By Karen Stewart and Briana Frenzel

The shifting climate toward evidence-based practices and evidence-based decision making has greatly increased the use of research in local government, which increases the need for the use of institutional review boards to ensure ethical research practices.

As the culture of government engages in research to improve efficiency and efficacy, opportunities for funding may require that research protocols have been followed. A key component of these protocols is the development of a plan and its review before any other step of the plan has been put into place.

“We the People of the United States . . . establish justice . . . promote the general welfare. . . .” We learned the Preamble to the Constitution in grade school. As local public servants, many of us have taken an oath of office to uphold and defend the Constitution.

What does this mean in a manager’s and an elected official’s daily work life? As stewards of the Constitution and public trust, they need to make certain that employees are working to establish justice and equality, while promoting the general welfare of others. They affect policies and practices that must do no harm to an individual while protecting the greater good of local government.

In order to protect the greater good and provide mandated services, managers are constantly in search of information to help them make the best business decisions possible. But at what cost?

Through the advances of technology, a world of information is at our fingertips. In this day and age of big data, how do we use information to make evidence-based decisions?

The answer to that question is that more often, local government managers are hiring researchers to help analyze information or conduct research based on specific populations, demands, and the needs of a community.

Researchers are either being hired as full-time employees or through procurement contracts to conduct research on such subjects as educating adolescents, violence and youth, co-occurring mental health illness and substance abuse, homelessness, veterans in the arrestee population, and law enforcement. Evidenced-based information is sought to make operational business decisions.

Evidence-based decision making (EBDM) has become a critical tool for public officials. The practice relies upon substantiation of how well a program or service works, often proven through research and publication.

When conducting human subject research, agencies need to take extra precautions to protect the individual rights of the research subjects. There are ethical standards that researchers need to maintain. To ensure these standards are met, an institutional review board (IRB) should be engaged to review the research protocols.

Some examples of when IRBs should be engaged include research on the children in a foster care system, the impact of HIV/STDs on individuals using the local public health system, the effects of drugs and alcohol on arrestees, and identifying circumstances that resulted in homelessness.

Federal grant funding requires, in many instances, that funded programs or services track their effectiveness in achieving outcomes. In these instances, proving its effectiveness may be an important part of the funding.

The research of human subjects to achieve EBDM needs to be approached with caution. It is critical that the necessary study protocols and ethical standards are met to protect both the research subjects and the researcher. Ensuring the protection of human subjects is the principal focus of an IRB.

Historically, research has not always protected its subjects. In the Tuskegee University syphilis study conducted from 1932 to 1972, for example, the Public Health Service studied the effects of untreated syphilis in 400 African American males.1,2

The participants were recruited without informed consent and under the belief that they would receive free treatment. The study found untreated syphilis led to a death rate double that of those treated, and it continued for 40 years with those in the untreated group never receiving available antibiotics.

Public outrage in response to published reports about the Tuskegee study led to the National Research Act in 1974, including the regulations for the Protection of Human Subjects (45-CFR-46) developed by the U.S. Department of Health and Human Services.

These regulations resulted in the Belmont Report of 1979, outlining the minimum ethical principles for research, including human subjects, which are:

1. Respect for persons. This focuses on the autonomy of an individual and the protection of those with diminished autonomy. In most cases, respect for persons demands that subjects enter into the research voluntarily and with adequate information.

The protected groups are considered vulnerable populations and include children, prisoners, mentally ill individuals, and pregnant women.

2. Beneficence. The obligation of the researcher to do no harm and to maximize benefits and minimize harms.

3. Justice. Justice in research requires fair treatment of groups and individuals, especially in regard to receiving the benefits and carrying the burden of the research.3

It is the primary responsibility of an IRB to ensure these principles are upheld.

The American Evaluation Association summarizes:4

“The primary way in which these regulations are enforced is through institutional review boards (IRBs), which are responsible for reviewing plans for research before any data are collected, monitoring research as it is being conducted, usually on an annual basis; and reviewing the results of research to assure that it is compliant with federal policy on the protection of human subjects.”

In addition to the protection of human subjects, IRBs play a role in protecting individual researchers. An IRB ensures that the research protocols comply with the requirements of the Belmont Report and identifies areas of the research that may need to be modified or where stronger protocols need to be implemented.

Lawsuits filed against investigators and others involved in research have led to settlements “based on perceived or real harm to research subjects.”5

While litigation may be cast wide to all involved, the “direct relationship between the investigator and the participant allows for a variety of legal duties to be used as the basis of a lawsuit.”6

When hiring an outside contractor to conduct human subject research, it is advisable to write into the contract that the researcher is responsible for meeting any IRB requirements. If you have local government staff conducting human subject research, you need to make certain that your employees are aware of the requirements for the use of an IRB.

So When Does Research Require IRB Review?

The Federal Policy for the Protection of Human Subjects (45 CFR Part 46 at http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title45/45cfr46_main_02.tpl) includes a two-part question to determine whether a study constitutes human subject research, thereby being subject to IRB review prior to data collection.

1. Is it research?

a. Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge….”

2. Does it involve human subjects?

a. Defined as “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.”

A public health department contacting local schools for aggregated absenteeism data related to a flu outbreak would not require review by an IRB. If the public health department, however, requested specific identifiable information about individual students absent due to the flu, this would require an IRB.

Programs that are federally funded are required to use IRBs when conducting human subject research.

Who Makes Up an IRB?

The composition of IRB membership is clearly defined in the Code of Federal Regulations under 45 CFR Part 46.107(a) that reads:

(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

How to Find an IRB

If your agency is responsible for engaging an IRB, there are two types of IRBs available. Universities have their own IRBs with protocol for approval prior to conducting research. These IRBs are available to researchers affiliated with the university, though many offer their services to the public.

The services may come with a fee and a three- to six-month timeline. This time occurs after planning the research project and before conducting the research, a time that may be especially sensitive in the public sector due to funding streams or the need for a prompt response to community priorities. Consideration of the IRB timeline must be factored into the research project.

Private IRBs also exist outside of the university setting. They typically have a shorter timeline; however, they may have higher fee structures than universities. Private IRBs are available to researchers regardless of affiliation.

It is best to work with your local government’s procurement office to identify private IRBs that may be on your state or local contract list, or search the Internet for a private IRB that can meet your human subject research needs.

The increased focus on EBDM—whether for funding, sharing an effective program with similar entities, or to protect against litigation—has made evaluation both critical and increasingly routine in the public sector. Does your organization’s research (or perhaps grant management, legal department, or human services) have an IRB available as necessary?

As a manager prepares for the next research project, addressing these important questions can protect the organization and most importantly the individuals that are the subject of the research.