Ronald Bayer, Ph.D.Professor and Co-Chair, Center for the History and Ethics of Public Health, Mailman School of Public Health, Columbia University"DR. BAYER: The co-op boards, in case you don’t know, investigate every aspect of your life to see whether you are good enough to be a neighbor. So I listen to this and I listen with concern because what should be a process of enhancing both the quality of the research and the ethical attention that researchers ought to pay to research subjects and the consequences of research has become something very different. And I say this as someone who is not opposed to regulation. I see regulation as central to a Democratic society. If it’s transparent, if it’s efficient, etcetera.And I hear this concern in an institution where people by and large are committed to human rights. That is, it is one aspect of the culture of schools of public health that the attention to vulnerable populations is high. And concern about the mission of public health being the mission to protect vulnerable populations is central.And so when I listen to this and I listen to people saying: Oh, the Goddamn IRB, forgive me, and the picayune questions they raise, and the impediments they impose upon the ability to do this work. I listen and I'm concerned and I think it is something that ought to be a matter of concern to all of us. That is, has the structure we have created become something very different from what we wanted and how do we fix it? And that is central fundamental question, not a matter of tinkering.The second issue I wanted to mention, and it’s related to this, is the way in which we assure that people who are going to conduct research are familiar with basic principles, understand the concepts, understand the tensions, etcetera. I, like everyone else at the Mailman School of Public Health have to take an online test to guarantee that I have read the right things and understand the right things. I did it several years ago and just last month I was told we now have to do it every three years, so I had to do it again. I have to tell you, it is the most insulting experience to sit in front of a screen, to download a text and then a series of questions to which there is only one right answer, and if God forbid you think that there may be an ambiguity or an uncertainty, you get the answer wrong.What has happened, and I listen to people talk about taking these tests, and they talk about it the way Russian social scientists used to talk about having to learn the right Marxist doxology in the old Soviet Union. They have to learn something, spit it back and give the right answer, and if you don't get a good enough score, you can't do research, you have to take the test again.How it happened that we came to think educating people about doing research in an ethical way became so contorted that it becomes like the joke about how kids used to learn the Pledge of Allegiance and they didn't know what any of the words meant, and so they garbled it up in some funny way and you would hear versions of what the Pledge of Allegiance is. It is like that when people talk about ethics of research as they -- look what you can do is you can download the text, put the question in front of you, read the text, find the answer. That's not education. And the reason I see it as a matter of concern is what it does is it raises contempt for the idea of education and becoming kind of sensitive to ethical complexities. And that's not where I think we should be going.It is in some way analogous to what has happened to the issue of privacy and the HIPAA regulations and the incessant plethora of pieces of paper from banks and insurance companies, printed and typed, I certainly can't read anymore, that tell you about their privacy protections. What do people think? All this privacy protection stuff is junk. Because it has become utterly bureaucratized.So, what’s the challenge it seems to me to this commission? There are many big issues about what kinds of research internationally and globally in a world that is increasingly unequal is ethical, but it seems to me -- it seems to me that it is time to revisit in a fundamental way both the institutions we've created, how they function, and how we educate people about fundamental ethical issues in research.I don't deny that there are certain fundamental things one can read and learn. One takes drivers test, one has to learn what a left hand signal is and what a right hand signal is. But there is something off when people see the entire process, not as something they feel proud about, but as something they experience as, in a way mortifyingly stupid, and stupefying -- that is what it is, stupefying.One last point and I'll stop. And this relates in part to this. I have been interested for the last several years in the question of ethics of public health surveillance, a central piece of what public health is about. You can't do public health without surveillance. The question of course is: what is the difference between public health surveillance, which is public health practice and is not subject to IRB review, and public health research, which is subject to IRB review?There is entire layer of personnel at the CDC whose I think sole function is to try to distinguish between public health research and surveillance activities. And I'll tell you, I'll end with the vignette I started with a vignette. I spoke to a guy and he said: You know, I got this protocol on my desk and I had to review to decide whether it was research or not. And I reviewed it and it got lost in the mess on my desk. So they sent it to me again. And I reviewed it again. And he said, then I found both and in one instance I had called it research and in one instance I called it practice. What does this mean? That he's inconsistent, that he’s foolish? No. It seems to me that it’s a complicated issue, we haven't resolved it. Trying to resolve it with a kind of formalistic definition of what is research seems to me inadequate to the challenge. It seems to me what this suggests and this is a huge domain in public health is the need to go beyond the issue of articulating standards for research qua research and say there are undertakings that don't fit the definition of research -- maybe oral history, maybe not surveillance or not -- and to think about what ethical standards ought to govern all those forms of inquiry, not simply those that bureaucratically fall within the niche. I'll stop there. Thank you. "http://bioethics.gov/cms/node/229Read more…
This provides us with a chance to voice our opinions on Human Subjects Research.Summary"The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects."ADDRESSES: Back to TopYou may submit comments, identified by docket ID number HHS-OPHS-2011-0005, by one of the following methods:* Federal eRulemaking Portal: http://www.regulations.gov. Enter the above docket ID number in the “Enter Keyword or ID” field and click on “Search.” On the next Web page, click on “Submit a Comment” action and follow the instructions.* Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
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Copy and paste from the US DHHS formerly the Department of Health, Education and Welfare"Why is the Federal government proposing changes to the Common Rule?This regulatory review effort is primarily about enhancing protections for human subjects.The federal government is considering changes to the Common Rule (45 CFR 46) for two reasons: (1) the human subject research landscape has changed dramatically since the early 1980s when the current regulations were first being formulated and (2) in light of that, there is a need to address effectiveness and the efficiency of the regulations for human subject protections in the current research environment.Since the promulgation of the Common Rule, there have been major increases in the volume of research, in multi-site studies, and in health services and social sciences research. New technologies for research—genomics, imaging, informatics—have also been developed and have altered the methods and aims of research with human subjects.These changes in the landscape have highlighted various issues regarding the efficiency and effectiveness of the current regulatory framework. The unnecessary burdens and workload carried by Institutional Review Board (IRBs) is often cited. Certain regulatory requirements of government agencies could be clarified and streamlined. Moreover, the regulatory framework does not appropriately calibrate research review and does not focus the review where it is needed most. The requirements and practices for informed consent should be enhanced to augment the quality and appropriateness of information conveyed to potential human subjects.For these and other reasons, the federal government has concluded that change is needed and would yield significant benefits—both to investigators and to human subjects.In brief, what aspects of the Common Rule is the government reexamining?The government has two overarching goals with respect to the revisions it is considering to the Common Rule: (1) to enhance the protection of research subjects and (2) to improve the efficiency of the review process.To accomplish these goals, seven possible regulatory reforms are envisioned and described in the ANPRM:1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.2. Using a single Institutional Review Board review for all domestic sites of multi-site studies.3. Updating the forms and processes used for informed consent.4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.5. Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.6. Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.7. Providing uniform guidance on federal regulations.How in particular would these changes enhance human subject protections?The changes under consideration will extend federal oversight to non-federally funded studies, i.e., those at institutions that receive any funding from Common Rule agencies for human subjects research.The changes under consideration would also give subjects the opportunity to decide whether their biological specimens may be used for future research and, if so, to specify types of research in which their biospecimens may not be used.If the risk-based framework for IRB review were more rationally refined, IRBs would be better able to concentrate their resources on the review of research that poses higher risk to subjects.In addition, the changes under consideration would facilitate and enhance informed consent by creating and utilizing standardized templates and explicitly delineating the information that potential research participants should know. This would have two benefits. The IRB’s task of reviewing proposed consent forms will now be greatly facilitated, and individuals contemplating participation in research will be better and more consistently informed.With respect to informational risks, new data security and information protection standards would be adopted, thereby reducing the potential for violations of privacy and confidentiality.Finally, the changes would systematize the collection and analysis of unanticipated problems and adverse events across all trials. Such a system would replace the complicated array of definitions and reporting requirements with harmonized rules. Consolidation of data reported using consistent vocabularies and terms would allow for more powerful and meaningful analyses of safety information across types of research studies. The ANPRM also considers a number of changes to improve the current system for the real-time prompt collection of data that will help enhance patient safety measures.What opportunities will the public have to express its views about these matters?First, an Advance Notice of Proposed Rulemaking (ANPRM) has been published in the Federal Register that describes the changes under consideration and invites public comments. The public will have 60 days to provide comments. During this comment period, the government will also provide a forum for stakeholders and interested members of the public to voice their opinions about these matters. All comments collected during this process will be vital to the process of producing a final draft of the revisions under consideration in the Common Rule.What is an "Advance Notice of Proposed Rulemaking (ANPRM)"?Before the federal government implements new regulations, it must typically issue a “Notice of Proposed Rulemaking” (NPRM). The purpose of such a notice is two-fold: (1) to inform the public of the specifics of the proposed regulations and (2) to provide the public with the opportunity to react to and comment on the proposed regulations. The public is offered an opportunity to comment, and its views are taken into account in developing and implementing the final regulations.An Advance Notice of Proposed Rulemaking (ANPRM) may precede the issuance of an NPRM if the government needs public input on various issues before proposing a rule. This ANPRM— Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators —presents and seeks comment on specific issues regarding possible changes to the Common Rule; it also raises questions about matters that may not appear as changes in the rule itself but are closely related to its implementation.The aim of this process—of issuing and gathering comments on first an ANPRM and then an NPRM—is to ensure a broad-based input from the multiple groups and organizations with an interest in the ethics and regulation of human subject research.After the government collects comments on the ANPRN, what will happen next?Public comments will be used in the process of developing specific proposed revisions to the Common Rule. These draft revisions will be publicized in a Notice of Proposed Rule Making and the public will have an additional opportunity to comment before any changes to the Common Rule are finalized. "
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"Advances in neuroscience are raising a host of new ethical, legal and social issues for healthcare practitioners. The Penn Conference on Clinical Neuroscience and Society reviews cutting-edge neuroscience relevant to psychiatry, neurology, physiatry, primary care and pediatrics, and focuses on the ethical, legal and societal impact of these developments."http://www.neuroethics.upenn.edu/index.php/events/clinical-conferencehttp://bioethics.gov/cms/node/270Read more…
"One of SACHRP’s recommendations to the commission is to “close the gap in oversight and harmonize the overlapping regulations governing human subject protections.” Possibilities, SACHRP noted, include having “a single federal regulatory agency for the oversight of research involving human subjects” or expanding the authority of an existing regulatory entity, such as OHRP, to all human subjects research."http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&id=3535Read more…
"Corporate governance and management oversight are flavour of the week with the shenanigans at Rupert Murdoch’s defunct News of the World on every front page. On a vastly different scale, a similar issue has cropped up in the bioethics community. A self-styled watchdog, the Project on Government Oversight, has called upon the chair of the Presidential Commission for the Study of Bioethical Issues to step down after allegations of ghostwriting by professors at her university."http://www.bioedge.org/index.php/bioethics/bioethics_article/9632/Read more…
"There is something intrinsically sacrificial about participating in biomedical research. Research exposes participants to some risks and often offer little no individual benefits. In some rare and extreme cases, research participants make the ultimate sacrifice: they die as a result of the intervention being tested. When this happens, there is a strong intuition that the participant's family should receive compensation for their loss. The intuition is also embedded in influential ethics guidance that researchers and their funders are supposed to adhere to: those conducting clinical trials are required to have insurance to cover such eventualities."-Global bioethics bloghttp://globalbioethics.blogspot.com/2011/06/doing-what-is-right-when-result-of.html"Clinical trials claimed 25 lives in 2010, only 5 paid compensation""NEW DELHI: Rs 3 lakh – that's the price a pharmaceutical company has paid to the family of a person who died in their clinical trial. Others weren't even this lucky.According to the Drug Controller General of India's (DCGI) records, 25 people died in clinical trials carried out by nine pharmaceutical companies in 2010. Families of five of these victims received "compensation for trial related death" — the amount ranging from Rs 1.5 lakh to Rs 3 lakh."-The Times of Indiahttp://articles.timesofindia.indiatimes.com/2011-06-06/india/29624892_1_clinical-trials-drug-controller-general-dcgiRead more…
Review of Babies by Design: The Ethics of Genetic Choice by Ronald M. Green and Enhancing Evolution: The Ethical Case for Making People Better by John Harrisby Richard Hayes, The American Interest (January - February 2008)"Our common human nature evolved over millions of years but has been stable over the few thousand years during which modern human values, behaviors and institutions have developed. When we look into the eyes of another person, we know something about that person-indeed, an enormous amount, far more than we realize-no matter how dissimilar we may otherwise be. Manipulating the foundations of human nature would change all this. If human minds start modifying the basic structures of the human mind-that is, if the agent of change becomes the object of change-there will no longer be a "there" there. We will have destabilized both the biological and social foundations of the human world."http://www.geneticsandsociety.org/article.php?id=3841Read more…
"Psychoneuroimmunology (PNI) is the study of the interaction between psychological processes and the nervous and immune systems of the human body.[1] PNI takes an interdisciplinary approach, incorporating psychology, neuroscience, immunology, physiology, pharmacology, molecular biology, psychiatry, behavioral medicine, infectious diseases, endocrinology, and rheumatology.The main interests of PNI are the interactions between the nervous and immune systems and the relationships between mental processes and health. PNI studies, among other things, the physiological functioning of the neuroimmune system in health and disease; disorders of the neuroimmune system (autoimmune diseases; hypersensitivities; immune deficiency); and the physical, chemical and physiological characteristics of the components of the neuroimmune system in vitro, in situ, and in vivo."http://en.wikipedia.org/wiki/Psychoneuroimmunology#Pharmaceutical_advancesHypersensitivities-refers to undesirable reactions produced by the normal immune system. These reactions may be damaging, uncomfortable, or occasionally fatal. Hypersensitivity reactions require a pre-sensitized (immune) state of the host.http://en.wikipedia.org/wiki/HypersensitivityAutoimmune diseases arise from an overactive immune response of the body against substances and tissues normally present in the body. In other words, the body actually attacks its own cells.http://en.wikipedia.org/wiki/Autoimmune_diseasesimmunodeficiency (or immune deficiency) is a state in which the immune system's ability to fight infectious disease is compromised or entirely absent. Most cases of immunodeficiency are acquired ("secondary") but some people are born with defects in their immune system, or primary immunodeficiency.http://en.wikipedia.org/wiki/Immune_deficiencyHistory:"Interest in the relationship between psychiatric syndromes or symptoms and immune function has been a consistent theme since the beginning of modern medicine.Walter Cannon, a professor of physiology at Harvard University, looked at the need for mental and physical balance throughout the organism and coined the term, Homeostasis in his book The Wisdom of the Body,1932, from the Greek word homoios, meaning similar, and stasis, meaning position.In his work with animals Cannon observed that any change of emotional state in the beast, such as anxiety, distress, or rage, was accompanied by total cessation of movements of the stomach. These studies into the relationship between the effects of emotions and perceptions on the autonomic nervous system, namely the sympathetic and parasympathetic responses that initiated the recognition of the freeze, fight or flight response. His findings were published from time to time in professional journals, then summed up in book form in The Mechanical Factors of Digestion, published in 1911. Dr. Cannon’s seminal work, Bodily Changes in Pain, Hunger, Fear and Rage was published in 1915.""Picking up on Cannon's work was Hans Selye. Selye experimented with animals putting them under different physical and mental adverse conditions and noted that under these conditions the body consistently adapted to heal and recover. Several years of experimentation that formed the empiric foundation of Dr. Selye's concept of the General Adaptation Syndrome. This syndrome consists of an enlargement of the adrenal gland, atrophy of the thymus, spleen and other lymphoid tissue, and gastric ulcerations.Selye describes three stages of adaptation, including an initial brief alarm reaction, followed by a prolonged period of resistance and a terminal stage of exhaustion and death. This foundational work led to a rich line of research on the biological functioning of glucocorticoids.[2]Mid 20th century studies of psychiatric patients reported immune alterations in psychotic patients, including numbers of lymphocytes [3][4] and poorer antibody response to pertussis vaccination, compared with nonpsychiatric control subjects.[5] In 1964 George F. Solomon et all. coined the term "psychoimmunology" and published a landmark paper: "Emotions, immunity, and disease: a speculative theoretical integration."[6]""There is now sufficient data to conclude that immune modulation by psychosocial stressors and/or interventions can lead to actual health changes. Although changes related to infectious disease and wound healing have provided the strongest evidence to date, the clinical importance of immunological disregulation is highlighted by increased risks across diverse conditions and diseases""For a concept to be psychosocial means for it to relates to one's psychological development in, and interaction with, a social environment."http://en.wikipedia.org/wiki/PsychosocialDo you really want to know the definition of "psychosocial intervention"?http://www.interventionjournal.com/downloads/12pdf/1204%20Ananda%20Galappatti.pdfRead more…
Source: wikipediahttp://en.wikipedia.org/wiki/NeuroimmunologyThe field of combining neurology and immunology.The study of "malfunction of either and or both systems that leads to disorders, and the physical, chemical, and environmental stressors that affect the two systems on a daily basis."In HSR we can find allowances for the use of environmental and social behavioral manipulation of the subject, the EPA has allowances for the use of chemicals and pharamachological agents."Neural targets that control thermogenesis, behavior, sleep, and mood can be affected by pro-inflammatory cytokines which are released by activated macrophages and monocytes during infection. Within the central nervous system production of cytokines has been detected as a result of brain injury, during viral and bacterial infections, and in neurodegenerative processes."thermogenics-heat creationcytokines-"are small cell-signaling protein molecules that are secreted by the glial cells of the nervous system and by numerous cells of the immune system and are a category of signaling molecules used extensively in intercellular communication" source wikipedia http://en.wikipedia.org/wiki/Cytokinemacrophages-white blood cellmonocytes-another kind of white blood cell""Neuroinflammation and neuroimmune activation have been shown to play a role in the etiology of a variety of neurological disorders such as stroke, Parkinson's and Alzheimer's disease, multiple sclerosis, pain, and AIDS-associated dementia. However, cytokines and chemokines also modulate CNS function in the absence of overt immunological, physiological, or psychological challenges. For example, cytokines and cytokine receptor inhibitors affect cognitive and emotional processes. Recent evidence suggests that immune molecules modulate brain systems differently across the lifespan."Wikipedia author quote from NIH
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"Neuroimmunology is a field combining neuroscience, the study of the nervous system, and immunology, the study of the immune system. Neuroimmunologists seek to better understand the interactions of these two complex systems during development, homeostasis, and response to injuries. A long-term goal of this rapidly developing research area is to further develop our understanding of the pathology of certain neurological diseases, some of which have no clear etiology. In doing so, neuroimmunology contributes to development of new pharmacological treatments for several neurological conditions. Many types of interactions involve both the nervous and immune systems including but not limited to the physiological functioning of the two systems in both health and disease, malfunction of either and or both systems that leads to disorders, and the physical, chemical, and environmental stressors that affect the two systems on a daily basis."We should note that with HSR deals directly with environmental manipulation in the studies and addresses this directly.http://en.wikipedia.org/wiki/Neuroimmunology#Neurodevelopmental_disordersRead more…
" Examining the dynamics of human vision is paramount in NGA’s efforts to advance technology’s role in geospatial intelligence from image production to include image interpretation. Automating this human sense will allow computers to perform basic steps of imagery analysis to lessen the workload for analysts, and thus expedite intelligence production. However, accurately capturing these processes cannot be done with a standard eye exam. Instead, research must be performed on the human brain, not with tissue samples and microscopes, but by advanced methods of tracking brain activity during visual stimuli."http://www.gpsworld.com/gis/government-military/nga-establishes-new-policy-pick-analysts039-brains-5415http://www.gpsworld.com/Read more…
"I have seen definitions of “social justice” that would include practices or beliefs which are antithetical to the Church’s teachings, e.g., abortion, same-sex marriage, euthanasia, some kinds of bio-medical experimentation. No, I don’t think “social justice” is the real element that makes a law school one that can call itself distinctively Catholic."http://www.uscatholic.org/blog/2011/03/social-justice-important-catholic-lawIntersection between social justice, faith based beliefs and human subjects research
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"During the Holocaust, Nazis referred to Jews as rats. Hutus involved in the Rwanda genocide called Tutsis cockroaches. Slave owners throughout history considered slaves subhuman animals. In Less Than Human, David Livingstone Smith argues that it's important to define and describe dehumanization, because it's what opens the door for cruelty and genocide."http://www.npr.org/2011/03/29/134956180/criminals-see-their-victims-as-less-than-humanRead more…
"Cross-cultural neuroethics aims to overcome potential misunderstandings that might arise when the worldview of researchers differs from that of the community they are investigating. Elana Brief of the National Core for Neuroethics at the University of British Columbia is involved in community-based participatory research, an approach that fosters collaboration between the investigators and their subjects, recognizing unique strengths that each brings to the work."http://www.dana.org/news/features/detail.aspx?id=30116Read more…
