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		Search Text: Home/About the NHLBI/< Back ToAdvisory and Peer Review Committees and Review Boards/Clinical Data Science Institutional Review Board (CDS-IRB)

Clinical Data Science Institutional Review Board (CDS-IRB)
    
        DescriptionThe NHLBI established the Clinical Data Science IRB (CDS-IRB) to provide a useful resource for the research community by offering—at no cost—central review of secondary research proposals utilizing NHLBI datasets for which IRB approval is required.As a central IRB for research protocols that propose secondary analyses of existing clinical data, the CDS-IRB will address the growing complexity of research and non-traditional uses of biomedical data. Broad utilization of the CDS-IRB will also provide an opportunity for the NHLBI to systematically understand the evolution and range of requests to conduct secondary analyses, recognize emerging trends, and explore ways to enhance data stewardship with the research community.BackgroundThe NHLBI endorses and promotes the broad and responsible sharing of clinical research data from NHLBI-supported clinical studies as well as the use of these data for subsequent research (i.e., secondary analyses). The NHLBI makes available to the research community hundreds of de-identified datasets from clinical trials and observational studies as well as from the Trans-Omics for Precision Medicine (TOPMed) program, which is providing deep whole-genome sequencing and other omics data to pre-existing clinical studies. A significant number of the NHLBI datasets, including nearly half of the TOPMed datasets, have an associated data use limitation of “IRB Approval Required” before they can be used for secondary research purposes.ImpetusThere is little extant guidance for IRB review of secondary analysis research of existing de-identified human datasets. The potential risks associated with secondary analyses are not necessarily the same as the risks associated with research that involves people (for example, direct physical harm to subjects). Ethical review of secondary analyses needs to consider possible risks such as re-identification, breach of privacy, and non-physical harm to the research participants and their families/descendants and communities. This includes the potential for stigmatization or discriminatory impact. In addition, the rapid pace of scientific and technological advances is making possible new research applications that could not have been anticipated even a few years ago and thus were not included in the original informed consent. In recognition of these challenges, NHLBI established the CDS-IRB to address ethical issues that may arise during secondary analyses.CDS-IRB ExpertiseThe CDS-IRB members are diverse by profession, expertise, ethnicity, gender, and geography. Collectively, CDS-IRB members are well versed in the federal regulations governing protection of research participants; biomedical and behavioral research; research ethics; institutional policies and practices; and issues that may be of concern to participants of cohort studies, including, for example, re-identification, third-party harms, data misuse, privacy, and stigmatization. This ensures that the CDS-IRB is well-poised to review proposals for secondary research. If necessary, however, the CDS-IRB members will consult with outside subject matter experts on an ad hoc basis. The CDS-IRB has also developed an ethics framework and principles to ensure consistent, comprehensive reviews of proposals for secondary analyses.Contact Information**Point of contact:** Julie Mikulla **Office Email:** cds-irb_helpdesk@emmes.com **Office Number:** (844) 200 - 8952How can I request CDS-IRB review of secondary research proposals?To request CDS-IRB review, your home institution must have a reliance agreement in place with the CDS-IRB. There are two ways in which this can be accomplished:By using the SMART IRB (the Streamlined, Multisite, Accelerated Resources for Trials IRB) Reliance platform (with more than 800 participating institutions), orBy signing the CDS-IRB’s Reliance AgreementOnce the Reliance Agreement is in place, you can apply for review by establishing an IRBManager account.There is no cost for using CDS-IRB services.If you have any questions about how to request CDS-IRB review, please email CDS-IRB_Helpdesk@emmes.com. For more information about establishing a reliance agreement and other general information pertinent to requesting CDS-IRB review, see the FAQ section below.Current CDS-IRB MembersBarbara E. Bierer, M.D. (IRB Chair)Barbara E. Bierer, MDProfessor of MedicineHarvard Medical SchoolBrigham and Women’s Hospital75 Francis StBoston, MA 02115Cell: (617) 827-7413bbierer@bwh.harvard.eduRead biosketchBarbara E. Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center,www.mrctcenter.org), a collaborative effort to improve standards for the planning and conduct of international clinical trials to harmonize policies for and approaches to clinical trial regulation. Dr. Bierer leads an effort to address the long-standing underrepresentation of diverse populations inresearch. In 2017, the MRCT Center launched the non-profit organization, Vivli (www.vivli.org), a global clinical research data sharing platform. In addition, she is the Director of the Regulatory Foundations, Ethics, and the Law program at the Harvard Catalyst, the Harvard Clinical and Translational Science Award, working across the academic spectrum to enable the clinical trial enterprise from study planning through recruitment to data acquisition and dissemination. She is the Director of Regulatory Policy for SMART IRB (www.SMARTIRB.org), a national effort to align single site IRB review of multi-site trials. She serves as Faculty in the Center for Bioethics, Harvard Medical School, and as Affiliate Faculty in the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. From 2003 – 2014, Dr. Bierer served as Senior Vice-President, Research at the Brigham and Women’s Hospital (BWH). During her tenure, Dr. Bierer founded and served as Executive Sponsor of the Brigham Research Institute and the Brigham Innovation Hub (iHub), a focus for entrepreneurship and innovation in healthcare. She has authored over 280 publications.In addition to her academic responsibilities, Dr. Bierer served or serves as Chair of the Secretary’s Advisory Committee for Human Research Protections, Department of Health and Human Services (2008-2012); as a member of the National Academies of Sciences Committee on Science, Technology and the Law (2007-2016); on the Board of Directors of Public Responsibility in Medicine and Research (PRIM&R) (2011-2020), Management Sciences for Health (MSH) (2013-2022), Vivli (2017-), North Star Review Board (2020-), and Generation Patient (2023-). She chairs the Board of Trustees of the Edward P. Evans Foundation, a foundation supporting biomedical research, and is on the board of directors of Clinithink, a company that transforms unstructured clinical text into computable data for clinical trials and population health management.Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School.Read lessMark Barnes, J.D., L.L.M.**mark barnes**Partner, Ropes & Gray LLP Co-chair, Subcommittee on Harmonization of Research Regulations, Secretary's Advisory Committee on Human Research Protections (SACHRP), US Department of Health and Human Services (HHS) Faculty Co-director and Executive Committee Co-chair, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) Faculty, Yale UniversityRead biosketchMr. Mark Barnes is a partner atRopes & Gray LLP, specializing in human and animal research, digital health, data privacy, stem cell and genetic research, research grants and contracts, research misconduct, and international research. He currently serves as co-chair of the Subcommittee on Harmonization of Research Regulations under the Secretary's Advisory Committee on Human Research Protections (SACHRP) for the US Department of Health and Human Services (HHS), faculty co-director of theMRCT Centerand serves as co-chair on their Executive Committee, and holds faculty positions at Yale University where he lectures at the Law School and School of Medicine. Additionally, he serves on theNIH HIV Prevention Trials Network (HPTN)Ethics Working Group, serves as the Ethics Advisor for the HPTN Trial 071 in South Africa and Zambia, and is on the Board of Directors forVivli, a non-profit organization founded by the MRCT Center dedicated to global clinical trial data sharing.Previously, he served as Executive Vice President and Chief Administrative Officer atSt. Jude Children's Research Hospitaland helped establish a vaccine study center in Zimbabwe in collaboration with Africa University. At Harvard University, he served as Senior Associate Provost for Research, Senior Research Officer, as well as the managing director of Harvard's Primate Research Center. During his tenure at Harvard, he started and directed the university’s PEPFAR-funded HIV/AIDS treatment programs in Nigeria, Tanzania and Botswana. Early in his career and as an associate professor at Columbia Law School, Mr. Barnes co- founded the AIDS Law Clinic, the first legal clinic that allowed law students to represent persons living with AIDS in anti-discrimination cases. The program was funded in part by the US Department of Education and received referrals from the New York City Commission on Human Rights and the State Division of Human Rights.Mr. Barnes has held senior appointed positions in the New York City and State departments of health, worked on the National Health Care Reform Task Force, and has authored or co-authored over 50 publications. He received his BA from Bennington College, his JD from Yale Law School, and his Master of Laws (LLM) degree from Columbia University School of Law.Read lessR. Graham Barr, M.D., Dr.P.Hgraham barrHamilton Southworth Professor of Medicine Professor of Epidemiology  Chief, Division of General Medicine Columbia University Medical Center Attending Physician, New York Presbyterian HospitalRead biosketchDr. Barr is the Hamilton Southworth Professor of Medicine, Professor of Epidemiology, and Chief of the Division of General Medicine at Columbia University Medical Center. He is a general internist and respiratory epidemiologist whose research focuses on chronic lung disease, pulmonary vasculature, and cardiopulmonary interactions using advanced imaging and molecular approaches on a population level.  He is PI of the Multi-Ethnic Study of Atherosclerosis (MESA) Lung Study, a 16-year investigation of emphysema on CT in the general population, and the SPIROMICS Heart Failure Study, a 12-year investigation of heart-lung interactions.Dr. Barr has authored over 375 peer-reviewed papers and has received numerous awards for his research.  He received his BA from Duke University, his MD from McGill University, and his Doctorate in Public Health at the Harvard School of Public Health.  He completed his residency at Columbia-Presbyterian Medical Center and a fellowship at Massachusetts General Hospital.Read lessMarcela Nava, Ph.D., M.S.S.W., M.P.P.marcela navaAssistant Professor, School of Social Work, The University of Texas at ArlingtonHealth Policy Research Scholar, Robert Wood Johnson FoundationRead biosketchDr. Nava is a health equity researcher who studies the political economy of health and public policy to look for “what works” in reducing health inequities and protecting community health. She is a Robert Wood Johnson Foundation Health Policy Research Scholar and Assistant Professor in the School of Social Work at The University of Texas at Arlington. She has a PhD in Public Policy and Political Economy and a Master of Public Policy from The University of Texas at Dallas, Master of Science in Social Work from The University of Texas at Arlington, and a Bachelor of Science in Social Work from Texas Christian University.Her current research focuses on the intersection of political, economic, and social contexts of immigrants and other marginalized groups in the U.S. She studies the ways that institutions influence health to develop multi-level, innovative, and common sense approaches for community health improvement. In the past, she practiced social work with homeless and runaway youth, families at risk of child abuse, and immigrant and refugee communities and oversaw various federally-funded community-based participatory research (CBPR) projects focused on women’s health. As an educator, she teaches graduate and undergraduate courses in social research methods, immigration and health policy, and community-based practice.Read lessEfthimios Parasidis, J.D., M.BE.Efthimios Parasidis Professor of Law, Moritz College of Law Professor of Public Health, College of Public Health Faculty Affiliate, College of Medicine, Center for Bioethics The Ohio State UniversityRead biosketchMr. Efthimios Parasidis holds a joint academic appointment with The Ohio State University at the Moritz College of Law and the College of Public Health and is a faculty affiliate with theCollege of Medicine’s Center for Bioethics. Additionally, he serves as Faculty Advisor for several boards and committees at Ohio State and as a consultant on law and bioethics for the US Air Force. His areas of expertise include health law, public health law and policy, bioethics, human subjects research, regulation of medical products, intellectual property, biotechnology law, military research ethics, and informed consent. In addition to teaching, he also counsels start-up companies on corporate and intellectual property matters and is a co-inventor on a patent application related to health information technology.Early in his career, Mr. Parasidis was selected as a Fulbright Scholar where he researched legal and ethical issues related to medical informed consent policies and practices in Greece. More recently, he was awarded a Faculty Scholar in Bioethics fellowship from theGreenwall Foundationwhere he examined the law and ethics of military research involving service members and biomedical enhancements. This work led to a book project with Oxford University Press (currently under contract). Prior to joining the Ohio State faculty, he was a professor at the Center for Health Law Studies at Saint Louis University and was an appointed member of the Law & Policy Workgroup of Missouri Health Connection, the entity responsible for creating Missouri’s health information exchange. Mr. Parasidis served as Assistant Attorney General for the State of New York, under Eliot Spitzer and Andrew Cuomo, as an associate with the Litigation group of Jones Day, and as a senior associate in the Intellectual Property group of Dickstein Shapiro. He also co-founded a health informatics start-up company.Mr. Parasidis has authored over 30 publications, several book chapters, and three books that include a casebook on the ethics and regulation of research with human subjects that he co-authored; he has given over 75 professional presentations to scientific and academic communities. He received his BA in philosophy from The College of New Jersey, and his master’s in bioethics (MBE) and JD from the University of Pennsylvania.Read lessPeipei Ping, FAHA, FISHR, Ph.D.Peipei PingProfessor, Physiology, Medicine/Cardiology, and BioinformaticsProfessor, Physiology, Medicine/Cardiology, and Bioinformatics Director, Data Science in Cardiovascular Medicine Director, NIH BD2K CoE and Coordination Center Associate Director of Scalable Analytics Institute Principal Investigator, Center for Excellence (CoE) for Big Data Computing Faculty, Cardiovascular Research Laboratory, University of California, Los Angeles (UCLA), David Geffen School of Medicine and School of Engineering President, North American Section , International Society of Heart Research Founder and Executive Operation Officer, International Forum of ProteomicsRead biosketchDr. Peipei Ping is a Professor of Physiology, Medicine/Cardiology, and Bioinformatics at the David Geffen School of Medicine, UCLA where she directs theData Science in Cardiovascular Medicineresearch program, and theNIH BD2K Center of Excellencein Biomedical Computing program. She also serves as associate director of theScalable Analytics Institute(ScAi) in the School of Engineering. Her research programs focus on cardiovascular proteomics and metabolomics, bioinformatics and data science, cardiac mitochondrial biology, and proteasome biology. Dr. Ping has made significant contributions to cardiovascular research, proteomics phenotyping, and Big Data science. She has led her investigative teams in characterizing the cardioprotective role of PKCε as well as other underlying mechanisms in cardiac injury and protection; pioneered the conceptualization and development of functional proteomics approaches to characterize signaling pathways in the heart; advanced proteomics/metabolomics technologies, including model systems, quantitative analyses, post-translational modification (PTM) studies, protein spatial/temporal dynamics, and omics data-driven biomarker discovery. Her programs have developed data science technologies including software tools and computational platforms that aim to integrate multi-omics data, text-mine electronic health records, promote data annotations, and thereby translate data to knowledge. In addition to her research, Dr. Ping is strongly committed to supporting and mentoring her students and has developed several cross-disciplinary educational programs that integrate computational biology, bioinformatics, computer science, statistics, and medical informatics in order to equip future investigators with skills required for the digital era of biomedicine.Dr. Ping sits on numerous advisory boards, editorial boards, and committees at both the national and international level, including President of theNorth American Section(NAS) of theInternational Society for Heart Research(ISHR). She is a Fellow of theAmerican Heart Association, theAmerican Physiological Society, and ISHR. She has authored over 200 peer reviewed papers and original articles and has received numerous awards for her scientific and medical contributions. She received her BS in biomedical engineering from Zhejiang University and her PhD from the University of Arizona in cardiovascular physiology. She completed postgraduate training in vascular biology, molecular cardiology and translational research.Read lessMario Sims, Ph.D., M.S., FAHAmario simsProfessor, Department of Medicine Chief Science Officer, Jackson Heart Study (JHS) Associate Director, Research Training, JHS Field Center Graduate Faculty, School of Graduate Studies in the Health Sciences Co-Investigator, JHS, Coordinating and Field Centers University of Mississippi Medical Center Graduate Learning Community Advisor, JHS Graduate Training and Education Center (GTEC) Jackson State UniversityRead biosketchDr. Mario Sims is a Full Professor of Social Medicine, Population and Public Health in the School of Medicine at University of California at Riverside. He is the Co-Director of the U54 NIH/NIMHD Health Disparities Research Center in the School of Medicine at the University of California at Riverside. He was recently a Professor of Medicine in the Department of Medicine at the University of Mississippi Medical Center and Chief Science Officer of the NIH/NHLBI-funded Jackson Heart Study (JHS). He was also Interim Director and Principal Investigator (PI) of the JHS and is a Social Epidemiologist with a background in Medical Sociology and Demography.His current research focuses on understanding the social and psychosocial determinants of cardiovascular disease (CVD) disparities, with a specific interest in examining the extent to which racism, stress, residential segregation, and psychosocial factors (e.g., resilience) influence CVD disparities. He has been the PI of NIH funding related to the social determinants of health and resilience and CVD among African American adults. Dr. Sims has published over 230 papers in scientific peer-reviewed journals and has given over 230 professional presentations at scientific conferences, symposia, and grand rounds.Dr. Sims He is the immediate Past Chair of the Social Determinants Committee of the American Heart Association’s Council on Epidemiology and Prevention and Council on Quality of Care and Outcomes Research. He is a member of the NIH National Advisory Council on Minority Health and Health Disparities (NACMHD). He is also a member of the NIH Clinical Data Science Institutional Review Board, and a member of the Observational Study Monitoring Board for the Nation Institutes of Heart Lung and Blood (NHLBI) American Lung Association Lung Health Cohort Study (Lung Health). He was recently elected a member of the National Academy of Medicine (NAM).Read lessMore Information

    
                General Questions
      
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		Clinical Data Science Institutional Review Board (CDS-IRB)
    **What is the Clinical Data Science Institutional Review Board (CDS-IRB) and why was it established?**The NHLBI established the CDS-IRB as a useful resource for the research community to address the ethical issues that may arise during secondary analyses of existing de-identified human genomic datasets. For proposals that utilize NHLBI datasets for which IRB approval is required, the CDS-IRB considers the potential risks associated with this type of research, such as re-identification of the original research participants, risks to family members, data misuse, breaches of confidentiality, harms to communities or groups, or the stigmatization of a population. The services of the CDS-IRB are offered free of charge. The charter of the CDS-IRB is located here.**My local IRB categorizes secondary analysis of de-identified data as "Not Human Subjects Research." Why do I need IRB review if the data is de-identified?**The NIH categorizes human genomic data as either unrestricted access (i.e., publicly available) or controlled access.1,2 The informed consent under which the data were collected is the basis for determining this level of access. When the dataset is submitted to an NIH data repository the submitting institution stipulates how the data may be used, one of which may require IRB approval.**Do I have to use the CDS-IRB or can my local IRB review my research protocol?**Utilization of the CDS-IRB is not required and review by your local IRB is acceptable for access.3 The NHLBI CDS-IRB has been provided as a free service for researchers who wish to utilize NHLBI datasets that require IRB review.**What are the requirements for institutions and investigators who want to utilize the CDS-IRB?**Institutions are required to have:A current Federalwide Assurance (FWA) issued by the Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP). Get detailed information on the FWA and the process of filing for an FWA. One of the requirements of filing for an FWA is to identify an IRB of Record. If you do not have an IRB to list on the FWA, contact the CDS-IRB Office for guidance.A reliance agreement in place, either directly between the institution and NHLBI, *or* through the SMART IRB process; *and*An institutional NIH eRA Commons account. Learn more about eRA Commons and how to obtain an account.Investigators must have:Human subjects protection training in accordance to their local institutional policies;A current curriculum vitae;Meeting the minimum qualifications of the NIH Data Access Committee located *here**; and*An investigator NIH eRA Commons account. Learn more about eRA Commons and how to obtain an account.


          
    Reliance Agreement Questions
      
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		Clinical Data Science Institutional Review Board (CDS-IRB)
    **What is a reliance agreement, why do I need one, and who needs to sign it?**A reliance agreement (also called an IRB Authorization Agreement) is a document that permits one or more institutions to rely on another IRB. Institutional officials or signatories of the involved institutions must sign the reliance agreement.*Only* researchers and institutions who want to cede IRB review to the CDS-IRB will need to enter into a reliance agreement. Those using their local IRB would not need to obtain a reliance agreement.**How does my institution enter into a reliance agreement to utilize the CDS-IRB?**There are two options for entering into a reliance agreement for ceding review to the CDS-IRB. The first option is through the signing of the NHLBI Reliance Agreement document which can be found on this website and the second option is through the SMART IRB platform where the NHLBI is a participating institution.For relying through the NHLBI Reliance Agreement, relevant institutional officials must review and sign the document and then submit the signed copy to the CDS-IRB Office at CDS-IRB_Helpdesk@emmes.com. CDS-IRB Office personnel will route the signed agreement to the NHLBI institutional official for review and final signature thus completing the reliance process.For relying through the SMART IRB, your institution must be a participating institution of the SMART IRB platform. Participating institutions are required by SMART IRB to designate a Point of Contact (POC) responsible to facilitate the SMART IRB reliance process. You can either talk to your institutional official from your local IRB office or check *here* to see if your institution participates with the SMART IRB Agreement. Here is an overview of the steps involved in relying on CDS-IRB through the SMART IRB system. For the specific steps involved and information required in initiating a request through the SMART IRB Online Reliance System, review the following SMART IRB checklist: https://smartirb.org/assets/files/Reliance-Checklist.pdf. A sample SMART IRB Reliance Request Form can be accessed at https://smartirb.org/assets/files/SampleRelianceRequestForm.pdf**My institution participates in the SMART IRB system. In that system, reliance on another IRB is generally on a case-by-case basis. But for review of secondary research involving NHLBI datasets, the reliance would need to be for a category of research, not case-by-case. Is this possible through the SMART IRB system?**Yes. Instead of using the SMART IRB Online Reliance System, the NHLBI CDS-IRB has developed a Letter of Acknowledgement (LoA) that can be signed by your local IRB, thereby establishing an "umbrella" arrangement. The LoA describes the type of research permitted under this arrangement and maintains adherence to the SMART IRB Master Common Reciprocal IRB Authorization Agreement. Once the LoA is signed, an investigator can bypass the step of obtaining local IRB permission and submit the agreed-upon research projects directly to the CDS-IRB. Contact your institution's SMART IRB Point of Contact (POC) to facilitate this process. The LoA for the CDS-IRB can be found on this website.**Who do I contact for questions or assistance on obtaining a reliance agreement or with the documentation process?**Contact the **CDS-IRB Office** by phone (844) 200-8952 or email: CDS-IRB_Helpdesk@emmes.com. Investigators should also contact their local IRB and/or their institutional SMART IRB POC who will work with the CDS-IRB Office to help facilitate the reliance agreement process.


          
    Application Submission Questions
      
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		Clinical Data Science Institutional Review Board (CDS-IRB)
    **Are there any criteria or requirements that need to be met before submitting an application for CDS-IRB review?**Yes.Criteria for CDS-IRB review:The proposed secondary research involves the use of NHLBI datasets that require IRB approval.Requirements for CDS-IRB review:Lead PI meets the minimum qualifications as set by the NIH Data Access Committee. Those qualifications can be found here;PI holds an NIH eRA Commons account. For more information about eRA Commons and how to obtain an account, visit the following website: https://public.era.nih.gov/commons.A reliance agreement is in place through either the NHLBI Reliance Agreement or the SMART IRB process;Institution's Federalwide Assurance (FWA) number. For more detailed information on the FWA and the process of filing for an FWA visit the following website: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/index.html.PI must obtain an IRBManager username and password through the CDS-IRB Office to submit through the application electronic process.**How should I prepare for submitting my application for review to the CDS-IRB?**The following steps and recommendations will assist with a more efficient submission process.Review the institutional and PI requirements described in the General Questions section above.Review the PI Responsibilities to the CDS-IRB.Compose a detailed Project Research Plan that includes, at a minimum, the sections laid out in the NHLBI CDS-IRB Research Project Plan Template.**What is the process for submitting a secondary research project to the CDS-IRB for review?**Review the Application Sample Form for the information that will be requested.Click on the IRBManager3link on this website and register for a username and password.Login to IRBManager and click on Start xForm on the upper left side of the page.Fill out the application questions.Submit the application. If the submitter is not the PI, an email will be sent to the PI with a link to provide an electronic signature within the application. The application will not be received by the CDS-IRB office until the PI signature has been completed and submitted.**Where can I ask for help if I can't upload documents into the CDS-IRB Application Website?**Contact the CDS-IRB Office by phone (844) 200-8952 or email: CDS-IRB_Helpdesk@emmes.com.


          
    Review Process Questions
      
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		Clinical Data Science Institutional Review Board (CDS-IRB)
    **What happens after I submit my application for the CDS-IRB review?**After the electronic signature has been provided by the PI and the Submit button has been clicked in IRBManagerTM two emails are generated:An acknowledgement email is sent to the submitter and PI, andAn alert email to the CDS-IRB Office that a submission has come in.The CDS-IRB Office conducts a preliminary administrative review to assess if all the required information has been provided and obtain any needed clarifications. Once the CDS-IRB Office has all the necessary information in hand you will receive an *update email* indicating the project has been forwarded for IRB review.The project is assigned to designated board members for the ethical review of the project.*If needed*, CDS-IRB Office personnel will contact you with board member requests for more information, clarifications, and/or additional documentation.The assigned board members present the project at an IRB meeting where a determination is made.You will be sent an email indicating the CDS-IRB determination.An overview of the CDS-IRB review process is located *here*.**How often does the CDS-IRB meet to review protocols?**Currently, the NHLBI CDS-IRB is meets on an ad hoc basis within a month of the completed initial application.**Who do I contact if I have questions about the review process?**Contact the **CDS-IRB Office** by phone (844) 200-8952 or email: CDS-IRB_Helpdesk@emmes.com.


          
    Documents
      
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		Clinical Data Science Institutional Review Board (CDS-IRB)
    CDS-IRB 2023/2024 Member RosterCDS-IRB CharterReview Process OverviewInvestigator Responsibilities to the CDS-IRBWorkflow for Reliance on CDS-IRB for Review of Secondary Research Proposals


          
    Forms
      
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		Clinical Data Science Institutional Review Board (CDS-IRB)
    Reliance Agreement:NHLBI CDS-IRB Reliance AgreementNHLBI CDS-IRB Letter of Acknowledgement (LOA)Submission FormsSample CDS-IRB Application Form


          
    References
      
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		Clinical Data Science Institutional Review Board (CDS-IRB)
    1. Refer to the NIH Genomic Data Sharing Policy for more information.2. Refer to the Points to Consider for Institutions and IRBs in Submission and Secondary Use of Human Genomic Data under the NIH GDS Policy for information on the process of categorizing data for public or controlled access.3. Review any requirements for data use for a specific dataset as noted in the Data Use Certificate, such as whether IRB review is required.4. IRBManagerTM is the electronic system for IRB application submission and management of IRB-related records used by the CDS-IRB. Back To Top Link
  

        

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