Some Thoughts on Stem Cell Research
What are the denizens of the blogosphere thinking about stem cell research now that it's in the news every day, new breakthroughs are arriving in close sequence, and the political battle seems to be heating up? This is a random selection from a perusal of Technorati, a very useful tool.
In reference to common religious and luddite arguments against progress, "note: they're already here" asks "What does it mean for something to be natural or unnatural?" The argument proposed is not a sound one overall, but it contains some thoughtful points and shows that people are thinking about these things:
For example, take the issue of stem cell research. The US government is banned from funding any stem cell research. Why? Because President Bush decided that it was "unnatural." But is it unnatural? President Bush, being a religious man, might say that a person who loses both their kidneys to disease did so because it was pre-ordained by God. To find another person who might have a kidney to donate is natural. To grow another kidney from stem cells would be unnatural, because only God should have the power to create people (or parts thereof).
The author does successfully demonstrate that the line between "natural" and "unnatural" is entirely abitrary and not fit to be used in any sensible debate. Not that politics sees much in the way of sensible, rational debate, but you know what I mean.
Virginia Postrel comments on both interesting news from Geron that I haven't seen detailed elsewhere and the Canadian ban on therapeutic cloning that I also mentioned at the Longevity Meme. I have to disagree with this point though:
The U.S. also has political gridlock--the best way to block new forms of regulation.
The best way to block new forms of regulation is to have a small government, one that lacks the resources and the will to interfere in every aspect of life.
On that note, the news regarding Pentagon funding of Swedish stem cell research had people confused. Early reports did not indicate that the research would have been allowed in the US, which led to comments like this one from Chris Mooney:
Is the Pentagon above the law? If not, how can it fund stem cell research? Is the DOD doing an end run around Bush's stem cell policy, or does that policy allow for some kind of battlefield exemption? Unfortunately, this annoying Reuters article on the Pentagon's funding of stem cell research in Sweden totally fails to address these central questions, leaving me completely confused about what to make of the latest news.
(Chris Mooney also has more on the Bioethics Council thing, which I suppose we can connect to stem cell research fairly directly). Another signature quote on the Pentagon funding is from the Stupid Evil Bastard:
How's this for ironic? The Pentagon has given a $240,000 grant to a team of Swedish scientists who are working with stem-cells in an attempt to develop an effective treatment for Parkinson's disease. The very sort of research that President Bush banned here in the United States back on August 9th, 2001. Words fail me. All I can do is sit here and shake my head and laugh at the ridiculousness of it all.
On a more serious note related to this topic, a post by Daniel McConchie on the way in which this Pentagon funding deal came about in the first place is well worth reading, even if I don't agree with his position on the potential of embryonic stem cell research.
On to baldness. It's fascinating, and heartwarming, that at least one vanity industry is getting it right. In the midst of a sea of useless products promoted as "anti-aging," the large hair regrowth industry is sinking serious money into regenerative medicine. I found this comment at Gerbil's Giant Gumball Gumbo:
Just goes to show how ludicrous Bush is by banning this type of research. While it is something as frivolous as baldness, some men find baldness a very restricting "disease". The future of health could soon rely on the study of stem cells and Bush is having none of it. Our scientists, our people, and the world are losing out.
OK...heres the deal. I give a crap that I'm bald. I have a crewcut down to about 3 mm and pretty much always have. But wanna place bets on whether the numbers for stem cell research will experience a bump with men 30+?
Cynicism says that self-interest will win out eventually for all new fields of medical research. The more uses that can be demonstrated, the more people will oppose the current restrictions. If vanity industries help the process along, and are putting money into serious research along the way, more power to them.
Were not gonna take it! No! Were not gonna take it, were not gonna take it anymore! [TS]
HOW MUCH LONGER ARE WE THE PEOPLE GOING TO PUT UP WITH THIS MANIPULATIVE MENTALLY SICK TWISTED FORM OF AUTHORITY AND GOVERNMENT DICTATORSHIP?
OUR FREEDOM IS AN OPTICAL ILLUSION. WE HAVE NO RIGHTS. HOW CAN WE TRUST THIS AUTHORITY OF POLICE AND GOVERNMENT PAWNS?
WE HAVE BEEN TAUGHT LIES FROM THE DAY WE WERE BORN. MOST OF OUR EDUCATION, MEDIA, NEWSPAPERS, ETC. PERSIST TO FURTHER MANIPULATE AND CONTROL IN AN ATTEMPT TO FORM THOUGHTS AND OPINIONS TOWARDS UNRELATED SOCIAL, ECONOMIC, POLITICAL EVENTS, AFFAIRS AND ISSUES TO KEEP WE THE PEOPLE CONSTANTLY BATTLING ONESELF AND ONE ANOTHER THEREFORE RESULTING IN WIDESPREAD MENTAL AND PHYSICAL ABUSE BY POLICE AND GOVERNMENT AUTHORITIES OF AN UNAWARE AND DEFENSELESS POPULATION CONSISTING OF WE THE PEOPLE. ----WAKE UP!----
THIS IS REALITY! THIS MANIPULATED CONTROLLED RESPONDING VARIABLE OF MENTALLY SICK TWISTED GAMES AND LIES NEEDS TO STOP AND STOP NOW!
____TEAMNOW____
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Funding Solicitations
OBER is requesting research application and proposals in support of the Microbial Genome Program.
Institutions: Notice 04-07
National Labs: Announcement 04-07
Preapplications for both are due January 29, 2004, and formal applications by April 15, 2004.
Organisms in the Program
Complete and in Progress
Sequencing Microbial Genomes to Uncover Potential Applications Relevant to DOE Missions
$Draft sequence by the DOE Joint Genome Institute.
?New microbes being sequenced by JGI.
??Sequenced by The Institute for Genomic Research.
*Completed and published (see http://wit.integratedgenomics.com/GOLD).
**Completed, not published (as of May 13, 2003).
Carbon Sequestration
$Azotobacter vinelandii AvOP (bacteria, 4.5 Mb): Aerobic, fixes nitrogen; found in soils worldwide; has nitrogenases incorporating molybdenum and vanadium (in addition to iron); relevant to energy use and carbon sequestration.
$Chlamydomonas reinhardtii (eukaryotes, ~100 Mb): Green alga, photosyntetic, widespread in environment, 17 chromosomes, widely used model system.
*Chlorobium tepidum (bacteria, 2.1 Mb): Photosynthetic; may play important role in earth?s overall carbon cycle.
$Chloroflexus aurantiacus J-10-fl (bacteria, 3 Mb): Modern version of organism that needs no oxygen for photosynthesis. Uses unique pathway to fix carbon dioxide.
??Colwellia 34H (bacteria, 5.3 Mb): Psychrophile, important in carbon and nutrient cycling in polar marine environments.
?Crocosphaera watsonii WH8501 (cyanobacteria, 3.6 to 5 Mb): Marine, unicellular; confined to waters from 26 to 32?C; temporally segregates carbon-dioxide fixation from nitrogen fixation.
?Emiliania huxleyi 1516 (marine algae, ~5 Mb): Marine coccolithophorids; role in global carbon cycling and sulfur transformation.
?Moorella thermoacetica ATCC39073 (bacteria): Fixes carbon dioxide in absence of oxygen; can grow on hydrogen, carbon dioxide, or carbon monoxide as sole carbon source; acetogenic.
*Nitrosomonas europaea ATCC25978 (bacteria, 2.2 Mb): Important in soil nitrogen cycling and ammonia oxidation; degrades chlorinated hydrocarbons; aids incorporation of carbon dioxide into biomass.
$Nostoc punctiforme ATCC29133 (bacteria, 10 Mb): Fixes carbon dioxide and nitrogen; produces hydrogen; survives acidic, anaerobic, and low-temperature conditions.
?Ostreococcus (eukaryotes, est. 8 to 10 Mb): Fast-growing, ubiquitous; important in marine carbon fixation.
?Prochlorococcus isolate NATL2A (prokaryotes, 1.7 to 2.4 Mb): Ocean carbon sequestration.
*Prochlorococcus marinus MED4 (bacteria, 1.7 Mb) and *Prochlorococcus marinus MIT9313 (bacteria, 2.4 Mb): Both abundant in temperate and tropical oceans; important in ocean carbon cycling; absorb blue light efficiently. MIT9313 is adapted to lower-light conditions (lower ocean depths).
**Rhodopseudomonas palustris CGA009 (bacteria, 5.5 Mb): Fixes carbon dioxide; produces hydrogen; biodegrades organic pollutants under both aerobic and anaerobic conditions.
$Rhodospirillum rubrum ATCC11170 (bacteria, 3.4 Mb): Phototrophic; grows in various conditions, including aerobic and anaerobic. Fixes nitrogen, grows on hydrogen; model for photosynthesis.
*Synechococcus WH8102 (bacteria, 2.4 Mb): Photosynthetic; important to ocean carbon fixation; genetically tractable.
?Synechococcus elongates PCC7 942 (cyanobacteria, 2.4 to 2.7 Mb): Carbon fixation; photosynthesis in fresh waters.
$Thalassiosira pseudonana (eukarya, ~25 Mb): Ocean diatom, major participant in biological ?pumping? of carbon to ocean depths.
$Trichodesmium erythraeum IMS101 (bacteria, 6.5 Mb): Key nitrogen-fixing microbe; major role in tropical and subtropical oceans.
Energy Production
?Anabaena variabilis ATCC29413 (cyanobacteria, 7 to 10 Mb): Filamentous heterocyst-forming; fixes nitrogen and carbon dioxide; produces hydrogen.
??Carboxydothermus hydrogenoformans (bacteria, 2.10 Mb): Gram positive; converts carbon monoxide and water to carbon dioxide and hydrogen.
*Methanobacterium thermoautotrophicum Delta H (archaea, 1.7 Mb): Produces methane; plays role in earth?s overall carbon cycle.
$Methanococcoides burtonii DSM6242 (archaea, 3 Mb): Extremophile adapted to cold (less than 5?C); produces methane.
*Methanococcus jannaschii DSM2661 (archaea extremophile, 1.7 Mb): May identify high-temperature, high-pressure enzymes; produces methane.
$Methanosarcina barkeri Fusaro (archaea, 2.8 Mb): Lives in cattle rumen; digests cellulose and other polysaccharides to produce methane. Very oxygen sensitive. Grows in variety of substrates.
?Methylobacillus flagellatus KT (proteobacteria, 3.1 Mb): Bioremediation; cycling of one-C compounds; environmentally benign bioprocessing into feedstocks.
??Thermotoga neopolitana ATCC49045 (bacteria, ~1.8 Mb): Combines with oxygen to produce hydrogen.
Bioremediation
$Acidithiobacillus ferrooxidans (bacteria, 2.9 Mb): Used in mining industry to sequester iron and sulfide.
?Burkholderia ambifaria (bacteria, 4.7Mb): Genomovar VII, smallest Burkholderia genome, biocontrol agent.
$Burkholderia fungorum LB400 (bacteria, 8 Mb): Outstanding degrader of polychlorinated biphenyls (PCBs).
?Burkholderia vietnamiensis G4 (bacteria, ~8 to 10 Mb): Genomovar V, degrades trichloroethylene and colonizes rhizosphere.
*Caulobacter crescentus (bacteria, 4.01 Mb): Potential for heavy-metal remediation in waste-treatment plant wastewater.
$Dechloromonas RCB (bacteria, 2 Mb): Oxidizes iron. Converts perchlorate to chloride; anaerobically oxidizes benzene to carbon dioxide.
??Dehalococcoides ethenogenes (bacteria, 1.5 Mb): Degrades dangerous solvent trichloroethene to benign products.
*Deinococcus radiodurans R1 (bacteria, 3 Mb): Survives extremely high levels of radiation; possesses DNA-repair capabilities for radioactive waste cleanup.
$Desulfitobacterium hafniense DCB-2 (bacteria, 4.6 Mb): Degrades pollutants such as chlorinated organic compounds that include some pesticides.
$Desulfovibrio desulfuricans G20 (bacteria, 3.1 Mb): Anaerobic; reduces sulfate, uranium, and toxic metals; corrodes iron piping; ?sours? petroleum with hydrogen sulfide.
??Desulfovibrio vulgaris (bacteria, 3.2 Mb): High potential for bioremediation through metal and sulfate reduction and sulfate utilization.
$Desulfuromonas acetoxidans (bacteria, 4.1 Mb): Marine microbe; reduces iron; oxidizes acetate to carbon dioxide under anoxic conditions via process coupled to sulfur reduction or iron (III).
$Ferroplasma acidarmanus fer1 (archaea, 2 Mb): Lives in most acidic conditions on earth. Oxidizes iron. Transforms sulfide in metal ores to sulfuric acid, leading to contamination of mining sites.
$Geobacter metallireducens (bacteria, 6.8 Mb): Widespread in freshwater sediments; gains energy by reducing iron, manganese, uranium, and other metals. Oxidizes toluene and phenol.
??Geobacter sulfurreducens (bacteria, 2.5 Mb): Reduces a variety of metals, including iron and uranium.
?Kineococcus radiotolerans nov (bacteria, 4.3 to 4.6 Mb): Highly radioresistant; degrades organic pollutants.
$Mesorhizobium BNC1 (bacteria, 5 Mb): Fixes nitrogen with leguminous plants. Agriculturally important.
??Methylococcus capsulatus (bacteria, 4.6 Mb): Uses methane as single carbon and energy source; generates pollutant-oxidizing enzymes; used commercially to produce biomass and other proteins.
$Novosphingobium aromaticivorans F199 (bacteria, 3.8 Mb): Degrades aromatic compounds in soil, including toluene, xylene, naphthalene, and fluorine.
$Pseudomonas fluorescens PFO-1 (bacteria, 5.5 Mb): Metabolically diverse. Degrades pollutants such as styrene, TNT, and polycyclic aromatic hydrocarbons. Useful in applications requiring bacteria release and survival in soil.
*Pseudomonas putida (bacteria, 6.1 Mb): High potential for bioremediation by reducing metal and pollutants.
?Ralstonia eutropha JMP-134 (bacteria, 7.24 kb): Gram negative; degrades chloroaromatic compounds and chemically related pollutants; potential for bioremediation.
$Ralstonia metallidurans CH34 (bacteria, 5 Mb): Contains two ?mega? plasmids. Resistant to wide variety of heavy metals, which accumulate on the cell surface. Strong potential for bioremediation of metals.
**Rhodobacter sphaeroides 2.4.1 (bacteria, 4.4 Mb): Metabolically diverse, grows in wide variety of conditions. Photosynthetic. Provides fundamental insights into light-driven, renewable-energy production. Can detoxify metal oxides, useful in bioremediation.
*Shewanella oneidensis MR-1 (bacteria, 4.5 Mb): May degrade organic wastes and reduce or sequester a range of toxic metals.
Cellulose Degradation
$Clostridium thermocellum ATCC27405 (bacteria, ~5 Mb): Degrades cellulose; potentially useful for conversion of biomass (cellulose) to energy.
$Cytophaga hutchinsonii ATCC33406 (bacteria, 4 Mb): Very abundant in nature; decomposes cellulose, lacks cellulosomes.
?Microbulbifer degradans 2-40 (bacteria, 6 Mb): Marine microbe; degrades and recycles insoluble complex poly-saccharides via protruding membrane structures called hydrolosomes; potential for conversion of complex biomass to energy.
$Phanerochaete chrysosporium (eukarya, ~30 Mb): ?White rot? fungus; aerobic and degrades both celluloses and lignins; can also degrade polyaromatic hydrocarbons.
?Rubrobacter xylanophilus (actinobacteria, ~2.6 Mb): Thermophile, highly radioresistant; degrades hemicellulose, xylan.
$Thermobifida fusca YX (bacteria, 3.6 Mb): Major degrader of organic materials.
?Trichoderma reesei RUT-C30, ATCC56765 (fungi, 33 Mb): Efficiently degrades cellulose.
Biotechnology and Applied Microbiology
*Aquifex aeolicus VF5 (bacteria extremophile, 1.5 Mb): Potential for identifying high-temperature enzymes.
*Archaeoglobus fulgidus DSM4304 (archaea extremophile, 2.1 Mb): Potential for identifying high-temperature and high-pressure enzymes; useful in oil industry.
$Bifidobacterium longum DJO10A (bacteria, 2.1 Mb): Anaerobic, gram-positive prokaryote; key component in promoting healthy human gastrointestinal tract.
$Brevibacterium linens BL2 (bacteria, 3 Mb): Applications in industrial production of vitamins, amino acids for fine chemicals, and cheese. Survives high salt, carbohydrate starvation, and extended drying conditions.
*Clostridium acetobutylicum (bacteria, 4.1 Mb): Produces acetone, butanol, and ethanol; useful for industrial enzymology.
$Ehrlichia chaffeensis Sapulpa (bacteria, 1 Mb): Intracellular, tick-transmitted rickettsia endemic in wild deer populations; causes human monocytic ehrlichiosis.
$Ehrlichia canis Jake (bacteria, 1 Mb): Closely related to E. chaffeensis; causes tick-borne disease in dogs (canine monocytic ehrlichiosis).
??Gemmata obscuriglobus UQM 2246 (bacteria, 9 Mb): Planctomycete; widely distributed in freshwater environments; displays a membrane-bound, DNA-containing nucleoid (presaging the nucleus?).
*Halobacterium halobium plasmid (archaea, 2.3 Mb): Potential for identifying high-salinity enzymes.
$Lactobacillus brevis ATCC367 (bacteria, 2 Mb): Vital in fermentation of food, feed, and wine.
$Lactobacillus casei ATCC334 (bacteria, 2.5 Mb): Used as starter culture in dairy fermentations and for bulk lactic acid production; found in plant, milk, and sourdough environments as well as human intestinal tract, mouth, and vagina.
$Lactobacillus delbrueckii bulgaricus ATCCBAA365 (bacteria, 2.3 Mb): Classic example of obligate homofermentative pathway for bulk production of lactic acid.
$Lactobacillus gasseri ATCC33323 (bacteria, 1.8 Mb): Naturally inhabits gastrointestinal tract of man and animals. Important for healthy intestinal microflora.
$Lactococcus lactis cremoris SK11 (bacteria, 2.3 Mb): Used extensively in food fermentation, especially cheese.
$Leuconostoc mesenteroides (bacteria, 2 Mb): Important role in several industrial and food fermentations.
$Magnetococcus MC-1 (bacteria, 4.5 Mb): Requires limited oxygen. Reduces iron. Produces magnetite, which has many practical commercial uses.
$Magnetospirillum magnetotacticum MS-1 ATCC31632 (bacteria, 4.5 Mb): Requires limited oxygen. Reduces iron, produces magnetite. Possible model for biomineralization and evolutionary responses. May serve as a geomagnetic tracer.
$Oenococcus oeni PSU1 (bacteria, 8 Mb): Lactic acid microbe occurring naturally in fruit mashes. Used in wineries for fermentation; acid and alcohol tolerant.
$Pediococcus pentosaceus ATCC25745 (bacteria, 2 Mb): Gram positive; facultatively anaerobic lactic acid microbe; acid tolerant; used as starter culture in sausage, cucumber, green bean, and soya milk fermentations; ripening agent of cheeses.
?Phytophthera ramorum UCD Pr4 (fungi, 24 to 40 Mb): Pathogen of California oak.
?Phytophthora sojae P6497 (fungi, 62 to 90 Mb): Soybean pathogen.
$Pseudomonas syringae B728a (bacteria, 5.6 Mb): Pathogenic to a variety of plant species, severely impacting both food and biomass production.
*Pyrobaculum aerophilum (archaea extremophile, 2.2 Mb): May identify high-temperature enzymes.
*Pyrococcus furiosus (archaea extremophile, 2.1 Mb): May identify high-temperature enzymes.
$Streptococcus thermophilus LMD-9 (bacteria, 1.8 Mb): Used as starter in cheese and yogurt fermentations; thermotolerant; noted for exopolysaccharide production.
*Thermotoga maritima M5B8 (bacteria extremophile, 1.8 Mb): Potential for identifying high-temperature, high-pressure enzymes. Metabolizes many simple and complex carbohydrates; possible sources of renewable carbon and energy.
Microbial Consortia
?Chlorochromatium aggregatum (green sulfur bacteria, plus epibiont, 2 to 10 Mb): Two-component culturable consortium; utilizes hydrogen, sulfur, as electron donors for carbon fixation.
?Environmental Geobacteraceae samples from former uranium mining sites and marind marine and freshwater sediments.
?Microbial community (including F. acidarmanus) from acid mine drainage at site in Iron Mountain, Calif. (bacteria, 30 BACs, 3 to 6 Mb): Low diversity; very low pH; environment well-characterized.
Sargasso Sea community, catalogue of marine microbial diversity in a low-nutrient environment.
Uncultured microbes in soil environments, being sequenced by JGI-Diversa collaboration.
Technology Development, Pilot Projects
*Borrelia burgdorferi B31 (bacteria, 1.4 Mb): Human pathogen that causes Lyme disease. One linear chromosome (915 kb) supported by DOE. Entire genome published by TIGR.
*Brucella melitensis 16M (bacteria, 3.3 Mb): Pathogenic to animals and humans; biothreat agent.
$Enterococcus faecium (bacteria, 2.8 Mb): Pathogenic to many organisms, including humans. Tolerates relatively high salt and acid concentrations.
$Exiguobacterium 255-15 (bacteria, 3 to 4 Mb) (NASA): Isolated from 2- to 3-million-year-old Siberian permafrost sediment; grows well at ?2.5?C; associated with infections in humans.
$Haemophilus somnus 129PT (bacteria, ~2.5 Mb): Vaccine strain of H. somnus, which causes systemic diseases in cattle; lacks surface-binding protein for immunoglobulins.
*Mycoplasma genitalium G-37 (bacteria, 580 kb): Human pathogen; serves as model for minimal set of genes sufficient for free living.
$Psychrobacter 273-4 (bacteria, 2.5 Mb) (NASA): Isolated from 20,000- to 40,000-year-old Siberian perma-frost sediment; grows well at ?2.5?C; radiation resistant.
$Streptococcus suis 1591 (bacteria, 2.2 Mb): Pathogen of pigs and humans. Causes meningitis, especially in tropical regions.
$Xylella fastidiosa Dixon (almond) (bacteria, 2.6 Mb): Pathogenic to economically important plants such as orange and almond trees.
$Xylella fastidiosa Ann1 (oleander) (bacteria, 2.6 Mb): Pathogenic to plants, particularly oleanders.
WHY DO THEY LIE WHEN THEY HAVE THE CURE FOR EVERYTHING WHY DO THEY LIE WHEN THEY HAVE THE CURE FOR EVERYTHING WHY?
Who will stop them when majority of the population doesn't even know who they themselves are, nevermind how or why. My opinion- FuckYouAll, Thank You, and... word of advice- Have a health issue? Drop into your local university and demand the cure. They have it.
REMEMBER-WE ARE ALL SUBJECTS OF THIS RESEARCH IN SOME FORM OR ANOTHER-REMEBER-WE ARE ALL SUBJECTS IN THIS EXPERIMENT
Maxxam Analyticals-Manipulating your food and air supply for years.
Check your local -privately owned and operated- Genetic Forensic DNA Laboratory-Funding made possible by DOE(US DepartmentofEnergy)
ohrp@osophs.dhhs.gov
TITLE 45
CODE OF FEDERAL REGULATIONS
PART 46
PROTECTION OF HUMAN SUBJECTS
* * *FuckYourResearch* * *
Revised NOW
Effective NOW
* * *EXPLOITINGTHECOMMERCIALIZATIONOFMANIPULATION* * *
Subpart A Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects)
Source: BIOINFORMADDICT
?46.101 To what does this policy apply?
(a) Except as provided in paragraph (b) of this section, this policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any Federal Department or Agency which takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by Federal civilian employees or military personnel, except that each Department or Agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States.
(1) Research that is conducted or supported by a Federal Department or Agency, whether or not it is regulated as defined in ?46.102(e), must comply with all sections of this policy.
(2) Research that is neither conducted nor supported by a Federal Department or Agency but is subject to regulation as defined in ?46.102(e) must be reviewed and approved, in compliance with ?46.101, ?46.102, and ?46.107 through ?46.117 of this policy, by an Institutional Review Board (IRB) thatoperates in accordance with the pertinent requirements of this policy.
(b) Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:1
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
(5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food isconsumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
(c) Department or Agency heads retain final judgment as to whether a particular activity is covered by this policy.
(d) Department or Agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the Department or Agency but not otherwise covered by this policy, comply with some or all of the requirements of this policy.
(e) Compliance with this policy requires compliance with pertinent Federal laws or regulations which provide additional protections for human subjects.
(f) This policy does not affect any State or local laws or regulations which may otherwise be applicable and which provide additional protections for human subjects.
(g) This policy does not affect any foreign laws or regulations which may otherwise be applicable and which provide additional protections to human subjects of research.
(h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. [An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a Department or Agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the Department or Agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the Department or Agency head, notices of these actions as they occur will be published in the Federal Register or will be otherwise published as provided in Department or Agency procedures.
(i) Unless otherwise required by law, Department or Agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes or research activities otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the Department or Agencyhead shall forward advance notices of these actions to the Office for Protection from Research Risks, National Institutes of Health, Department of Health and Human Services (DHHS), and shall also publish them in the Federal Register or in such other manner as provided in Department or Agency procedures.1
1 Institutions with DHHS-approved assurances on file will abide by provisions of Title 45 CFR Part 46 Subparts A-D. Some of the other departments and agencies have incorporated all provisions of Title 45 CFR Part 46 into their policies and procedures as well. However, the exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization, Subparts B and C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, Subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
?46.102 Definitions.
(a) Department or Agency head means the head of any Federal Department or Agency and any other officer or employee of any Department or Agency to whom authority has been delegated.
(b) Institution means any public or private entity or Agency (including Federal, State, and other agencies).
(c) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
(e) Research subject to regulation, and similar terms are intended to encompass those research activities for which a Federal Department or Agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentallyregulated by a Federal Department or Agency solely as part of the Department's or Agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).
(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) data through intervention or interaction with the individual, or
(2) identifiable private information.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
(g) IRB means an Institutional Review Board established in accord with and for the purposes expressed in this policy.
(h) IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.
(i) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
(j) Certification means the official notification by the institution to the supporting Department or Agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
?46.103 Assuring compliance with this policy -- research conducted or supported by any Federal Department or Agency.
(a) Each institution engaged in research which is covered by this policy and which is conducted or supported by a Federal Department or Agency shall providewritten assurance satisfactory to the Department or Agency head that it will comply with the requirements set forth in this policy. In lieu of requiring submission of an assurance, individual Department or Agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Protection from Research Risks, National Institutes Health, DHHS, and approved for Federalwide use by that office. When the existence of an DHHS-approved assurance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to Department and Agency heads shall also be made to the Office for Protection from Research Risks, National Institutes of Health, DHHS.
(b) Departments and agencies will conduct or support research covered by this policy only if the institution has an assurance approved as provided in this section, and only if the institution has certified to the Department or Agency head that the research has been reviewed and approved by an IRB provided for in the assurance, and will be subject to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum include:
(1) A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself. This requirement does not preempt provisions of this policy applicable to Department- or Agency-supported or regulated research and need not be applicable to any research exempted or waived under ?46.101 (b) or (i).
(2) Designation of one or more IRBs established in accordance with the requirements of this policy, and for which provisions are made for meeting space and sufficient staff to support the IRB's review and recordkeeping duties.
(3) A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution; for example: full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant. Changes in IRB membership shall be reported to the Department or Agency head, unless in accord with ?46.103(a) of this policy, the existence of a DHHS-approved assurance is accepted. In this case, change in IRB membership shall be reported to the Office for Protection from Research Risks, National Institutes of Health, DHHS.
(4) Written procedures which the IRB will follow (i) for conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (ii) for determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and (iii) for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject.
(5) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Department or Agency head of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) any suspension or termination of IRB approval.
(c) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and manner as the Department or Agency head prescribes.
(d) The Department or Agency head will evaluate all assurances submitted in accordance with this policy through such officers and employees of the Department or Agency and such experts or consultants engaged for this purpose as the Department or Agency head determines to be appropriate. The Department or Agency head's evaluation will take into consideration the adequacy of the proposed IRB in light of the anticipated scope of the institution's research activities and the types of subject populations likely to be involved, the appropriateness of the proposed initial and continuing review procedures in light of the probable risks, and the size and complexity of the institution.
(e) On the basis of this evaluation, the Department or Agency head may approve or disapprove the assurance, or enter into negotiations to develop an approvable one. The Department or Agency head may limit the period during which any particular approved assurance or class of approved assurances shall remain effective or otherwise condition or restrict approval.
(f) Certification is required when the research is supported by a Federal Department or Agency and not otherwise exempted or waived under ?46.101 (b) or (i). An institution with an approved assurance shall certify that each application or proposal for research covered by the assurance and by ?46.103 of this policy has been reviewed and approved by the IRB. Such certification must be submitted with the application or proposal or by such later date as may be prescribed by the Department or Agency to which the application or proposal is submitted. Under no condition shall research covered by ?46.103 of the policy be supported prior to receipt of the certification that the research has been reviewed and approved by the IRB. Institutions without an approved assurance covering the research shall certify within 30 days after receipt of a request for such a certification from the Department or Agency, that the application or proposal has been approved by the IRB. If the certification is not submitted within these time limits, the application or proposal may be returned to the institution.
(Approved by the Office of Management and Budget under Control Number 9999-0020.)
??46.104--46.106 [Reserved]
?46.107 IRB membership.
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
(c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
(d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
(e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
(f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB
?46.108 IRB functions and operations.
In order to fulfill the requirements of this policy each IRB shall:
(a) Follow written procedures in the same detail as described in ?46.103(b)(4) and to the extent required by ?46.103(b)(5).
(b) Except when an expedited review procedure is used (see ?46.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting
?46.109 IRB review of research.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.
(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with ?46.116. The IRB may require that information, in addition to that specifically mentioned in ?46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with ?46.117.
(d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
(e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
(Approved by the Office of Management and Budget under Control Number 9999-0020.)
?46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
(a) The Secretary, HHS, has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate, after consultation with other departments and agencies, through periodic republication by the Secretary, HHS, in the Federal Register. A copy of the list is available from the Office for Protection from Research Risks, National Institutes of Health, DHHS, Bethesda, Maryland 20892.
(b) An IRB may use the expedited review procedure to review either or both of the following:
(1) some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,
(2) minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in ?46.108(b).
(c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which have been approved under the procedure.
(d) The Department or Agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure.
?46.111 Criteria for IRB approval of research.
(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.
(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by ?46.116.
(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by ?46.117.
(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
?46.112 Review by institution.
Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.
?46.113 Suspension or termination of IRB approval of research.
An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination or approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the Department or Agency head.
(Approved by the Office of Management and Budget under Control Number 9999-0020.)
?46.114 Cooperative research.
Cooperative research projects are those projects covered by this policy which involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. With the approval of the Department or Agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.
?46.115 IRB records.
(a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
(2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
(3) Records of continuing review activities.
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members in the same detail as described in ?46.103(b)(3).
(6) Written procedures for the IRB in the same detail as described in ?46.103(b)(4) and ?46.103(b)(5).
(7) Statements of significant new findings provided to subjects, as required by ?46.116(b)(5).
(b) The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the Department or Agency at reasonable times and in a reasonable manner.
(Approved by the Office of Management and Budget under Control Number 9999-0020.)
?46.116 General requirements for informed consent.
Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:
(1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
(2) a description of any reasonably foreseeable risks or discomforts to the subject;
(3) a description of any benefits to the subject or to others which may reasonably be expected from the research;
(4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
(5) a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
(6) for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
(7) an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
(8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
(b) additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(1) a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
(2) anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
(3) any additional costs to the subject that may result from participation in the research;
(4) the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
(6) the approximate number of subjects involved in the study.
(c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:
(1) the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
(2) the research could not practicably be carried out without the waiver or alteration.
(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
(1) the research involves no more than minimal risk to the subjects;
(2) the waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) the research could not practicably be carried out without the waiver or alteration; and
(4) whenever appropriate, the subjects will be provided with additional pertinent information after participation.
(e) The informed consent requirements in this policy are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.
(f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, State, or local law.
(Approved by the Office of Management and Budget under Control Number 9999-0020.)
?46.117 Documentation of informed consent.
(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
(b) Except as provided in paragraph (c) of this section, the consent form may be either of the following:
(1) A written consent document that embodies the elements of informed consent required by ?46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or
(2) A short form written consent document stating that the elements of informed consent required by ?46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
(Approved by the Office of Management and Budget under Control Number 9999-0020.)
?46.118 Applications and proposals lacking definite plans for involvement of human subjects.
Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an award may be made. However, except for research exempted or waived under ?46.101 (b) or (i), no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Department or Agency.
?46.119 Research undertaken without the intention of involving human subjects.
In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted, by the institution, to the Department or Agency, and final approval given to the proposed change by the Department or Agency.
?46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
(a) The Department or Agency head will evaluate all applications and proposals involving human subjects submitted to the Department or Agency through such officers and employees of the Department or Agency and such experts and consultants as the Department or Agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.
(b) On the basis of this evaluation, the Department or Agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one.
?46.121 [Reserved]
?46.122 Use of Federal funds.
Federal funds administered by a Department or Agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied.
?46.123 Early termination of research support: Evaluation of applications and proposals.
(a) The Department or Agency head may require that Department or Agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the Department or Agency head finds an institution has materially failed to comply with the terms of this policy.
(b) In making decisions about supporting or approving applications or proposals covered by this policy the Department or Agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the Department or Agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to Federal regulation).
?46.124 Conditions.
With respect to any research project or any class of research projects the Department or Agency head may impose additional conditions prior to or at the time of approval when in the judgment of the Department or Agency head additional conditions are necessary for the protection of human subjects.
Subpart B Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Source: Federal Register: November 13, 2001 (Volume 66, Number 219), Rules and Regulations, Page 56775-56780, from the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr13no01-9].
?46.201 To what do these regulations apply?
(a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates conducted or supported by the Department of Health and Human Services (DHHS). This includes all research conducted in DHHS facilities by any person and all research conducted in any facility by DHHS employees.
(b) The exemptions at Sec. 46.101(b)(1) through (6) are applicable to this subpart.
(c) The provisions of Sec. 46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in Sec. 46.101(f) is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.
(d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
?46.202 Definitions.
The definitions in Sec. 46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:
(a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
(b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other means.
(c) Fetus means the product of conception from implantation until delivery.
(d) Neonate means a newborn.
(e) Nonviable neonate means a neonate after delivery that, although living, is not viable.
(f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.
(g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated.
(h) Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be included in research only to the extent permitted and in accordance with the requirements of subparts A and D of this part.
?46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart and the other subparts of this part.
?46.204 Research involving pregnant women or fetuses.
Pregnant women or fetuses may be involved in research if all of the following conditions are met:
(a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;
(b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means;
(c) Any risk is the least possible for achieving the objectives of the research;
(d) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in
Needless to say folks, if you have a point to make, please try to make it more cogently (and less expansively) than the above post...
Heck, just try to make it clear...
stem cell research is good.
Health-care insurance corporations are going to allow stem-cell therapy for the population?
Health care insurance corporation CEOs want more and more millions per year in bonuses... not stem cell therapy.
As long as health care insurance corporation are between health care and us.. we're pretty much dead ducks.