Letters to the editor

Abstract

Furthermore, it would cut the cost and morbidity associated with antirejection medications required in conventional implantology. [...]it might help solve the present shortage of suitable organs for transplantation. Perry's reliance on legal terminology and case law epitomizes the tendency of most Institutional Review Boards (IRBs) to focus far too much attention on whether the informed consent form details all of the risks, the nondisclosure of which could result in a lawsuit, and far too little attention on whether the final document is likely to be comprehended by its probable reader. While a few IRBs may permit research that fails to adequately disclose risks, a vast majority are obsessed with avoiding lawsuits and the scrutiny of federal regulators. Because of this, the challenges facing researchers are seldom knowing whether their consent form meets the legal requirements.

AN EDITORIAL APOLOGY

Recently we misapprehended and subsequently printed a letter that caused some embarrassment to a Phi Kappa Phi member and to one of our member institutions, New Mexico Highlands University. We apologize to that person and to NMHU and take full responsibility for our oversight.

-Editor

LETTERS TO THE EDITOR

We student and faculty members of the Honor Society of Phi Kappa Phi at New Mexico Highlands University make the following response to the statement in "Letters to the Editor," National Forum (Summer 1999) regarding our professor, colleague, and president of Phi Kappa Phi: Our president is the antithesis of a professor who exhibits "declining faculty competence and motivation due to tenured positions." Exceptional competence is demonstrated in this respected professor's teaching, scholarship, and service to the university community.

Robert Mishler, David Engstrom, Sara Hanna, Mary Shaw, Jose Villarreal, Gene Barrow, Margaret Vazquez-Geffroy, Ursel Albers, Merryl Kravitz, Michael Withnall

New Mexico Highlands University

STRATEGIC BEHAVIOR AND COMPETITION IN THE INFORMATION AGE: THE MICROSOFT CASE

I found the article on Microsoft and the Department of Justice (DOJ) to be about as short-sighted as the government has been on this issue. The breakup of Microsoft would be a huge blow to the entire computer industry and more importantly to consumers. Antitrust laws are designed to protect the consumer; they are not designed to make every company equal. To say that consumers do not have a choice is ridiculous. Not only do hardware vendors get to load whatever software they want on the machines they sell, consumers have proven that they know how to get the software they want. After all, Netscape is still the number one hit site on the Internet. If consumers want a new IMac,TM they can go to the store and buy one. As an employee in the software industry, I will say that competition is fierce and growing everyday. Every year, software companies make billions of dollars selling their products and trying to make them better. But evil Microsoft ... it goes and gives its Internet browser away for free. How terrible for the consumers! Maybe many have forgotten that Netscape used to give its browser away for free, too, until it realized that it had a large percentage of the market and decided to start charging for the browser. In the meantime, the government is spending millions of taxpayer dollars trying to protect other companies. If you don't agree with what the DOJ is doing to the computer industry, I would recommend your letting Congress know how you feel by visiting the following website: http://www.microsoft.com/freedomtoinnovate

Cindy Crane Monroe, Washington

I write concerning Charles Peake's article on the Microsoft antitrust case (Forum on Business and Economics, Summer 1999). I take offense at his rather opinionated and totally one-sided analysis. I expect higher standards from Phi Kappa Phi. It is a very controversial subject and probably best left to others. But if addressed in National Forum, it would seem more prudent and fairer to have both sides presented. After all, there are many very savvy people with strong views, both pro and con, on the government's case.

Bill Epling

The purpose of our columns is for our columinists to offer their opinions. Reader Responses to those opinions are welcomed.

-Editor

ISSUES IN BIOMEDICAL RESEARCH

I enjoyed your last issue (Summer 1999). As a physician I like to see updates on the latest technology. You might want to look at some issues in medicine as well. I completed my MBA for physicians at the University of Houston last year, and we had some excellent discussions about the direction and course of the field, in light of Managed Care and public policy. Keep up the good work.

Bob Berman, M.D., Ph.D., MBA

MUSICAL CROSSOVERS

In the Summer 1999, Phi Kappa Phi Journal (Forum on The Arts, "Issues in Biomedical Research," Summer 1999), Rollin R. Potter speaks of two compact disc albums by Dawn Upshaw. One is of the music of Rodgers and Hart.

Please note that the correct spelling is Rodgers, not Rogers. Even if it's true that the disc has the misspelling, I'm surprised that the chair of the Department of Music at California State University at Sacramento wouldn't catch the error, not to mention your proofreader.

Carol Leigh Ansonia, Connecticut

PLURIPOTENT STEM CELLS: A PRIMER

The recent article outlining the science of pluripotent cell production and related NIH policy was well written - as far as it went ["Issues in Biomedical Research," Vol. 79, No. 3, Summer 1999. However, an obvious ethical problem was not discussed - probably because NIH guidelines now prevent the government from funding bits and pieces of seminal (but probably trivial) R&D.

The problem is that a blastocyst (embryo) clone of an adult human can be viably implanted in a receptive female. It can then be allowed to develop to virtually full-term and then legally aborted. Then, various organs or other structures can be harvested from the aborted fetus and implanted in the diseased adult. From several vantage points, such technology is highly desirable because it would permit implantation of life-saving organs absent the fear of immune rejection by the recipient. Furthermore, it would cut the cost and morbidity associated with antirejection medications required in conventional implantology. Moreover, it might help solve the present shortage of suitable organs for transplantation.

Certainly, my scenario still faces a number of technical obstacles. For example, the organs of near-infants are often not large or fully developed enough to take over the full demands of the adult organism. (Perhaps five or six infant-size kidneys could be implanted instead of one adult kidney?) However, foreseeable impediments seem surmountable. Furthermore, to my knowledge, private research and development to this end is legal. And, once available, it's hard to imagine that there would not quickly be a lucrative market for such therapies.

Not to moralize, but a society that allows partial birth abortions at the whim of the "mother" can make no ethically consistent argument against the process I outline here. Indeed, it should not be difficult to develop the technologies needed to eliminate cortical brain function (to obviate concerns about the pain a fetus may experience during abortion) in utero - thereby perhaps making the whole endeavor less unsavory than late-term legal abortion is now.

Indeed, it is a Brave New World. Mike Rethman, DDS, MS Kaneohe, Hawaii

INFORMED CONSENT IN RESEARCH

It is disappointing that philosopher Clifton Perry focuses almost exclusively on legal issues in his discussion of Informed Consent in Research ["Issues in Biomedical Research," Summer 1999, Vol. 79, No. 31. Perry's reliance on legal terminology and case law epitomizes the tendency of most Institutional Review Boards (IRBs) to focus far too much attention on whether the informed consent form details all of the risks, the nondisclosure of which could result in a lawsuit, and far too little attention on whether the final document is likely to be comprehended by its probable reader.

While a few IRBs may permit research that fails to adequately disclose risks, a vast majority are obsessed with avoiding lawsuits and the scrutiny of federal regulators. Because of this, the challenges facing researchers are seldom knowing whether their consent form meets the legal requirements. IRBs are insisting that researchers meet this standard and then some. As an example, I recently conducted a survey of the end-of-life decision-making preferences of older adults. Before approval, the IRB insisted that several sentences be added to my consent form, including the statement that "the only alternative to participating in this study is to not participate in this study." All of the added sentences were accurate. Their inclusion probably had no effect on persons' willingness to participate. But what is less certain is whether the addition of irrelevancies resulted in a document in which the real risks to participation were obscured.

The ethical challenge for researchers is to make sure that the forced inclusion of legalese and irrelevancies does not keep participants from fully understanding the genuine risks that their participation may entail. Unfortunately, while these risks are greatest for persons whose illness is most severe, the consent forms for the research projects into which these persons are recruited are typically the longest and most complex.

Beyond this challenge, researchers also must confront the growing shift of research dollars from institutions governed by federal guidelines to private persons or organizations whose commitment to informed consent (and to objective and accurate science) may be less. By focusing on the simplistic question of what consent forms must disclose to be legal, Perry diverts attention from far more important questions such as how researchers can assure participants understand what they have been told and how informed consent can be preserved without driving research away from institutions and researchers committed to this value.

Steve Hines West Virginia University