Georgetown Law Faculty Blog

Formula Fights (Timothy Westmoreland)

The Congressional reauthorization of the Ryan White CARE Act, distributing $2 billion in funding for health care services for people with HIV/AIDS, has slowed to a stop—at least for a while. The bill is not caught up in debates about informed consent and HIV testing. It’s not stuck on arguments about medical standards of care or about discrimination against people with AIDS or about the appropriateness of being candid with young people about the risks of sex and drugs.

Nope. The Ryan White legislation is tangled in what is widely (and unaffectionately) known in the Congress as “a formula fight.”

Formula fights are debates about how to allocate funds around the country. Should big States get big allocations? Should little States get at least a minimum amount? Often this debate is about a fixed amount of money, so all formula changes are zero-sum games: If one allocation goes up, another must come down. That makes the politics especially harsh.

  Consider the current Ryan White debate: One Congressman said, “This bill is designed to have clear winners and losers in funding, and there should be none.”[i] His position was contrary to another Congressman, who said, “It shouldn’t matter where you live in the country when it comes to accessing medical care and therapy.” A Senator who supports the formula in the bill argued, “It is time for Ryan White funds to be distributed more evenly.”[ii]

Formula fights are hardly unique to the Ryan White bill. There are allotments, allocations, and schedules for distributing funds among the States (and sometimes among local governments, too) throughout the U.S. Code, including health care, student aid, transportation, and homeland security. One analysis has put the amount of such formula grants at $400 billion a year and has identified a range of seventeen formula factors and twelve formula program components that may be used in them. [iii]

Some of these formulas are relatively straightforward. For instance, funds are to be distributed on the basis of population.[iv]

But some of them are an “amalgamation of a bad story problem from high school algebra and … forensic calculus.”[v] For example:

Determination Under Formula—Subject to subsection (b), the Secretary shall determine the amount of the allotment … for a State … in accordance with the following formula: A(X/U)…. For purposes of paragraph (1), the term ‘U’ means the sum of the respective terms ‘X’ determined for the States….. [T]he term ‘X’ means the product of an amount equal to the product of the term ‘P,’ as determined for the State involved under paragraph (5) and the factor determined under paragraph (8) [Determination of Certain Factor]… and the greater of 0.4 and an amount equal to an amount determined of the State in accordance with the following formula: 1-.35 (R% / P%).[vi]

There are myriad significant public policy issues buried in these formulas. Should the Congress give more money to States with lower average incomes (thus helping poor States)? Should the Congress give more money to States that put their own money into policy efforts (thus rewarding them for doing good things) or should it give more money to States that don’t (thus helping residents with unmet needs and, incidentally, rewarding the States that don’t use their own money)? Should the Congress recognize that some problems (e.g., pollution, drugs) tend to be worse in States with large urban areas? Should States that have been getting a stream of Federal funds continue to get a reliable portion of it, even as circumstances change?

And so on…. Consequently there is no universal answer to formula fights in the Congress.

Formula fights may seem arcane, and they often are in their specifics. But their occurrence is not an accident. They are intrinsic to the structure of the Congress itself.

In fact, a dispute over a formula was a fundamental part of the creation of the Constitution during the Philadelphia Convention of 1787. In throwing out the Articles of Confederation and drafting a constitution, the Framers hotly debated the type of representation in the new legislative branch. It was the “most bitter controversy of the Convention.”[vii]

· There was the Virginia Plan, i.e., the legislature should be proportionally divided, with big States having more seats.  One representative declared, “equal numbers of people ought to have an equal no. of representatives.”[viii] Without power being proportional to numbers, Madison warned, “we make a paper confederacy, but that will be all.”[ix]

· There was the New Jersey plan, i.e., the legislature should be evenly divided, with each State having the same number of seats. “Otherwise”, it was said, “the smaller States must have been destroyed instead of being saved.”[x] A representative from one of the smaller States explained that anything other than uniform representation would be “a system of slavery for 10 States” since the three largest States (Virginia, Massachusetts, and Pennsylvania) could effectively control the body.[xi]

· And eventually there was the Connecticut Compromise (or the Great Compromise), i.e., Senators should be allocated two to a State, while Members of the House of Representatives should be “apportioned among the several States… according to their respective Numbers [of people].”[xii]

That carried the day, and “[o]n July 16, the convention adopted the Great Compromise by a heart-stopping margin of one vote.”[xiii] “[W]ithout that vote, there would likely have been no Constitution.”[xiv]

With that vote, however, were sowed the seeds for near-endless debates and discussions about how Federal money should be distributed. The Framers punted, and that is the genius and bedevilment of Congressional representation. It’s neither about equality nor proportionality. It’s about both.

Thus Wyoming has two Senators and one Member of the House. And California also has two Senators and 53 (or almost one out of eight) Members of the House.

And consequently, unless Federal assistance is uniquely needed in just one or a few States,[xv] the Congress is likely to spend a great deal of its time fighting over the “fair” formula. The structure pre-ordains it.

But at least the Ryan White legislators and staff can take comfort in one thing: The cube root in the original statutory formula was repealed ten years ago.[xvi]

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[i] Kaiser Family Foundation, Daily HIV Report, “Politics and Policy: House Panel Approves Reauthorization of Ryan White Care Act,” September 21, 2006.

[ii] Id.

[iii] Public Policy Institute of California, “Federal Formula Grants and California,” (2004).

[iv] Cf. The Social Services Block Grant, 42 USC 1397b.

[v] Testimony of Tim Westmoreland, Senate Finance Committee, “Hearings on the Use of Medicaid Funds,” September 6, 2000.

[vi] “Block Grants to States for Mental Health Services,” (42 USC 300x-7).

[vii] Weberry v. Sanders, 376 US 1 (1964).

[viii] The Records of the Federal Convention of 1787 (Farrand ed. 1911) [hereafter “Farrand”], p.179.

[ix] Farrand, 472.

[x] Farrand, 177, quoting David Brearly of New Jersey.

[xi] Farrand, 438, quoting Luther Martin of Maryland.

[xii] See Farrand, 343, and Article I, section 2 of the Constitution.

[xiii] Richard A. Baker, Historical Minutes, “Formative Years of the U.S. Senate (1787-1800).”

[xv] E.g., Hurricane Katrina assistance, although note even there that funds to reimburse “host States” for caring for refugees has been widespread.

[xvi] Public Law 104-146 (1996), amending 42 U.S.C. 300ff-28.

Human Subject Research on Prisoners

Recently, the Institute of Medicine (IOM) published a report, Ethical Considerations for Revisions to the DHHS Regulations for Protection of Prisoners Involved in Research. The Press portrayed the report as a relaxation of the regulatory requirements for conducting biomedical research on prisoners-- which is inflamatory and controversial. The Sunday NY Times published a story implying, although not explicitly stating, that the IOM report could allow grave abuses of prisoners of the kind that routinely occurred before the enactment of federal regulations governing human subject research. The NY Times followed that front page story with an editorial expressing concern with the IOM report. (USA Today had a more favorable editorial). Yet, in most respects, the IOM report tightened, not relaxed, safeguards for prisoner research. I chaired the IOM Committee and to set the record straight, it will be helpful to explain the Committee's charge, as well as provide an accurate account of what the IOM recommended.

The Committee’s task—to review the ethics regarding research involving prisoners—was as challenging as it was important. Research is critically important in providing knowledge needed for informed and enlightened prison policy, as well as for affording health benefits to prisoners. At the same time, research could impose unacceptable risks on prisoners, complicated by serious concerns about the potential for coercion in the prison environment. The history of prisoner research is plagued with illustrations of unconscionable abuses. Getting the balance right between scientifically rigorous research and ethically appropriate treatment of prisoners is vital in a decent, humane society. It was a difficult task in which the Committee had to take account of history, demography, vulnerability, and the realities of prisoner life.

The charge of our Committee, the Institute of Medicine Committee on Ethical Considerations for Revisions to the Department of Health and Human Services Regulations for Protection of Prisoners Involved in Research, was to explore whether the conclusions reached in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research remain appropriate today. The Commission’s path-breaking report on the ethical values of human subject research resulted in regulation of all human subject research funded by the U.S. Department of Health and Human Services (DHHS). The provisions regarding research on prisoners are contained in Subpart C of the regulations.

Specifically, the Committee was asked to: (1) consider whether the ethical bases for research with prisoners differ from those for research with non-prisoners, (2) develop an ethical framework for the conduct of research with prisoners, (3) based on the ethical framework developed, identify considerations or safeguards necessary to ensure that research with prisoners is conducted ethically, and (4) identify issues and needs for future consideration and study.

Past abuse in biomedical research in prisons has engendered deep distrust among prisoners and their advocates. It is impossible to ignore the historical exploitation of prisoners and their current misgivings about the biomedical research enterprise. The prison population, moreover, has markedly changed since 1979. It is vastly larger in number with disproportionate representation of African Americans, Latinos, persons with mental illness, and other historically disenfranchised populations. Many women and children are also incarcerated in American prisons today. Prisoners are particularly vulnerable to exploitation not only because of their low socioeconomic status, but also due to the realties of prison life. Although conditions are widely variable, overall prisoners are subjected to high levels of coercion (explicit and implicit). The prison environment makes it difficult to assure even minimal standards for ethical research such as informed consent and privacy.   

Given these realities, the easiest thing would have been to recommend a virtual ban on human subject research involving prisoners. Yet, the Committee felt that this would be a mistake. Research affords the potential of great benefit as well as burden. It can help policymakers to make correctional settings more humane and effective in achieving legitimate social goals such as deterrence and rehabilitation. Research can also help policy makers better understand and respond to the myriad health problems faced by prisoners such as HIV/AIDS, tuberculosis, hepatitis C, mental illness, and substance abuse. Respect for prisoners also requires recognition of their autonomy. If a prisoner wants to participate in research, his or her views should be taken into account. The overall goal, then, is to permit scientifically rigorous research to the extent that it confers significant benefit without undue risk and in accordance with the prisoner’s wishes.

The critical question facing the Committee was whether, given all these factors, current federal regulation is ethically sound and has achieved an appropriate balance between scientific knowledge and prisoner vulnerability. Our answer, after an exhaustive study, was an emphatic “no.” Although the ethical principles articulated by the National Commission are still largely apt, the Committee found that the federal system of human subject protection is deficient.

The Committee was surprised and disappointed to find that there were no systematic data sources on the quantity and quality of prisoner research in the United States. Committee members searched the literature and determined there is a great deal of research involving prisoners taking place that appears to be largely unregulated. The most glaring problem is that the federal rules cover only a small fraction of the research being undertaken in prisons. This is because the regulations (45 C.F.R. § 46) do not cover human subject research unless it is funded by a few federal agencies, or the sponsoring institution has voluntarily adopted Subpart C. All of the research supported through other sources (e.g., federal, state, or private) is outside the scope of regulatory protection. Subpart C also only applies to narrowly defined “prisoners,” not including individuals who are under state imposed limitations of liberty but not in traditional prison settings. There appears to be no morally defensible reason for excluding a large number of prisoners from human subject protection, as is currently the case.

The Committee boldly recommends five paradigmatic changes in the system of ethical protections for prisoner research. First, expand the definition of “prisoner” to include a much larger population of persons whose liberty is restricted by virtue of sentence, probation, parole, or community placement. Second, ensure universal, consistent standards of protection so that safeguards based on sound ethical values apply to prisoner research irrespective of the source of funding. Third, shift from a category-based to a risk-benefit approach to defining ethically acceptable research so that prisoners are never exposed to research risks unless there is a distinctly favorable benefit-to-risk ratio. Fourth, update the ethical framework established by the National Commission to include collaborative responsibility—the concept that research should be conducted in meaningful collaboration with the key stakeholders notably prisoners and prison staff. Finally, enhance systematic oversight of research involving prisoners so that human subject protections are more rigorous and more reliable than those that exist under the existing Institutional Review Board (IRB) mechanism.

The treatment of prisoners (both respect for their rights and concern for their health and wellbeing) is a principal measure of a decent and civilized society. It is, therefore, imperative that the executive and legislative branches give due consideration to the proposals in this report.