Institutional Review Boards and Open Access Publishing

The New York Times has an article about whether the rules for Human Subjects protection, enforced by Institutional Review Boards, have in fact gone overboard (in terms of onerous regulations that protect no one):

As Ethics Panels Expand Grip, No Field Is Off Limits

By PATRICIA COHEN

Ever since the gross mistreatment of poor black men in the Tuskegee Syphilis Study came to light three decades ago, the federal government has required ethics panels to protect people from being used as human lab rats in biomedical studies. Yet now, faculty and graduate students across the country increasingly complain that these panels have spun out of control, curtailing academic freedom and interfering with research in history, English and other subjects that poses virtually no danger to anyone.

The panels, known as Institutional Review Boards, are required at all institutions that receive research money from any one of 17 federal agencies and are charged with signing off in advance on almost all studies that involve a living person, whether a former president of the United States or your own grandmother. This results, critics say, in unnecessary and sometimes absurd demands.

Among the incidents cited in recent report by the American Association of University Professors are a review board asking a linguist studying a preliterate tribe to "have the subjects read and sign a consent form," and a board forbidding a white student studying ethnicity to interview African-American Ph.D. students "because it might be traumatic for them."

Of course, those who conduct research with human participants, whether in the biomedical sciences, psychology, or sociology, should adhere to guidelines that protect the rights of the individuals involved, as outlined in The Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. However, as nearly everyone in research can attest, having your project held up for months because of changes like this...

(1) Results of the study to date – line f was changed from “total men and women minorities enrolled” to “minorities” as requested.

...is counterproductive!

[NOTE: the example above was taken from an actual cover letter for a revised protocol.]

This brings me to the next topic (which is related, you'll see): Open Access Publishing, illustrated by such journals as the Public Library of Science family. The concept of making the results of publically funded research freely available to all is a worthy one. The idea of charging a taxpayer $39.00 to read an article important to her health such as this:

Ozanne EM, Annis C, Adduci K, Showstack J, Esserman L. (2007). Pilot trial of a computerized decision aid for breast cancer prevention. Breast J. 13: 147-54

This study sought to evaluate a shared decision-making aid for breast cancer prevention care designed to help women make appropriate prevention decisions by presenting information about risk in context. The decision aid was implemented in a high-risk breast cancer prevention program and pilot-tested in a randomized clinical trial comparing standard consultations to use of the decision aid.

is an outlandish affront perpetrated by Blackwell Synergy, Elsevier, and other publishers (see press coverage).

One of the down sides of Open Access Publishing is the steep price that investigators must pay to publish their research. For instance, publication charges at PLoS Medicine (and others) are $2500! However,

We offer a complete or partial fee waiver for authors who do not have funds to cover publication fees. Editors and reviewers have no access to payment information, and hence inability to pay will not influence the decision to publish a paper.

But who (at a major research university) wants to admit they can't afford to pay?

Another problem is the journal policy of wanting to obtain signed patient consent forms!! For example, this from PLoS Clinical Trials:

Protocol Submission

If authors have published their trial protocol in a peer-reviewed journal, then they should simply cite it in their submission to PLoS Clinical Trials. If the original protocol has not been published separately, it should be provided on submission, ideally uploaded through the electronic manuscript submission system, as a supporting file. The protocol need not include case record forms, patient information leaflets, or consent forms, although we (and reviewers) reserve the right to see patient consent forms in particular circumstances. Authors should also provide any subsequent amendments from the original protocol.

This stipulation is in express violation of the consent forms themselves! The forms typically have a lengthy confidentiality clause, and PLoS's request of viewing signed consent forms, which contain protected information (i.e., the participant's name), is not allowed! So presumably, here they mean just a blank copy of the form. However,

Our policy conforms to the Uniform Requirements, which states:

"Patients have a right to privacy that should not be infringed without informed consent. Identifying information should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that the patient be shown the manuscript to be published. Complete anonymity is difficult to achieve, and informed consent for publication should be obtained if there is any doubt. If data are changed to protect anonymity, authors should provide assurance that alterations of the data do not distort scientific meaning. When informed consent has been obtained it should be indicated in the published article."

In the unusual situation that a manuscript reports individual patient information that might potentially identify them, informed consent of the patient(s) will be required. Please use this form to obtain the patient's permission, and FAX to the PLoS UK office. PLoS Clinical Trials' open access license means that the images and text we publish online become available for any lawful purpose. This information should be conveyed when obtaining consent for publication from patients.

Now this stipulation does require submission of signed consent forms. Of course, you don't want to go around publishing identifying information from your participants, but the way PLoS defines "complete anonymity" is rather liberal (e.g., "Patient X is a 53 year old male..." would be too specific).

Any ideas or opinions on these matters?

Deep Brain Stimulation For Phantom Limb Pain

A clinical study of deep brain stimulation for the treatment of phantom limb pain (Bittar et al., 2005) reviews not only the treatments and mechanisms of phantom limb pain, but the historical aspects as well:

The 16th century French military surgeon Ambroise Pare was the first to medically document the phenomena of phantom limb sensation and phantom limb pain in 1551:

"For the patients, long after the amputation is made, say they still feel pain in the amputated part. Of this they complain strongly, a thing worthy and almost incredible to people who have not experienced this"

In 1830, the neurologist Charles Bell published a description of the condition in The Nervous System of the Human Body. The term ‘phantom’, however, is often credited to the American military surgeon Silas Weir Mitchell, who in 1871 gave the first modern description of a post-surgical ‘ghost’ occurring in an amputee:

"There is something almost tragical, something ghastly, in the notion of these thousands of spirit limbs haunting as many good soldiers, and every now and then tormenting them... when... the keen sense of the limb’s presence betrays the man into some effort, the failure of which of a sudden reminds him of his loss"

Bittar RG, Otero S, Carter H, Aziz TZ. (2005). Deep brain stimulation for phantom limb pain. J Clin Neurosci. 12: 399-404.

Phantom limb pain is an often severe and debilitating phenomenon that has been reported in up to 85% of amputees. Its pathophysiology is poorly understood. Peripheral and spinal mechanisms are thought to play a role in pain modulation in affected individuals; however central mechanisms are also likely to be of importance. The neuromatrix theory postulates a genetically determined representation of body image, which is modified by sensory input to create a neurosignature. Persistence of the neurosignature may be responsible for painless phantom limb sensations, whereas phantom limb pain may be due to abnormal reorganisation within the neuromatrix. This study assessed the clinical outcome of deep brain stimulation of the periventricular grey matter and somatosensory thalamus for the relief of chronic neuropathic pain associated with phantom limb in three patients. These patients were assessed preoperatively and at 3 month intervals postoperatively. Self-rated visual analogue scale pain scores assessed pain intensity, and the McGill Pain Questionnaire assessed the quality of the pain. Quality of life was assessed using the EUROQOL EQ-5D scale. Periventricular gray stimulation alone was optimal in two patients, whilst a combination of periventricular gray and thalamic stimulation produced the greatest degree of relief in one patient. At follow-up (mean 13.3 months) the intensity of pain was reduced by 62% (range 55-70%). In all three patients, the burning component of the pain was completely alleviated. Opiate intake was reduced in the two patients requiring morphine sulphate pre-operatively. Quality of life measures indicated a statistically significant improvement. This data supports the role for deep brain stimulation in patients with phantom limb pain. The medical literature relating to the epidemiology, pathogenesis, and treatment of this clinical entity is reviewed in detail.

Phantom Limb

The Shins

For a more accurate musical take on Phantom Limbs, see Men in a War (and listen to the song by Suzanne Vega).

alternative time consciousness platform

Here's a really alternative conception of time...

Reproduced from THE ORDER OF TIME.

FILOGNOSY

Statement of Purpose

The purpose of this site is to give clear and unequivocal instruction on the filognosy as proposed by The Order of Time. The Order of Time proposes for the science, politics, spirituality, personal interest, art and surfing of an alternative of time-consciousness. For that purpose it has developed e-books, designs, articles, definitions, timetables, a humanities directory for searching the net and even a game for searching on your identity for your life's mission. The complexity and diversity of The Order of Time might obscure the simplicity of its basic premises. To be clear about this simplicity this site offers straight questions and answers of a basic nature that will explain the concepts of consciousness, discipline, duality, liberation, order etc.

There's also a book of rules:

The Other Rules
How to be in love with the world (and her)

These rules cover not only Daily Life, but also Dating, Relations (rule y: Avoid free sex, intoxicants, financial speculation and the use of animal), Sport (rule j: Always shower), and most importantly, Making Love:

h) If you think you don't need: accept things going bad.
Sex is, once conditioned to it a need. It makes a balance of neurotransmitters in the brain, a balance of energy and foodintake in the body, a balance of associations in society and a certain type of duty to the Godhead of worship, the political leader, scientific paradigm or even a climate. Sometimes the fix of sexual behavior is called life, while others call it a kind of death as nothing seems to happen outside the line of sexual conditioning: one does not really develop other interests or intelligence. Also creativity can be seriously blocked attached to certain perversions finding no resistance or genius.

v) Care for love-play after the climax.
Just as important not to be egoistically after sexual gratification it is also important to share the success of achieving on a higher level of discharge. Many people simply use others at the 'way to the top'. But the other is not simply a staircase or a sex-object to be discarded after success. It is because of the support of the government, the spouse, the teachers, the religion, the culture of whatever that one could achieve. Gratitude is a very important value in the appreciation of as well the sexual orgasm as a societal success. ... Sexual orgasm and societal success go together also although it is somewhat of a paradox to be a cultural success and a intimate success at the same time. Usually success of sexual people is made by celibates working behind the screen. [MY EMPHASIS]

The copyrights of the materials at this site are settled thus that each may use and copy them freely, provided it is done without a profit-motive.

Time Is A Delusion

Time, if we can intuitively grasp such an identity, is a delusion: the difference and inseparability of one moment belonging to its apparent past from another belonging to its apparent present is sufficient to disintegrate it.

-- Jorge Luis Borges, A New Refutation of Time

Present Tense

Lately, The Neurocritic (and recent neuronews) has been focused on the past and the future. But what about the present? What happens to the brain when we are truly focused on the present moment? Overlapping brain areas activated while remembering the past/imagining the future include medial prefrontal cortex, posterior cingulate, and parahippocampal gyrus (Okuda et al., 2003; Addis et al., 2007; Szpunar et al., 2007). Are these regions (and others specific to past or future) deactivated when one resides in the present moment? And what does this state entail, phenomenologically speaking? Mindfulness is now a very popular topic of academic study, and numerous universities have centers for research on mindfulness and the application of mindfulness techniques in clinical practice.

The Centre For Mindfulness Research And Practice (University of Wales, Bangor)

Center for Mindfulness in Medicine, Health Care, and Society (University of Massachusetts Medical School)

Mindfulness Practice Center (University of Vermont)

UCSD Center for Mindfulness

etcetera...

What is mindfulness? According to Wikipedia, mindfulness is

the practice whereby a person is intentionally aware of his or her thoughts and actions in the present moment, non-judgmentally. Mindfulness is applied to both bodily actions and the mind's own thoughts and feelings.

One of the pioneers in this area is Richie Davidson, director of the Laboratory for Affective Neuroscience at the University of Wisconsin. Certainly, this topic can cover an entire blog, but in terms of neuroimaging studies, the literature on mindfulness-based meditation is sparse. However, two preliminary experiments were reported at conferences and summarized by Cahn and Polich (2006) in their comprehensive review, Meditation States and Traits: EEG, ERP, and Neuroimaging Studies. One of these fMRI studies (Baerentsen, 2001), and another one by Ritskes et al. (2003), employed 45 sec on/45 sec off bouts of meditation/rest (not entirely conducive to entering the appropriate state). At any rate, Baerentsen (2001) reported activations in the dorsolateral prefrontal cortex (PFC), anterior cingulate cortex (ACC), hippocampus, and right temporal lobe, and deactivations in the visual cortex. Ritskes et al. (2003) also reported increased activity in dorsolateral PFC (R>L) plus the basal ganglia. They saw decreased activity in the occipital lobe but also in the anterior cingulate (in contrast to Baerentsen, 2001). Hmm. Anyway. Commonalities include deactivation in the occipital cortex (which is activated in the past/future studies, presumably due to imagery) and activation in dorsolateral PFC.

At first glance, the latter finding seems curious because dorsolateral PFC is involved in attention, working memory, and other executive control-type functions. Although meditation is relaxing, it is

a state of concentrated attention on some object of thought or awareness.

This point was stressed by Lazar and colleagues (2000), who reported greater activity in dorsolateral PFC, parietal lobe, ACC, striatum, hippocampus/parahippocampus, etc. during the practice of Kundalini meditation, which involves a focus on breathing and silent repetition of phrases during inhalation and exhalation.

Another unpublished study compared two forms of meditation: Kundalini (mantra-based) or Vipassana (mindfulness-based). These were contrasted with control conditions of rest, random number generation, and paced breathing (Lazar et al., 2003). Similar (but nonoverlapping) regions in frontal and parietal cortices and some subcortical areas were more active during the two types of meditation than during the control conditions. A common area of activation was in the dorsal ACC. Overall, these findings suggest a focused state of attention during meditation, which engages an attentional network (mostly) unlike what is seen in studies of past and future time travel. Areas common to reflecting upon the past, present, and future include the hippocampus and parahippocampal gyrus.

References

Addis DR, Wong AT, Schacter DL. (2007). Remembering the past and imagining the future: Common and distinct neural substrates during event construction and elaboration. Neuropsychologia 45: 1378-1385.

Baerentsen KB. (2001). Onset of meditation explored with fMRI. Neuroimage 13: S297.

Cahn BR, Polich J (2006). Meditation States and Traits: EEG, ERP, and Neuroimaging Studies. Psych Bull. 132: 180-211.

Lazar SW, Rosman IS, Vangel M, Rao V, Dusek, H, Benson H, et al. (2003, November). Functional brain imaging of mindfulness and mantra-based meditation. Paper presented at the meeting of the Society for Neuroscience, New Orleans, LA.

Lazar SW, Bush G, Gollub RL, Fricchione GL, Khalsa G, Benson H. (2000). Functional brain mapping of the relaxation response and meditation. NeuroReport 11: 1581-1585.

Okuda J, Fujii T, Ohtake H, Tsukiura T, Tanji K, Suzuki K, et al. (2003). Thinking of the future and the past: The roles of the frontal pole and the medial temporal lobes. Neuroimage 19: 1369–1380.

Ritskes, R., Ritskes-Hoitinga, M., Stodkilde-Jorgensen, H., Baerentsen, K., & Hartman, T. (2003). MRI scanning during Zen meditation: The picture of enlightenment? Constructivism in the Human Sciences 8: 85-90.

Szpunar KK, Watson JM, McDermott KB. (2007). Neural substrates of envisioning the future. Proc. Natl. Acad. Sci. Published online before print January 3, 2007.

past present future

We're here, there, not here, not there, swirling like specks of dust, claiming for ourselves the rights of the universe. Being important, being nothing, being caught in lives of our own making that we never wanted. Breaking out, trying again, wondering why the past comes with us, wondering how to talk about the past at all.

--Jeanette Winterson, Lighthousekeeping