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Basic studies of how our brains work are now clinical trials NIH

first_imgStudies of how a normal person’s brain processes images could be labeled clinical trials under a new National Institutes of Health policy.  © Vassar College/Karl Rabe Country * Afghanistan Aland Islands Albania Algeria Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia, Plurinational State of Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, the Democratic Republic of the Cook Islands Costa Rica Cote d’Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Korea, Democratic People’s Republic of Korea, Republic of Kuwait Kyrgyzstan Lao People’s Democratic Republic Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, the former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Martinique Mauritania Mauritius Mayotte Mexico Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Norway Oman Pakistan Palestine Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Qatar Reunion Romania Russian Federation Rwanda Saint Barthélemy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania, United Republic of Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela, Bolivarian Republic of Vietnam Virgin Islands, British Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe This example suggests “that almost all basic science behavioral research and experimental psychopathology research would be viewed misleadingly as a clinical trial,” wrote neuroscientist William Iacono of the University of Minnesota in Minneapolis in one of more than 30 comments expressing concern on the Open Mike blog of NIH extramural chief Michael Lauer.Critics also find NIH’s reasoning inconsistent. Case No. 22 states that a study of learning in children will not be considered a trial because an evaluation of learning “has no clear link to health.” It is not clear why a study of memory in adults would be health-related and yet learning in children would not, several researchers argued in comments.Cognitive psychologist Nora Newcombe of Temple University in Philadelphia, Pennsylvania, who studies childhood learning, writes that although “it’s nice to be exempted from the regulatory burden,” she worries that if her research isn’t considered health-related, “will there later be criticism of funding from NIH?”The Association of American Medical Colleges (AAMC) in Washington, D.C., shares concerns about the case studies. They “don’t provide as much clarity as the research community would need” to know which projects must follow the new clinical trial policies, says Heather Pierce, AAMC’s senior director for science policy. NIH’s Lauer says the agency is trying to address the concerns. “We are continuing to receive feedback on the case studies and anticipate updating them, including Case 18, in the next 2 weeks and as needed on an ongoing basis to eliminate confusion,” Lauer said in a statement. By Jocelyn KaiserAug. 25, 2017 , 1:55 PM The National Institutes of Health (NIH) in Bethesda, Maryland, has confirmed that the agency’s definition of clinical trials now includes imaging studies of normal brain function that do not test new treatments. The change will impose new requirements that many researchers say don’t make sense and could stifle cognitive neuroscience.Although NIH revised its definition of clinical trials in 2014, the agency is only now implementing it as part of a new clinical trials policy. Concerns arose this summer when an NIH official said the definition could apply to many basic behavioral research projects, including brain studies—for example, having healthy volunteers perform a computer task while wearing an electrode cap or lying in an MRI machine. Scientists say the new requirements—such as training and registration on clinicaltrials.gov—are unnecessary, will impose a huge paperwork burden, and will confuse patients seeking to enroll in trials.NIH told ScienceInsider in July that the agency was still deciding exactly which behavioral studies would be covered by the new definition. On 11 August, the agency released a set of case studies that has confirmed many researchers’ fears. Case No. 18 states that a study in which a healthy volunteer undergoes MRI brain imaging while performing a working memory test is now a clinical trial because the effect being evaluated—brain function—is a health-related outcome.center_img Email Click to view the privacy policy. Required fields are indicated by an asterisk (*) Sign up for our daily newsletter Get more great content like this delivered right to you! Country Basic studies of how our brains work are now clinical trials, NIH sayslast_img

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