Law in the Laboratory

A Guide to the Ethics of Federally Funded Science ResearchBy ROBERT P. CHARROW

THE UNIVERSITY OF CHICAGO PRESS

Copyright © 2010 The University of Chicago
All right reserved.
ISBN: 978-0-226-10164-4

Contents

Preface………………………………………………………………………………..vii1 Observations about the Law, the Legal Mind, and Our Legal System……………………………12 Government Funding of Research in the United States……………………………………….123 How Is the “Integrity of Research” Regulated: What Is Research Misconduct?…………………..494 Protecting Human Subjects: Bits, Bytes, and Biopsies………………………………………1105 Financial Conflicts of Interest: The Legacy of Shoeless Joe Jackson…………………………1796 Who Can Gain Access to Your Data?……………………………………………………….2217 Intellectual Property: Who Owns Your Inventions, Words, Data, and Specimens?…………………2498 What Regulations Govern the Welfare of Laboratory Animals?…………………………………290Appendix A: A Short Guide to the Unusual World of Legal Citations…………………………….301Appendix B: Oft en-Used Abbreviations……………………………………………………..304Appendix C: Links to Relevant Laws and Regulations………………………………………….306Appendix D: Approaches to Problems………………………………………………………..308Index………………………………………………………………………………….323

Chapter One

Observations about the Law, the Legal Mind, and Our Legal System

THE NATURE OF THE LAW AND LEGAL THOUGHT IN A NANOSHELL

This book crosses two disciplines—science and law. The legal and the scientific minds have many things in common, and their approaches to problems are similar in many respects. Scientists and lawyers both strive to state the problem precisely, to gather whatever facts there might be, and to apply the appropriate scientific or legal principles to those facts to yield a solution. And both scientists and lawyers tend to be critical thinkers; they ask lots of questions to better understand what is happening.

Both scientists and lawyers attempt to synthesize a “rule” from observation. A scientist might call his “rule” a hypothesis and then set about testing it to see if it holds up. A lawyer might look to a group of cases dealing with similar situations and attempt to tease out of those court opinions a single legal principle that explains all of the courts’ decisions in that group. Scientists and lawyers use their theories and principles, respectively, to predict the future. For example, a physicist might use the laws of motion to determine how long it will take for an apple to hit the ground when dropped by a fraternity pledge from the top of a university tower. A lawyer might use tort law and criminal law to tell her client, a college senior, what might happen to his fraternity if that apple were to hit a passerby.

There are, though, salient differences between the two disciplines. Some differences are obvious. For example, lawyers tend to be wordsmiths and are usually highly attuned to subtle differences in the meanings of words, phrases, or sentences. Other differences may not be so obvious. For example, the law is performative. If a court declares that someone is guilty or that someone is dead or that someone is divorced, those individuals are legally guilty, dead, and divorced, respectively. The external truth may not be relevant. Can you imagine a modern scientist declaring, based on his beliefs, that the human body has four humors and the key to good health is keeping them in balance? The law is also more concerned with setting up mechanisms for resolving disputes in socially acceptable ways than it is with establishing the truth. Finally, lawyers represent clients, and their job is to develop arguments or strategies that will benefit their clients rather than society as a whole. Thus, lawyers are paid to be biased; scientists, in theory, are not.

It is difficult to explain legal thought in the abstract and impossible to explain it in a few pages. Rather, throughout this book I highlight aspects of legal thought while discussing how our legal system operates, especially in the areas relevant to those receiving federal grants.

FROM WHENCE DO OUR LAWS COME?

In high school and perhaps even college, we are taught that Congress enacts laws, the executive branch enforces those laws, and the courts interpret them. This, of course, is not the way things really work, at least not today. Everyone seems to be in the business of making laws—Congress passes laws, executive agencies issue rules that are every bit as binding as the laws that Congress passes, and the courts, in the course of resolving disputes, actually make law. Laws enacted by Congress, treaties ratified by the Senate, and rules issued by executive branch agencies are sometimes referred to as positive law. Laws made by the courts in the course of resolving disputes are referred to as common law. In the discussion of intellectual property (see chapter 7), I point out that an author owns an enforceable copyright in his written work even if he does not register it with the Library of Congress. Courts have recognized that even without the official imprimatur of registration, the person who created the work owns the intellectual property. Because courts on their own have recognized and enforced this property interest, it is called a common law copyright.

Laws in the United States have a hierarchy. The Constitution takes precedence over all laws. Federal statutes and ratified treaties take precedence over federal regulations. Federal regulations, in turn, take precedence over informal agency statements. Federal statutes, treaties, and regulations take precedence, in most cases, over state laws that may be inconsistent with those statutes, treaties, and regulations.

Congress Makes Laws

Each year Congress enacts about 250 laws; during the two-year 110th Congress (2007–8), Congress passed and the president signed 460 new laws ranging from one that renamed a recreation area in Vermont after a former senator from that state to another that appropriated funds for the National Science Foundation (NSF). Two types of laws affect the scientific community—authorizations and appropriations. Authorizing legislation creates a new program or modifies an existing program. For example, NSF was created in 1950 by authorizing legislation entitled the National Science Foundation Act of 1950. Over the years, Congress has amended the NSF Act through various reauthorizations. Most recently, it enacted the National Science Foundation Authorization Act of 2002. Reauthorization legislation normally modifies existing law and authorizes Congress to appropriate funds, usually in specific amounts, to accomplish the goals of the law. Authorizing legislation, though, does not provide any money; it merely makes it possible for Congress to provide that money through separate legislation. That separate legislation is called an appropriations act, and as its name implies, it appropriates specific sums to each agency to be used for specific purposes. Annual funding for NSF and the National Institutes of Health (NIH) is set out in separate appropriations acts.

In addition to passing laws, Congress has oversight authority over the various executive branch agencies and departments. This authority is exercised through the various House and Senate committees and subcommittees with jurisdiction to enact authorization or appropriations legislation for that agency or department. An oversight hearing is normally conducted when the committee or subcommittee is displeased with certain actions taken by the agency and wishes to investigate the matter further. NIH, for example, is subject to the primary jurisdiction of three House committees—the Committee on Energy and Commerce, the Committee on Oversight and Government Reform, and the Committee on Appropriations. Other House committees have limited jurisdiction over certain aspects of NIH (e.g., Committee on Homeland Security with respect to bioterrorism research and the Committee on Ways and Means with respect to clinical trials affecting Medicare or Medicaid recipients).

Authorizing legislation creates new programs or modifies existing ones. Not infrequently, authorizing legislation can be remarkably spare. Congress paints with a broad brush and leaves it to others, namely the administrative agencies, to fill in the details. For example, Congress ordains that the air we breathe and the water we drink should be clean, but it leaves it to the Environmental Protection Agency to define what we mean by “clean” air and water. Correspondingly, when Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which greatly expanded Medicare coverage to include most outpatient prescription drugs, it left it to the Secretary of Health and Human Services to actually create the new program through regulation. It took Congress fewer than 25,000 words to spell out the new drug benefit in legislation; it took the Secretary more than 425,000 words to give life to the new program in his regulation. Regulations are a ubiquitous feature of American government; yet, executive branch rulemaking is never mentioned in the Constitution and is a relatively recent arrival.

Administrative Agencies Make Laws

How have regulations become such a prominent feature of our government? Some of this phenomenon can be traced to a curious crime committed more than 125 years ago where the National Gallery is now located in Washington, D.C. A former academic, who had developed one of the more ingenious proofs of the Pythagorean Theorem, was about to board a train for a reunion at Williams College. Before he could board the train, he was shot and killed. The crime would likely have engendered little public attention were it not for the fact that the victim, James Garfield, was president of the United States. The assailant, Charles J. Guiteau, was a disappointed and delusional office seeker who had failed to obtain a political appointment in the Garfield administration. Up until then, most government employees were political appointees, from the cabinet officers down to the lowly clerks. Garfield’s assassination changed things. It led Congress to pass the Pendleton Civil Service Reform Act in 1883.

The Pendleton Act did two things. It created the first independent agency, the United States Civil Service Commission, and it created a career bureaucracy independent of who was in power. It is ironic that the first independent agency was one that was charged with generating the career civil servants who would later populate new agencies as they cropped up. Sure enough, agencies did crop up; slowly at first, and then with increasing speed. Five years after the creation of the Civil Service Commission, Congress created the Interstate Commerce Commission to regulate what railroads could charge, and thus began the proliferation of independent agencies. During the next fifty years, the number of federal agencies exploded. During the 1930s, it seemed that a week couldn’t pass without some new agency and its acronym popping up.

But who controlled what the agencies did? Interestingly, these regulating agencies were themselves largely unregulated. Academics, including most notably Roscoe Pound, dean of the Harvard Law School and a botanist (not a lawyer), began questioning the wisdom of entrusting a significant slice of our government to unelected regulators who did their work in secret and were answerable to no one. With the end of both the Second World War and the Great Depression, Congress enacted the Administrative Procedure Act (APA) to regularize the operations of all administrative agencies, including cabinet departments; non-independent agencies, such as the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Defense Advanced Research Projects Agency (DARPA); and independent agencies, for example, the National Science Foundation (NSF). The APA is the “constitution” of modern administrative law and has remained relatively unchanged over the past sixty years.

The APA divides the work of federal agencies into two broad categories—adjudications and regulations. An adjudication is a trial before an administrative agency aimed at resolving a past dispute. Many agencies have multitiered hearing processes, sometimes starting with a hearing before an administrative law judge (ALJ) and ending with a review by the head of the agency. For example, if a state feels that it has been shortchanged by the Medicaid program, it can seek a hearing before the Departmental Appeals Board. If someone believes that he or she was improperly denied Social Security benefits, that person can ask for a trial before an ALJ in the Social Security Administration. And if the holder of a television license believes that the Federal Communications Commission (FCC) should not revoke its license, it can ask for a hearing before an ALJ in the FCC. The hearing is usually between an individual or company and the agency itself.

Whereas adjudications are usually retrospective, the second category, creating regulations, or rulemaking, is prospective. Rulemaking is one of the most important prerogatives of an agency. The APA does a number of things, including defining what a regulation is and what an agency must do before it can issue one. Regulations come in two varieties—big ones and little ones. A big rule really makes law by filling in a vague congressional outline. The rules that define clean air and clean water or that give life to the Medicare prescription drug program are big rules, technically called legislative rules, as are the rules governing scientific misconduct, human subjects, and financial conflicts of interest. By contrast, a little rule, called an interpretive rule, does not really change much. For example, suppose that Congress enacts a detailed funding program for a certain type of research. The funding agency then issues legislative rules fleshing out the program and specifying that institutions that wish to apply for funding must do so within thirty calendar days after announcement appears in the Federal Register. However, the agency neglected to define whether the thirty calendar days would be satisfied if the proposal were mailed on the thirtieth day or received by the agency on the thirtieth day. The agency publishes a rule indicating that the agency must receive the proposal within thirty days. This latter issuance would be an interpretive rule because it clarifies an existing rule and addresses only a relatively small aspect of the overall program. Tomes have been written about the differences between a big rule and a little rule. Big rules make it into the Code of Federal Regulations; little rules rarely do. Big rules limit an agency’s discretion by compelling agency personnel to act in a certain way; little rules do not. Big rules also have significant effects on those outside government; little rules usually do not.

But why all the concern? Should anyone care? After all, most practicing lawyers probably could not tell you the difference between a legislative rule and an interpretive one. You should care because most of your research is funded by federal agencies, and in many instances these agencies will attempt to regulate your research or your funding through rules or issuances, some of which may have been issued in the wrong way. An agency can issue a big rule only in certain limited ways; it can issue a little rule almost any way it wishes. If an agency misclassifies a legislative rule as an interpretive one and fails to adhere to the necessary formalities, a court is obligated to strike the rule down.

Most legislative rules are issued through what is called notice-and-comment rulemaking. The agency first publishes its rule as a proposed rule, which, among other things, sets out the agency’s rationale for the rule and the options that it considered and rejected; the agency then solicits public comment. Some proposed rules are so technical and affect so few persons that they attract relatively few comments. Other proposed rules, though, may be considerably more controversial and can attract tens of thousands of comments.

Notice-and-comment rulemaking is time consuming and requires those in a bureaucracy to jump through many hoops. Many agencies, including NIH and FDA, do not even have independent authority to issue legislative rules; that authority rests with the Secretary of Health and Human Services, and the Secretary does not have authority to issue legislative rules without the approval of the Office of Management and Budget within the White House. Given the hassle associated with issuing big rules, there is a tendency within the bureaucracy to misclassify legislative rules as interpretive ones, thereby avoiding all the sign-offs, approvals, and analyses of comments. Misclassification is not a theoretical concern, especially within NIH. For example, the NIH rules governing research involving recombinant DNA appear to have been issued without notice-and-comment rulemaking even though they are legislative rules, but more about that later.

A recent case involving Yale University’s hospital illustrates the significance of the distinction between legislative and interpretive rules. Physicians at Yale-New Haven Hospital had been conducting a clinical trial of a new implantable cardioverter defibrillator (ICD); the purpose of the trial was to gather data that the manufacturer could submit to FDA to gain approval of the device. Of the Yale-New Haven patients enrolled in the trial, forty-eight were Medicare beneficiaries (e.g., over sixty-five years of age). Medicare, however, refused to pay for their hospitalization and treatment because the ICD was “experimental” and had not been approved by FDA. Previously, Medicare had made these coverage decisions on a case-by-case basis, independently weighing the safety and effectiveness of the new unapproved device. However, before the clinical trial started at Yale, Medicare published a statement in one of its manuals that it would reimburse hospitals only if the medical device had been approved by FDA. It would no longer do a post hoc case-by-case assessment. Yale-New Haven Hospital sued, arguing that Medicare’s new rule requiring FDA approval as a condition of coverage was a legislative rule and because it had not been issued through notice-and-comment rulemaking it was invalid. Medicare argued that it was an interpretive rule and could be issued informally. The trial court agreed with Yale-New Haven and vacated the manual’s provision. The appeals court affirmed, but on different grounds.

Courts Make Laws

Our courts also make law. However, unlike Congress, which passes a statute, or an administrative agency, which issues a regulation, courts make law indirectly in the process of resolving a dispute between parties. This is what is referred to as the common law or case law. For example, suppose that you were involved in an automobile accident and were sued by the driver of the other car. He claims that you drove negligently (i.e., not as a reasonably prudent person would have driven under similar circumstances) because you exceeded the speed limit and your excessive speed caused the accident. You acknowledge exceeding the speed limit, but argue that you acted reasonably because everyone drives on that road at the speed you were driving; the posted speed limit is far below the safe speed. The plaintiff believes that he should win automatically because you admitted violating a traffic law. What weight should the violation be given? Should it be dispositive—if you violate a criminal statute or regulation or traffic law, then you are automatically negligent? Or should it merely be some evidence, but not dispositive, that you acted negligently? Or should it count for nothing? Suppose that your case goes up to the highest court in your state, and the court decides that violating a traffic law is merely some evidence of negligence. That court has effectively made law in the course of resolving a dispute between two drivers: Violation of a traffic ordinance can be some evidence of negligence, but it is not dispositive. Lower courts in that state will be obligated to follow the higher court’s ruling. It becomes precedent.

(Continues…)

Excerpted from Law in the Laboratoryby ROBERT P. CHARROW Copyright © 2010 by The University of Chicago. Excerpted by permission of THE UNIVERSITY OF CHICAGO PRESS. All rights reserved. No part of this excerpt may be reproduced or reprinted without permission in writing from the publisher.
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