ORI Introduction to RCR: Chapter 1. Rules of the Road
As public support for research grew after World War II, the public, through its elected officials, became more interested in the way research is practiced. Over time, concerns began to surface about some of these practices, focusing initially on the use of animals and humans in research and later on research misconduct. When it appeared that the research community was not doing enough to address these concerns, government turned to regulation.
Government regulations usually begin in Congress. When a potential problem is identified, Congress calls hearings to learn more about the problem and then passes legislation to fix it. The regulations covering the use of humans and animals in research as well as research misconduct stem from three acts passed by Congress:
- the 1966 Animal Welfare Act (PL 89-544),
- the 1974 National Research Act (PL 93-348), and
- the 1985 Health Research Extension Act (PL 99-158).
These and other research-related acts give the Federal Government the authority to regulate the research it funds.
Along with the authority to address problems, Congress usually provides guidance on general objectives, but it seldom drafts detailed regulations. This job falls to the Federal agencies in the Executive Branch of government, which are responsible for carrying out the law. Federal agencies translate Congressional directives into regulations (also called rules), policies, and guidelines.
In 1989, the Department of Health and Human Services (HHS) established the Office of Scientific Integrity (OSI) and the Office of Scientific Integrity Review (OSIR), in response to the 1985 Health Research Extension Act. The Office of Research Integrity (ORI) was established in 1992 and assumed the responsibilities previously assigned to OSI and OSIR. In addition to responding to misconduct, ORI undertook a number of steps to promote integrity and responsible research practices. The ORI Introduction to RCR is a result of that effort.
Regulations. When Federal agencies translate Congressional directives into regulations, they must follow provisions set out in the Federal Administrative Procedure Act (5 USC 551-702). As its name implies, this act establishes procedures for developing new regulations, including steps for getting public input. Before establishing a new regulation, an agency must issue a draft regulation, obtain and consider public comment, and then issue the final regulation. Each step must be published in the Federal Register–the “official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents” (link). Objections raised during the public comment period must be addressed before the final regulation is adopted. After it is adopted, the final regulation is incorporated into the Code of Federal Regulations and becomes official government regulatory policy that must be followed.
Agency policies and guidelines. Executive Branch agencies have the authority to issue some policies as part of their normal operation. The National Institutes of Health (NIH), for example, has the authority to establish policies for grant awards. From time to time, it changes these policies to assure that its research funds are spent wisely and responsibly. It is in this capacity that NIH issued a special RCR “Training Grant Requirement” in 1989 and the more recent “Required Education in the Protection of Human Research Participants” (discussed in Chapter 3).
Federal agencies also issue Guidelines, which recommend but do not require a particular course of action. To help research institutions handle allegations of research misconduct (see Chapter 2), ORI issued as guidelines a Model Policy and Procedures for Responding to Allegations of Scientific Misconduct (link). In this case, the model policy is intended to provide guidance and does not impose binding requirements on institutions.
The plethora of Federal regulations, policies, and guidelines that affect research can be confusing. They do not always speak with one voice. The same aspect of a research project can be subject to regulations by more than one Federal agency, as for example the use of human or animal subjects. Common Federal regulations, such as the Federal Policy on Research Misconduct (discussed in Chapter 2) and the “Common Rule” for human subjects research (discussed in Chapter 3), are not truly common regulations until they have been adopted by all agencies. In addition, distinctions between regulations, policies, requirements, guidelines, and recommended practices can be difficult to understand.
Researchers are well advised to seek help when it comes to understanding Federal and state research regulations. The Federal agencies that regulate research have comprehensive Web pages that list and explain their policies and regulations and readily answer questions. For local advice, your institutional research administrators may be the best place to begin.