Roy G. Spece

The OHRP and SUPPORT - Another view

A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT.

Industry Reimbursement for Entering Patients into Clinical Trials: Legal and Ethical Issues

Pharmaceutical manufacturers commonly contract with clinical investigators for pre-market testing of new products. The per-patient reimbursement offered to the investigator generally exceeds the per-patient costs incurred by the investigator. This excess represents a windfall that can be used to pay for travel, equipment, or supplies, or to fund research for which the investigator cannot obtain funding through peer-reviewed granting channels. This excess raises a potential conflict of interest, because it may lead the investigator to propose experimental treatment for a patient when the patient might be better served by conventional treatment or by no treatment at all. Not only does this situation pose a conflict of interest, it also is a conflict of which few patients are aware and fewer are informed. We propose that all experimental subjects be informed of the source, amount, and mechanism of funding for the experimental treatments they undergo. Further, we propose that payments from pharmaceutical manufacturers for pre-market testing of drugs go to the medical school dean rather than to the individual investigator. With this money, the dean can defray the direct as well as the indirect costs of the clinical study; the remainder, which would otherwise go directly to the investigator, should be placed in a funding pool for which the entire medical school could compete. This solution largely eliminates conflict of interest, addresses informed consent, and reasonably balances the interests of the experimental subject, the clinical investigator, the pharmaceutical manufacturer, and the academic institution.

Rate of refusal to participate in clinical trials.

With a diffident potential subject reluctant to ask questions, this can also occur if the investigator explains the experimental procedure too quickly for the potential subject to understand, or if the explanation employs too much medical jargon. Moreover, the investigator has a duty to probe a potential experimental subjects understanding of the procedure. The investigator can consciously or inadvertently apply duress to the potential subject, so that the subject infers that if he does not participate in the study, he will: (1) incur the ill-will of the clinical investigator (this is especially threatening when the investigator is also the experimental subjects own physician); or (2) jeopardize his chances of recovery. Erroneous determination of capacity to give consent represents yet another means by which an investigator could violate the requirements for informed consent. Ob-

Scrutinizing Strict Scrutiny

Standards of review dominate personal liberties practice, and we must take them seriously if we heed calls to take (constitutional) lawyering seriously. Standards are poorly articulated and undertheorized. They must be properly fashioned by exploring and reconciling the logic and purpose of each of their components. We do this with strict scrutiny both to energize an important standard of review and model a proper approach. Our analysis is primarily within the context of higher education affirmative action cases because they typify the ambiguity of strict scrutiny; one such case – Fisher v. University of Texas at Austin -- could return to the Court next term.We derive a preferred articulation of strict scrutiny with six achievable but rights-protective requirements. Strict scrutiny is especially energized by separating its “ends question” about compellingness from its “means question” about interest advancement. Then state interests are compelling only if of a special nature, analogous to requiring fundamental rights to have special attributes irrespective of any intrusion.The preferred version of strict scrutiny is applied to Fisher, which involves a university program that considers race as one diversity factor combined with a top ten percent law. Our contrarian conclusion is that the law is unconstitutional, but that the Court should save the university program by severing it from the law. It is contrarian because most authorities - whether invoking an anti-subjugation, anti-classification, or antibalkanization perspective -- accept supposedly racially neutral top ten percent laws. We invoke a nuanced conception of antibalkanization applicable in Fisher’s unique circumstances. Our conclusion is also based on a rich conception of academic freedom with two complementary aspects that place it at the foundation of freedom of speech. These aspects combine to protect universities from external impositions such as the Texas law, allowing them to accommodate diversity and demonstrated academic capacity.