Coddling Human Guinea Pigs

I agree with the fact that human subjects must be respected, given privacy (HIPPA), treated with dignity, provided appropriate access/denial of treatment, and MUST be willing participants. These individuals must sign informed consent and possess the capability of making the decision to be part of the research study. I believe that vulnerable populations such as minors or those with disabilities should not be persuaded into participating in "risky" research without advisement/cooperation decided by an informed caregiver. However, to "protect" an inmate from potential psychological damage from an interview question is like protecting a child learning to walk from falling down. Inmates in this country have too many rights as it is. They have more opportunities behind bars (e.g., free medical/dental/vision, free education/training programs, hot meals, place to sleep, pool tables, puppies behind bars, living situations similar to college dorms) then many of them would have outside of prison. Who is paying? We are. If these prisoners are capable of planning a well thought out terrorist act against innocent people, they are more than capable of deciding whether they want to participate in research. If we allow researchers and scientists to prevent crime in our society or to find groundbreaking evidence to support medicines that cure....we WILL be the best country. posted by AKavaller 9-24-08

As an IRB member and Chair for many years, I would like to raise several concerns about Sharon Begley's article. First, Federal regulations protect prisoners from exploitation in research. Along with pregnant women, children, very elderly people and others, prisoners receive special protections under Federal regulations because they are considered to be a vulnerable population. To a great extent this is due to well known past abuses of prisoners and other institutionalized populations. IRB's must be specially trained and constituted in order to consider and approve research studies involving prisoners. Even though some in our society might consider people convicted of bombing or of other crimes less worthy of respect, the fact remains that they are entitled to the same, and even enhanced, protections as any other research subject.


Second, at several points in the article there are somewhat disparaging references to non-scientist IRB members. IRB's are Federally required to have at least one non-scientist at every meeting. This is so the perspectives of ordinary people who are not involved in scientific research can add their opinions to the committee's deliberations. These non-scientist members are extremely valuable and help prevent a "rubber stamp" mentality or bias towards researchers. Further, they help imagine the research as it would appear to prospective subjects, who are also likely to be non-scientists. When an IRB is concerned that it does not have sufficient expertise in the area of the study being proposed, it is a simple matter to have the researcher give an overview prior to the deliberation and voting phases, or to obtain the opinion of an outside consultant. It is also worth noting that all IRB members, whether they are scientists or not, must have specific training in the responsible conduct of research on human subjects.

IRB's are unfortunately easy targets. But most research proposals are approved by IRB's within 2 to 4 meetings. Much depends on the quality of the proposal itself. Cancer protocols undergo careful development and review before they get to a local IRB; in my experience, these protocols are usually approved at the first meeting where they are presented. Delays in research approvals and in the development of new drugs are caused by many factors other than IRB's.

The author seems to have spoken only to researchers with negative opinions, It is important to hear many sides of the question. Research instututions risk having their research temporarily suspended, or even shut down if Federal regulations are not met. Of greater concern, many prestigious institutions have conducted research that has raised serious ethical issues or even harmed human subjects. One has only to remember the tragic case of Jesse Gelsinger, who died in a gene study, to recognize that research on human subjects needs careful scrutiny. IRB's are an essential piece of this oversight.

Ellen W Bernal,

I am pleased that Sharon Begley has raised the issue of ???Coddling Human Guinea Pigs??? (Newsweek August 25th). As a newly qualified veterinarian, I am fully awareof the necessity for animal involvement in clinical research that benefits humans. However, research on humans themselves is less prevalent and this seems to be contradictory to the desired outcome ??? better understanding of our own physiology and diseases. I do, however, see two reasons for this which are not a result of Institutional Review Board (IRB)???hyperprotectionism??? or because clinical research ???isn???t innovative enough??? to attact National Institute of Health (NIH) funding.
Firstly, the studies that require people to be both the assessors and the subjects are made problematic by one thing: the human mind. Our own complexity, as yet only fractionally understood, makes data collection and objectivity in such research incredibly difficult. How can you quantify a psychological phenomenon like ???motivation towards terrorism???? We, as a species of animal, have a highly developed neurological capacity. We are social, political and ethical beings with our own beliefs and morals. Not only this, but the way we live turns our bodies into history books of our lives and experiences ??? whether we smoke, have kept fit, received good nutrition in childhood etc. In summary, we are individuals. Individual variation is the major barrier to clinical tests yielding conclusive quantitative results. In human testing, there are often a large number of variables to take into account at the final evaluation stage. This is one reason why cloned mice in controlled breeding programs are excellent alternatives to humans. You can produce reliable graphs and result tables after the experiments have been conducted, because there is less interference from the ???unknowns???. Since reliable results are currently the foundation of scientific progress, the IRBs are keen to fund this type of research. The institutions that they represent have a budget and a bottom line and they want to see a return on their investment. Good results are more likely to lead to safe drugs or therapeutics which, obviously, can generate revenue in the future. Pressure from above, not hyperprotectionism, is responsible for this.
Secondly, in addition to this institutional pressure, governments acting in the interests of the generally non-scientific public have slowly stifled the creativity of scientific research, through tighter regulations and legal ???hoop jumping???. The financial cost of these procedural assault courses is a prime cause for many research projects being ???halted at the gate??? and why funding is limited to the chosen few. Not only is money in the kitty low but the cost of each clinical trial is inflated. Until expenses decrease and the freedom to explore ideas is given back to the qualified experts, the human mind and human physiology will continue to be an enigma.

???Let???s agree that people who are altruistic enough to volunteer for experiments should know what they are in for???.??? Sharon Begley beings her essay on ???Coddling Human Guinea Pigs???. Ms Begley goes on to attack Institutional Review Boards that attempt to assure that in the name of clinical research. Although there is much to object to in our current system of research regulation, Ms Begley should attend to the mounds of research that show that people in clinical research rarely join up for altruistic reasons and that they also rarely fully understand what they are getting into.

Ms. Begley did get the right view of clinical research. In my experience, NIH reviewers tend not to comprehend clinical care and favor basic science that has little relevance toward health care, despite the funding agency being the National Institutes of "Health." Few studies funded by the NIH will have any immediate benefit toward health care. Such studies are simply not considered attractive.

You clearly did not get the right view of research. You failed to mention why the studies with humans in them would receive lower ratings than those with non-humans. You do not think it will be because of methodological flaws? With mice and other animals you have no drop-outs, which is HUGE in research, also it is much easier to run double blind experiments that way. Also its extremely hard to run true experimental methodologies on people, because if the treatment seems to work is it ethical to with hold it from the control group? Also you knock the IRB's, well its up to the research to make the argument why the research should be funded if they do not argue well or it is a poor study they will be rejected. I am sure this happens way more than people just saying - "its on humans we shouldn't fund i.t" The whole idea of an IRB is to have as diverse a grouping of people as possible, and most are intelligent and if you show the benefits of the study then they will pass it. I think its absurd that you rail against NIH ratings of studies without supplying any more information than studies with people score lower. Did you have no measure of strength of research design? i also think you should lay-off IRBs. Lastly in the opening paragraph you say the "psychological scars" that could be caused by deception in psychological research. Do you have any proof that this ever happens? The Zimbardo Prison study, and the Milgram shock study are the two most powerful studies ever done and NOT 1 person has had lasting negative effects, as both authors have published in their research and books.I think your article did not favors to science to the general public and is miss/ill-informed.