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 descent. J 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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"Positive Experience of Informed Consent Understanding at a Metropolitan Multi-Institutions CTSA Hub". 29 July, 2020. Jane Anyasa Otado, Reyneir Magee, John Kwagyan, Sarah Vittone, Debra Ordor, Amy Loveland and MaryAnne Hinkson.
Assya Pascalev (Presenter), “Waiting Rooms, Chatrooms and the Disappearing Subject”, talk given at the 2019 EACME Conference of the European Centers for Medical Ethics, Oxford University, UK (Sept. 12-14, 2019) – in person
Assya Pascalev (Presenter), „The Ethical Challenges of Using of Social Media for Clinical Trail Recruitment”, 2019 Conference Bioethics in the Age of Science, Belgrade, Serbia, (Oct. 10-11, 2019) – in person
Assya Pascalev (Panelist), “Ethical Aspects in Digital Health and Care”, panel discussion at the 2019 International Conference on Personalized Coaching and ICT Environments for Wellbeing and Care, Odense University, Odense, Denmark (Nov. 19-21, 2019) – in person
Assya Pascalev (Invited Speaker), “The Ethics of Consent”, talk given to the Hellenic National Bioethics Commission, Greece (March 23, 2020) – via Zoom
Assya Pascalev (Presenter), "Prevention of Trafficking in Human Beings for Organ Removal", Expert Meeting on Combating Trafficking in Human Beings for the Removal of Organs, Organization for Security and Co-operation in Europe - OCCE, Vienna, Austria (July 6-7, 2020) – via Zoom
Assya Pascalev (Presenter), "The Principle of Justice and the Bulgarian Vaccine Prioritization Plan", Expert Forum on Vaccine Ethics organized by the Bulgarian Helsinki Committee and Bulgarian Center for Bioethics, Sofia, Bulgaria (30 March 2021) - via Zoom
Otado, JA, Thomas VG, Callier S, Rockcliffe F, Johnson D, Scott, DM. Knowledge, Attitudes, and Experiences Towards Genetic Research Among Persons of African Descent | Download PDF
Otado, JA, Kwagyan, J., Odor, D., Adler, P., Vittone, S. Satisfaction & Perceptions of Research Participants in Clinical and Translational Studies. | Download PDF
Adler, Priscilla, JA Otado, Sarah Vittone, Judith Baigis; Educational Program on Ethics, Regulations and Study Implementation for Clinical Trials, presented at the CTSA, the Sixth Annual Clinical Research Management Workshop, June 2-4, 2013, Washington, DC
Otado, JA, Kwagyan J, Edwards D, Ukaegbu A, Rockcliffe F, Osafo N. Successful Strategies for Recruitment of African Americans into Clinical and Translational Studies, Translational Science, April 2014, Washington, DC
Otado, JA, Kwagyan, J, Thomas, Y. Informed Consent Understanding Among a High-Risk Minority Population, PRIM&R 2011: Advancing Ethical Research Conference, National Harbor, MD
GHUCCTS Training/Courses:
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GHUCCTS Training (Study Coordinators) - Ethics, Regulatory & Study Implementation for Research Involving Human Subjects, March 2018 | Download PDF
Zimmet Sheila. Certified Research Administrator Study Session. July 20, 2017 | Download PDF
Zimmet Sheila. Research Regulatory Issues. October 10, 2014 | Download PDF
Giordano J. Updates on neuroethical, legal and social issues in this year of DBS research and clinical therapeutics. Plenary: Sixth Annual Deep Brain Stimulation Think Tank, Atlanta, GA. 17 May 2018.
Giordano J. Neuroscience and technology and the need for neuroethics. Plenary: Brain Health and Performance Summit, Ohio State University, OH. 6 April 2018.
Giordano J. Neuroplasticity, performance optimization and neuroethico-legal considerations. Invited lecture: Arizona State University DC Campus Center Workshop on Neuroplasticity and Performance, Washington, DC. 30 March 2018.
Giordano J. Building better brains: Neurotechnology and the need for informed neuroethics. Invited Annual O’Malley Lecture, Loyola Marymount University, CA. 20 March 2018.
Giordano J. Non-invasive brain stimulation to optimize cognitive and motor performance: Neuroethical issues and address. Invited plenary: US Air Force Office of Scientific Research Conference on Non-Invasive Neuromodulation and Performance Enhancement; Arlington, VA. 13 March, 2018.
Giordano J. PANS and PANDAS as neuro-inflammatory spectrum disorders: Implications for ethical assessment and care. Invited plenary and session chair: Common Threads Conference 2018; Columbia University, NY. 10. March, 2018.
Giordano J. Predictive and prescriptive neurology: Emerging neurotechnology and the need for neuroethics. Invited grand rounds: Medical College of Wisconsin; Milwaukee, WI, 9 March 2018.