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Regulatory, Ethics, Knowledge and Support

Learn more about Regulatory, Ethics, Knowledge and Support (REKS) and the resources available. 

  • What's It All About

    The mission and goals of the Regulatory Ethics Knowledge and Support (REKS) component of GHUCCTS are to:

    • Provide expert guidance and assistance in promoting safety and protection of research participants; and to develop and promote innovative training and educational resources for investigators (with an emphasis on diverse, under-represented populations).

    • Provide ethical consultation to GHUCCTS investigators in the design and implementation of clinical and translational research.

    • To facilitate and assist with the regulatory management of GHUCCTS intra- and inter-institutional CTSA research.

    The REKS component emphasizes promoting and preserving the integrity of the research, the researcher and the research enterprise, preserving the trust between the public and the research enterprise, and the public trust in the fruits of the research process.


    Summary of REKSs top accomplishments from the past 10 years

  • Who is Responsible

    Jane Otado, MD HeadshotREKS Interim Director : Jane Otado, PhD

    Dr. Jane Otado holds a Doctorate in Medical Sociology/Social Demography and a Master’s in International Development and Health. She completed a post-doctoral fellowship at the Centers for Disease Control and Prevention (CDC).  Dr. Otado is currently with GHUCCTS and serves as Regulatory Ethics, Knowledge and Support, REKS Director. Her responsibilities include coordination of REKS activities and providing regulatory assistance to research investigators. This entails assisting investigators to meet regulatory and ethical obligations regarding human research protection via consultations with investigators, research ethicists, and regulatory personnel at GHUCCTS institutions, thereby reducing the regulatory burden on investigators and facilitating the conduct of research in an ethical, efficient and compliant manner. 

    Prior to joining the faculty of Howard University's Department of Community Health and Family Medicine, Dr. Otado served as the Manager of Comprehensive Cancer Prevention Program for the District of Columbia Department of Health. Prior to joining the DC Dept. of Health, served as a Senior Research Associate in Geriatrics section, Howard University Department of Medicine and as a Senior Associate with Institute of College Research Development & Support, Silver Spring, MD. Dr. Otado has extensive experience working with clinical trials and as a research participant advocate for more than 10 years.  She has presented workshops on health services research relative to issues on minority aging; informed consent process, recruitment strategies; and research ethics.

    Her research interests include minority population relative to issues of availability of and accessibility to health care services to include maternal and child health issues; prenatal care utilization; and adolescent health. Her current research activities focus on recruitment strategies and retention of minorities into clinical trials; satisfaction and perceptions of research participants in clinical trials; and understanding of informed consent among African Americans; and Knowledge, attitude and behavioral aspects of genetic research among African Americans.

    James Giordano, MD headshotDirector, REKS Ethics Subcomponent : James Giordano, PhD

    Dr. James Giordano is a Professor in the Departments of Neurology and Biochemistry, and Chief of the Neuroethics Studies Program of the Pellegrino Center for Clinical Bioethics at the Georgetown University Medical Center, Washington DC. He has served as a Research Fellow of the European Union Human Brain Project; a consultant to the Organization for Economic Cooperation and Development (OECD), an appointed member of the US Department of Health and Human Services Secretary’s Advisory Council for Human Research Protection; as an appointed member of the Neuroethics, Legal and Social Issues Advisory Panel of the Defense Advanced Research Projects Agency (DARPA), and as Senior Science Advisory Fellow of the Strategic Multilayer Assessment Group of the Joint Staff, Pentagon.   

    The author of over 275 publications, 7 books, and 15 governmental whitepapers, he is an Overseas Fellow of the Royal Society of Medicine (UK); was elected to the European Academy of Science and Arts (EC) and the Dana Alliance of Brain Initiatives (DABI), and named as a Distinguished Lecturer of both the Institute for Electrical and Electronics Engineers (IEEE), and Sigma Xi – The National Scientific Honor Society in recognition of his achievements.

    REKS Leadership : Marc R. Blackman, MD

    Marc R. Blackman, M.D. serves as a Senior Physician Scientist and Chief, Laboratory of Geriatric Endocrinology and Metabolism, and formerly served as Associate Chief of Staff for Research and Development, at the Washington DC VA Medical Center; the Assistant Dean for VA Research and Professor of Medicine and Rehabilitation Medicine at Georgetown University; a member of the Executive and Steering Committees, and co-Director of the Patient Clinical Interaction Module, of the Georgetown-Howard Universities Center for Clinical and Translational Science; Clinical Professor of Medicine and Biochemistry and Molecular Medicine at the George Washington University School of Medicine; and Professor of Medicine (Part-time) at the Johns Hopkins University Schools of Medicine.

    Dr. Blackman facilitates and expands the varied clinical, translational and laboratory based research and research training programs within the DC VAMC, and with the VA’s academic partners, and pursues his own funded research programs in neuroendocrinology, reproductive endocrinology, and gerontology/geriatrics. 

    Dr. Blackman is a member of multiple medical and scientific societies, and has served as a scientific consultant for various government, academic, industrial, and private organizations.  He was a member of the National Advisory Committee for Endocrinology and Aging in the NIA’s Biology of Aging Program, and of the Executive Committee of the GCRC’s National Program Directors Association.  Dr. Blackman served as a member of the NIH/NIA’s Aging Systems and Geriatrics Study Section. He is a frequent national and international lecturer, and consultant on various aspects of neuroendocrinology and aging.  Dr. Blackman has received numerous teaching and academic awards, and has published more than 475 scientific journal articles, editorials, books, chapters, and abstracts.

    Sheila Zimmet, BSN, JD headshotREKS Consultant : Sheila Zimmet, BSN, JD

    Sheila Cohen Zimmet was the Georgetown University Medical Center Senior Associate Vice President for Regulatory Affairs and Conflict of Interest Officer, the Georgetown University Research Integrity Officer. and until recently, the REKS Director.    Ms. Zimmet previously served as Associate Dean for Research Integrity for Weill Cornell Medical College, until returning to Georgetown in these roles, in which she had oversight responsibility for an array of research ethics and compliance matters. She currently maintains her faculty position as an Adjunct Associate Professor at the Georgetown University Medical Center.

    Ms. Zimmet is a former neonatal intensive care nurse, Senior Associate Counsel to the Georgetown University Medical Center, and the University’s first Director of Research Assurance and Compliance. Ms. Zimmet completed a four-year term on the Advisory Council of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). She also served on the Steering Committee for the AAMC Forum on Conflict of Interest in Academe. She is a former two-term member of the National Center for Research Resources (NCRR) Advisory Council (1996-2000 and 2004-2008). Ms. Zimmet frequently speaks on issues related to research ethics and compliance matters at local, national and international professional meetings.

    Assya Pascalev, PhD headshotREKS Ethics Subcomponent Member : Assya Pascalev, PhD

    Dr. Assya Pascalev is an Associate Professor of Philosophy and Director of the interdisciplinary program in Health Care Ethics at Howard University College of Medicine. Dr. Pascalev holds a Ph.D. in applied philosophy, and has held academic appointments in the department of philosophy at Howard University and the department of philosophy at the University of North Florida, where she was the Associate Director of the Center for Ethics, Public Policy and the Professions.

    Dr. Pascalev is a member of the Task Force on Social Media at the Board of Medicine, D.C. Department of Health. She is also a member of the European Platform on Ethical, Legal and Psychosocial Aspects of Organ Transplantation, and a member of the Editorial Board of the Ethics Journal. Her professional interests are in the areas of medical ethics, research ethics, applied and professional ethics, and social and political philosophy. She has published and presented on end-of-life ethics, the ethics of organ transplantation, the ethics of biotechnology and food ethics.

    Sarah B. Vittone DBe, MSN, RN headshotREKS Ethics and Research Participant Advocate : Sarah B. Vittone DBe, MSN, RN

    Dr. Vittone is an Assistant Professor, Georgetown University and Clinical Ethics Consultant with the Pellegrino Center for Clinical Bioethics at the Georgetown University Medical Center, Washington DC. She holds a Doctor of Bioethics and has twenty years’ experience in clinical and research ethics.  She is a member of the GHUCCTS Scientific and Prioritization Committee for Safety and Human Protection Reviews with cross over responsibilities on the GHUCCTS IRB-E. She serves on the Adverse Event/ DSMB Committee of the GHUCCTS IRB-E. Dr. Vittone provides consultation to Investigators and Research Teams on specific issues in human protection and safety. She provides research ethics training in collaboration with GHUCCTS REKS members. Dr. Vittone has research interests in decision making for others and research ethics. She is a frequent regional and national speaker on these topics. Dr. Vittone serves as the Georgetown Research Participant Advocate supporting CTSA research participants.

    Headshot of REKS member Dr. Jim BoscoeREKS Leadership: James (Jim) H. Boscoe, MA, CIP
    Jim Boscoe is the Director of the MedStar Health Research Institute Office of Research Integrity (ORI). ORI is primarily responsible for the regulatory oversight of clinical and pre-clinical research for MedStar Health and coordinates the research process with other components of the MedStar Health Human Research Protections Program as well as Research Operations. Jim is also the MedStar Health representative to the Regulatory, Ethics, Knowledge & Support (REKS) component of GHUCCTS. Jim previously worked as an IRB Manager with the Johns Hopkins University School of Medicine IRB. Prior to his work in research ethics and regulations, Jim was a Board Certified Behavior Analyst and has worked with children with feeding disorders, children and adults with developmental disabilities, and adults with substance use disorders.

    For Investigators

    Shaunagh Browning, DNP, RN, FNP-BC serves as the director for the Office of Research Quality Assurance (ORQA) and Interim Director of the Institutional Review Board. Her work in clinical research at Georgetown began as a study coordinator in 1990. Since then, she has coordinated numerous clinical trials. In addition, Shaunagh has been a certified family nurse practitioner since 1999 and provided clinical care to research patients in addition to coordinating the projects. In the past, her work included managing a clinical research unit and assisting many investigators in the implementation of their clinical research projects. Shaunagh received her BSN from George Mason University in 1988, her MS in Nursing from Georgetown University in 1998, and her Doctorate in Nursing Practice in 2019. Shaunagh’s work has centered on the role of the clinical research coordinator, with emphasis on the clinical research nurse and education of staff and scientists with the goal of research quality and efficiency.


    For Research Participants

    Research (RPA) Program

    The Research Participant Advocacy (RPA) Program is a program that assists current and potential research subjects/participants with their participation in research/clinical trials. If you need help with reaching and/or communicating with a member of the research team, the RPAs can help you by facilitating communication with the study investigators and/or other members of the research team. The RPAs are also available for general inquiries about participation in research or to discuss questions/concerns about participation in research.

    You can leave a message for the Research Participant Advocates (RPAs) at any time by calling the 24-Hour Phone Number at (202) 681-2872 or by sending an email to wecare@ghuccts.org.

  • Tell Me More

    What We Do | The regulatory team are a resource for study coordinators and investigators and other key personnel on engagement, protection and consenting of study participants.  The Research participants specialists help investigators and study coordinators comply with the ethical guidelines and regulatory requirements related to the engagement and protection of study participants. Areas of assistance include: informed consent development; data and safety monitoring (DSMP); and informed consent process.

    REKS are active participants in planning, designing, and conducting training in ethical and regulatory issues related to the conduct of research. For instance, Research Participants specialists conduct face-to-face, a biannual GCP training offered to study coordinators and investigators. They also provide needed inputs in any other training on responsible conduct of research as it pertains to the engagement, protection, and safety of study participants.

    We provide assistance to:

    • Investigators/Researchers
    • Current Research Subjects/Participant
    • Potential Research Subjects/Participants
    • Research Administrators
    • Healthcare Consumer and Provider Members of the Community

    What type of assistance do we provide?

    • For investigators/researchers and research administrators
      • Assistance in designing clinical translational research
      • Assistance in preparing an application for IRB and other applicable regulatory review
      • Review data safety
      • Assistance in conducting clinical translational research in compliance with applicable regulations
      • Assistance in compliance with applicable reporting procedures while conducting clinical translational research
      • Assistance in ensuring that the clinical translational research promotes both the safety and welfare of research subjects and benefits the public health
      • Assist with ethical considerations for conducting clinical translational research
    • For current research subjects/participants
      • Provide access to general information about research and participation in research
      • Facilitate communication between subjects/participants and all members of the research team
      • Discuss questions or concerns with subjects/participants about participation in research/clinical trials
    • For potential research subjects/participants
      • Provide access to general information about research and participation in research
      • Discuss questions or concerns with subjects/participants about participation in research/clinical trials
    • For Healthcare Consumer and Provider Members of the Community
      • Provide access to information about ongoing research studies/clinical trials
      • Provide access to information on participating in research/clinical trials as a study site

     What are our goals?

    • To provide regulatory and ethics support for investigators
    • To promote an integrated program of regulatory support, ethics, and responsible conduct of research
    • To establish and promote continuing education programs
    • To promote ethics and responsible conduct of research training for investigators
    • To promote ethics research and scholarship
    • To implement a program of participant advocacy that focuses on protecting the health, welfare, and rights of research participants

    REKS Publications

    Forrest, L., C. Sedmak, S. Sikder, S. Grewal, S.M. Harman, M.R. Blackman, R. Muniyappa, Effects of Growth Hormone Administration on Hepatic Insulin Sensitivity and Glucose Effectiveness in Healthy Older Adults, Endocrine 2019 Jan 7. doi: 10.1007/s12020-018-01834-4.

    Workman, T.E., Y. Shao, J. Kupersmith, F. Sandbrink, J.L. Goulet, N.M. Shara, C. Spevak, C. Brandt, M.R. Blackman, Q. Zeng-Treitler, Explainable Deep Learning Applied to Understanding Opioid Use Disorder and Its Risk Factors, 6th International Workshop on Big Data Analytic Technology for Bioinformatics and Health Informatics @ 2019 IEEE International Conference on Big Data, Dec. 9-12, 2019 Los Angeles, CA.

    Huynh, L.M., M. Burns, D.D. Taub, M.R. Blackman, and J. Zhou, Chronic neurobehavioral impairments and decreased hippocampal expression of genes important for brain glucose utilization in a mouse model of mild TBI, Front Endocrinol (Lausanne), 2020 Sep 18; 11:556380.doi: 10.3389/fendo.2020.556380. eCollection 2020.

    Gollie, J.M., M.O. Harris-Love, S.S. Patel, N.M. Shara and M.R. Blackman, Relationship between Rate of Force Development, Maximal Force and Physical Function in Older Adults with and without Chronic Kidney Disease Predialysis, medRXiv.org; https://doi.org/10.1101/19013557, submitted for publication.

    "Ethical Implementation of Wearables in Pandemic Response: A Call for a Paradigm Shift," by Marielle S. Gross, Assya Pascalev and Robert C. Miller. Harvard University Rapid Response Impact Initiatives/COVID-19, May, 2020.

    Okun M, Giordano J. On target yet off-label: Regulatory policy issues in guidance and support of deep-brain stimulation for small-n disorders. JAMA-Neurology 117(12) (2020).

    Shook JR, Giordano J. Toward a new neuroethics in a multipolar and multicultural world. Global-E 13(56): (2020)
    DiEuliis D, Giordano J. COVID-19: Lessons to be learned for biosecurity and future operational environments. J Def Res Engineer 8(3): (2020)

    Hanekamp YN, Giordano J, Sharan G, Calabrese EJ. Low dose radiation therapy as a potential lifesaving treatment for COVID-19-induced acute respiratory distress syndrome (ARDS). Radiation Oncol, 16: 2-8 (2020).
    Calabrese EJ, Tsatsakis A, Agathokleous E, Giordano J, Calabrese V. Does green tea induce hormesis? J Dose Response, 1-13 (2020).

    Ramirez-Zamora A, Giordano J, Gunduz A, et al. Advances in neurophysiology, adaptive DBS, virtual reality, neuroethics, and technology. Front Hum Neurosci 4(54): 1-17 (2020).

    DeFranco JP, Rhemann M, Giordano J. The emerging neurobioeconomy: Implications for national security. Health Security 18(4): 66-80 (2020).

    Calabrese EJ, Calabrese V, Tsatsakis A, Giordano J. Hormesis and ginkgo biloba (GB): Numerous biological effects of GB are mediated via hormesis. Aging Res Rev 8(1): 4-16 (2020)

    De Franco JP, Giordano J. Mapping the past, present, and future of brain research to navigate the directions, dangers, and discourses of dual-use. EC Neurol 12(1): 1-6 (2020).

    DeFranco JP, DiEuliis D, Giordano J. Redefining neuroweapons: Emerging capabilities in neuroscience and neurotechnology. PRISM 8(3): 48-63 (2019).

    Agraharam R, Giordano J. On the value of p: Toward improving statistical and translational significance – and value – of studies and the applicability of neurotechnology for precision medicine. Ethics Biol Engineer Med 9(1): 17-20 (2019).

    Snow JJ, Giordano J. Aerosolized nanobots: Parsing fact from fiction for health security – a dialectical view. Health Security 17(1): 74-76 (2019).

    Calabrese EJ, Bhatia TN, Calabrese V, Dhawan G, Giordano J, Hanekamp YN, Kapoor R, Kozumbu WJ, Leak RK. Cytotoxicity models of Huntington’s disease and relevance of hormetic mechanisms: A critical assessment of experimental approaches and strategies. Pharmacol Res 150: 104371 (2019).

    DeFranco JP, DiEuliis D, Bremseth LR, Snow JJ. Giordano J. Emerging technologies for disruptive effects in non-kinetic engagements. HDIAC Currents 6(2): 49-54 (2019).

    Ramirez-Zamora A, Giordano J, Boyden ES, et al. Modulation of brain networks and application of advanced neuroimaging, neurophysiology, and optogenetics. Front Neurosci: Neural Technol. 35 (2019).

    DeFranco JP, Calabrese E, Giordano J. Restoring cerebral circulation and function postmortem: A multidimensional analysis. Brain Circ 5(2) 1-3 (2019).

    Shook JR, Giordano J. Consideration of context and meanings of neuro-cognitive enhancement: The importance of a principled, internationally capable neuroethics. AJOB-Neuroscience 10(1): 48-61 (2019)

    Sisbarro O, Giordano J. How stringent a P? Addressing p-values and the future conduct of translational research in neurology. EC Neurology 11(7): 2-6 (2019).

    Scott, D.M., Thomas, V.G., Otado, J. et al. (2019). Attitudes and experiences regarding genetic research among persons of African descentJ Community Genet

    Adler, P, Otado, JA, Kwagyan, J. (2020). Satisfaction and perceptions of research participants in clinical and translational studies: An urban multi-institution with CTSA

    Otado, JA, Kwagyan J, Edwards D, Ukaegbu A, Rockcliffe F, Osafo N . Culturally competent strategies for recruitment and retention of African American populations into clinical trials. | Download PDF

    Umar, Nisser, Muktar H.A, Otado, JA, Gillum, RF, Obisesan, T (2011). Ethnic-based differences in the association of self-perceived health status and doctor’s office utilization: longitudinal study on aging. Clinical Interventions in Aging, 2011:6 295-301.

    Giordano J, Shook JR. Neuroscience, neurotechnology, medicine and society: The need for an informed and integrative neuroethics. Eur Med J. 7(3) (2018).

    Zeldes N, Dilger H, FitzGerald KT, Kohls NB, Moore E, Nöfer E, Giordano J. Transnational patients: Practical and ethical implications for medical practices and health promotions policy. World Med Health Pol 10 (2) 2-12 (2018).

    Giordano J, Shook JR. Neuroethics: What it is, does – and should do. Health Care Ethics USA, 2: 1-5 (2018).

    DiEuliis D, Lutes CD, Giordano J. Biodata risks and synthetic biology: A critical juncture. J Bioterrorism Biodef 9(1): 2-14 (2018).



    REKS Presentations
     

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  • Our Resources

    2021 REKS Summer Series Recording: Pathway to Decentralized Clinical Trials

    The goal of this series is to discuss new developments in regulations affecting decentralized clinical trials. 

    • "Introduction to Decentralized Clinical Trials" featuring Nichelle Cobb (SMART IRB) - June 16th | Watch Recording
    • "Options for In-Home Clinical Trial Visits" featuring Petros Okubagzi (MedStar) - June 30th | Watch Recording
    • "E-Consent" featuring Mary Anne Hinkson (MedStar) - July 14th | Watch Recording
    • "Remote Informed Consent" featuring Stephen Hansen (FDA) - July 28th | Watch Recording
    • "Using Telehealth Technology for Virtual Clinical Trial Visits" featuring Heidi Maloni (VAMC) - August 11th | Watch Recording
    • "Remote Clinical Trial Monitoring" featuring Shaunagh Browning (ORQA) - August 25th | Watch Recording

    2021 Annual Spring Regulatory and Hot Topics in Clinical Research Conference

    The 2021 Virtual Conference was split into two days: "Moving Swiftly to Combat the COVID-19 Global Health Crisis" on April 23, 2021 and "Beyond COVID-19: Challenges & Lessons Learned during a Pandemic" on April 30, 2021. For more details, download the 2021 Meeting Agenda or stream the full conference archive here.


    2020 Annual Spring Regulatory and Hot Topics in Clinical Research

    The 2020 Web Conference focused on “COVID-19: the Virus, Preparedness in the time of Crisis, and Clinical Research". Below are recording archives of the sessions. For more information, view the 2020 Meeting Agenda.


    Good Clinical Practice (GCP)

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    Georgetown-MedStar New e-IRB System: Huron Click

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    Ethics, Regulations, and Study Implementation for Research involving Human Subjects: Advanced Course

    Building on the basic online course, advanced topics in these areas will be presented twice a year in a face-to-face format. 

    Contact Dr. Sarah Vittone for more information at sarah.vittone@georgetown.edu or sign up to be notified when the next training is scheduled

    2020 Agenda | Course Descriptions | Speaker Profiles | Download Presentations


    Regulations, Policies and Guidance

    Regulations, Policies and Guidance

    NIH Definition of a Clinical Trial:
    (This is significant in determining what needs to be registered on clinicaltrials.gov and when results are required to be reported)

    A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.   

    See FAQs and Case Studies on the NIH webpage to determine if your research is considered a clinical trial. 

    * This is relevant to funding opportunities, obligations of registration and results reporting via ClinicalTrials.gov, and to sIRB requirements.

    NIH - Research and Training Resources

    NIH Research Methods Resources

    The NIH is launching a series of initiatives in 2017–2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the entire clinical trial lifecycle, from concept to results reporting.

    The Research Methods Resources website provides investigators with important research methods resources to help them satisfy these new requirements. While the website currently only addresses methodological issues inherent in trials that randomize groups or deliver interventions to groups, new methods-related topics and resources will be added in the future. For a guided tour of this website, please refer to a recent Mind the Gap webinar, which presents additional information about its relevance to the new NIH requirements for clinical trials applications, a summary of the methodological issues inherent in nested study designs, and a demonstration of how to use the Group-Randomized Trials (GRT) Sample Size Calculator.

    Informed Consent Videos - Office for Human Research Protections


    Working with Special Populations

    Inclusion Across the Lifespan:

    The Inclusion Across the Lifespan Policy (NOT-OD-18-116) applies to all grant applications for human subject research submitted on or after January 25, 2019.

    The purpose of this policy is to ensure individuals are included in clinical research in a manner appropriate to the scientific question under study so that the knowledge gained from NIH-funded research is applicable to all those affected by the researched diseases/conditions. The policy expands the Inclusion of Children as Participants in Clinical Research Policy to include individuals of all ages. The policy also:

    • Clarifies potential justifications for age-based exclusion criteria
    • Requires participant age at enrollment to be provided in progress reports

    See the NIH Policy Information website for links to the policies and additional information.         

    Sex as a Biologic Variable:

    NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies. Strong justification from the scientific literature, preliminary data, or other relevant considerations must be provided for applications proposing to study only one sex. Investigators are strongly encouraged to discuss these issues with NIH program staff prior to submission of applications. Consideration of Sex as a Biological Variable in NIH-funded Research.

    Women's Health - VA Research - Veterans Affairs:

    New initiatives to accelerate women Veterans' healthcare research and its impacts include the VA Women's Health Research Network, the Women Veterans' Healthcare CREATE, and the EMPOWER Quality Enhancement Research Initiative (QUERI)


    Rigor and Reproducibility

    Enhancing Reproducibility through Rigor and Transparency  

    Rigor and Transparency FAQ

    Rigor and Reproducibility Training Resources

    HHS - Office of Research Integrity (ORI) and ORI General Resources


    Responsible Conduct of Research

    US Office of Research Integrity (ORI)






      oA research study in which one or more humabjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of th



    ose interventions on health-related biomedical or behavioral outcomes.   

    See FAQs and Case Studies on the NIH webpage to determine if your research is considered a clinical trial. 

    * This is relevant to funding opportunities, obligations of registration and results reporting via ClinicalTrials.gov, and to sIRB requirements.

    NIH - Research and Training Resources

    NIH Research Methods Resources

    The NIH is launching a series of initiatives in 2017–2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the entire clinical trial lifecycle, from concept to results reporting.

    The Research Methods Resources website provides investigators with important research methods resources to help them satisfy these new requirements. While the website currently only addresses methodological issues inherent in trials that randomize groups or deliver interventions to groups, new methods-related topics and resources will be added in the future. For a guided tour of this website, please refer to a recent Mind the Gap webinar, which presents additional information about its relevance to the new NIH requirements for clinical trials applications, a summary of the methodological issues inherent in nested study designs, and a demonstration of how to use the Group-Randomized Trials (GRT) Sample Size Calculator.


    Working with Special Populations

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    Rigor and Reproducibility

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    Responsible Conduct of Research

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    Additional Useful Information

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