Research Participation as a Responsibility of Citizenship

by Suzanne M. Rivera, Ph.D.

For legitimate reasons, the human research enterprise frequently is regarded with suspicion.  Despite numerous rules in place to protect research participants’ rights and welfare, there is a perception that research is inherently exploitative and dangerous.

Consequently, most people don’t participate in research.  This is not only a fairness problem (few people undergo risk and inconvenience so many can benefit from the knowledge derived), but also a scientific problem, in that the results of studies based on a relatively homogeneous few may not be representative and applicable to the whole population. Larger numbers of participants would improve statistical significance, allowing us to answer important questions faster and more definitively.  And more heterogeneous subject populations would give us information about variations within and between groups (by age, gender, socio-economic status, ethnicity, etc.).

Put simply, it would be better for everyone if we had a culture that promoted research participation, whether active (like enrolling in a clinical trial) or passive (like allowing one’s data or specimens to be used for future studies), as an honorable duty.    (Of course, this presumes the research is done responsibly and in a manner consistent with ethical and scientific standards, and the law.) Read More

Is the USTR Trading Away Doctors’ Rights to Freely Perform Medical Procedures?

By Adriana Lee Benedict 

The 14th round of negotiations for the Trans-Pacific Partnership Agreement (TPPA, a multilateral trade agreement currently being negotiated by the USTR and 10 other countries) is currently underway in Leesburg, VA.  Last month, KEI posted a brief video blog about an interesting provision (Article 8.2) of the TTPA’s leaked draft IP chapter calling for patentability of diagnostic, therapeutic and surgical methods.  Critically, KEI pointed out that current US law (35 U.S.C. 287(c))—which was amended after widespread concern from physicians’ associations regarding the adverse public health effects of medical method patent liability were brought to light with Pallin v. Singer, 36 U.S.P.Q.2d (BNA) 1050 (D. Vt. 1995)—immunizes medical practitioners from patent infringement suits concerning medical methods, although the draft TPPA provision makes no such exception.  The proposed provision is also contrary to Article 27(3) of TRIPS and Article 1709(3)(a) of NAFTA, all of which allow countries to exclude such medical methods from patentability, as well as Rule 39.1 of the 1970 PCT, which exempts International Searching Authorities from having to conduct patent searches relating to medical methods.

Medical professional societies, including the WMA, AMA, AAOS, ACOG and ASRC, have also opposed medical procedure patents on ethical grounds.  The WMA has explained that patents are not necessary to incentivize innovation in medical procedures: “Unlike device development, which requires investment in engineers, production processes, and factories, development of medical procedures consists of physicians attaining and perfecting manual and intellectual skills… physicians already have both obligations to engage in these professional activities as well as rewards for doing so.”  The WMA has also noted a number of adverse effects on access to medical care resulting from medical procedure patents, including higher costs, fewer physicians available and/or willing to perform patented procedure, and less innovation in medical procedures.

So what does this mean for the TPPA negotiating parties? Read More

Discrimination in the Doctor-Patient Relationship

By Holly Fernandez Lynch

Nir Eyal’s post below has teed up the issue of doctors refusing to accept patients for reasons that seem to be pretty questionable.  The latest example has to do with obesity, but there are plenty of others having to do with vaccination status, sexual orientation, and the like.  Sometimes these refusals can be clearly categorized as conscientious objections (religious or otherwise).  And other times they are  a bit fuzzier, such as when the refusals are rooted in attempts to drive changes in behavior  (e.g., “get vaccinated or you can’t be my patient”) or when they stem from having inadequate staffing or equipment.  But for the patient, all of these refusals can feel discriminatory.   And that raises the obvious question: can doctors legally discriminate against patients?  The answer: it depends.  Sometimes yes, and sometimes no.

First, bear with me while I make the obligatory pitch for my book, Conflicts of Conscience in Health Care, which is now a few years old, but the issues are still very much live.  In that book, I delve deeply into the question of how to balance provider conscience and patient access.  In general, I argue that it is important to protect provider conscience, to a point (or points) – and those points have to do with burden on the patient and avoidance of invidious discrimination.   Read More

Broadening “Innovation Law & Policy” (and “Human Subjects Research”)

By Michelle Meyer

In legal scholarship and education, innovation law and policy is virtually synonymous with intellectual property in general, and with patent law in particular. This is curious and, I think, misguided. We expend considerable effort designing optimal incentives for innovation. We expend similar effort ensuring that socially useful knowledge, once produced, is widely and accurately disseminated. But if knowledge-producing activities themselves are suboptimally regulated, neither upstream incentives to engage in them nor downstream mechanisms to disseminate their fruits will much matter.

In Regulating the Production of Knowledge: Research Risk-Benefit Analysis and the Heterogeneity Problem, I

critically examine[] that regulatory framework, adopted by more than one dozen federal agencies in the U.S. and many other countries, which governs the vast majority of those knowledge-producing activities that have the greatest potential to affect human welfare: research involving human beings, or “human subjects research” (HSR). [The Article] focuses on the primary actors in the regulation of HSR — licensing committees called Institutional Review Boards (IRBs) which, before each study may proceed, must find that its risks to participants are “reasonable in relation to” its expected benefits for both participants and society. It argues for a particular interpretation of this risk-benefit standard and, drawing on scholarship in psychology, economics, neuroscience and other fields, argues that participant heterogeneity prevents IRBs from carrying out their regulatory duty. Instead, the regulatory system implicitly responds to the heterogeneity problem with risk aversion that is costly not only to researchers and society but, critically, to would-be research participants. The Article concludes by laying out the policy options that remain in the wake of the heterogeneity problem’s intractability: continuing the legal fiction of risk-benefit analysis, honestly embracing the heterogeneity problem and its costs, or jettisoning IRB risk-benefit analysis. A companion Article develops the possibility of the third option.

HSR is not, of course, unknown to the legal academy. Read More

No Doctor for the Obese?

by Nir Eyal

Yesterday, Boston public radio station WBUR interviewed a Massachusetts primary care physician who refuses to admit new obese patients. She claims that it’s because she lacks proper equipment, but she seems to have mixed motives. Earlier she had admitted that it’s rather because she feels that if they don’t lose the weight, “I’m paying the cost of other people’s choices.” I bet if she lacked the equipment for wheelchair-bound patients, she would go buy it.

In an upcoming post (09/07: update here), Holly Fernandez Lynch, who, along with Glenn Cohen, gets kudus for kicking off this blog, will explain whether it’s legal for doctors to reject obese patients. But before rejecting them becomes the next trend, is it right?

A whopping 35.7% of Americans are obese, and the trend continues upwards. Obesity increases risk for heart disease, stroke, type II diabetes, and various cancers. It costs the system a fortune. We must tackle this problem head on. But conditioning physician access on weight loss is not the way. Read More

Should Mitt Romney (or Others Who are Pro-Life) Support Rape and Incest Exceptions to Abortion Bans?

by Glenn Cohen 

As America’s attention focused on the Republican Convention and the Obama campaign tries to portray a “Republican War on Women” at the Democratic one, last week Mitt Romney tried to clarify his position on abortion, namely: while he is generally against abortion, he would make an exception for cases where the mother has been raped or is the victim of incest. While politically savvy, based on other beliefs Mitt Romney has, this position is hard to defend if not incoherent.  Here is why: 

Mitt Romney, like most people who would outlaw abortion, must subscribe to two core beliefs: (1) Fetuses are persons and get the full panoply of the rights of persons from early on in their development (for Romney, like many, at “conception”), or at least possess a right not to be killed. (2) The mother’s interest in protecting her bodily integrity, making important reproductive or life choices, etc, does not outweigh the fetus’ right not to be killed. This is why Romney and other pro-lifers would prefer that abortion be banned even in the first trimester.

This logic is not incompatible with exception for the health or life of the mother. Through the well-known doctrine of self-defense, the criminal law has long recognized that an individual may be justified in killing to protect his or her own life, or possibly health, and these exceptions merely reflect a similar view as to fetuses.

The rape and incest exceptions, though, are on a different footing entirely.

Read More