviewed by an IRB. The review process should be explicitly noted in the methods section of the manuscript. It is our strong preference that all designations of exemption be rendered by an IRB. However, if an investigator without ready access to an IRB feels that the work reported in their manuscript falls into one of the exempt categories, he/she should identify the exemption category and explicitly detail their justification in the cover letter to the journal. This justification will then be reviewed by the editor-in-chief, the associate editor, the consulting editor for human subjections protections, and 1 or more content experts as needed. Submissions deemed human subjects research, which lack IRB review, will not be given consideration for publication in the JPHMP until such review has been conducted and sufficiently documented. Submissions that meet the criteria for exemption following editorial review will advance in the review process as usual. Working together will help ensure the conduct of ethical public health research, ensure the protection of human subjects, and preserve the public trust.
1. Department of Health and Human Services. Public welfare: protection of human subjects. Vol 45 CFR §46 (2009).
2. Jones JH. Bad Blood: The Tuskegee Syphilis Experiment. New York, NY: Free Press; 1993.
3. National Research Act, Pub L No. 93-348.
4. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. In: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Washington, DC: US Government Printing Office; 1979.