Notice of NIAIDs Participation in PA-19-217 Administrative Supplement for Research on Bioethical Issues (Admin Supp Clinical Trial Optional)"
Apr 04 2019
Notice NIAID’s Participation PA-19-217 Administrative Supplement Research Bioethical Issues Admin Supp Clinical Trial Optional)" Notice Number: NOT-AI-19-054 Key Dates Release Date: April 05, 2019 Related Announcements PA-19-217 NOT-OD-19-101 Issued National Institute Allergy Infectious Diseases NIAID) Purpose purpose this Notice to inform potential applicants the National Institute Allergy Infectious Diseases NIAID) participating, effective immediately, in PA-19-217 “Administrative Supplement Research Bioethical Issues Admin Supp Clinical Trial Optional)". following information shown initalics) been added: Part 1. Overview Information Components Participating Organizations National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) Fogarty International Center FIC) National Center Advancing Translational Sciences NCATS) National Heart, Lung, Blood Institute NHLBI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Mental Health NIMH) National Institute Minority Health Health Disparities NIMHD) National Institute Nursing Research NINR) Office Strategic Coordination Common Fund) Catalog Federal Domestic Assistance CFDA) Number(s) 93.121, 93.172, 93.173, 93.233, 93.242, 93.273, 93.286, 93.307, 93.310, 93.350, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.865, 93.866, 93.989 Part 2. Full Text Announcement Section I. Funding Opportunity Description Areas Research Interest the Administrative Supplement NIH seeks fund research ethical considerations related biomedical research. issues fall within scope research policy activities the NIH may beyond focus any Institute Center. Overarching areas research interest include are limited to: New emerging technology development use, such as: gene editing; organoids; artificial intelligence; machine learning; brain implants modulation; digital health; consumer-generated data Clinical non-clinical data sharing; big data data science analytics; integration data research, including clinical, research, environment, social media, participant/patient provided, other Precision personalized medicine Personal, institutional, research privacy security Learning Healthcare System; interface clinical research clinical care; pragmatic trials Crowdsourcing, citizen science, DIY biomedical research Participant driven, directed, sponsored clinical research Patient/participant representation research oversight, including appropriate return research results incidental findings Special vulnerable population research, including pediatric, palliative care, emergency, disaster, pandemic research Individual community health, treatment, and/or research disparities; accessing sharing benefits research; post-study obligations Issues related the inclusion Tribal American Indian/Alaska Native populations Issues related the inclusion populations underrepresented research Current emerging regulatory environments Innovative study design, conduct, management, oversight, including methods obtaining documenting informed consent; virtual clinical trials International research including research resource-constrained settings, transnational research, research low middle income countries Research stigmatized conditions Historical analyses bioethics issues Novel approaches enhancing bioethics infrastructure training addition overarching areas interest, individual Institutes Centers indicated following specific areas research interest: NCI National Cancer Institute NCI) interested bioethics issues relevant cancer research care, such issues raised cancer clinical trials, cancer cohorts, cancer prevention studies, cancer centers, prospective biobanking, projects using existing samples/tissues. Bioethical issues interest include are limited issues raised new therapies/technologies; patient participant perception comprehension; patient, participant, community engagement; return results; new methods recruitment/retention hard reach” participants. Additional issues be found here:https://epi.grants.cancer.gov/bioethics-cancer-research.html. NHGRI National Human Genome Research Institute NHGRI) interested applications investigate address bioethical issues related the of genetics genomics research, clinical medicine healthcare, society. NHGRI supports studies specific conditions diseases only the proposed work produce knowledge is generalizable transferable other genetic conditions. NIA National Institute Aging NIA) interested applications address topics relevant its core mission. more information, please see:https://www.nia.nih.gov/about/mission FIC Fogarty International Center FIC) interested research ethical issues relevant low- middle-income countries, particular, studies conducted investigators these countries. NINDS National Institute Neurological Disorders Stroke NINDS) interested research bioethical neuroethical questions relevant its mission seek fundamental knowledge the brain nervous system to that knowledge reduce burden neurological disease. addition the general areas interest listed above, areas interest specific NINDS include are limited the ethical implications of: aspects neuroscience research human participants, such differing stakeholder views trial design, return research results participants, patient consent-related issues, therapeutic misconception including rare diseases); research brain organoids ex vivo human brain tissue; collecting sharing human brain data, such de-identification, privacy, re-use practices; development use neuromodulation neuroimaging technologies, such device maintenance, data security, intended unintended uses these technologies; predictive/diagnostic research related brain disorders; advances neural recording and/or neuromodulation specifically use children. Additional information the NINDS mission be found here:http://www.ninds.nih.gov/about_ninds/mission.htm. Note applications must consider bioethical and/or neuroethical questions be within general scope the parent award. Also, NINDS not consider applications include basic research activities research vertebrate animals. NCATS National Center Advancing Translational Sciences NCATS) interested research ethical issues cross disease domains span translational research spectrum. NCATS encourages collaboration between translational researchers bioethics researchers projects addressing ethical challenges moving discoveries laboratory, clinic, community interventions improve health. NIMHD National Institute Minority Health Health Disparities NIMHD) interested supporting research projects the ethical, legal, social implications research participation and/or health care racial/ethnic minority other health disparity populations. Areas interest NIMHD include are limited studies seek understand address cultural preferences; values norms ensure ethical equitable conduct research delivery health care; ethical integration social biomedical sciences e.g., social epigenomics incorporation social determinants the health care system); mitigating stigmatization, group harms, unintended social implications research. NICHD TheEunice Kennedy ShriverNational Institute Child Health Human Development NICHD) interested bioethical issues relevant research involving children, pregnant women, people disabilities. Research the fields developmental biology, reproductive health, pediatrics, population health, medical rehabilitation, research addresses health disparities improves prevention efforts among populations served NICHD, well areas identified high-priority research areas the institute of particular interest. andhttps://www.nichd.nih.gov/grants-contracts/research-areas/prioritiesfor current research priorities the institute inhttps://www.nichd.nih.gov/about/org/strategicplanregarding future themes the Institute. NHLBI National Heart, Lung, Blood Institute NHLBI) interested research bioethics issues relevant its Strategic Vision https://www.nhlbi.nih.gov/about/strategic-vision), its focus heart, lung, blood, sleep conditions. Specific examples include, are limited to: return research results e.g., genomic, omic, environmental) participants communities, such environmental toxins may impact community health, handoff between research clinical care, providing genetic counseling large scales Waivers informed consent obtaining consent surrogates Ethics cardiopulmonary support Novel emerging technologies, such machine learning bias algorithm overreach physician autonomy Privacy confidentiality especially large datasets), such artificial intelligence applied imaging data concerns may arise multi-omics profiles impact NIH policy changes, such updates the management genomic summary results Issues related working understudied vulnerable populations e.g., pregnant women, pediatric perinatal patients, Indigenous groups), such community engagement ensuring equal access research advances Investigators encouraged contact NHLBI staff discuss ideas. Investigators interested developing applications this funding opportunity announcement strongly encouraged discuss ideas specific IC contacts listed below prior submission ICs varying levels interest high priority areas. NIAAA National Institute Alcohol Abuse Alcoholism NIAAA) interested bioethics applications address topics relevant its mission research priorities provided its strategic plan. information, please see:https://www.niaaa.nih.gov/strategic-plan NIAID NIAID particularly interested supporting supplemental projects focus ethical issues relevant domestic international collaborative research HIV/AIDS its co-morbidities TB, malaria, hepatitis, sexually transmitted infections), other infectious diseases; ethics clinical trials implementation science; ethical issues relevant NIAID's scientific mission. Applications include conceptual work bioethics, empirical work gathering analyzing data relevant ethical issues research, a combination the two. empirical projects, data collection include quantitative qualitative methods, both. Although intended be exhaustive list, particular interest projects on: Ethical issues research involving adolescents young adults Ethical issues research curing HIV Ethical, legal policy issues research big data Ethics research involving child-bearing age pregnant women Applications addressing empirical research informed consent not interest. NIAMS mission The National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) to support research the causes, treatment, prevention arthritis musculoskeletal skin diseases; training basic clinical scientists carry this research; the dissemination information research progress these diseases. NIAMS also conducts supports basic research the normal structure function bones, joints, muscles, skin. Basic research involves wide variety scientific disciplines, including immunology, genetics, molecular biology, structural biology, biochemistry, physiology, virology, pharmacology. Clinical research areas include rheumatology, orthopedics, dermatology, metabolic bone diseases, heritable disorders bone cartilage, inherited inflammatory muscle diseases, sports rehabilitation medicine. NIAMS interested bioethics topics relevant its core mission. NIBIB National Institute Biomedical Imaging Bioengineering NIBIB) interested applications address topics relevant its core mission. more information, please see:https://www.nibib.nih.gov/research-funding. NIDCD National Institute Deafness Other Communications Disorders NIDCD) interested applications address topics the areas hearing, balance, taste, smell, voice, speech, language. more information, please see:NIDCD Strategic Plan. NIDCR National Institute Dental Craniofacial Research NIDCR) interested applications propose bioethics research relevant dental, oral, craniofacial health. more information, please see:https://www.nidcr.nih.gov/about-us/mission. NIDDK National Institute Diabetes Digestive Kidney Diseases NIDDK) interested applications address topics relevant its core mission. more information, please see:NIDDK Research Areas. NIMH Priority areas research include are limited bioethical considerations around privacy issues; consent capacity, agency, autonomy; of predictive analytics; safety monitoring; participant, provider, community perceptions comprehension research; issues related the engagement recruitment understudied groups; additional safety ethical considerations necessary conducting research populations risk suicide https://www.nimh.nih.gov/funding/clinical-research/conducting-research-w...). addition, bioethics new interventions technologies, biobanking approaches, use biospecimens biopreparations of interest. NINR NINR interested studies examining bioethical issues related end life palliative care EOLPC) research consider including not limited to): EOLPC needs individuals serious, advanced illness, particularly vulnerable populations such as: children, frail elderly, individuals limited decision-making capacity. Prioritization patient preferences, beliefs, values respect treatment and/or end life decision making. needs/challenges families, caregivers, proxy decision makers individuals serious, advanced illness. Disparities access EOLPC individuals across settings urban, rural, remote), including differences among socioeconomic, racial/ethnic geographic sub-populations. Because the complex, multi-factorial nature this issue, multi-disciplinary teams highly encouraged. Common Fund Office Strategic Coordination Common Fund) supported projects propose include relevant investigations Research Bioethical Issues eligible apply. Section VII. Agency Contacts Scientific/Research Contact(s) Jennifer Plank-Bazinet, Ph.D. Office Science Policy/Office the Director OSP/OD) Telephone: 301-435-8342 Email:email@example.com Nicole Lockhart National Human Genome Research Institute NHGRI) Telephone: 301-480-2493 Email:firstname.lastname@example.org Tammara Jenkins, MSN, RN, PCNS-BC Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6837 Email:email@example.com Mollie Minear, Ph.D. National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-0448 Email:firstname.lastname@example.org Aynur Unalp-Arida, MD, MSc, PhD National Institute Diabetes Digestive Kidney Diseases NIDDK) Telephone: 301-594-8879 Email:email@example.com Khara Ramos, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-594-2614 Email:firstname.lastname@example.org Barbara Sina, Ph.D. Fogarty International Center FIC) Telephone: 301-402-9467 Email:email@example.com Elaine Collier, M.D. National Center Advancing Translational Sciences NCATS) Telephone: 301-435-0794 Email:firstname.lastname@example.org Emilie Caga-Anan, J.D. National Cancer Institute NCI) Telephone: 240-276-6738 Email:email@example.com Kristina McLinden, Ph.D. National Institute Aging NIA) Telephone: 301-827-2563 Email:firstname.lastname@example.org Pamela Wernett, Ph.D. National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-827-5391 Email:email@example.com Joana Roe National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3213 Email: Joana.Roe@nih.gov Robyn Bent, M.S. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-827-2272 Email:firstname.lastname@example.org Todd Merchak National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-496-8592 Email:email@example.com Trinh Ly, M.D. National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-496-5061 Email:firstname.lastname@example.org Leslie Frieden, Ph.D. National Institute Dental Craniofacial Research NIDCR) Telephone: 301-496-4263 Email:email@example.com Andrea Beckel-Mitchener, Ph.D National Institute Mental Health NIMH) Telephone: 301-443-2847 Email:firstname.lastname@example.org Nancy Jones, Ph.D., M.A. National Institute Minority Health Disparities NIMHD) Telephone: 301-594-8945 Email:email@example.com Lynn Adams, Ph.D. National Institute Nursing Research NINR) Telephone: 301-594-8911 Email:firstname.lastname@example.org Leslie K. Derr, Ph.D. Office Strategic Coordination Common Fund) Telephone: 301-594-8174 Email:email@example.com Financial/Grants Management Contact(s) Bryan Clark, MBA Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6975 Email:firstname.lastname@example.org Eunica Haynes National Institute Diabetes Digestive Kidney Diseases NIDDK) Telephone: 301-827-4018 Email:Haynese@niddk.nih.gov Tawana McKeither National Heart, Lung, Blood Institute NHLBI) Telephone: 301-827-9238 Email:email@example.com Tijuana Decoster, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone 301-496-9531 Email:firstname.lastname@example.org Monique Day, Ph.D. National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4797 Email:Monique.email@example.com Bruce Butrum Fogarty International Center FIC) Telephone: 301-496-2075 Email:firstname.lastname@example.org Harvey Kincaid National Center Advancing Translational Sciences NCATS) Telephone: 301-435-0850 Email:email@example.com Crystal Wolfrey National Cancer Institute NCI) Telephone: 240-276-6277 Email:firstname.lastname@example.org Deanna Ingersoll National Human Genome Research Institute NHGRI) Telephone: 301-435-7858 Email:Deanna.Ingersoll@nih.gov Traci Lafferty National Institute Aging NIA) Phone: 301-496-8987 Email:email@example.com Judy Fox National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-443-4704 Email:firstname.lastname@example.org Dhana Khurana National Institute Allergy Infectious Diseases NIAID) Telephone: 240-669-2966 Email: Vandhana.Khurana@nih.gov Leslie Littlejohn National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5055 Email:Leslie.Littlejohn@nih.gov Christopher Myers National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-435-0713 Email:email@example.com Diana Rutberg, M.B.A. National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-4798 Email:firstname.lastname@example.org Terri Jarosik National Institute Mental Health NIMH) Telephone: 301-443-3858 Email:email@example.com Priscilla Grant, JD National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-8412 Email:firstname.lastname@example.org Ronald Wertz National Institute Nursing Research NINR) Telephone: 301) 594-2807 Email:email@example.com Chris Darby Office Strategic Coordination Common Fund) Telephone: 301-480-1059 Email:DarbyCh@mail.nih.gov other aspects this FOA remain same. Inquiries Please direct inquiries to: Joana Roe National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3213 Email: Joana.Roe@nih.gov